That's only if you include all infections within the two week window between shots. If you look at the tail end (ie, after the shot has time to be effective) it seems more like 90.
The issue with this is that it's the SECOND shot that gives you your long term immunity. If you only get one shot your immunity is allegedly going to wane somewhat quickly.
That is typically how the second shot works. We don't actually know.
It is possible the second shot isn't needed at all. It is possible that the first shot works for 45 days and then stops working completely. Experts doubt both of these extremes, but cannot actually say they are false because they don't know.
Yes they have data for results of 1 shot of 2 shot vaccines.
Moderna has 80% in single shot I believe but it degrades over time so there is a second shot.
The 66% that does not degrade and can be kept in room temperature is not bad at all. Most vaccines are not 90%. Most flu vaccine don't cover all different types but they still protect people as they get some sort of immunity to major types A,B etc.
Worth pointing out that two of the viruses[0][1] responsible for the Common Cold share the same exact Family (in fact, the exact Genus[2]) as SARS-CoV-2 [3].
This isn't to say that the progression is certainly in this direction (better evidence of that dates back to 2009 [4]), but hey, there's hope that that's the direction.
This isn't like antibiotics. The 66% is how many people are provided some level of immunity, just reducing the infectible population; it doesn't directly cause issues for the virus the way an antibiotic interferes with the functioning of a bacterium. It might culture a strain that's better at infecting folks for whom the vaccine doesn't prove effective, if there's a common factor there and the virus can use it.
It is not yet known if any of the vaccines completely prevent infection; there are concerns the vaccinated might still be able to be asymptomatic carriers.
Yeah I guess I was asking if having only partial-immunity effectively acts as a filter or creates pressure so that rarer mutated strains make it through and are given a pathway to infection/reproduction.
From your response: "It might culture a strain that's better at infecting folks for whom the vaccine doesn't prove effective, if there's a common factor there and the virus can use it." it sounds like the answer is yes.
It might make it through, but in that case it would be better adapted for those the vaccine didn't work on; this could actually make it less infectious for those the vaccine would work on, so it's questionable whether it would be any better or worse overall.
Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all without FDA then people would realize how bloated our government really is.
We saw this with Boeing - as the private company realised that the regulatory body wasn't going to hold it accountable, the private company started trading off profit versus safety with the result being lower short term costs and more dangerous planes.
Doesn't need to be every time, it "just" needs to meet or beat the current FDA record. The FDA has approved treatments in the past that turned out to be harmful for substantial numbers of people. If the industry could reliably replicate the FDA's present track record (which is, overall, very good) then the FDA could be shown to be unnecessary.
However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.
I think this is a bit of a disingenuous approach. There's a slippery slope here.
Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless."
If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs.
Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.
The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously enforce the use of statistical proof that interventions work through bodies like the FDA.
Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor.
The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence.
Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance.
As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this?
All of these drugs were approved by the FDA's "process".
Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.
I'm sufficiently versed on the days of snake oil. I'm also familiar with the modern follies of the FDA, including artificial spinal disk treatments, "standard of care" balks, etc.
Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that the FDA found to actually contain drugs, or drugs that failed QC while on the market, not the pristine batches and data that would have gotten the drug approved in the first place.
To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded.
You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.
The irony is specifically why I posted it. FDA approval is treated as a "gold standard" yet we have lots of evidence that it isn't. Companies lie, make non-intentional mistakes not caught by the FDA, there's all sorts of issues with it. The FDA review process is more like an editor checking spelling than actual rigorous analysis.
I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy.
I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example:
Gold is independent labs find similar results to internal labs (verified)
Silver is only internal labs produced results, not reproduced elsewhere
etc.
> I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous.
Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.
Its been 10 years since that employment so I don't recall the details. We would get annual "FDA training" on how to report, document, etc. my particular employer always stressed on being accurate and doing what was right for the patient. But "over-reporting" was discouraged... I always related it to a police investigation. Don't give them any more information than asked, you never know what rabbit hole they will go down, risking rejection.
We could also have achieved nothing at all for our money, or have given thousands of healthy people permanent autoimmune conditions or killed them through adverse reactions and after all that we still wouldn't have known if what we were doing actually did anything to slow the pandemic. People on hacker news should know just how hard it is to really know something, the human immune system is far more complex than any code base, the only way to know if something works is to test it, and test it thoroughly, which is exactly what the "burdensome" regulation requires.
This 'don't test it, just do it' idea really shows how paniced and irrational people are. The reasons to not rush out a population wide vax campaign are significant.
For example: the otherwise promising and effective candidate from QUT accidentally causes you to test positive for HIV on the common/cheap/simple assays, which would make effective HIV testing vastly more expensive in the population and cause a huge anti-vax movement. I think we are happy that this side effect is constrained the the small trials group.
Maybe this needs to be explained in computer terms: would you be upset if Apple rushed out a security patch and that caused every iphone to reboot randomly during odd numbered months, and was unpatchable?
There's always going to be work for the FDA, there's an unending stream of new diseases/conditions and cures. I very much doubt they are worried about running out of work
During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.
Personally, I’d rather take the J&J which uses old, proven tech. In 5 years we will know a lot more about nRNA vaccine long-term safety, and I’ll be much more comfortable taking an nRNA vaccine at that point.
When I’m eligible, I still may take the nRNA, but my preference is on older tech at this point.
I fully acknowledge that the nRNA is extremely likely to be safe, but it’s just my preference
Adenovirus vaccines are also a newish tech (not that anything wrong with that, that's why we have safety testing). Its not as bleeding edge as mRNA but its definitely not a traditional vaccine
Don't tell him that. He's willing to get any vaccine at all and the world desperately needs to be vaxxed. If people want to take adenovirus vaxs because they feel its safer I say just let them.
I think what continues to surprise me (after talking about these for months now) is his underlying assumption that the third choice is a likely option. While the continued rate of spread seems to suggest to me that really we have a near binary option:
1. get injected with some vaccine soon, expose your body to a controlled amount of slightly noxious chemicals and hope your body learns how to eliminate them before they degrade on their own
2. contract COVID-19 soon, expose your body to those same noxious chemicals, plus a bunch of others that help it spread throughout your body and cause damage and linger, possibly for weeks or sometimes until you die
(excluding extreme options, like living alone for the next 5 years far from other humans, or dying of a mundane cause sooner)
Yeah, I'd personally hedge for 50-70% shots based off tested techniques that inoculates against severe cases. I'll also bias towards options with less onerous cold chain requirements. No part of covid response has been trouble free so far, vaccines rollout will be no different. Have had several front line / medical friends advice to bias away from Pfizer due to behind the scene incompetence. Currently Pfizer is limited to hospital settings in my country due to excess requirements, and guess what, hospital staff has been running ragged for over a year.
Some think the Adenovirus-vetor vaccines have more risk of certain side-effects, especially if (by chance or a prior vaccination) the person was previously infected by a related Adenovirus.
By contrast, the mRNA vaccines do the same thing in the end - get your cells to appear infected & emit the target spike proteins – in the narrowest possible way, via a subset of the changes an Adenovirus infection causes.
As I understand it, the risk is not to do with the adenovirus but with the use of PEG (polyethylene glycol) or similar analogues, to make the active ingredient last longer, which may cause an allergic reaction[1] to sensitized people. The AZ vaccine does not use PEG (nor J&J, Novovax IIRC).
The complication with the adenovirus carrier is that you immune system may attack the carrier so effectively that you don't get enough exposure to the coronavirus protein that it is carrying, and hence don't develop a strong enough immune response to it. This causes problems determining how people will respond to varied treatment schedules (delay of the booster shot, mixing of vaccines, etc).[2][3]
There are a number of direct risks related to the Adenovirus itself. Multiple adenovirus vaccine programs have been scrapped over the years because of these issues:
For example, famously, one Ad-based HIV vaccine was found to increase the chances of getting HIV. People still theorize that it might be due to the vector itself:
(that said, these platforms are certainly better validated than the mRNA-based vaccines. There's an approved rabies virus vaccine based on adenovirus.)
Your video specifically mentions triggering a 'cytotoxic T-cell' - that's a cell that kills virus-infected cells. What's more, it doesn't explicitly state that all the bodily cells that receive the foreign mRNA survive.
I'm pretty sure they're attacked & destroyed by the immune system for their emission of foreign proteins - that is, they "appear infected". And, some time after the mRNA was introduced – days? weeks? – it's all used up, because unlike a full viral vector, it doesn't code for more invasive genetic material, only proteins. And, the cells it hijacked are in some combination, destroyed by the immune system or revert back to normal, non-threatening operation.
If you have a more specific reference that denies the mRNA-altered cells are attacked-as-if-infected, I'd appreciate seeing it. But that video doesn't make that claim, and in fat the reference to 'cytotoxic T-cells' implies the opposite.
(Also, as the sibling response elaborates, the problems with Adenovirus-vectors are not limited to PEG reactions.)
I don't see any a-priori issues with mRNA safety - mRNA is by design an ephemeral product with no chance of self-replication. Its long term efficacy on the other hand is yet unknown and the supply chain issues are significant (it's a result of mRNA being an ephemeral cellular product being stored artificially).
Of course if you made an mRNA virus to produce some sort of toxic cellular protein then safety would be an issue - which is what the phase 1 and 2 trials are about. Phase 4 is about finding the one in a million adverse reactions.
God! This is such a huge misconception it's concerning that people still need to be this concerned. You don't have to hold back on the mRNA vaccine.
There is no such thing as long term issues that *suddenly appear after months or years". It simply can't happen because they don't have pharmacodynamics and you don't take them that regularly. They are not the same thing as medication.
Long term side effects like after the polio vaccine in the 70s always occur IMMEDIATELY after vaccination. Hours to days, maybe a week. These vaccines are in your body for a short period of time before they produce the spike protein from the mRNA instruction. All effects happen very fast. If you get vaccinated you might feel ill within the day.
So why did we only notice some effects of vaccines much later, for example narcolepsy in swine flu? Answer: it's all statistics. Some side effects have a chance of only 1:60.000 or even much less. Do you know how long it usually takes to vaccinate enough people to find something that occurs only in one out of 60.000 times? The answer is months or years.
But for COVID we have already vaccinated millions of people in multiple countries with multiple political systems and ideologies in power. No serious issues whatsoever. I know people who did get pretty sick for 2-3 days (basically bad cold) from the mRNA vaccine but that's GOOD. They are not infected, it's just a short term immune reaction that will disperse without causing serious harm and it shows the vaccine does what it is designed for: invoke an immune response.
And 2 days of symptoms are much better than 3 weeks with symptoms including hospitalization and long term effects due to an active virus in your body.
> Long term side effects like after the polio vaccine in the 70s always occur IMMEDIATELY after vaccination.
Sure, but this is different. Suppose a target cell happens to be expressing a retrotransposon that by chance binds to the mrna vaccine and integrates it into host dna in an inopportune spot, could cause elevated risk of cancer years from now. I think it's highly unlikely, and plan on getting an mrna vaccine myself but there are whole classes of side effects we can't simply rule out because "traditional vaccines show immediate effects"
> mRNA technology is new, but not unknown. They have been studied for more than a decade. mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person. mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person's DNA.
I have a phd in biochemistry. I can tell you this is categorically wrong: "mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person's DNA"
It should say almost never. It's low enough for the risk to be worth it, but posting actually wrong absolute statements risks causing a backlash, the last year should have taught us all this basic condition of humanity
Agreed that accuracy is important, and we're in sort of a safe space here on Hacker News, but at the same time I feel that the media's portrayal of vaccines so far has done us a disservice. "only 66% effective" may be accurate, but if it's 100% effective against hospitalization that should be the lede. It's also true that we have not proven that vaccines prevent asymptomatic spread, but that's not the same as saying they don't; they almost definitely do, and by being "scientifically accurate" we give rise to people thinking "hmm, this vaccine is only slightly better than a coin flip and I can still spread, what's the point." That's NOT TRUE! Again, all of these vaccines are nearly 100% effective against serious infection and almost definitely inhibit spread—that should be the headline!!!
>Long term side effects like after the polio vaccine in the 70s always occur IMMEDIATELY after vaccination.
Have there been any long term double blind studies (e.g. 20+ years) to actually verify that this is the case? Or is this all based on the current models of how vaccines and their components behave in the body and what effects they have?
Sorry, but I take issue with that statement: 100% protection against death and hospitalization for a tiny minority that are susceptible.
Your statement makes it sound like everyone that gets it will die when that is absolutely not true.
In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.
Edit: Oh here we go again... drive-by downvotes. Care to state your reasons?
"Chest X-rays of asymptomatic patients – those infected but without symptoms – exhibited a severe chest X-ray 70%-80% of the time, but those with COVID-19 symptoms had one every time, she also added."
There are things that can make living quite uncomfortable. So while yes not everyone will be hospitalized and die, there is still a lot of reasons to get any decently effective vaccine.
Edit:
"Bankhead-Kendall, who has treated thousands of patients since the pandemic began last March, says patients who had COVID-19 symptoms show a severe chest X-ray every time, and those who were asymptomatic show a severe chest X-ray 80 percent of the time."
> exhibited a severe chest X-ray 70%-80% of the time
With a sample size of what? That's a nonsense statement that can't be scrutinised.
Edit, found this: The finding is promising but will require further research given the small size of the study with only 82 patients, mostly male and average age over 50
82 people over the age of 50. It also doesn't mention how healthy these people were.
This is typical of pretty much all media coverage: very little facts but also very little to throw back at them...
It's not a peer reviewed study, and it includes only the people whose situations were severe enough to be sent to a radiologist. But it's enough to conclude that it's more than just a dismissably small number of cases.
Sorry, it says nothing of the sort. All the evidence, including government statistics, tell is it is precisely that, a dismissably small number outside known vulnerable groups.
You realize over 70m people in the US are obese right and another 100m are overweight? Known vulnerable groups include 170m people right there. I can't take your argument seriously.
Public health experts, in the US and other western countries, deserve no credibility due to their handling of the obesity crisis. There are clear and obvious steps that governments could take to end obesity, but public health experts have failed to even make an effort to make them happen. Instead they have sat by and watched millions upon millions of people become obese, which is vastly more harmful to the average person's health than the coronavirus.
I do not even think an argument can be made that their failure is due to incompetence.
Oh yes. I'm sure that a population that can't follow simple recommendations to wear a damn mask will listen to the CDC when it says to stop eating Big Macs.
Telling people not to eat McDonald's is the best you can come up with?
How about requiring every high school student to spend two hours per day doing strenuous physical exercise in order to graduate? How about considering it a failure for a student to graduate without being in excellent athletic form, on par with the student being unable to do algebra?
If the people in charge wanted to make that happen, they could do it by spending a tiny fraction of the public money at their disposal on propaganda, but all indications are that they don't want a population that's in great physical shape, even though it would obviously be good for them.
People who are in great shape when they graduate high school might still become fat, but people who graduate from high school fat will almost certainly spend their lives that way.
They could also regulate extremely sugary foods like how tobacco, which is less harmful, is regulated, where you have to be 18 to buy it and have to ask for the cashier to get it for you, rather than having it in your face at the checkout aisle.
Whining about how hard it is on their website is exactly the sort of reason why they have no credibility. They're not really trying, and pretty much everyone can sense that, even if they don't have it spelled out for them.
Of course there are specific individuals that are focused on one or the other, but there are also specific individuals who span both concerns. Significant examples include the secretary of health and human services and the surgeon general, among other high level administrators, who ultimately decide who will be managing both problems.
If said leadership wanted people that would take the clear and simple steps needed to solve the obesity crisis to be in charge of that problem, then the obesity crisis would have been solved. The obesity crisis has not been solved, so we can only conclude that the leadership does not want the right people to be involved. Yet presumably we should also believe that said leadership has our best interests in mind now that there's a new virus going around, when they have already irrefutably demonstrated that they don't?
What I don't understand with people who reply like this is why bother taking the chance? My thought is that people have never experienced a severe respiratory illness before, while I have and because of that I'm appropriately level set on how bad the consequences can be for an individual.
Nothing like back to back cases of bad pneumonia 19 years ago to make me take this whole thing seriously.
My understanding is the hospitalization rate even for young and healthy (20-44) is around 10%. 1 in 10 odds for something happening is really a quite good chance of that thing happening.
And you have every reason to be incredibly cautious. Were I in your shoes I'd likely err on the side of caution too.
Hospitalisation rate says nothing other than they were in hospital. It could have been because they were feeling a bit rough but utterly terrified due to all the scaremongering that's going around. Or they may have been close to deaths door. No way to tell.
The figures don't lie: There are vulnerable groups that can be severely symptomatic and even die from this but they make up a tiny tiny fraction of the population.
The figures don’t lie. Of one hundred people with covid, two will die and ten will be suffering three months later.
The portion suffering long covid is growing too, and it’s poorly understood. Damaged hearts and lungs for example and there are plenty of accounts about.
What are you pushing for? There are places we can look to where covid ran free, it isn’t pretty.
Assess your actual chances of catching and suffering from covid. Then balance it against the risk of a rushed experimental gene therapy still in initial trials.
Edit: Remember that none of the media and government published figures show recovery rates - this is hugely important.
Elsewhere in this thread you argue that because only 400 people without underlying conditions have died, restrictions should be removed. The other 100k don’t seem to be of concern.
I don’t think ‘balanced reporting’ is the full extent of what you are after.
I'm talking about balancing the risk! Yes that 400 figure is foundational to my argument and yes, we should lift the restrictions.
But if you are really sick, you'd be at home, in your bed taking it easy anyway especially if your symptoms are as severe as some of the COVID reports suggest.
And it's not balanced reporting I want either, it's accurate reporting with facts that can be challenged or verified: most articles are incredibly vague when it comes to COVID and some have incredibly low numbers that, at first glance, look damning but are still tiny numbers.
Edit: deleted the 100,000 sentece - In response to that number, yes it may be a large number but there is no breakdown of the cases. For all you know, they were all 90+ years old with previous underlying conditions. All the figures we see have very little behind them that can substantiate the measures taken, while at the same time trigger responses in all of us that make them hard to argue against without coming across as callous but the numbers are not there to justify the lockdowns.
You can't link to the exact thing, but choose "Coronavirus Risk Perceptions" and split by age.
People under 40 believe that their risk of dying from the virus is over 10% on average. The actual risk for that age group is somewhere around 0.02%, which means they're overestimating their risk of dying by a factor of 500.
Five hundred! It's mindboggling how wrong people are.
But once you see those numbers, it becomes clear why there is such widespread support for strict lockdowns.
However, even with the accurate numbers, I would still say the case for the mRNA vaccines is strong. I think you are exaggerating the risks of the mRNA vaccines, in the same way that regular people are exaggerating the risks of the virus.
I'm quite confident people probably over-estimate their chance of dying in a plane crash by a few orders of magnitude as well. People are careful about their own lives, which is probably a good survival mechanism.
What specific policy are you suggesting? The more <40 year olds that get the virus, the more virus there is. The more virus there is, the more people who are spreading the virus, the more people who can get the virus, including people at very high risk of dying or being disabled from it.
As far as I'm aware no place has let the virus spread uncontrollably, think everything was fine, and not lock down at some point. The policy clearly has to be somewhere in between fully locked down and fully opened up, and I'm not sure discriminating by age and health is going to be some magical solution.
I think the biggest problem is the hyper-focus on a single cause of death. People look at the covid-19 death numbers, and have no idea how many people actually die in a normal year.
And this causes people to focus on ensuring nobody dies of covid-19 to the exclusion of everything else. Yes, it absolutely sucks that a lot of vulnerable people in elder care facilities have died of it, but it's equally tragic that a lot of them have died of cognitive decline due to not being allowed to see their family and friends, or not being allowed to see each other.
Or that people are dying or going to die because hospitals and patients alike are postponing care and checkups and routine surgeries, because they're afraid of hospitals being overrun with covid-19 patients, or because they're afraid hospitals will increase spread.
I belong to the privileged class of people who can work from home, I've done it for years, and I live far away from friends and family, so I've been doing weekly video calls for years. The effect for me, personally, is pretty much zero. A lot of people who drive policy are like me, and therefore think lockdowns are no big deal.
But lockdowns are absolutely miserable for a large amount of people. There's a very good reason that we're seeing violent anti-lockdown protests in several countries, because a lot of people are completely fed up with the restrictions.
So, in terms of specific policy, I want governments to encourage and enable people to isolate and distance and keep themselves safe, but I don't want them to enforce it. People have to be allowed to make their own choices, their own risk analysis, and live with the consequences. As we already do for a lot of things.
One example of encouragement is to have good sickpay policies in place, so that no-one feels they "have to" get to work even though they're sick or possibly infected, either out of social obligation or financial necessity.
> and I'm not sure discriminating by age and health is going to be some magical solution.
It's too hard to lock down and isolate a fraction of the population, therefore the solution is to lock down the entire population, except "essential" workers? This argument doesn't make sense to me.
Yeah, this is a false dichotomy. There are other options other than lockdown vs no lockdown. You can have a social safety net and pay people to stay home. But if you're insistent that these are the only two options, look at Sweden. Their economy suffered despite not locking down last year because guess what, it turns out people don't want to go out and risk dying. So if your economy is doing to have mass unemployment, you may as well do that and avoid the death and injury. Or better yet, borrow at low interest rates and let people be unemployed but not destitute.
> You can have a social safety net and pay people to stay home. But if you're insistent that these are the only two options, look at Sweden.
I think that first sentence sounds like a great strategy, and it's perfectly in line with what I suggested. Coincidentally, that's exactly what Sweden did as part of its strategy. So I'm not so sure how Sweden is an example of the opposite?
> guess what, it turns out people don't want to go out and risk dying.
If people are voluntarily doing that, what's the point of having the government enforce the lockdown?
> So if your economy is doing to have mass unemployment, you may as well do that and avoid the death and injury.
Again, lockdowns aren't 100% free. They also cause death, injury, and misery. Suicides are up, domestic violence is up, cancer screenings are down, drug overdoses are up, alcoholism is up, depression is way up. Poor kids in the US who relied on school lunches as their only decent meal of the day are suffering nutritionally, and will lose years of their life because of malnutrition now.
I have a friend who was sick with covid for months, and she's got a long way to recovery. I have a friend who just got out of the ICU after having been there a couple of weeks, he's in shit shape, but alive. That sucks. But I also have friends who were close to suicide because they were unemployed, isolated, and really depressed. That also sucks.
There are no easy choices in this mess, and yet lockdowns are sold as an easy choice by people for whom it is easy, and failure to lock down is portrayed as some sort of moral failing, which is horrifying to me.
> Again, lockdowns aren't 100% free. They also cause death, injury, and misery. Suicides are up, domestic violence is up, cancer screenings are down, drug overdoses are up, alcoholism is up, depression is way up.
In NZ the suicide rate dropped, despite a lockdown that was considerably more severe than done in many places.
Possibly making this misleading, NZs suicide rate is atrocious to begin with.
Yes, there was a hell of a lot of grim news and poor stats - but the below seems a little hard to to believe. They will lose years of life?
> Poor kids in the US who relied on school lunches as their only decent meal of the day are suffering nutritionally, and will lose years of their life because of malnutrition
So, Sweden is third least affected country in that list. It's missing Norway and Finland, though, but a quick google shows Norway at -3.5% and Finland at -4.0%, both worse than Sweden.
At the same time, the covid-19 deaths in Sweden is pretty close to the EU average, now, after the winter surge:
> the solution is to lock down the entire population, except "essential" workers? This argument doesn't make sense to me.
This is how covid has been eradicated in NZ and Australia. Locking down part of the population doesn’t work - isolating the vulnerable from those that are less likely to die isn’t possible.
> People have to be allowed to make their own choices, their own risk analysis, and live with the consequences.
And where has this worked? A portion of people refuse to listen to advice, refuse to wear masks and refuse to isolate. People go out while sick, they congregate in groups. Why should the vulnerable have to be exposed to this? If everyone follows the rules, you get back to normal faster.
An approach based on evidence is the way to get results.
1. I've never met anyone in the last year who thought Covid had a 100% death rate. Do you know anyone who believes this?
> In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.
Over 10,000 people under age 70 have died from covid, why does it matter if they have underlying symptoms?
But most people are unhealthy, with one condition or another. It's misleading to throw out most of the population and then say "but look how small the numbers are for the sliver that's left!"
Healthy is subjective but when you say it like that then, yes, everyone has something.
However, there are a bunch of things that will greatly increase your chances of dying from COVID: diabetes, obesity, cancer, immune-related illnesses so this is what I am referring to. It's fair to say that people with one or more of those (not an exhaustive list) are "unhealthy".
So, it's not misleading: it's people who are vulnerable either due to age or health reasons that are at risk of dying, no one else.
It was even raised by an MP recently and he asked Boris Johnston why we're getting locked down when only 400 or so people with no underlying conditions have died... everyone else had underlying conditions related to poor health that made them susceptible so they should have been locked down and the rest of us left to get on with things.
> everyone else had underlying conditions related to poor health that made them susceptible so they should have been locked down and the rest of us left to get on with things.
This seems wildly expensive and impractical. Who's going to take care of all those people? Where are you going to house them (many of them live with people without those conditions)? Do you know how many people have diabetes, just to grab the first item off your list?
34.2 million people in the US are estimated have diabetes and you're proposing housing all of them (and a bunch of other people) in isolation for a year or two while everyone else goes about their business.
That's a lot of housing to find somewhere, food to provide, etc. Now try to do it in, say, six months.
At it's peak, unemployment from COVID shutdowns in the US looks like they were around 20-30M last summer. So in terms of making sure those people still have income, the number of people isn't too dissimilar, but that number has declined and we also didn't have to find new, isolated, housing, food, and other services for that group.
It's also a lot of people suddenly pulled out of their existing jobs and out of the regular in-person retail market, which means you're still not going to avoid some of the shocks we're seeing anyway.
You are assuming that the 34 million with diabetes are in the workforce. Based on the age distributions of people with diabetes, most are probably retired or disabled.
Given that high blood pressure, and being overweight are concidered underlying conditions, people with "no underlying conditions" might be < 20% of the total population.
High blood pressure is a serious underlying condition (and counted as an underlying condition in Covid death). Obesity is counted as an underlying condition at stage 1 (between 30 and 35 BMI).
>Obesity alone means ~40% of the population of the US
And that is in large part thanks to the government and its public health experts, who we are now, I guess, supposed to believe have our interests in mind, even though, by letting 40% of the population become obese, when there are plain and simple steps they could have taken to prevent it, they have irrefutably demonstrated they do not actually care about the health of the population.
"letting" seems like a strong verb. I'm all for empathy for those who struggle with maintaining a healthy weight—imagine being addicted to something that you must consume about 3 times a day to stay alive—but it seems a stretch to lay the blame of obesity on the feet of public health experts. Are they also responsible for alcoholics? Other drug addicts?
They could set one simple achievable goal which would drastically reduce obesity: every single high schooler graduates as an athletic machine. The government could do it easily. Schools already require students to participate in gym class, the problem is that it's an absolute joke. They could change that if they wanted. The health benefits are obvious. It's not like they don't know it's an option. They just make excuses for why they can't make any progress fighting obesity, probably because they don't want a healthy population.
Of course some in shape people will become fat as adults, but almost all fat adolescents stay fat until they die.
It is not a short list. Here is the list of high risk conditions for age 16-64 from my health department.
Cancer,
Chronic kidney disease,
COPD (chronic obstructive pulmonary disease),
Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies,
Immunocompromised state (weakened immune system) from solid organ transplant,
Overweight (BMI > 25 kg/m2, but < 30 kg/m2),
Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2),
Severe Obesity (BMI ≥ 40 kg/m2),
Pregnancy,
Sickle cell disease,
Down Syndrome,
Smoking/Vaping (more than 20 days a month),
Type 2 diabetes mellitus,
Asthma (moderate-to-severe),
Cerebrovascular disease (affects blood vessels and blood supply to the brain),
Cystic fibrosis,
Hypertension or high blood pressure,
Immunocompromised state (weakened immune system) from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines,
Neurologic conditions, such as dementia,
Liver disease,
Pulmonary fibrosis (having damaged or scarred lung tissues),
Thalassemia (a type of blood disorder),
Type 1 diabetes mellitus,
Down Syndrome
Now, include the people who live with anyone with those conditions or the people who care or regularly interact with people with these conditions. We end up with a large percentage of the population. The proposal to lockdown/isolate only people with higher risk conditions is completely impractical.
Long covid is a problem that is going to keep on giving. A large portion of those who get covid will have symptoms 6 months later, and many cases are life altering.
Excess mortality shows us ~100,000 extra people died in the UK since COVID started. Antibody testing suggests that this was a result of ~10% of people being infected. I’ll let you do the maths for deaths due to herd immunity, and whether that is a “tiny minority”.
People at risk include people with diabetes and asthma.
In Scotland, the most hospital beds have been occupied by the 45 - 64 age group. Not sure about other parts of the UK.
> Excess mortality shows us ~100,000 extra people died in the UK since COVID started.
It still doesn't negate the argument that it only affects the vulnerable.
And those in the hospital beds: what were their conditions while in there? What were their underlying health issues (if any)? Did they recover?
I'm not saying people don't get sick, I'm saying the cure is worse than the disease especially when the ones dying are a tiny fraction of the population.
Edit: I live in Scotland - we have had the "sick man of Europe" title for a long time and we have an obesity crisis here [0]
In a “do nothing” scenario we would probably expect hundreds of thousands more vulnerable people dying before their time in the UK, along with who-knows how many 45-64 year olds (and other age groups) due to overwhelmed hospitals. We’ve seen that overwhelmed hospitals can’t do normal things like cancer treatment either, so tally that up too.
This is worth some inconvenience and higher taxes to me. I guess some people have no vulnerable relatives and no co-morbidities, or maybe value things like going to the pub above their gran. Personally I would rather have my 80 year old dad and 76 year old mum around for another few years than spend a week in Tenerife this year.
I live in the UK and we have the NHS so their job is to look after people when they get sick (and, to a certain extent, use preventative measure like education where appropriate).
But the UK governments largest spend is the NHS. We pay a fortune every year for it. So if they can't do their job then heads should roll among politicians and NHS brass.
My argument is that the death rate does not justify the measures that are being taken: by all means protect the vulnerable (my parents are in that class) but the rest of us have been locked down when the stats absolutely do not justify it.
I haven't even mentioned the economic cataclysm we are facing... that's another story!
It isn’t possible to protect the vulnerable while having rampant covid in the young and healthy, society doesn’t work like that.
Here in New Zealand we isolate new arrivals in hotels and they are strictly monitored. There are only a few thousand people there at any given time, and despite the huge effort, covid still escapes into the community every so often.
> It isn’t possible to protect the vulnerable while having rampant covid in the young and healthy, society doesn’t work like that.
Then why do the numbers keep going up despite locking down everyone? Why didn't governments institute a policy that keeps people away from those in vulnerable groups with a £1000 fine for breaches? Mandated masks etc. That would have been just as manageable. Lockdowns do not work, the figures clearly show that yet people still mandate for more lockdowns? I don't get it.
> and despite the huge effort, covid still escapes into the community every so often.
yes, but who is dying from it? It's the old and vulnerable, not the young and non-vulnerable: the vast majority of people will not die from this!
> Lockdowns do not work, the figures clearly show that yet people still mandate for more lockdowns?
What figures show that lockdown doesn’t work? I’m in New Zealand. We had community covid multiple times and have eradicated it (with lockdowns initially).
Keep in mind that our initial lockdown was very strict, particularly compared to UK style lockdowns.
In the UK the cases are falling fast, why do you say otherwise? There are less new cases each day.
No one is dying from covid here and hasn’t for a long time, touch wood, hopefully that continues.
Hi, Victoria, Australia here. Today, our state is at 24 days of zero community transmission of covid, managed largely via a small lockdown after a small outbreak from interstate.
Before that small outbreak, we were up to 80-ish days of zero community transmission of covid, after a much much larger outbreak which was brought under control by a robust lockdown which began in March and continued into December.
Lockdowns work, if people obey them. And we’re proof of that.
> Today, our state is at 24 days of zero community transmission of covid, managed largely via a small lockdown after a small outbreak from interstate. Before that small outbreak, we were up to 80-ish days of zero community transmission of covid, after a much much larger outbreak which was brought under control by a robust lockdown which began in March and continued into December. Lockdowns work, if people obey them. And we’re proof of that.
So let's re-phrase: you had one of the longest lockdowns in the world (110 days), spanning the fall, winter and spring...and then it came back in the summer, and you had to do it again. And you're in an isolated island nation with almost no international travel.
Your story does not encourage me about the feasibility of the strategy you advocate -- it underscores how tenuous the situation actually is.
People rail against lockdowns and claim eradication isn’t possible for various reasons, yet when shown examples of where it has worked and the freedoms it has allowed somehow that is also not an option.
If everyone did it, we would have a solution.
What Victoria achieved looked an impossible task for a while there, and shows that a severe outbreak can be corrected. That’s an achievement that can’t be underestimated.
Why anyone in Australia or NZ would want to travel internationally for anything other than absolutely essential travel is baffling to me - outside of travel, we have achieved normality. Rampant covid and freedom of movement is not the freedom I want.
> If it wasn't for other people, my plan would be perfect!
I laughed.
The plan is good, it belongs to Dr Ashley Bloomfield and The Ministry of Health here in NZ.
I was using ‘we’ in a global sense, but unfortunately Bloomfield has no jurisdiction out there.
> you had one of the longest lockdowns in the world (110 days)
If you want to be precise, there was one lockdown in April->May, and then the major one in July->November that we’ve been talking about. It was 112 days for that second lockdown, the severe one. (note that the exact restrictions changed over that period, but 112 days was the period for which there were any restrictions around when you were allowed to leave your home)
> spanning the fall, winter and spring
No, that would require around 270 days. The 112-day lockdown included the second half of winter and most of spring, but didn’t include any of Fall (which is March->May here in Australia, and also we call it Autumn).
The first (much less severe) lockdown did take place in part of Fall, though. But that wasn’t part of the 112 day period that you were talking about.
> and then it came back in the summer, and you had to do it again
It was a small handful of cases in a corner of the state and we just backed up one step in the scheduled reduction of restrictions to make sure things didn’t get out of control; it lasted about three weeks before the government was satisfied that it was contained and restrictions resumed easing.
It absolutely wasn’t a case of “do it all again”.
> And you're in an isolated island nation with almost no international travel.
Note that “almost no international travel” is because it was shut down by the government, to protect against the spread of Covid. That’s another option that’s available to other countries.
It might also interest you to know that we’re holding the Australian Open here in about a week, with folks arriving from all over the world. They’re apparently expecting to have 30,000 spectators attending per day, in person.
> Your story does not encourage me about the feasibility of the strategy you advocate -- it underscores how tenuous the situation actually is.
Oh, it’s absolutely tenuous. Absolutely. Everyone has to be working together for it to effectively bring cases down to zero, as has happened here in Australia and in New Zealand. One bad apple or one selfish person in the wrong place can undo the sacrifices of thousands of people who are doing the right thing.
But what’s the alternative? Just stand around and watch the corpses pile up? (3500 covid deaths yesterday in the USA, for example)
I would take the lockdown over that, personally. In fact, I did. And today, after the lockdown has ended, I went to work in an office. And I took public transport to get there.
0 locally acquired cases, for the 24th day in a row.
Why do you believe that the FDA is holding them back?
So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?
The FDA isn't scheduled for anything. They told AZ long ago that their trail wouldn't meet FDA standards, and so AZ started a new trail that would. Everyone assumes the approval will happen in April, but that is just an educated guess.
That’s just semantics around the word “scheduled”. The FDA insisted on a course of action that makes it unlikely the AZ vaccine will receive an EUA before April. They did this despite the fact that pretty much no one with vaccine expertise doubts that it will meet the safety standards or the (relatively low) efficacy standards required to grant that EUA.
No one disputes that AZ screwed up their trial, but it doesn’t make sense to prevent people from accessing a safe and reasonably effective vaccine just to make a point about that. That’s why the UK and EU have approved it and are moving forward with distribution, while the US waits months for absolutely perfect data before doing anything.
No, they haven't. Johnson and Johnson hasn't applied for emergency authorization yet. Assuming they do next week and all goes well it will likely be available by March.
I can give you a laundry list right now. For example, millions of vials are cracking around the rim, several of the filling rooms have mold issues, one of the vial hoppers is leaving metal particulates in the vials, weekly OOS for manufacturing impurities..I think the public would freak out if they knew what was happening in the supply chain.
>> If this is in any way true, you need to contact a journalist ASAP.
??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.
The way I'm interpreting the statement is that these issues are happening today during the production of Covid vaccines that have already been approved and are being sent out.
I think this is just a normal part of the scale up process, and why things are time consuming.
The AZ vaccine seems to be the best candidate as it can be distributed at fridge temperature. It looks like the novavax vaccine (protein + adjuvant design) may actually prevent invection. The goal of the 1st generation of vaccines is to prevent severe illness.
That's fifty years ago. If you think a fifty years ago story is why the FDA is delaying, I differ. They're delaying because of IPR chauvinism, and massive amounts of NIH and I'm not talking about nih.gov
The FDA approved phen-fen, vioxx, des, the opiod disaster.. the hold up on AZ is not because they have magic time machine insight into why AZ should be delayed.
We're limited by supply, so the existence of (limited quantities of) better vaccines isn't a good reason to block people from choosing to get a safe vaccine that still provides a reasonable degree of protection.
There are plenty of people in the lower-risk categories who would prefer to get a >60% effective vaccine now, rather than wait months for their turn in line for vaccines with the highest efficacy.
Not hospitalized does not mean no damage, short or long term. That is not to say this vaccine is a bust, but I for one was disappointed in the efficacy. The Novavax vaccine appears to be better and is also able to use existing supply chain technology.
On the other hand it's quite sad that we as humanity have already developed two vaccines with 95% (or even higher) effectiveness but are not able (or rather: are too greedy) to share this knowledge to vaccine every human on earth as fast as possible.
Instead the US and Europe are putting trade restrictions in place to keep the vaccines for themselves. India and China are more than capable to produce the vaccines in insane quantities but IP law doesn't let them.
It's not a tech problem, it's a production problem. There are only a few companies on earth that are capable of producing the precursor chemicals for these mRNA vaccines, and until now they were geared towards producing small batch research drugs. They are expanding rapidly but production capacity is at 100%.
Yeah I just don’t understand why we can’t put the full industrial capacity of the U.S. government behind this. I’m genuinely curious about the on-the-ground details which make manufacturing this stuff hard. Would love to see the playbook for raw materials to vial of vaccine.
I'm really struggling to understand these numbers.
In some other articles I'm seeing that it offers 100% protection against hospitalisation and death.
"The J&J vaccine was 85 per cent effective at preventing severe Covid-19. Twenty-eight days after the jab, it offered “complete protection” from hospitalisation and death." [1]
Wouldn't having "severe" infection require hospitilisation?
> Some people have to, because there simply isn't any hospital in their area with space for them.
Citation needed on that one. There is a lot of media fearmongering out there that results in outliers and things that are normal practice getting taken out of context and blown up into something scary.
You can see it in statistics. When the hospitalization starts dropping while case counts are going up, it's because more cases are being managed at home.
Prioritizing critical care is normal when care is in short supply, but it means that you are more likely to have to deal with COVID at home when the local healthcare system is overstressed.
> on Nov. 1, the Covid Tracking Project’s seven-day average showed about 80,000 new cases — which we would predict should lead to about 2,800 new hospitalizations a week later, by Nov. 8. Instead, there were 2,600, a little fewer than expected. On Nov. 15, we had 146,000 new cases, which should have resulted in about 5,100 new hospitalizations by Nov. 22. However, there were fewer than 3,700. This pattern of declining rates of hospitalization continued through the end of November.
> What is happening is pretty simple: Because hospitals are filling up, they are admitting fewer and fewer people. Any doctor or nurse will tell you that as the demand for beds soars, the threshold for admission rises with it...
> The decision on whether to admit a patient depends on two things: clinical judgment and bed availability. Critically ill patients will always be admitted. But as hospitals start to fill up, those who are less sick — younger covid patients, or those whose oxygen levels aren’t yet dangerously low — get sent home. These patients would be safer in a hospital bed, but there isn’t one available for them anymore.
Presumably severe includes some people who don’t need hospitalization. Some high risk patients can get new monoclonal antibody treatments that may prevent them from needing hospitalization. Some people are sent home from the ED with oximeters and told to come back if their oxygen saturation drops below a certain threshold and a doctor calls them everyday. Hospitals in hard-hit area have to be very judicious about only admitting patients who really need it so there may be some severe/high risk cases that are just closely followed as an outpatient.
I think they are saying none of the hospitalized cases occurred after twenty-eight days, but statistically they can't really say it provides 100% hospitalization prevention at that point even if that is accurate. At lease one expert on CNN indicated protection was continuing to increase throughout the study which is promising. I'd like to see a follow-up.
The contrast between the response to Astrazeneca and J&J is striking. Similar efficacy numbers, but Astrazeneca is still banned and got terrible headlines. J&J has all positive headlines. I don't know if this is just because more time has passed and people realize it was dumb to not approve Astrazeneca? Is "Supercovid" just making people realize we can't wait around?
I think J&J, Astrazeneca, and Novavax all easily surpass the "net expected benefit" threshold and should all be approved immediately. In the US, this would allow us to end this thing within 90 days.
BTW - I do think it would be more helpful if you report on the numbers between vaccines to use your primary metric as "100% Effective at Preventing Death", then use 68% or whatever as your secondary metric. This better reflects the differences between the vaccines so far. All are amazing at protecting against what people care about most.
Yeah, I don't get why the Astrazeneca vaccine approval in the US is being delayed till (reportedly) March. Is it because Pfizer and Moderna are US companies charging a lot more money vs. Oxford/Astrazeneca being UK and not making any money on their vaccine?
I think it's because of the transverse myelitis scare during AZ's Phase 3 tests, combined with AZ's dosage quality control issues making it really hard to interpret efficacy data.
The US trial got delayed but is due to complete by March I think. It will resolve some questions raised from the UK trial. Besides this, it looks like AZ is way behind on production anyway. With UK and EU fighting over the doses, the US may take a while to get any.
> In the US, this would allow us to end this thing within 90 days.
It... would not. We need half a million (edit: billion of course, oops) doses to "end this thing", and those just aren't going to be there from any combination of manufacturers. If that kind of result was really on the table, a new administration and congressional leadership would be moving mountains to get that win.
But yes: AZ should probably be approved faster than it is and I don't know what the delay is.
The most direct reason for the delay in approving the AZ vaccine in the US is that as of early this month they had not submitted for approval.
They are waiting for the results from a larger US-based trial.
I'm not sure why they aren't going with the same trial data they used to submit requests elsewhere, but it could have something to do with the FDA approval process. The FDA evaluates drug approval requests the way a lot of people were saying the FAA should have evaluated Boeing's 737 Max certification application.
The FDA takes your trial data and then does their own analysis of safety and efficacy. They also have an independent advisory committee that looks over both the company's work and the FDA's work. Many other places, such as the UK, rely more on trusting the company's analysis.
The AZ vaccine was the one that had the error in running the trial that gave some people half of the dose they were suppose to get, and the results suggested that results were better for them than for those who got the full dose. The trial wasn't designed to test half dose vs full dose, and so the set of people who ended up getting half vs full are not really a good set to draw conclusions from.
Perhaps AZ thinks that submitting based on a later trial without that error will overall lead to faster approval than submitting an earlier trial that would probably take longer for the FDA and the independent advisory committee to analyze?
I agree that the AZ vaccine was safe and should have been given US approval. That said, this data is for a single dose compared to AZ's two doses so it is a bit apples-to-oranges.
The issue with Astrazeneca is that they messed up part of their clinical trials.
The results weren’t even negative. A subset of their trial group received a different amount of vaccine which seemed to show greater efficacy later.
The issue, and thus the “mistrust”, is that if they messed up that rather critical part of their clinical trials then what else could they have messed up?
I suspect the title was abbreviated to fit HN length requirements, but it cut out perhaps the most important part. This data is for a single shot. There is an ongoing trial for boosting with a second shot down the line, but having a single shot that's known to be effective at eliminating the disease and extremely effective at reducing severe cases and hospitalizations is a game changer. We can vaccinate lower risk populations with this vaccine and do it twice as fast. Once everyone is vaccinated, we can invite people to come back for a second shot as a booster. From the phase 1/2 trial data I saw, I'd expect a second shot to boost the efficacy to numbers approaching the mRNA vaccines.
Edit: It also only needs to be refrigerated so it eliminates a lot of coordination related to frozen transportation, scheduled appointments, etc. will be eliminated.
What is the optimal vaccination strategy? So far, it just seems like we're following "vaccinate healthcare workers and the most vulnerable" and that, on the surface, seems intuitive. But is there some other sort of algorithm that can determine the best way to reduce overall transmission the fastest? Random vaccinations? Targeted groups in different regions? Double shots for vulnerable before single shots for others? Mobile vaccination services?
well we definitely shouldn't be vaccinating people who've had and recovered from the virus before we vaccinate other who haven't, and we most likely shouldn't be giving out second shots before more people get a first shot. Of course individual risk and exposure plays a role, but the incremental protection conferred by the second shot in the arm of a person who's already recovered from covid is pretty low, even if they are a healthcare worker.
> we most likely shouldn't be giving out second shots before more people get a first shot.
It's mostly thinking out loud because sometimes the most effective solution is a bit counter-intuitive. There may be some value in getting more people to a guaranteed 100% protection. Right now, in Canada, we seem to be following an intuitive route. But in BC, they've already administered ~4000 second doses. (Likely only in long term care facilities). https://www.cbc.ca/news/canada/british-columbia/covid-19-upd...
So it seems like the strategy there may be to get those residents to 2 shots before others.
One strategy, which wouldn't be applicable to most places in the United States right now, is to target a couple levels of potential contacts of every case. So when a person tests positive, you vaccinate all their contacts, and then all those people's contacts, and you can be pretty sure to have broken that line of transmission.
This is what I was looking for. That seems to make a lot of sense.
> which wouldn't be applicable to most places in the United States right now
Which begs the question: how do you delineate regions for strategies in a pandemic? Political/provincial/municipal borders are useless when you're talking about disease transmission. Does it then make sense to have different strategies for different areas (and to divide areas up based on completely different concepts -- like proximity to major highways, for instance).
Since you asked, my layman's strategy would be to keep prioritizing the groups at most risk of negative consequences to get the mRNA vaccines and open a second "lane" with less stringent requirements to get a shot of the J&J vaccine. So right now where I live, healthcare workers and people 65+ can get the vaccine and it looks like it'll be another month before they add more eligibility. Perhaps you would open up another lane to say, frontline workers (retail, teachers, etc.) so they can get the J&J vaccine right now or wait until the eligibility for the mRNA vaccine gets relaxed to them. Upside is this gets the most at-risk individuals access to significant protection the quickest. Downside is that forego "really good" protection for "amazing" protection and get sick while they're waiting.
Pure armchair speculation, but I'd at least like public heath officials to explain their logic.
Tier 0: High risk daily exposure. (Medical, Rescue, Law Enforcement)
Tier 1: Frequent contact with Tier 0 (elderly in care) and/or high risk of complications (anyone in a hospital setting for an extended duration).
+++ My tier 2 seems to differ from public health models, at least that I've seen. My logical basis is to break transmission vectors. +++
Tier 2: Those who can't social distance well; essential workers with contact. This group should include anyone in unavoidable public service positions of any sort. E.G. (but not exhaustive): Teachers, grocery store workers, restaurant workers, chefs, warehouse and delivery workers.
Tier 3: High risk but CAN social distance and isolate.
Tier 4: Everyone else; possibly stratified by some score of age, prior medical conditions / risk factors, etc.
The most annoying thing for me is how easily people can game the “healthcare worker” definition. I know folks who are on the board of healthcare facilities, zero interaction with patients of course, and they get first priority and have already completed both rounds. Similarly, folks who stay at home all of the time to take care of disabled family get first priority, despite no external contact.
Meanwhile, teachers who are forced to stay in a confined space with dozens of little rugrats who despise wearing masks, especially when coughing/sneezing, still haven’t gotten anything.
Nobody knows. The experts have their ideas, but there is no way to be sure.
One problem is optimal needs to consider the real world, not the ideal world. West Virgina (typically the butt of backwards people jokes) has done more vaccinations per capita than any other state even though their allocation per capita is the same as other states. This is because that state has decided that the optimal strategy is getting vaccines in arms, not ensuring it is the ideal arms: by not having the overhead of checking eligibility they can give their doses faster which is better than a slower pace of only getting the vaccine into the right people.
Note, I simplified West Virgina's strategy, it is more complex. Just less complex than other states.
Controversial, but what if we instead gave them to those that wanted it the most? In other words, let the 20–30 yr olds that are itching to socialize & travel get it; it may not seem fair, but as a "harm reduction" strategy could still make sense. If they're going to be going out to dinner, meeting friends, and traveling anyway, might as well inoculate them…
One idea I haven’t seen discussed, which I think is interesting although politically intractable:
What if we allocated doses geographically, with a goal of (1) getting some regions fully reopened and back to work immediately, but also (2) establishing a sort of inverse quarantine zone where we’ve stamped out COVID and keep it to zero.
Again I think in the real world this won’t work because we already have shown the western world largely won’t obey quarantines / lockdowns etc.
But if our primary goal was to eliminate the disease - which seems worthwhile if we could pull it off - then a geographic approach might be more effective than a distributed approach.
Specifically, I think you’d have a better chance of getting vaccination rates into the 90% range and subsequently via travel restriction keep these green zones clean so that even those who refuse the vaccination aren’t acting as a reservoir for it.
Is there some resource that compares all the vaccines, an article or a blog post? I would guess that a vast majority of people don't have time/knowledge to look into official reports. One big table with different companies, number of people in trials, results etc. would be nice. For example, what I just found out is that Moderna is actually not 95% effective on all age groups but on 18-65 [1].
Back to J&J. How old were the 15% that did develop the most serious symptoms? The article says that "more than 40 per cent had other illnesses [...] including obesity, diabetes and HIV." Isn't the base rate for obesity in a population something like that or higher? Finally, if we just look at the numbers (if they are even comparable), can we objectively rank these vaccines by how good they are? No ones feelings should be hurt if we can conclude that their vaccine is close to useless (think of how vaccinated population will demand loose measures although 40% of them are still at risk).
I find the Johnson and Johnson Press Release [1] more informative. It gives a lot more detail on the study, including linking to their protocol [2].
It’s unfortunate, but the different vaccine trials all have different demographics and different measures of efficacy. IIRC, the Moderna “95%” is not “only 5% developed COVID” but rather “95% didn’t end up showing any symptoms” while AstraZeneca was doing weekly testing (again this is from memory). With so many people being asymptomatic, the difference between “95%” and “66%” is in the details (which is definitely why Johnson and Johnson also highlight their 72% in the US, and 85% against hospitalization/death).
tl;dr: each vaccine group made reasonable, independent choices for their effectiveness metrics, but they’re not the same metric.
They do not have different measures of eficacy. AZ did more testing to look at symptomatic infections but that was not used in the primary efficacy calculation.
If they didn't have symptoms, they weren't counted in the headline efficacy numbers we're talking about.
"The primary outcome was virologically confirmed, symptomatic COVID-19, defined as a NAAT-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia)."
Just a nit: they don't have exactly the same outcome measure, definition of "severe", "symptomatic", etc.
Nor were they conducted in the same, time, or the exactly same demographics. Nor did they use the same protocol: testing weekly with a swab and detecting and informing the participant of a positive status will get that person to report symptoms to the trial more often than if you don't.
They use similar measures of efficacy but they're not the same thing and are not perfectly comparable. Still, it seems very likely that the mRNA vaccines are much better than AZ.
You’re absolutely right, but I didn’t want the overall message to get lost in the details. I’ve been seeing people parrot the “AZ is actually much better than it looks because they included asymptomatic patients” for months now and it’s just incorrect.
I’m honestly confused! Can you point me to your source for the excerpts in your sibling comments?
Edit: reading your lancet link now (sorry about that).
My understanding from reading the description of the Moderna results was “XX / YYY people developed covid; but we didn’t test everyone in the YYY set” (so people who definitely got it / went to a hospital / whatever are in XX, but asymptomatic cases may not be). Agreed?
My understanding of the AZ studies (despite all their other mistakes) is that participants were being tested weekly, regardless of symptoms. Is that incorrect, or are you suggesting something else?
I definitely don’t want to repeating misinformation.
Second Edit: after looking at table 2 in [1] and comparing the results to the common headline “about 60% effective” [2], it seems like media are reporting the “two standard doses” results. That might be what some folks end up doing, and it’s regretful that the study design went all over the place.
Either way, thanks for the nuance! I will update my future comments to note that the confidence intervals including the asymptomatic results are wildly large, such that they need serious discounting.
A subset of people in the AZ study were tested weekly. However the primary endpoint was prevention of symptomatic disease. For someone to count in the top line efficacy number they would have to show symptoms and test positive on PCR. This is roughly equivalent to what the other studies did, although exact definition of "symptomatic" and how they monitored that can be slightly different. There's a common perception I've seen a lot that the AZ numbers are sandbagged because it included asymptomatic cases but that's not the case. If someone never developed symptoms they don't factor in to the 60% efficacy number.
As the other commenter pointed it may be possible that someone had mild symptoms they were ignoring then tested positive on the weekly screening and said "oh yeah I do have a sore throat" but the numbers should still be roughly comparable. It's not worth diving into 94% vs 95% efficacy but I think we can be pretty confident that the 95% vaccine is more effective than the 60% vaccine.
This is also muddied because the AZ trials were a bit of a mess with dosing error and varying times between shots. So now we have a number of different subgroups with their own statistics but not a big enough sample size to say anything confidently about half dose vs full dose or 2 weeks vs 12 weeks. The confidence intervals are a mile wide, but they still get talked about (and even drive policy) adding a lot of noise to the discussion about how effective the vaccine really was.
The NIH news release Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released [1]:
> An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.
> The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant.
Bloomberg quoted “No severe allergic reactions,” to the J&J, yet my cousin-in-law is in the hospital right now with Guillain–Barré syndrome following the J&J clinical trial shot. Granted this is rare and can happen with any vaccine (I believe?), but it’s pretty strange to read about the lack of negative reactions when I personally know someone who has been affected.
NB: I’m not advocating there is anything largely wrong or unsafe about it.
The mRNA vaccines are obviously the gold standard, they're what you want, if you're in a position to pick.
The traditional vaccines, like this one and the Astra Zeneca one appear to be efficient at preventing hospitalization/death. That's great - it will ease the extreme load on the hospitals, and also reduce deaths greatly.
> The mRNA vaccines are obviously the gold standard, they're what you want, if you're in a position to pick.
That might end up being true, but see my comment about the different “efficacy” measures and demographic differences [1]. We don’t have as clear cut a statement as that, and instead need to proceed (for now) with “all of the approved ones seem to prevent death or serious illness. Take what you can”.
If it didn't disqualify me from receiving an mRNA vaccine later, sure. But right now it seems like you get one vaccine only and given that holding out for mRNA may be advisable.
Unlikely. There has never been (to my knowledge) any vaccine that prevented your from getting a different one latter. People get flu vaccines yearly and nobody asks what the last one you got was even though there a dozens of manufactures.
You shouldn't get one vaccine and then a week latter get a different one. (I'd guess this is safe, but there is no reason to do it). However getting one and then a year latter a different one is normal practice and shouldn't be a problem.
In short, take what you can get now. If COVID is still a problem in a year (I'm assuming there is a lot more supply of vaccine then) ask your doctors if you should get a different booster.
Odds are good than in 6 months to a year we will have a different vaccine anyway to cover the variants. The vaccines don't seem to be doing well against the South Africa strain of Covid (only applying to the few that have done real trials, many need more testing), so it is back to the drawing board already.
from my understanding if you take a different vaccine your body treats it as a virus which it already knows from the first vaccine you took and then attacks the vaccine generating antibodies. So technically it should either work as a booster or if your body has forgotten about the virus (don't know how that works) then act as a first dose.
I originally thought the Oxford/AstraZeneca vaccine was significantly behind the mRNA vaccines in efficacy. But then I learned that the Oxford trials PCR-tested every participant regularly, while the Pfizer and Moderna trials only tested participants that were showing symptoms. So there's a very real chance that behind that ~95% number the mRNA vaccines also had asymptomatic cases that were never discovered during trials, and the actual protection is nearly the same as the Oxford one. The mRNA vaccines still seem like a great leap forward, and they don't come with the potential complications of resistance to the vector virus that adenovirus-based vaccines do - but I'm less sure now that they actually offer better protection overall.
> But then I learned that the Oxford trials PCR-tested every participant regularly, while the Pfizer and Moderna trials only tested participants that were showing symptoms.
That seems substantial, weird and important. Source?
"The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. "
I think you're right, now that I know what to look for. The AZ/Oxford vaccine has lower symptomatic efficacy than the mRNA ones, and it's asymptomatic efficacy is lower still. We don't know what the asymptomatic efficacy of the mRNA vaccines is yet, but since their symptomatic efficacy is higher, it would be reasonable to expect their asymptomatic efficacy to also be higher.
So at the end of the day, the main question regarding the AZ/Oxford vaccine is whether a half-dose starter shot regimen, or longer time between doses can bring its efficacy more consistently up around 90%, which would make it only slightly less effective than the mRNA ones, or if it's efficacy is actually just lower.
The half dose and longer time efficacy numbers have confidence intervals around 50-60% wide, definitely need to do more testing on that. I agree its the biggest question to answer for them (aside from just getting cleaner data through the US trial that will hopefully report soon). I believe they were also doing a study with mixed doses of Oxford/Sputnik.
The links you provided seem to be for AstraZenica's vaccine, though, not for Moderna's or Pfizer's (which is what 'm12k was originally talking about). That seems to suggest that Oxford/AZN were only testing symptomatic trial participants, no? And says nothing about what Moderna or Pfizer were doing?
Moderna and Pfizer/Biontech did not do regular screening to check for asymptomatic cases, aside from some samples taken in between the shots. Oxford/AZ did regularly screen some participants, but the primary efficacy analysis only looked at symptomatic cases similar to the mRNA vaccines.
Ok, but the question in the thread was about sources showing that Moderna & Pfizer did not do regular screening; seems like no one had found that info earlier, but I now see someone downthread has posted more about this.
"Unlike other vaccines being trialled, the Oxford team had been taking weekly swabs from all volunteers to check whether they were infected but showing no symptoms."
This does not mean that this is reflected in the efficacy numbers. Read the paper and protocols they very clearly specify symptomatic disease confirmed with PCR.
"To test for asymptomatic infections, participants in COV002 in the UK were asked to provide a weekly self-administered nose and throat swab for NAAT testing from 1 week after first vaccination using kits provided by the UK Department of Health and Social Care (DHSC)"
Moderna:
https://www.nih.gov/news-events/news-releases/phase-3-clinic...
"Investigators will closely monitor participant safety. They will call participants after each vaccination to discuss any symptoms and will provide participants with a diary to record symptoms and a thermometer for temperature readings. If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours."
https://www.nejm.org/doi/10.1056/NEJMoa2035389
"although our trial showed that mRNA-1273 reduces the incidence of symptomatic SARS-CoV-2 infection, the data were not sufficient to assess asymptomatic infection, although our results from a preliminary exploratory analysis suggest that some degree of prevention may be afforded after the first dose"
Pfizer:
https://www.sciencemediacentre.org/expert-reaction-to-phase-...
"The Pfizer study did not report studies of the impact of its vaccine on asymptomatic infection. The Oxford study reported that efficacy for “asymptomatic or symptoms unknown infection” based on weekly self-swabbing was 3·8% (−72·4 to 46·3%) following standard dose and 58·9% (95% CI 1·0 to 82·9) following low dose regimen."
https://www.nejm.org/doi/10.1056/NEJMoa2034577
"These data do not address whether vaccination prevents asymptomatic infection; a serologic end point that can detect a history of infection regardless of whether symptoms were present (SARS-CoV-2 N-binding antibody) will be reported later"
PS: Sorry, but it took a little while to dig up original sources to random news articles I'd read months earlier
I'd also point out that "not replying in 1 hour" is a very high bar. HN doesn't give notifications of thread replies, I don't know what timezone that person was in and people have real lives that take priority over forum discussions.
I sometimes post something here and completely forget to look for replies. I'd hate to come back a week later to find out I'd been vilified for it.
Apologies if I got it wrong but I thought you made a comment (later deleted) along the lines of "you've made a strong claim and 1 hour later still haven't provided evidence".
Because it was deleted I can't check if it was you or not. I had it open in a tab and it disappeared when I refreshed.
I found this document https://www.astrazeneca.com/media-centre/press-releases/2020... which stated about the phase I/II trial that "Weekly COVID-19 PCR testing is performed". However, the phase II/III and phase III trials state "Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR" (slightly different wording in the two cases)
No. AstraZeneca also tested with weekly PCR surveillance. But the efficacy numbers we're comparing between AstraZeneca and the mRNA vaccines are measures of how often they prevents symptomatic illness-- a very similar standard to that used in the Moderna and Pfizer trials (but not absolutely, directly comparable).
Unfortunately, the AZ trial is a mess. One way it was a mess is that the error bars on how much they prevent all illness (not just symptomatic illness) go all the way down to 1%.
One must also take into account the fact that when the Moderna and Pfizer vaccines were tested, the South African, U.K., and Brazilian variants didn’t exist. In the J&J trial they were dominant. As a result they are not comparable. The J&J vaccine had 0 cases of severe disease in the treatment arm and that really is the statistic one is looking for.[1]
The MRNA vaccines were tested prior to the existence of the variants. The Jansen vaccine efficacy was likely affected by the existence of these variants, so I’m not sure we can assume the MRNA vaccines are better.
Gold standard? They have not been previously used on us humans and there are far more side-effects w/mRNA than traditional vaccines. I'll take J&J's '66%' over any mRNA vaccine.
Downvotes without replies again. It is definitely worth debate. What if J&J's second shot gets it up to the same 95%? (even if they are not advocating a second shot at this time)
After all, these vaccines do not prevent the virus directly, they're just there to coax the body to produce new things. Both teach the body about the spike protein. It does seem like the mRNA vaccines are given a not-yet-due congratulations on every medium I see yet mRNA vaccines have absolutely zero history of pandemic ending at this time. Yes that may change, but to call them a gold standard now that's just not accurate.
Looking at that comment it might be because it just asserts “there are far more side-effects w/mRNA than traditional vaccines” without any explanation or sources.
Claiming that there are ‘far more side effects’ is more than a little disingenuous, and smacks of either ignorance or willful misrepresentation of the facts here.
Can you help me find the covid-19 side effects tracking website? I can't seem to find it. In fact I can't find anything that's enumerating the data publicly. I can't answer your comment at all without any data.
The US has various vaccine trackers for side effects. They are anyone can put anything in them. (including things like alien abduction), but they give us a guide as to what is reported. Something like 1 in 100,000 has an allergic reaction in 15 minutes and needs treatment (an epi-pen). That is the only side effect I've heard of.
The numbers of allergic reaction are different for Moderna and Pfizer. If you have a history of allergies you should consult your allergist for advice.
The above numbers are public, but I'm not sure where I read them. As always I'm just a guy on the internet, if you need medical advice see a doctor.
So how can there be claims like ‘there are more side effects’ without any data?
You don’t get to make claims and then require someone else to provide data to disprove them. If you make the claim you have to provide the data yourself.
> What I'm concerned about is the long-term chronical diseases that's been reported
When I looked into it I was shocked at how many people have long term affects after the flu. One of the studies I saw in a comprehensive paper looking at heart swelling and the flu showed a shocking amount of this in even non-hospitalized flu patients! [0]
Apparently any virus that attacks the lungs and.or nervous system leaves behind a lot of damaged people. Most of the time things like heart swelling go away after a couple months. But some people are permanently damaged. This can happen with all viruses, even the common cold kills people. Covid appears to be no different in this regard.
The mRNA vaccines are 95%, J%J is 66%. The former number is confirmed by the FDA, while the latter is a press release (probably accurate, but they might be hiding something while would be used to make them look better). The J&J vaccine just isn't as good. It is good enough, but not as good.
Of course it is possible that the difference is because a vaccine resistant strain is running around now and so J&J got unlucky by not starting their trails as soon. However right now all the numbers we have say J&J isn't as good. Good enough probably, but not as good.
I get that, but what makes you think that mRNA are any more effective than the J&J? You can’t just compare the numbers across trials. Just because 95% is bigger then 66% doesn’t make it more effective.
Such confidence about "gold standard" is hard to justify without ANY studies on mRNA long-term effects (how could there be > this is brand new vaccine technology and delivery).
I would actually argue it is "safer" to take a more traditional vaccine (which have a long history of safety studies, including longer-term one) than an untested (in the long-term sense) mRNA vaccine, given equal efficacies. So, maybe not the J&J if we can truly compare % efficacies given with the mRNA ones (as others have noted, they might not be comparable as different measures were used), but give what we know I would pick the Oxford-AstraZeneca vaccine over the mRNA ones.
There is no scientifically plausible way for there to be long term side effects. RNA is critical to life, so if there were long term side effects life itself wouldn't even be possible.
They are somewhat similar to the mRNA vaccines, triggering cells in the recipients body to produce the SARS-CoV2 protein, but the mechanism is different, they use a virus to introduce the instructions into the cells instead of mRNA. The carrier virus has been altered so that it can't reproduce.
No, Sputnik V is a Vector vaccine just like AstraZeneca and Johnson&Johnson. There are several ones in development in China which all seem to be based on more "old school" technologies.
In terms of development they seem to be pretty far behind. As far as I know, none of the Russian or Chinese efforts have published serious data about safety and efficacy yet. According to publically available data, the vast majority of vaccinations done so far used European/American mRNA vaccines [1].
There’s decades of research on mRNA, which we also know is temporary (explaining its fragility and ultra-cold requirement) and never enters the nucleus. Seems intrinsically safer than adenovirus-based vaccines.
are there any long-term concerns about mRNA vaccines? I have a feeling that the messenger response isn’t something that goes away easily. I’d rather take the AZ vaccine
For a virus where 99+% recover naturally? Imo this was way overblown.
The cure, in the form of RNA modification seems much scarier. What happens when new vaccines in this form interact with each other? I don't know, and no one else does. Hard pass for me.
I think you might have a misunderstanding of how the mRNA vaccines work. The mRNA in the vaccines are simply read by your cells to produce the spike proteins to train your immune system.
There is no RNA (or DNA for that matter) modification taking place in vivo.
"Messenger RNAs, also known as mRNA, are one of the types of RNA that are found in the cell. This particular one, like most RNAs, are made in the nucleus and then exported to the cytoplasm where the translation machinery, the machinery that actually makes proteins, binds to these mRNA molecules and reads the code on the mRNA to make a specific protein. So in general, one gene, the DNA for one gene, can be transcribed into an mRNA molecule that will end up making one specific protein."
Still doesn't address how modifications would interact together.
273 comments
[ 3.5 ms ] story [ 155 ms ] threadIn some places people are not getting both shots of vaccines. FDA approved two different shots of 2 shot vaccines.
At this time they should just immunize everybody with one shot at least.
edit: for pfizer & moderna.
It is possible the second shot isn't needed at all. It is possible that the first shot works for 45 days and then stops working completely. Experts doubt both of these extremes, but cannot actually say they are false because they don't know.
Moderna has 80% in single shot I believe but it degrades over time so there is a second shot.
The 66% that does not degrade and can be kept in room temperature is not bad at all. Most vaccines are not 90%. Most flu vaccine don't cover all different types but they still protect people as they get some sort of immunity to major types A,B etc.
This isn't to say that the progression is certainly in this direction (better evidence of that dates back to 2009 [4]), but hey, there's hope that that's the direction.
[0] https://en.wikipedia.org/wiki/Human_coronavirus_HKU1
[1] https://en.wikipedia.org/wiki/Human_coronavirus_OC43
[2] https://en.wikipedia.org/wiki/Betacoronavirus
[3] https://en.wikipedia.org/wiki/Severe_acute_respiratory_syndr...
[4] https://www.scientificamerican.com/article/pandemic-payoff/
It is not yet known if any of the vaccines completely prevent infection; there are concerns the vaccinated might still be able to be asymptomatic carriers.
From your response: "It might culture a strain that's better at infecting folks for whom the vaccine doesn't prove effective, if there's a common factor there and the virus can use it." it sounds like the answer is yes.
I have no idea how the FDA can hold back these vaccines in good conscience while peoples are dying by the thousands on a daily basis.
You forgot a critical distinction: safely every time
However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.
Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless."
If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs.
Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.
The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence.
Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this?
All of these drugs were approved by the FDA's "process".
https://www.fda.gov/drugs/drug-safety-and-availability/drug-...
To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded.
You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.
I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy.
I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example:
Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.
Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.
If we had started releasing the vaccine in August of last year we probably could have saved 100,000 lives.
Also the FDA doesn't regulate medicine. Only drugs. All the rest of medicine doesn't fall under FDA regulation (like surgeries).
For example: the otherwise promising and effective candidate from QUT accidentally causes you to test positive for HIV on the common/cheap/simple assays, which would make effective HIV testing vastly more expensive in the population and cause a huge anti-vax movement. I think we are happy that this side effect is constrained the the small trials group.
Maybe this needs to be explained in computer terms: would you be upset if Apple rushed out a security patch and that caused every iphone to reboot randomly during odd numbered months, and was unpatchable?
https://en.wikipedia.org/wiki/Thalidomide
Or from drugs not being researched or approved because it's too expensive to do an fda trial?
During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.
When I’m eligible, I still may take the nRNA, but my preference is on older tech at this point.
I fully acknowledge that the nRNA is extremely likely to be safe, but it’s just my preference
1. get injected with some vaccine soon, expose your body to a controlled amount of slightly noxious chemicals and hope your body learns how to eliminate them before they degrade on their own
2. contract COVID-19 soon, expose your body to those same noxious chemicals, plus a bunch of others that help it spread throughout your body and cause damage and linger, possibly for weeks or sometimes until you die
(excluding extreme options, like living alone for the next 5 years far from other humans, or dying of a mundane cause sooner)
By contrast, the mRNA vaccines do the same thing in the end - get your cells to appear infected & emit the target spike proteins – in the narrowest possible way, via a subset of the changes an Adenovirus infection causes.
The complication with the adenovirus carrier is that you immune system may attack the carrier so effectively that you don't get enough exposure to the coronavirus protein that it is carrying, and hence don't develop a strong enough immune response to it. This causes problems determining how people will respond to varied treatment schedules (delay of the booster shot, mixing of vaccines, etc).[2][3]
The mRNA vaccines do not get your cells to 'appear infected'. See https://www.youtube.com/watch?v=LcTEmHlvY10
[1] https://www.sciencemag.org/news/2020/12/suspicions-grow-nano... [2] https://www.sciencedirect.com/science/article/pii/S152500160... [3] https://blogs.sciencemag.org/pipeline/archives/2020/12/02/ta...
https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vect...
For example, famously, one Ad-based HIV vaccine was found to increase the chances of getting HIV. People still theorize that it might be due to the vector itself:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
(that said, these platforms are certainly better validated than the mRNA-based vaccines. There's an approved rabies virus vaccine based on adenovirus.)
I'm pretty sure they're attacked & destroyed by the immune system for their emission of foreign proteins - that is, they "appear infected". And, some time after the mRNA was introduced – days? weeks? – it's all used up, because unlike a full viral vector, it doesn't code for more invasive genetic material, only proteins. And, the cells it hijacked are in some combination, destroyed by the immune system or revert back to normal, non-threatening operation.
If you have a more specific reference that denies the mRNA-altered cells are attacked-as-if-infected, I'd appreciate seeing it. But that video doesn't make that claim, and in fat the reference to 'cytotoxic T-cells' implies the opposite.
(Also, as the sibling response elaborates, the problems with Adenovirus-vectors are not limited to PEG reactions.)
Of course if you made an mRNA virus to produce some sort of toxic cellular protein then safety would be an issue - which is what the phase 1 and 2 trials are about. Phase 4 is about finding the one in a million adverse reactions.
There is no such thing as long term issues that *suddenly appear after months or years". It simply can't happen because they don't have pharmacodynamics and you don't take them that regularly. They are not the same thing as medication.
Long term side effects like after the polio vaccine in the 70s always occur IMMEDIATELY after vaccination. Hours to days, maybe a week. These vaccines are in your body for a short period of time before they produce the spike protein from the mRNA instruction. All effects happen very fast. If you get vaccinated you might feel ill within the day.
So why did we only notice some effects of vaccines much later, for example narcolepsy in swine flu? Answer: it's all statistics. Some side effects have a chance of only 1:60.000 or even much less. Do you know how long it usually takes to vaccinate enough people to find something that occurs only in one out of 60.000 times? The answer is months or years.
But for COVID we have already vaccinated millions of people in multiple countries with multiple political systems and ideologies in power. No serious issues whatsoever. I know people who did get pretty sick for 2-3 days (basically bad cold) from the mRNA vaccine but that's GOOD. They are not infected, it's just a short term immune reaction that will disperse without causing serious harm and it shows the vaccine does what it is designed for: invoke an immune response.
And 2 days of symptoms are much better than 3 weeks with symptoms including hospitalization and long term effects due to an active virus in your body.
Sure, but this is different. Suppose a target cell happens to be expressing a retrotransposon that by chance binds to the mrna vaccine and integrates it into host dna in an inopportune spot, could cause elevated risk of cancer years from now. I think it's highly unlikely, and plan on getting an mrna vaccine myself but there are whole classes of side effects we can't simply rule out because "traditional vaccines show immediate effects"
> mRNA technology is new, but not unknown. They have been studied for more than a decade. mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person. mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person's DNA.
https://www.cdc.gov/vaccines/covid-19/hcp/mrna-vaccine-basic...
It should say almost never. It's low enough for the risk to be worth it, but posting actually wrong absolute statements risks causing a backlash, the last year should have taught us all this basic condition of humanity
Have there been any long term double blind studies (e.g. 20+ years) to actually verify that this is the case? Or is this all based on the current models of how vaccines and their components behave in the body and what effects they have?
Your statement makes it sound like everyone that gets it will die when that is absolutely not true.
In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.
Edit: Oh here we go again... drive-by downvotes. Care to state your reasons?
https://www.usatoday.com/story/news/factcheck/2021/01/26/fac...
There are things that can make living quite uncomfortable. So while yes not everyone will be hospitalized and die, there is still a lot of reasons to get any decently effective vaccine.
Edit:
"Bankhead-Kendall, who has treated thousands of patients since the pandemic began last March, says patients who had COVID-19 symptoms show a severe chest X-ray every time, and those who were asymptomatic show a severe chest X-ray 80 percent of the time."
With a sample size of what? That's a nonsense statement that can't be scrutinised.
Edit, found this: The finding is promising but will require further research given the small size of the study with only 82 patients, mostly male and average age over 50
82 people over the age of 50. It also doesn't mention how healthy these people were.
This is typical of pretty much all media coverage: very little facts but also very little to throw back at them...
https://observer.com/2021/01/covid-long-term-health-impacts-...
It's not a peer reviewed study, and it includes only the people whose situations were severe enough to be sent to a radiologist. But it's enough to conclude that it's more than just a dismissably small number of cases.
I do not even think an argument can be made that their failure is due to incompetence.
And if you would like to become educated on the government's role in fighting obesity, and its recommendations, you can go to https://www.cdc.gov/obesity/strategies/index.html
How about requiring every high school student to spend two hours per day doing strenuous physical exercise in order to graduate? How about considering it a failure for a student to graduate without being in excellent athletic form, on par with the student being unable to do algebra?
If the people in charge wanted to make that happen, they could do it by spending a tiny fraction of the public money at their disposal on propaganda, but all indications are that they don't want a population that's in great physical shape, even though it would obviously be good for them.
People who are in great shape when they graduate high school might still become fat, but people who graduate from high school fat will almost certainly spend their lives that way.
They could also regulate extremely sugary foods like how tobacco, which is less harmful, is regulated, where you have to be 18 to buy it and have to ask for the cashier to get it for you, rather than having it in your face at the checkout aisle.
Whining about how hard it is on their website is exactly the sort of reason why they have no credibility. They're not really trying, and pretty much everyone can sense that, even if they don't have it spelled out for them.
If said leadership wanted people that would take the clear and simple steps needed to solve the obesity crisis to be in charge of that problem, then the obesity crisis would have been solved. The obesity crisis has not been solved, so we can only conclude that the leadership does not want the right people to be involved. Yet presumably we should also believe that said leadership has our best interests in mind now that there's a new virus going around, when they have already irrefutably demonstrated that they don't?
Nothing like back to back cases of bad pneumonia 19 years ago to make me take this whole thing seriously.
My understanding is the hospitalization rate even for young and healthy (20-44) is around 10%. 1 in 10 odds for something happening is really a quite good chance of that thing happening.
Hospitalisation rate says nothing other than they were in hospital. It could have been because they were feeling a bit rough but utterly terrified due to all the scaremongering that's going around. Or they may have been close to deaths door. No way to tell.
The figures don't lie: There are vulnerable groups that can be severely symptomatic and even die from this but they make up a tiny tiny fraction of the population.
What are you pushing for? There are places we can look to where covid ran free, it isn’t pretty.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2...
Assess your actual chances of catching and suffering from covid. Then balance it against the risk of a rushed experimental gene therapy still in initial trials.
Edit: Remember that none of the media and government published figures show recovery rates - this is hugely important.
But if you are really sick, you'd be at home, in your bed taking it easy anyway especially if your symptoms are as severe as some of the COVID reports suggest.
And it's not balanced reporting I want either, it's accurate reporting with facts that can be challenged or verified: most articles are incredibly vague when it comes to COVID and some have incredibly low numbers that, at first glance, look damning but are still tiny numbers.
Edit: deleted the 100,000 sentece - In response to that number, yes it may be a large number but there is no breakdown of the cases. For all you know, they were all 90+ years old with previous underlying conditions. All the figures we see have very little behind them that can substantiate the measures taken, while at the same time trigger responses in all of us that make them hard to argue against without coming across as callous but the numbers are not there to justify the lockdowns.
You can't link to the exact thing, but choose "Coronavirus Risk Perceptions" and split by age.
People under 40 believe that their risk of dying from the virus is over 10% on average. The actual risk for that age group is somewhere around 0.02%, which means they're overestimating their risk of dying by a factor of 500.
Five hundred! It's mindboggling how wrong people are.
But once you see those numbers, it becomes clear why there is such widespread support for strict lockdowns.
However, even with the accurate numbers, I would still say the case for the mRNA vaccines is strong. I think you are exaggerating the risks of the mRNA vaccines, in the same way that regular people are exaggerating the risks of the virus.
What specific policy are you suggesting? The more <40 year olds that get the virus, the more virus there is. The more virus there is, the more people who are spreading the virus, the more people who can get the virus, including people at very high risk of dying or being disabled from it.
As far as I'm aware no place has let the virus spread uncontrollably, think everything was fine, and not lock down at some point. The policy clearly has to be somewhere in between fully locked down and fully opened up, and I'm not sure discriminating by age and health is going to be some magical solution.
I think the biggest problem is the hyper-focus on a single cause of death. People look at the covid-19 death numbers, and have no idea how many people actually die in a normal year.
And this causes people to focus on ensuring nobody dies of covid-19 to the exclusion of everything else. Yes, it absolutely sucks that a lot of vulnerable people in elder care facilities have died of it, but it's equally tragic that a lot of them have died of cognitive decline due to not being allowed to see their family and friends, or not being allowed to see each other.
Or that people are dying or going to die because hospitals and patients alike are postponing care and checkups and routine surgeries, because they're afraid of hospitals being overrun with covid-19 patients, or because they're afraid hospitals will increase spread.
I belong to the privileged class of people who can work from home, I've done it for years, and I live far away from friends and family, so I've been doing weekly video calls for years. The effect for me, personally, is pretty much zero. A lot of people who drive policy are like me, and therefore think lockdowns are no big deal.
But lockdowns are absolutely miserable for a large amount of people. There's a very good reason that we're seeing violent anti-lockdown protests in several countries, because a lot of people are completely fed up with the restrictions.
So, in terms of specific policy, I want governments to encourage and enable people to isolate and distance and keep themselves safe, but I don't want them to enforce it. People have to be allowed to make their own choices, their own risk analysis, and live with the consequences. As we already do for a lot of things.
One example of encouragement is to have good sickpay policies in place, so that no-one feels they "have to" get to work even though they're sick or possibly infected, either out of social obligation or financial necessity.
> and I'm not sure discriminating by age and health is going to be some magical solution.
It's too hard to lock down and isolate a fraction of the population, therefore the solution is to lock down the entire population, except "essential" workers? This argument doesn't make sense to me.
I think that first sentence sounds like a great strategy, and it's perfectly in line with what I suggested. Coincidentally, that's exactly what Sweden did as part of its strategy. So I'm not so sure how Sweden is an example of the opposite?
> guess what, it turns out people don't want to go out and risk dying.
If people are voluntarily doing that, what's the point of having the government enforce the lockdown?
> So if your economy is doing to have mass unemployment, you may as well do that and avoid the death and injury.
Again, lockdowns aren't 100% free. They also cause death, injury, and misery. Suicides are up, domestic violence is up, cancer screenings are down, drug overdoses are up, alcoholism is up, depression is way up. Poor kids in the US who relied on school lunches as their only decent meal of the day are suffering nutritionally, and will lose years of their life because of malnutrition now.
I have a friend who was sick with covid for months, and she's got a long way to recovery. I have a friend who just got out of the ICU after having been there a couple of weeks, he's in shit shape, but alive. That sucks. But I also have friends who were close to suicide because they were unemployed, isolated, and really depressed. That also sucks.
There are no easy choices in this mess, and yet lockdowns are sold as an easy choice by people for whom it is easy, and failure to lock down is portrayed as some sort of moral failing, which is horrifying to me.
In NZ the suicide rate dropped, despite a lockdown that was considerably more severe than done in many places. Possibly making this misleading, NZs suicide rate is atrocious to begin with.
Yes, there was a hell of a lot of grim news and poor stats - but the below seems a little hard to to believe. They will lose years of life?
> Poor kids in the US who relied on school lunches as their only decent meal of the day are suffering nutritionally, and will lose years of their life because of malnutrition
https://www.mentalhealth.org.nz/assets/Suicide/Chief-Coroner...
A forecast, but with data up to November 2020, which means it's probably not gonna change substantially when we have the full year data:
https://www.statista.com/statistics/1102546/coronavirus-euro...
So, Sweden is third least affected country in that list. It's missing Norway and Finland, though, but a quick google shows Norway at -3.5% and Finland at -4.0%, both worse than Sweden.
At the same time, the covid-19 deaths in Sweden is pretty close to the EU average, now, after the winter surge:
https://ourworldindata.org/coronavirus-data-explorer?zoomToS...
The obvious conclusion of that data is that lockdowns destroy your economy, but don't actually save lives.
This is how covid has been eradicated in NZ and Australia. Locking down part of the population doesn’t work - isolating the vulnerable from those that are less likely to die isn’t possible.
> People have to be allowed to make their own choices, their own risk analysis, and live with the consequences.
And where has this worked? A portion of people refuse to listen to advice, refuse to wear masks and refuse to isolate. People go out while sick, they congregate in groups. Why should the vulnerable have to be exposed to this? If everyone follows the rules, you get back to normal faster.
An approach based on evidence is the way to get results.
What is a "severe chest X-ray"? This story was debated on Twitter[1].
I agree with the (unforgiving) statements put there.
[1] https://twitter.com/Craig_1_1_7/status/1351203220878716928
And if it would actually end the pandemic and let me go into a store without a %$@#&#@ mask, I'd gladly swallow the syringe whole, sideways.
> In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.
Over 10,000 people under age 70 have died from covid, why does it matter if they have underlying symptoms?
So, basically, if you are healthy, your chances are absolutely tiny that you will die if you catch it.
So, yeah, it matters a whole lot actually.
Healthy is subjective but when you say it like that then, yes, everyone has something.
However, there are a bunch of things that will greatly increase your chances of dying from COVID: diabetes, obesity, cancer, immune-related illnesses so this is what I am referring to. It's fair to say that people with one or more of those (not an exhaustive list) are "unhealthy".
So, it's not misleading: it's people who are vulnerable either due to age or health reasons that are at risk of dying, no one else.
It was even raised by an MP recently and he asked Boris Johnston why we're getting locked down when only 400 or so people with no underlying conditions have died... everyone else had underlying conditions related to poor health that made them susceptible so they should have been locked down and the rest of us left to get on with things.
This seems wildly expensive and impractical. Who's going to take care of all those people? Where are you going to house them (many of them live with people without those conditions)? Do you know how many people have diabetes, just to grab the first item off your list?
34.2 million people in the US are estimated have diabetes and you're proposing housing all of them (and a bunch of other people) in isolation for a year or two while everyone else goes about their business.
That's a lot of housing to find somewhere, food to provide, etc. Now try to do it in, say, six months.
At it's peak, unemployment from COVID shutdowns in the US looks like they were around 20-30M last summer. So in terms of making sure those people still have income, the number of people isn't too dissimilar, but that number has declined and we also didn't have to find new, isolated, housing, food, and other services for that group.
It's also a lot of people suddenly pulled out of their existing jobs and out of the regular in-person retail market, which means you're still not going to avoid some of the shocks we're seeing anyway.
And that is in large part thanks to the government and its public health experts, who we are now, I guess, supposed to believe have our interests in mind, even though, by letting 40% of the population become obese, when there are plain and simple steps they could have taken to prevent it, they have irrefutably demonstrated they do not actually care about the health of the population.
"letting" seems like a strong verb. I'm all for empathy for those who struggle with maintaining a healthy weight—imagine being addicted to something that you must consume about 3 times a day to stay alive—but it seems a stretch to lay the blame of obesity on the feet of public health experts. Are they also responsible for alcoholics? Other drug addicts?
Of course some in shape people will become fat as adults, but almost all fat adolescents stay fat until they die.
That's >40% of US adults[1] and ~30% of UK adults[2] covered already.
[1] https://www.cdc.gov/obesity/data/adult.html
[2] https://digital.nhs.uk/data-and-information/publications/sta...
Cancer, Chronic kidney disease, COPD (chronic obstructive pulmonary disease), Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies, Immunocompromised state (weakened immune system) from solid organ transplant, Overweight (BMI > 25 kg/m2, but < 30 kg/m2), Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2), Severe Obesity (BMI ≥ 40 kg/m2), Pregnancy, Sickle cell disease, Down Syndrome, Smoking/Vaping (more than 20 days a month), Type 2 diabetes mellitus, Asthma (moderate-to-severe), Cerebrovascular disease (affects blood vessels and blood supply to the brain), Cystic fibrosis, Hypertension or high blood pressure, Immunocompromised state (weakened immune system) from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines, Neurologic conditions, such as dementia, Liver disease, Pulmonary fibrosis (having damaged or scarred lung tissues), Thalassemia (a type of blood disorder), Type 1 diabetes mellitus, Down Syndrome
Now, include the people who live with anyone with those conditions or the people who care or regularly interact with people with these conditions. We end up with a large percentage of the population. The proposal to lockdown/isolate only people with higher risk conditions is completely impractical.
People at risk include people with diabetes and asthma.
In Scotland, the most hospital beds have been occupied by the 45 - 64 age group. Not sure about other parts of the UK.
It still doesn't negate the argument that it only affects the vulnerable.
And those in the hospital beds: what were their conditions while in there? What were their underlying health issues (if any)? Did they recover?
I'm not saying people don't get sick, I'm saying the cure is worse than the disease especially when the ones dying are a tiny fraction of the population.
Edit: I live in Scotland - we have had the "sick man of Europe" title for a long time and we have an obesity crisis here [0]
[0] - https://www.obesityactionscotland.org/media/1026/obesityfact...
This is worth some inconvenience and higher taxes to me. I guess some people have no vulnerable relatives and no co-morbidities, or maybe value things like going to the pub above their gran. Personally I would rather have my 80 year old dad and 76 year old mum around for another few years than spend a week in Tenerife this year.
I live in the UK and we have the NHS so their job is to look after people when they get sick (and, to a certain extent, use preventative measure like education where appropriate).
But the UK governments largest spend is the NHS. We pay a fortune every year for it. So if they can't do their job then heads should roll among politicians and NHS brass.
My argument is that the death rate does not justify the measures that are being taken: by all means protect the vulnerable (my parents are in that class) but the rest of us have been locked down when the stats absolutely do not justify it.
I haven't even mentioned the economic cataclysm we are facing... that's another story!
Here in New Zealand we isolate new arrivals in hotels and they are strictly monitored. There are only a few thousand people there at any given time, and despite the huge effort, covid still escapes into the community every so often.
Then why do the numbers keep going up despite locking down everyone? Why didn't governments institute a policy that keeps people away from those in vulnerable groups with a £1000 fine for breaches? Mandated masks etc. That would have been just as manageable. Lockdowns do not work, the figures clearly show that yet people still mandate for more lockdowns? I don't get it.
> and despite the huge effort, covid still escapes into the community every so often.
yes, but who is dying from it? It's the old and vulnerable, not the young and non-vulnerable: the vast majority of people will not die from this!
The cure is worse than the disease.
What figures show that lockdown doesn’t work? I’m in New Zealand. We had community covid multiple times and have eradicated it (with lockdowns initially).
Keep in mind that our initial lockdown was very strict, particularly compared to UK style lockdowns.
In the UK the cases are falling fast, why do you say otherwise? There are less new cases each day.
No one is dying from covid here and hasn’t for a long time, touch wood, hopefully that continues.
https://www.worldometers.info/coronavirus/country/uk/
Hi, Victoria, Australia here. Today, our state is at 24 days of zero community transmission of covid, managed largely via a small lockdown after a small outbreak from interstate.
Before that small outbreak, we were up to 80-ish days of zero community transmission of covid, after a much much larger outbreak which was brought under control by a robust lockdown which began in March and continued into December.
Lockdowns work, if people obey them. And we’re proof of that.
So let's re-phrase: you had one of the longest lockdowns in the world (110 days), spanning the fall, winter and spring...and then it came back in the summer, and you had to do it again. And you're in an isolated island nation with almost no international travel.
Your story does not encourage me about the feasibility of the strategy you advocate -- it underscores how tenuous the situation actually is.
If everyone did it, we would have a solution.
What Victoria achieved looked an impossible task for a while there, and shows that a severe outbreak can be corrected. That’s an achievement that can’t be underestimated.
Why anyone in Australia or NZ would want to travel internationally for anything other than absolutely essential travel is baffling to me - outside of travel, we have achieved normality. Rampant covid and freedom of movement is not the freedom I want.
> Why anyone in Australia or NZ would want to travel internationally for anything other than absolutely essential travel is baffling to me
"If it wasn't for other people, my plan would be perfect!"
I laughed.
The plan is good, it belongs to Dr Ashley Bloomfield and The Ministry of Health here in NZ. I was using ‘we’ in a global sense, but unfortunately Bloomfield has no jurisdiction out there.
If you want to be precise, there was one lockdown in April->May, and then the major one in July->November that we’ve been talking about. It was 112 days for that second lockdown, the severe one. (note that the exact restrictions changed over that period, but 112 days was the period for which there were any restrictions around when you were allowed to leave your home)
> spanning the fall, winter and spring
No, that would require around 270 days. The 112-day lockdown included the second half of winter and most of spring, but didn’t include any of Fall (which is March->May here in Australia, and also we call it Autumn).
The first (much less severe) lockdown did take place in part of Fall, though. But that wasn’t part of the 112 day period that you were talking about.
> and then it came back in the summer, and you had to do it again
It was a small handful of cases in a corner of the state and we just backed up one step in the scheduled reduction of restrictions to make sure things didn’t get out of control; it lasted about three weeks before the government was satisfied that it was contained and restrictions resumed easing.
It absolutely wasn’t a case of “do it all again”.
> And you're in an isolated island nation with almost no international travel.
Note that “almost no international travel” is because it was shut down by the government, to protect against the spread of Covid. That’s another option that’s available to other countries.
It might also interest you to know that we’re holding the Australian Open here in about a week, with folks arriving from all over the world. They’re apparently expecting to have 30,000 spectators attending per day, in person.
> Your story does not encourage me about the feasibility of the strategy you advocate -- it underscores how tenuous the situation actually is.
Oh, it’s absolutely tenuous. Absolutely. Everyone has to be working together for it to effectively bring cases down to zero, as has happened here in Australia and in New Zealand. One bad apple or one selfish person in the wrong place can undo the sacrifices of thousands of people who are doing the right thing.
But what’s the alternative? Just stand around and watch the corpses pile up? (3500 covid deaths yesterday in the USA, for example)
I would take the lockdown over that, personally. In fact, I did. And today, after the lockdown has ended, I went to work in an office. And I took public transport to get there.
0 locally acquired cases, for the 24th day in a row.
So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?
No one disputes that AZ screwed up their trial, but it doesn’t make sense to prevent people from accessing a safe and reasonably effective vaccine just to make a point about that. That’s why the UK and EU have approved it and are moving forward with distribution, while the US waits months for absolutely perfect data before doing anything.
These are pretty extraordinary claims.
If this isn't true, then you should delete this immediately.
??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.
The AZ vaccine seems to be the best candidate as it can be distributed at fridge temperature. It looks like the novavax vaccine (protein + adjuvant design) may actually prevent invection. The goal of the 1st generation of vaccines is to prevent severe illness.
The UK versus FDA Thalidomide experience is at least one good reason.
The FDA approved phen-fen, vioxx, des, the opiod disaster.. the hold up on AZ is not because they have magic time machine insight into why AZ should be delayed.
There are plenty of people in the lower-risk categories who would prefer to get a >60% effective vaccine now, rather than wait months for their turn in line for vaccines with the highest efficacy.
I'll take the first vaccine that becomes available to me, and I highly doubt they'd give me a choice at the clinic anyway.
Here, we're targeting the actively-circulating virus. The match should be better, but getting enough into arms is the obvious problem.
Instead the US and Europe are putting trade restrictions in place to keep the vaccines for themselves. India and China are more than capable to produce the vaccines in insane quantities but IP law doesn't let them.
In some other articles I'm seeing that it offers 100% protection against hospitalisation and death.
"The J&J vaccine was 85 per cent effective at preventing severe Covid-19. Twenty-eight days after the jab, it offered “complete protection” from hospitalisation and death." [1]
Wouldn't having "severe" infection require hospitilisation?
[1] https://www.ft.com/content/d05c7c57-da11-42a1-aa33-b66052c90...
Some people have to, because there simply isn't any hospital in their area with space for them.
Citation needed on that one. There is a lot of media fearmongering out there that results in outliers and things that are normal practice getting taken out of context and blown up into something scary.
Prioritizing critical care is normal when care is in short supply, but it means that you are more likely to have to deal with COVID at home when the local healthcare system is overstressed.
> on Nov. 1, the Covid Tracking Project’s seven-day average showed about 80,000 new cases — which we would predict should lead to about 2,800 new hospitalizations a week later, by Nov. 8. Instead, there were 2,600, a little fewer than expected. On Nov. 15, we had 146,000 new cases, which should have resulted in about 5,100 new hospitalizations by Nov. 22. However, there were fewer than 3,700. This pattern of declining rates of hospitalization continued through the end of November.
> What is happening is pretty simple: Because hospitals are filling up, they are admitting fewer and fewer people. Any doctor or nurse will tell you that as the demand for beds soars, the threshold for admission rises with it...
> The decision on whether to admit a patient depends on two things: clinical judgment and bed availability. Critically ill patients will always be admitted. But as hospitals start to fill up, those who are less sick — younger covid patients, or those whose oxygen levels aren’t yet dangerously low — get sent home. These patients would be safer in a hospital bed, but there isn’t one available for them anymore.
https://www.washingtonpost.com/outlook/2020/12/07/covid-hosp...
It is like having some sort of immunity to type A,B, Spanish, etc of flu and getting them still but not dying like in early 1900s.
Rural USA area hit hard.
I think J&J, Astrazeneca, and Novavax all easily surpass the "net expected benefit" threshold and should all be approved immediately. In the US, this would allow us to end this thing within 90 days.
It... would not. We need half a million (edit: billion of course, oops) doses to "end this thing", and those just aren't going to be there from any combination of manufacturers. If that kind of result was really on the table, a new administration and congressional leadership would be moving mountains to get that win.
But yes: AZ should probably be approved faster than it is and I don't know what the delay is.
They are waiting for the results from a larger US-based trial.
I'm not sure why they aren't going with the same trial data they used to submit requests elsewhere, but it could have something to do with the FDA approval process. The FDA evaluates drug approval requests the way a lot of people were saying the FAA should have evaluated Boeing's 737 Max certification application.
The FDA takes your trial data and then does their own analysis of safety and efficacy. They also have an independent advisory committee that looks over both the company's work and the FDA's work. Many other places, such as the UK, rely more on trusting the company's analysis.
The AZ vaccine was the one that had the error in running the trial that gave some people half of the dose they were suppose to get, and the results suggested that results were better for them than for those who got the full dose. The trial wasn't designed to test half dose vs full dose, and so the set of people who ended up getting half vs full are not really a good set to draw conclusions from.
Perhaps AZ thinks that submitting based on a later trial without that error will overall lead to faster approval than submitting an earlier trial that would probably take longer for the FDA and the independent advisory committee to analyze?
The results weren’t even negative. A subset of their trial group received a different amount of vaccine which seemed to show greater efficacy later.
The issue, and thus the “mistrust”, is that if they messed up that rather critical part of their clinical trials then what else could they have messed up?
Edit: It also only needs to be refrigerated so it eliminates a lot of coordination related to frozen transportation, scheduled appointments, etc. will be eliminated.
It's mostly thinking out loud because sometimes the most effective solution is a bit counter-intuitive. There may be some value in getting more people to a guaranteed 100% protection. Right now, in Canada, we seem to be following an intuitive route. But in BC, they've already administered ~4000 second doses. (Likely only in long term care facilities). https://www.cbc.ca/news/canada/british-columbia/covid-19-upd...
So it seems like the strategy there may be to get those residents to 2 shots before others.
> which wouldn't be applicable to most places in the United States right now
Which begs the question: how do you delineate regions for strategies in a pandemic? Political/provincial/municipal borders are useless when you're talking about disease transmission. Does it then make sense to have different strategies for different areas (and to divide areas up based on completely different concepts -- like proximity to major highways, for instance).
Tier 0: High risk daily exposure. (Medical, Rescue, Law Enforcement)
Tier 1: Frequent contact with Tier 0 (elderly in care) and/or high risk of complications (anyone in a hospital setting for an extended duration).
+++ My tier 2 seems to differ from public health models, at least that I've seen. My logical basis is to break transmission vectors. +++
Tier 2: Those who can't social distance well; essential workers with contact. This group should include anyone in unavoidable public service positions of any sort. E.G. (but not exhaustive): Teachers, grocery store workers, restaurant workers, chefs, warehouse and delivery workers.
Tier 3: High risk but CAN social distance and isolate.
Tier 4: Everyone else; possibly stratified by some score of age, prior medical conditions / risk factors, etc.
Meanwhile, teachers who are forced to stay in a confined space with dozens of little rugrats who despise wearing masks, especially when coughing/sneezing, still haven’t gotten anything.
One problem is optimal needs to consider the real world, not the ideal world. West Virgina (typically the butt of backwards people jokes) has done more vaccinations per capita than any other state even though their allocation per capita is the same as other states. This is because that state has decided that the optimal strategy is getting vaccines in arms, not ensuring it is the ideal arms: by not having the overhead of checking eligibility they can give their doses faster which is better than a slower pace of only getting the vaccine into the right people.
Note, I simplified West Virgina's strategy, it is more complex. Just less complex than other states.
What if we allocated doses geographically, with a goal of (1) getting some regions fully reopened and back to work immediately, but also (2) establishing a sort of inverse quarantine zone where we’ve stamped out COVID and keep it to zero.
Again I think in the real world this won’t work because we already have shown the western world largely won’t obey quarantines / lockdowns etc.
But if our primary goal was to eliminate the disease - which seems worthwhile if we could pull it off - then a geographic approach might be more effective than a distributed approach.
Specifically, I think you’d have a better chance of getting vaccination rates into the 90% range and subsequently via travel restriction keep these green zones clean so that even those who refuse the vaccination aren’t acting as a reservoir for it.
Back to J&J. How old were the 15% that did develop the most serious symptoms? The article says that "more than 40 per cent had other illnesses [...] including obesity, diabetes and HIV." Isn't the base rate for obesity in a population something like that or higher? Finally, if we just look at the numbers (if they are even comparable), can we objectively rank these vaccines by how good they are? No ones feelings should be hurt if we can conclude that their vaccine is close to useless (think of how vaccinated population will demand loose measures although 40% of them are still at risk).
[1] https://www.bbc.com/future/article/20210114-covid-19-how-eff...
It’s unfortunate, but the different vaccine trials all have different demographics and different measures of efficacy. IIRC, the Moderna “95%” is not “only 5% developed COVID” but rather “95% didn’t end up showing any symptoms” while AstraZeneca was doing weekly testing (again this is from memory). With so many people being asymptomatic, the difference between “95%” and “66%” is in the details (which is definitely why Johnson and Johnson also highlight their 72% in the US, and 85% against hospitalization/death).
tl;dr: each vaccine group made reasonable, independent choices for their effectiveness metrics, but they’re not the same metric.
[1] https://www.jnj.com/johnson-johnson-announces-single-shot-ja...
[2] https://www.jnj.com/coronavirus/covid-19-phase-3-study-clini...
It looks like as long as it's safe to do it, the 2nd shot is worth it.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
"The primary outcome was virologically confirmed, symptomatic COVID-19, defined as a NAAT-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia)."
Nor were they conducted in the same, time, or the exactly same demographics. Nor did they use the same protocol: testing weekly with a swab and detecting and informing the participant of a positive status will get that person to report symptoms to the trial more often than if you don't.
They use similar measures of efficacy but they're not the same thing and are not perfectly comparable. Still, it seems very likely that the mRNA vaccines are much better than AZ.
Edit: reading your lancet link now (sorry about that).
My understanding from reading the description of the Moderna results was “XX / YYY people developed covid; but we didn’t test everyone in the YYY set” (so people who definitely got it / went to a hospital / whatever are in XX, but asymptomatic cases may not be). Agreed?
My understanding of the AZ studies (despite all their other mistakes) is that participants were being tested weekly, regardless of symptoms. Is that incorrect, or are you suggesting something else?
I definitely don’t want to repeating misinformation.
Second Edit: after looking at table 2 in [1] and comparing the results to the common headline “about 60% effective” [2], it seems like media are reporting the “two standard doses” results. That might be what some folks end up doing, and it’s regretful that the study design went all over the place.
Either way, thanks for the nuance! I will update my future comments to note that the confidence intervals including the asymptomatic results are wildly large, such that they need serious discounting.
[1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
[2] https://www.bbc.com/news/world-europe-55862233
As the other commenter pointed it may be possible that someone had mild symptoms they were ignoring then tested positive on the weekly screening and said "oh yeah I do have a sore throat" but the numbers should still be roughly comparable. It's not worth diving into 94% vs 95% efficacy but I think we can be pretty confident that the 95% vaccine is more effective than the 60% vaccine.
This is also muddied because the AZ trials were a bit of a mess with dosing error and varying times between shots. So now we have a number of different subgroups with their own statistics but not a big enough sample size to say anything confidently about half dose vs full dose or 2 weeks vs 12 weeks. The confidence intervals are a mile wide, but they still get talked about (and even drive policy) adding a lot of noise to the discussion about how effective the vaccine really was.
> An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.
> The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant.
[1] https://www.nih.gov/news-events/news-releases/janssen-invest...
NB: I’m not advocating there is anything largely wrong or unsafe about it.
And yeah GBS can happen with any vaccine but more importantly also from viral infections. Generally more frequently from the viruses themselves.
The traditional vaccines, like this one and the Astra Zeneca one appear to be efficient at preventing hospitalization/death. That's great - it will ease the extreme load on the hospitals, and also reduce deaths greatly.
What I'm concerned about is the long-term chronical diseases that's been reported (https://www.mayoclinic.org/diseases-conditions/coronavirus/i...), hitting a substantial part of the infected.
We need more clarity to which degree the non-mRNA-vaccines prevent these pretty horrobile chronic diseases.
That might end up being true, but see my comment about the different “efficacy” measures and demographic differences [1]. We don’t have as clear cut a statement as that, and instead need to proceed (for now) with “all of the approved ones seem to prevent death or serious illness. Take what you can”.
[1] https://news.ycombinator.com/item?id=25959872
You shouldn't get one vaccine and then a week latter get a different one. (I'd guess this is safe, but there is no reason to do it). However getting one and then a year latter a different one is normal practice and shouldn't be a problem.
In short, take what you can get now. If COVID is still a problem in a year (I'm assuming there is a lot more supply of vaccine then) ask your doctors if you should get a different booster.
Odds are good than in 6 months to a year we will have a different vaccine anyway to cover the variants. The vaccines don't seem to be doing well against the South Africa strain of Covid (only applying to the few that have done real trials, many need more testing), so it is back to the drawing board already.
That seems substantial, weird and important. Source?
https://clinicaltrials.gov/ct2/show/NCT04516746
"The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age [ Time Frame: 1 year ]
A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs
≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case."
https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
"The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. "
So at the end of the day, the main question regarding the AZ/Oxford vaccine is whether a half-dose starter shot regimen, or longer time between doses can bring its efficacy more consistently up around 90%, which would make it only slightly less effective than the mRNA ones, or if it's efficacy is actually just lower.
https://www.bbc.co.uk/news/health-55308216
https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
"To test for asymptomatic infections, participants in COV002 in the UK were asked to provide a weekly self-administered nose and throat swab for NAAT testing from 1 week after first vaccination using kits provided by the UK Department of Health and Social Care (DHSC)"
Moderna:
https://www.nih.gov/news-events/news-releases/phase-3-clinic... "Investigators will closely monitor participant safety. They will call participants after each vaccination to discuss any symptoms and will provide participants with a diary to record symptoms and a thermometer for temperature readings. If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours."
https://www.nejm.org/doi/10.1056/NEJMoa2035389 "although our trial showed that mRNA-1273 reduces the incidence of symptomatic SARS-CoV-2 infection, the data were not sufficient to assess asymptomatic infection, although our results from a preliminary exploratory analysis suggest that some degree of prevention may be afforded after the first dose"
Pfizer:
https://www.sciencemediacentre.org/expert-reaction-to-phase-... "The Pfizer study did not report studies of the impact of its vaccine on asymptomatic infection. The Oxford study reported that efficacy for “asymptomatic or symptoms unknown infection” based on weekly self-swabbing was 3·8% (−72·4 to 46·3%) following standard dose and 58·9% (95% CI 1·0 to 82·9) following low dose regimen."
https://www.nejm.org/doi/10.1056/NEJMoa2034577 "These data do not address whether vaccination prevents asymptomatic infection; a serologic end point that can detect a history of infection regardless of whether symptoms were present (SARS-CoV-2 N-binding antibody) will be reported later"
PS: Sorry, but it took a little while to dig up original sources to random news articles I'd read months earlier
I sometimes post something here and completely forget to look for replies. I'd hate to come back a week later to find out I'd been vilified for it.
Where did you get that from?
Because it was deleted I can't check if it was you or not. I had it open in a tab and it disappeared when I refreshed.
Unfortunately, the AZ trial is a mess. One way it was a mess is that the error bars on how much they prevent all illness (not just symptomatic illness) go all the way down to 1%.
[1] https://twitter.com/chrislhayes/status/1355352505987854340
After all, these vaccines do not prevent the virus directly, they're just there to coax the body to produce new things. Both teach the body about the spike protein. It does seem like the mRNA vaccines are given a not-yet-due congratulations on every medium I see yet mRNA vaccines have absolutely zero history of pandemic ending at this time. Yes that may change, but to call them a gold standard now that's just not accurate.
Looking at that comment it might be because it just asserts “there are far more side-effects w/mRNA than traditional vaccines” without any explanation or sources.
The numbers of allergic reaction are different for Moderna and Pfizer. If you have a history of allergies you should consult your allergist for advice.
The above numbers are public, but I'm not sure where I read them. As always I'm just a guy on the internet, if you need medical advice see a doctor.
You don’t get to make claims and then require someone else to provide data to disprove them. If you make the claim you have to provide the data yourself.
Please list those. Should be easy as you claim there's so many of them. Also please prove how often those many side effects occur. Thank you.
When I looked into it I was shocked at how many people have long term affects after the flu. One of the studies I saw in a comprehensive paper looking at heart swelling and the flu showed a shocking amount of this in even non-hospitalized flu patients! [0]
Apparently any virus that attacks the lungs and.or nervous system leaves behind a lot of damaged people. Most of the time things like heart swelling go away after a couple months. But some people are permanently damaged. This can happen with all viruses, even the common cold kills people. Covid appears to be no different in this regard.
[0] http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.685...
Why? There isn't any evidence that they're more effective than the J&J one.
Of course it is possible that the difference is because a vaccine resistant strain is running around now and so J&J got unlucky by not starting their trails as soon. However right now all the numbers we have say J&J isn't as good. Good enough probably, but not as good.
I get that, but what makes you think that mRNA are any more effective than the J&J? You can’t just compare the numbers across trials. Just because 95% is bigger then 66% doesn’t make it more effective.
I would actually argue it is "safer" to take a more traditional vaccine (which have a long history of safety studies, including longer-term one) than an untested (in the long-term sense) mRNA vaccine, given equal efficacies. So, maybe not the J&J if we can truly compare % efficacies given with the mRNA ones (as others have noted, they might not be comparable as different measures were used), but give what we know I would pick the Oxford-AstraZeneca vaccine over the mRNA ones.
Here's the "platform" for the AstraZeneca vaccine:
https://en.wikipedia.org/wiki/ChAdOx1
They are somewhat similar to the mRNA vaccines, triggering cells in the recipients body to produce the SARS-CoV2 protein, but the mechanism is different, they use a virus to introduce the instructions into the cells instead of mRNA. The carrier virus has been altered so that it can't reproduce.
So they aren't traditional vaccines either.
It would be fun if the least trusted sources ended up being the more reliable ones.
In terms of development they seem to be pretty far behind. As far as I know, none of the Russian or Chinese efforts have published serious data about safety and efficacy yet. According to publically available data, the vast majority of vaccinations done so far used European/American mRNA vaccines [1].
[1] https://ourworldindata.org/covid-vaccinations
I think the sinovac one is the traditional one in the sense that it uses the same format as the measles vaccine I took a few months back.
There is no RNA (or DNA for that matter) modification taking place in vivo.
"Messenger RNAs, also known as mRNA, are one of the types of RNA that are found in the cell. This particular one, like most RNAs, are made in the nucleus and then exported to the cytoplasm where the translation machinery, the machinery that actually makes proteins, binds to these mRNA molecules and reads the code on the mRNA to make a specific protein. So in general, one gene, the DNA for one gene, can be transcribed into an mRNA molecule that will end up making one specific protein."
Still doesn't address how modifications would interact together.