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I might be wrong, but I thought any human trial needs at least a full one-year follow-up to make sure that the vaccine didn't cause any damage, side effects, reactions, etc, and that indeed created long term immunity.

It seems to me that rushing the timelines potentially opens up a lot of risks for post-vaccine side effects. Doesn't it?

Yes it does. Vaccines can and do cause serious side effects and some can take quite some time to manifest.
That's what the article says, human trials in fall this year and then a regulatory filing a year later. There is basically no chance of a vaccine for this being widely available before 2022. That assumes that one of these vaccines works, despite no vaccine for a coronavirus ever passing regulatory approval (hence this is a hard problem, and plenty of incentive to vaccinate against things like common cold which would be a nice money earner for a someone).
I laugh every time someone telling me we will have something by winter... We will live with quarantine and social distincing for quit for a while.
We might yet have a vaccine in 6 months (optimistically) [0] though 12 to 18 months is much more realistic. Different categories of vaccines have different manufacturing and safety profiles [1] depending on which we a vaccine candidate might be approved sooner than expected, especially since 3 novel, previously untested platforms have made it to clinical trials, already.

[0] Even if shortcuts ... can be found, it is unlikely that a vaccine would be available earlier than 6 months after the initiation of clinical trials. Realistically, SARS-CoV-2 vaccines will not be available for another 12–18 months. From: https://www.cell.com/immunity/fulltext/S1074-7613(20)30120-5...

[1] https://www.cell.com/action/showFullTableHTML?isHtml=true&ta...

There are animal vaccines for coronaviruses that have regulatory approval, just none for humans.

There is zero incentive to make a vaccine for the common cold. Let me introduce you to the multi-tens of billion dollar OTC common cold treatment market.

>I thought any human trial needs at least a full one-year follow-up to make sure ...

Depends what you mean by "need". If you're talking about a risk/benefit calculation for getting a vaccination, I expect it will play out very differently for high-risk elderly folks vs low-risk young adults.

As a lay person, I found this to be a very informative article.

One thing I didn't see mentioned was a recent article that caught my attention - apparently, tobacco may be used as means of production for a potential vaccine [0].

Given that the linked article was published on April 1, I initially thought it to be satire. Upon further consideration, though, it not only seems to be genuine but it makes sense: tobacco is likely one of the best understood plants from a genetic standpoint, with a long history of successful genetic modification using both traditional and modern approaches. It's certainly one of the best understood that also has large-scale production capabilities, and I would imagine that the tobacco industry has more incentive than most to seek the positive PR that this could bring.

Finally, setting aside the greater political context, it seems to me that the FDA under the Trump administration is more flexible and risk-tolerant than any point in my lifetime (and perhaps in living memory). There are certainly many challenges that will have to be overcome before we get to the point that we're able to widely roll out an effective vaccine, but I strongly suspect that this flexibility will result in a speed of development and approval that will surprise many of us. Of course, that speed will come with associated risks, but that's just the nature of things.

I would not be surprised to see widespread voluntary human testing of promising vaccine candidates in the next six months - perhaps even sooner if a promising candidate ends up being derived from the past few years' work in creating a vaccine for SARS-CoV-1.

0: https://www.dailymail.co.uk/news/article-8175855/BAT-claims-...

I am really concerned about the fact that the FDA is trying to fast track stuff.

I just want to offer a perspective of why this is dangerous. We are having some serious issues with flouroquinolone antibiotics. The side-effects of the medication are insane and under-reported. 9 years ago I was given the antibiotic for an infection, my body went into shock, I was released the next day with some odd neurological issues. None of it reported to the FDA, few months later I got tendon pain. I go to mayo clinic, they disagree the antibiotic caused it. Seen 30+ physicians in the span of 2 years, 2 agreed that it is possible. One of them said to wait it out, and refused to actually put it in my chart. The antibiotics carry a 'black label' and clearly state side effects may occur up to 1 year. I reported it to the FDA, then I found groups of people suffering from chronic fatigue, tendon raptures, weird neurological symptoms, some had diagnosis of 'fibromyalgia', some had chronic tendinitis, yet after reviewing their medical information they found they took a flouroquinolone antibiotic but nobody ever even suggested that it could be that.

This bring me to Tamiflu fiasco. Governments have spent billions of dollars to purchase Tamiflu to fight the flu. Later reports came out about issues with the studies, the maker picking positive studies and withholding neutral or negative information. It has not proven much better than the drugs we already use to treat the flu.

Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people. Doing any scientific research with panic in the back of your mind and high pressure from politicians and people is dangerous IMO. Especially, in a profit driven healthcare system.

Fast tracking a medication can have terrible results, cost billions of dollars, and cripple hundreds of people.

All of this is true, and yet in our current situation, not fast tracking can have even worse results, cost trillions of dollars and kill millions of people.

It is a difficult situation, but the cure should not be worse than the disease. I just offered my perspective. I am not an expert in medical research, and hope that qualified people can do their jobs and find a safe treatment/vaccine. However, I am scared that people that say 'No' will be silenced or removed, kind of like people in Theranos, who were experts in their fields.
Look up what happened in India with the polio vaccine..
Woah, I just looked it up....I have never heard of this. According to a study 490,000 cases of paralysis were caused by the oral polio vaccine from 2000-2017. Wow.
Yeah this is a known thing. That's why we don't vaccinate against polio but try to keep it out of the country.
The US still vaccinates against polio, but we don’t use the OPV anymore: https://www.cdc.gov/vaccines/vpd/polio/index.html

The OPV is still used in the few countries where there is polio in the wild because it does have advantages over the IPV.

Ah yes, thanks for the clarification.
Where the heck are you getting that 490,000 number from? The oral polio vaccine (aka OPV/Sabin) uses a weakened form of the live virus, which known to revert occasionally to virulent form.

Here’s what the WHO site says:

“Since 2000, more than 10 billion doses of OPV have been administered to nearly 3 billion children worldwide. As a result, more than 13 million cases of polio have been prevented, and the disease has been reduced by more than 99%. During that time, 24 cVDPV outbreaks occurred in 21 countries, resulting in fewer than 760 VDPV cases.”

https://www.who.int/news-room/q-a-detail/what-is-vaccine-der...

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6121585/

From article: We calculated the number of paralyzed children each year which exceeded the expected numbers (assuming a NPAFP rate of 2/100,000) and the results are displayed in Table 2. A total of 640,000 children developed NPAFP in the years 2000–2017, suggesting that there were an additional 491,000 paralyzed children above our expected numbers for children with NPAFP.

This is not a good paper and that number of 491,000 children is ludicrous.
Tendon rupture on and after flouroquinolone use is now a known thing. If you are prescribed them and you feel tendon tenderness then you are supposed to tell your doctor and they will prescribe something else. It doesn't happen to everyone though and some flouroquinolones are better than others (in terms of less side effects).

Tamiflu seems to work but reduces symptoms by 1-2 days basically. It may also blunt the overall disease impact in your body as well.

There will probably be meta studies on whether fast tracking vs the regular process are equivalent, worse or better than each other.

Tamiflu has always been a joke considering the 24h window you have to start using it for such little payoff. It's disturbing how much money is wasted on stockpiling it.
The 24 hour window isn't necessarily strict. It just takes longer to work after that.
It's worse than that. Because this is a vaccine, it means that everybody will take it, while healthy.

That means that the entire population will trade a 0.3% to 4% risk of death (depends on what study you go with, lower numbers seem to be more likely) for the unknown risk of the vaccine. Thus people better be sure there is no severe side effect, even if rare.

Those 4% are 0.04% for some and 40% for others. Now the question is, if you're young and healthy, do you prefer the virus or the untested vaccine?
I don't understand the connection between your experience with a fluoroquinolone and fast tracking. 9 years ago, most of the fluoroquinolone antibiotics had already been on the market for many years.
Yes. I am not keen on taking the FDA equivalent of the 737-MAX.
thank you for sharing your experience. i hope you feel better
Dengue fever vaccine is probably the best example. https://en.wikipedia.org/wiki/Dengvaxia_controversy

From https://news.ycombinator.com/item?id=22511832 :

> "The story of dengue vaccine development is a cautionary tale. The first time you get dengue is usually not too bad, but it can be deadly if you get it again. Part of that is hypothesized to be driven by your own immune system, which, once immunized against one strain, produces antibodies against it in the next infection. However, if it's a slightly different strain of dengue the second time around, the antibodies meant to neutralize the disease are believed to make the disease more virulent instead (antibody-dependent enhancement). The immune system makes it worse. So when a dengue vaccine that didn't fully immunize against all strains was developed (not deliberately, people tried to immunize against all strains but this is a case where less efficacy than expected made things worse), it didn't make things better. It ended up priming people to get dengue."

The numbers involved are just so hard to imagine. Even if we create a vaccine as safe as flu shot it will kill on the order of 1000 people worldwide (1:10m). We have to hope that they will be randomly distributed and not the first volunteers who take it...
There's also a good chance we might force this on people against their will (If the current panic is any indication.)
Look at the current death rates. Requiring a tested vaccine is a reasonable response. Requiring an untested vaccination is not something I see happening. I guess we could get to "you can't do certain things like go to large gatherings" if you don't have the vaccine or evidence of having had it.

Meanwhile, In the US 12.x k people at a minimum died of this in the last 7 days, doubling the previous total deaths. There's also a much higher death rate overall than in the past, many of those must be related to covid-19 [1]. If current trends follw, In another week the 25,000 total current deaths will double, in other words, 25,000 are on track to die of covid in a week. It's not just new york; from that same site, in the last 7 days new york's total went from 7k to 15k total cumulative deaths - new york is still doubling every week, even though they look to slow down.

The deadly statistics are fantastically interesting. NY itself had about 8k net new deaths the last week, the rest of the us had about 10k. Both are doubling on a weekly basis.

1. https://covidtracking.com/data/us-daily

For those who don't recognize the author, he is a well-known biochemist working in pharmaceuticals whose blogs are generally very well informed and well worth the read.

Also sometimes extremely funny. Read https://blogs.sciencemag.org/pipeline/archives/category/thin... for good examples of that.

I think Derek might object to being called a biochemist - he is actually an organic chemist by training.
Ah. Thanks for the correction.
I worry that the vaccine won't be effective. To stop this coronavirus we basically have to quarantine and stop human activity for a few months. We are already down that rabbit hole so we just need to stay the course and really isolate as much as we can. The govt is going to have to help people to get through the next 6 months.
So what happens when we end quarantine in 6 months? We'll just have a COVID epidemic 6 months from now. Isolation does not stop the spead, it only slows the spread.

As soon as isolation is lifted, whether that be in a month or 10 years, the spread will resume. Unless of course either a) herd immunity is developed or b) a vaccine is developed.

We've only ever eradicated one infectious disease in all of human history (smallpox) and we had a vaccine for that. See: https://www.historyofvaccines.org/index.php/content/articles...

Well, no, if you have enough isolation then the virus runs out of hosts. It goes extinct unless it can survive latently or in some other host species. If we are getting infected by bats consistently then we are in trouble.
That's wishful thinking. The virus will survive in Africa, or India, or many of the other places that are incapable or unwilling to enforcing a complete lockdown (many of these places are in the US itself).

As I mentioned above, we have only ever erradicated _one_ infectious disease in all of human history. The chances of COVID, with its highly infectious nature, being the second are quite slim.

Just like the first outbreak, all it takes is one person with the virus to start the whole process over again.

Yeah, it goes along with strong border control.

All international travel is going to be restricted for a very long time regardless of antibody and PCR tests.

This all started with one person, November 17th 2019. By mid March 2020 the world was shut down. So we literally have to be sure there are 0 cases in a country before it can unlock again. And before international travel can really begin again we need to be sure there are 0 cases in the world.

None of that really seems doable for all but the smallest countries. So the answer is herd immunity, either through contracting the virus, or via a vaccine.

This is the unfortunate truth many fail to see. At some point we will have to decide to do what we can for those at high risk, and try to go about our normal lives again. We can require masks in public, even ban truly large gatherings (hundred plus), keep the high risk isolated, but at some point, if we all stay isolated, there'll be repercussions beyond just the economy. How many new relationships have started in the last month? How will peoples mental state handle prolonged isolation?

The virus likely entered the US in early February, and in 2 months shut down the country. Literally one case will lead to another outbreak, we've already seen it happen.

On the off chance that China develops a working vaccine first, how could America ensure its safety?
The exact same way as with every other vaccine from any other country.
I don't know what inspired GP's question, but I think he's getting at the fact that China is known to be faking their numbers from the beginning of the outbreak to show how effective the leaders are in combating the virus. So, in reality, we have no idea whether their methods are successful or not. Same with a vaccine, if China reports an extremely effective vaccine, available immediately, invented thanks to Xi's vision and leadership; Then do we just start using it here in the US, or do we have another year of hiding in our houses while we run trials while the rest of the credulous world gets back to work?
"China is known to be faking their numbers"

I haven't seen an explanation of South Korea then. Are they faking their statistics too? If not, then China's reported stats don't seem so incredible.

Personally I haven't even seen a more detailed accusation than "China is faking their numbers [because they obviously are, they're China]" - that is, other than flat-Earth level "oh look at the mobile phone number cancellation data that's definitely trustworthy and definitely indicates people being erased".

Not to mention any attempts at quantifying what's the level of the alleged manipulation of the data. Is it suspected to be undercounted by an order of magnitude? Two orders? Three orders? Why?

It's Gordon Chang-style propaganda. Before this, it was china was faking their economic data. China was a house of cards about to collapse. I guess all the chinese made iphones, computers, everything was not real either.
Sorry, I do see I've been living in a shrinking echo chamber of the news seen by me and my shrinking list of contacts and I should have provided some sources, e.g.: https://www.bloomberg.com/news/articles/2020-04-01/china-con...

I happen to believe SK's report's (long explanation), I happen not to believe China's (looonger explanation), but my opinion really doesn't matter; US officials don't believe the China and that's before considering the US's response may have already been hampered by NIMBYism (https://www.snopes.com/fact-check/us-coronavirus-test/)

Trump said he doesn’t believe China numbers. And he probably knows the real numbers from the NSA.
I'd like to believe we will start mass manufacturing all promising candidates long before testing is complete.

The stakes are so high this time that it's important _as soon as_ testing results are deemed adequate, they can start distributing them, even if it means manufacturing stuff that doesn't ultimately pan out.

(unrelated to this but related to Bill), why are there so many people hating on Bill Gates when he talks about this virus and any prospects etc.? It's not like he's a plain celebrity, I mean he's in philanthropy etc, he's known for helping people with these kinds of issues. Just boggles my mind
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I haven't heard of anybody hating on Bill Gates lately. Do you have a link perhaps to show me some example of this because I don't know what you're talking about
Checkout reddits r/conspiracy for a quick and condensed glimpse into the current insanity.
It's absolutely insane.

There is a guy I know who thinks ID2020 is a secret plan of Bill Gates for giving everyone a chip and track everyone ( that's the conspiracy theory), based on some so called "Anon YouTube movies"

Instead of believing that Gates already had the experience with Ebola, to foresee that the world is not ready for a global pandemic.

His words literally were ( as a response):

> Forget it. Nothing will change my mind, bro.

It's absolutely nuts. Some of them also believe that 5G cause Corona and in chemtrails.

There is literally no logic that can change their mind, lol.

An article about the subject can be found here: https://www.thenewhumanitarian.org/news/2020/04/15/id2020-co...

and this is not a new subject for him. He has been thinking about this for many years. Needless to say it, he is also extremely intelligent.
> why are there so many people hating on Bill Gates when he talks about this virus and any prospects etc.?

Because Gates was what Zuckerburg is today. The real question is why are there so many Gates' supporters?

> I mean he's in philanthropy etc

Yes, following in Rockefeller's footsteps. "Philanthropy" is a PR move. Gates probably has the world's best PR team.

> Just boggles my mind

Probably because you don't come from a CS/tech background.

In 20 or 30 years, zuckerburg is going to set up a family "charity" and the masses will worship him as a saint. Setting up "family controlled charities" is probably the most effective PR move amongst the uber-wealthy. Building hospitals is another one. Donating to schools is another. These people didn't grow a conscious when they retired, they just bought a world class PR team.

He’s given $38 billion to his foundation so far, on track to eventually give close to $100 billion. What, exactly, is he getting in PR that’s possibly worth $38+ billion? He’s not even selling anything!

And his foundation’s charter even specifies that the money needs to be spent within 30 or so years of his death, meaning he doesn’t get the sort of immortality Carnegie/Rockefeller/Ford/Lilly did.

> He’s given $38 billion to his foundation so far, on track to eventually give close to $100 billion.

In other words, he gave himself the money via a tax protected vehicle? How noble.

> What, exactly, is he getting in PR that’s possibly worth $38+ billion?

He's not paying $38 billion. He still has it. That's the point. He's paying nothing for good press. Getting people to defend him for moving his money from one place to a tax protected sheltered and being praised for it. Kinda like how you are doing it.

> And his foundation’s charter even specifies that the money needs to be spent within 30 or so years of his death, meaning he doesn’t get the sort of immortality Carnegie/Rockefeller/Ford/Lilly did.

"Spent". You mean setting up other charities, scholarships, etc are set up.

You need to have some selection beforehand. There's not enough manufacturing capacity to go around.
Worse: a WHO official (apologies to trump supporters) said that you can’t divert much capacity because that risks causing outbreaks of other diseases. So have to create a lot of new capacity.
The history of rushed vaccines is not good. The first attempt at a polio vaccine was rushed through with inadequate safety measures and resulted in 40,000 children getting sick, some with permanent paralysis.

There are good reasons vaccines take years to be approved. I’m very worried we’ll see a repeat of historical mistakes in the current rush.

https://en.m.wikipedia.org/wiki/Cutter_Laboratories#The_Cutt...

Not to mention the social stigma if the 1st attempt goes wrong, potentially reducing people's inclination to get the vaccine.
No that it matters, but it wasn’t a safety issue with the vaccine, but a manufacturing issue. The vaccine was perfectly safe, it just wasn’t manufactured to the correct specification.
The method of manufacture is part of the FDA approval
Yes it is, but if it isn’t followed then you can’t blame the vaccine. Many other companies made the same vaccine using the same processes without issue. The Salk vaccine is very safe if manufactured to specification.
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I do wonder how effective and safe an old-fashioned inoculation could be in the absence of a vaccine.

A small quantity of the virus could be introduced to your leg where it is away from your lungs and bloodstream. Your body could fight the virus there.

That's a type of vaccine. If you want to figure out how safe and effective it is, you need to run a clinical trial. Same as amy other vaccine. If you got started now, you'd be running behind some of the other approaches that are already in clinical trials, so, um, get started fast?
Most likely very effective especially if you were to find a strain that didn’t make you seriously ill. Pity nobody seems interested in actually finding such a strain.
He discuses that in his blog. There are 2 types of such vaccines.

Live ones, that are exactly like you said, low infectious strain, and dead ones, where they kill the virus and it sometimes still produces correct antibodies.

there are several of such types of vaccines in development

I want to point out that 5 vaccines (out of 78) are in phase 1 trials (4 of those actively looking for volunteers, visit clinicaltrials.gov links below to see if you qualify):

1. mRNA-1273 (lipid nanoparticle encapsulated mRNA vaccine encoding S protein) by Moderna: https://clinicaltrials.gov/ct2/show/NCT04283461

2. Ad5-nCoV (Adenovirus type 5 vector that expresses S protein) by CanSino Biologicals: NCT04313127.

3. INO-4800 (DNA plasmid encoding S protein delivered by electroporation) by Inovio Pharmaceuticals: https://clinicaltrials.gov/ct2/show/record/NCT04336410

4. LV-SMENP-DC (Dendritic cell modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins; administered with antigen-specific cytotoxic T lymphocyte) by Shenzhen Geno-Immune Medical Institute: https://clinicaltrials.gov/ct2/show/NCT04276896

5. Pathogen-specific artificial antigen-presenting cell (aAPCs modified with lentiviral vector expressing synthetic minigene based on domains of selected viral proteins) by Shenzhen Geno-Immune Medical Institute: https://clinicaltrials.gov/ct2/show/NCT04299724

Ref: https://www.nature.com/articles/d41573-020-00073-5

> Roughly estimated, even a seasonal flu vaccine might kill about one out of every ten million recipients though such a reaction – we give it to everyone possible, though, because far more people will die if we don’t.

Yeah that’s frightening, but really true? I’ve never heard of a single person dying from the flu vaccine locally.