16 ms·

FDA Issuing Emergency Use Authorization for First Covid-19 Vaccine

207 points by simonpure 6y ago

ipnon 6y ago
What was the point in waiting? What was under the consideration for so long that the FDA needed to wait weeks or months after all of the data has been released?
- Fjolsvith 6y ago
  Election related.
  - rantwasp 6y ago
    i enjoy a conspiracy theory as much as the average joe, but this stuff is getting out if hand
    - Karupan 6y ago
      I used to enjoy harmless ones like aliens or flat earthers, but the ones in 2020 are just outright dangerous.
      - rantwasp 6y ago
        flat earthers were funny until we needed their help to flatten the curve
    - creddit 6y ago
      I highly doubt it's related to the election, but there is a "conspiracy theory" that is entirely plausible to me which is that the paternalistic leaders of the FDA/CDC believe that by taking longer to "validate" the data they are going to be better at convincing anti-vaxxers of the safety of the vaccine. The data analysis here is comically straightforward! This doesn't take 3wks! There's a reason the UK has already approved it! https://marginalrevolution.com/marginalrevolution/2020/12/how-badly-has-the-fda-been-lagging.html https://marginalrevolution.com/marginalrevolution/2020/12/ho...
  - DonHopkins 6y ago
    That's what people who don't believe in science and disdain listening to scientists claim.
    - tehjoker 6y ago
      Trump threatened to fire the FDA administrator unless he authorized it today. That's not the hallmark of a careful analysis. https://www.washingtonpost.com/health/2020/12/11/trump-stephen-hahn-fda-covid-vaccine/ https://www.washingtonpost.com/health/2020/12/11/trump-steph... From a personal perspective, I want a safe and effective vaccine as soon as anyone would. I do not want to be propagandized into taking something potentially dangerous just because it lets the business community make money. What I want is a careful, rigorous, and non-politicized decision making process before I can trust the output of an experimental process. This has clearly not happened.
      - ummonk 6y ago
        I hate Trump's bullying tactics as much as the next person, but let's be clear - the FDA had completed its data analysis and released it a few days ago, and then the advisory panel yesterday supported its endorsement. At this point it was clear the vaccine was safe and effective, and an EUA should be rapidly announced by the FDA, whether the Trump would pressure them or not.
        tehjoker 6y ago
        I don't understand then, why would the FDA need to be threatened? Wouldn't they try to move as fast as possible within the bounds of reason?
        macksd 6y ago
        Trump threatening someone does not imply they needed to be threatened.
        tehjoker 6y ago
  - aaomidi 6y ago
    With more platforms taking an anti misinformation stance I wonder if HN is planning to do the same? Even though we have a smaller reach.
- ummonk 6y ago
  They only released the data 3 days ago. Or are you talking about the marketing release of data, which needed to be properly analyzed?
  - ardit33 6y ago
    The application and data was submitted 3 weeks ago... it took 3 weeks for the FDA to drag their feet and just say the obvious... It is like the titanic is burning and these guys are playing violin...
    - roseway4 6y ago
      The FDA reran, in a matter of weeks, the entire analysis undertaken by Pfizer’s pharmacologists and statisticians over a series of months.
      - zaroth 6y ago
        To be fair, this was an extremely basic analysis on a relatively minuscule amount of data, where the form and format of data and the method of analysis has been prescribed months ago. There was no decision that shouldn’t have been made ahead of time. Either it met the predefined criteria or it didn’t.
        Retric 6y ago
        Regulators need to independently verify more than just raw calculations. The incentives to hide or falsify data can be enormous.
        zaroth 6y ago
        The only thing that couldn’t be verified until the last minute was the unblinded results. Everything else should have been a continuous process of pre-verification up to the point the 128 positive confirmed COVID cases were unblinded. Assume the unblinded results will be good enough, and verify everything else you would normally verify ahead of time. The only thing that remains is to verify the unblinded cases the day they are announced. And not just that but your approval thresholds should already be preset and preregistered, the doses already distributed to point-of-care, and nurses start administering shots the very next day. Yes it’s a big waste of money if it turns out not to work. That’s the whole point. Turns out the vaccine is highly effective 10 days after the first dose. We could have been doing at least a million doses a day since November 19th. Realistically even long before then.
- starpilot 6y ago
  They needed to wait months to see if the people who received vaccine did not get the virus, and that they also were not harmed by the vaccine. This isn't some binary instantaneous outcome.
  - koolba 6y ago
    They’re arguing about analyzing the data more quickly rather than spending three weeks analyzing it. There’s no additional data gleamed in that time period.
- ardit33 6y ago
  I was wondering as well... the data was submitted about 3 weeks ago... I understand that it is extensive data (for about 44,000 patients), but taking 3 weeks to compile/analyze seems excessive. They should have put in an army of analyzers into it... There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling.... The FDA should be treating this as a war effort, and not drag their feet into pointless bureaucratic 'safety' theater.
  - baskire 6y ago
    sadly those extra days gained would do little to even put a dent in that figure.
    - xyzzyz 6y ago
      Alas, UK managed to approve the same vaccine a week ago. A week of delay means extra 15-20 thousands of lives lost.
      - bigyikes 6y ago
        Also the sooner a vaccine is released, the sooner you can dampen the exponential growth, potentially compounding the lives saved. Not sure how significant of an effect this might be, though.
        addicted 6y ago
        We still don’t know if the vaccine prevents transmission. So that may not even be true.
        bigyikes 6y ago
        I didn’t know that, thanks! I guess I need to learn more about how vaccines work. I thought that vaccine implied immunity which implied that transmission is prevented.
        6y ago
- addicted 6y ago
  I’d question what was the point of rushing this out? The vaccines are gonna be supply constrained for a while. The same number of people will be vaccinated on Jan 31 (or the day before the next batch of vaccines become available) whether we start today or a few weeks from now. At this point the more important consideration should be not doing anything that might even slightly reduce public faith in the vaccine.
  - maxerickson 6y ago
    The first batch of Pfizer vaccine is enough to vaccinate a substantial portion of the vulnerable elderly (after vaccinating healthcare workers). Given that they are the ones that are dying at the highest rates, getting it deployed as fast as possible is likely to extend quite a few lives. It's not like they've executed well on your last point in the meantime.
  - nsgi 6y ago
    > The same number of people will be vaccinated on Jan 31 That could still mean a big difference in the number of deaths. Some of those people may die/become seriously ill before Jan 31 before the vaccine gets to them
    - lupire 6y ago
      Not a big difference. A few thousand. A drop in the bucket compared to the 250K and any more ahead killed because many Americans are making a religion of intentionally refusing to limit their spreading of the virus.
- scoopertrooper 6y ago
  What's the point in rushing? Production is already going at full speed and they're not yet ready to begin the vaccination programme. Rolling this thing out is going to be a massive operation given the delicate conditions it must be stored under and the coordination across thousands of health systems required. All the preparation work is well under way and the timing of this approval doesn't impact it in the slightest.
  - creddit 6y ago
    Yeah who cares about the lives being lost in the meantime?
    - scoopertrooper 6y ago
      My point was that none of the work required to prepare to begin the vaccinations was held up by the work of reviewing the studies and granting approval. Furthermore, how many lives would be lost if society didn't have confidence in the approval process and declined vaccination? Russia is suffering this exact problem at the moment. https://www.washingtonpost.com/world/europe/rusisia-vaccine-sputnik-interest/2020/12/10/005917fa-3702-11eb-9699-00d311f13d2d_story.html https://www.washingtonpost.com/world/europe/rusisia-vaccine-...
- _Microft 6y ago
  They did not 'wait'. The FDA needed the time to do their job. Contrary to what some people would like to believe government agencies are not rubber-stamping factories.
  - nottrobin 6y ago
    I know nothing about what goes into approving a vaccine, but I am genuinely curious how come the US FDA was a whole 10 days behind the UK in approving this, and were also beaten by Bahrain and Canada. Is it because they're genuinely more careful? Or is it just bureaucracy?
    - makomk 6y ago
      The UK was unusually aggressive in getting everything in place to roll out this vaccine early - not just the approval process, but other logistics as well. The FDA, on the other hand, was under pressure to delay approval for partisan election-related reasons; the press created the perception that approving the vaccine early would be an evil plot by Trump to win the election. If the trials had reached enough cases to return results earlier, the difference could've been really dramatic because those delaying tactics essentially imposed a minimum length of time the trial had to run for in a slightly stupid way.
Karupan 6y ago
This is good news for everyone. Countries which can’t afford to or don’t have the expertise to thoroughly test and review multiple vaccines can take a cue from the ones that have approved them. Supply is a different issue of course.
mchusma 6y ago
I hope they learned some lessons here and seek to accelerate lifting the ban on the Johnson & Johnson and Astrazeneca vaccines. Work they can do to get those approved in the next few weeks are what can end the pandemic in Q1. In the US, given by Feb, there will have been about 100M infected, It really only takes about 100M vaccines to hit herd immunity. Between Pfizer, Moderna, J&J and Astrazeneca it's reasonable to expect/demand 100M out by Feb. The FDA's approach of "moving slow to give confidence" cost lives and does not actually build confidence. Allowing this vaccine to be taken by the willing was among the easiest decisions ever made, and their pretending otherwise was absurd. It would have built more confidence if they said within 24 hours of the EUA filing "hey public, this was an easy call. We already looked at all this data over months, cut no corners. This isn't a borderline approval, this looks amazing."
- tppiotrowski 6y ago
  How are you arriving at 100M infected by February? The current case count is at around ~15M with ~250,000 cases being reported yesterday. To reach 100M by February you would need close to ~2M cases a day for every day between today (Dec 11th) and February 1st.
  - ceejayoz 6y ago
    https://www.npr.org/sections/coronavirus-live-updates/2020/11/26/939365087/government-model-suggests-u-s-covid-19-cases-could-be-approaching-100-million https://www.npr.org/sections/coronavirus-live-updates/2020/1... > The actual number of coronavirus infections in the U.S. reached nearly 53 million at the end of September and could be approaching 100 million now, according to a model developed by government researchers. > The model, created by scientists at the Centers for Disease Control and Prevention, calculated that the true number of infections is about eight times the reported number, which includes only the cases confirmed by a laboratory test.
  - ummonk 6y ago
    Infection count is a lot higher than case count. If you divide the number of deaths by an IFR of 1% you get 30 million infected so far, while with an IFR of 0.5% you get 60 million. There are probably half a million infections every day right now, so 100 million by February doesn't seem that far fetched. Though I see no reason to complain about the FDA dragging its feet, given that the bottleneck to vaccinating the populace is manufacturing, not authorization.
todipa 6y ago
How will the logistics work? Who gets access to this vaccine first?
- FlyMoreRockets 6y ago
  Generally, health care workers and those most at risk are being granted early access. From a public safety perspective, I wonder if perhaps those most likely to spread the disease should be the first to be innoculated rather than those most likely to have a bad outcome.
  - ed25519FUUU 6y ago
    I’ve heard this argument before, I’m still convinced that covering at-risk groups first is the best idea. Even if it still continues to spread for months, we can bring the deaths way down, and give our isolated elderly generation a much-needed opportunity to see family and friends.
    - dehrmann 6y ago
      > give our isolated elderly generation a much-needed opportunity to see family and friends There's concern that elderly people's weaker immune systems won't react as strongly to the vaccine, so it won't be as effective. https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone-dissenter-on-why-long-term-care-residents-shouldnt-receive-covid-19-vaccine-first/ https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone...
  - aphextron 6y ago
    >From a public safety perspective, I wonder if perhaps those most likely to spread the disease should be the first to be innoculated rather than those most likely to have a bad outcome. The argument is that the vaccine has not been proven to prevent infection and spread. Only to prevent severe disease in those who do get infected. So administering it to those with comorbidities, for now, is the most effective means of reducing overall mortality based on known evidence.
WalterGR 6y ago
"White House Reportedly Told FDA Head: Approve Vaccine Today Or Resign" https://www.forbes.com/sites/joewalsh/2020/12/11/white-house-reportedly-told-fda-head-approve-vaccine-today-or-resign/ https://www.forbes.com/sites/joewalsh/2020/12/11/white-house... I don't know which sources add new information (if any of these): https://www.cnbc.com/2020/12/11/white-house-threatens-to-fire-fda-chief-unless-covid-vaccine-oked-friday-report.html https://www.cnbc.com/2020/12/11/white-house-threatens-to-fir... https://www.independent.co.uk/news/world/americas/us-politics/covid-vaccine-white-house-fda-resign-b1770296.html https://www.independent.co.uk/news/world/americas/us-politic... https://www.cnn.com/2020/12/11/politics/white-house-fda-chief-approve-covid-vaccine-resign/index.html https://www.cnn.com/2020/12/11/politics/white-house-fda-chie...
- r00fus 6y ago
  Why now?
  - IfOnlyYouKnew 6y ago
    Because they were going to do it anyway, and this makes it look like Trump has something to do with it. It's the same mechanism I use to impress people with my ability to order cats to "come to me or don't, or... go scratch that couch".
ivraatiems 6y ago
The development of a vaccine of this apparent efficacy at this speed is an astonishing scientific achievement, and if it is as good as it appears to be, it is an immense moment for medical science. Plus, the way this vaccine works is absolutely fascinating: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different... In technical terms, it seems to me they're almost like unit testing for the body: You take out everything except the bit you care about most, and subject it to intense scrutiny until you develop a correct response.
- ed25519FUUU 6y ago
  First time in history when the entire world was working on a single problem.
  - deleted 6y ago
    [deleted]
  - zaroth 6y ago
    It took roughly 48 hours to develop the vaccine once China published the genetic sequence. The actual study design was nothing particularly impressive. This was by no means a “entire world” effort. I think the untold story of production and distribution could be interesting, but most of that is yet to be written.
    - chemeng 6y ago
      Agreed, we’ve never produced a vaccine of this type at scale nor managed the required supply chain considerations. Making 10K efficacious non-harmful vaccines for a trial may be much easier than making 100M or 1B. Some processes don’t scale easily.
    - divbzero 6y ago
      > The actual study design was nothing particularly impressive. Now that vaccines can be designed so quickly, I wonder what if anything can be done to speed up the testing of their safety and efficacy.
ElHacker 6y ago
This is great news! I'll definitely be in line to get it whenever my turn comes. A thing that keeps worrying me is the amount of people I've seen/chatted with (empirical evidence) that don't trust these vaccines. The most common comments they make are: "I don't want to be guinea pig", "How do I know the government won't control me", and more conspiracy theories. All of these fears seem to come from misinformation on the internet, friends and family get a ton of memes/fake news through WhatsApp highlighting the unproven negative effects of the vaccine. Is there any effective way to control the propagation of misinformation on these platforms? How would one even get started to tackle that problem?
- warent 6y ago
  I think the best we can do is lead by example in the short term, and in the long term investigate the failure of education systems that bring this about
  - lame-robot-hoax 6y ago
    This is what I think too. I try to do my best to talk to these people and alleviate their fears. But as well, I predict that as their family and friends and millions of people in general in front of them receive the vaccine, and end up fine, that it will change their mind. The vaccine will go from being spooky to no big deal.
- bt1a 6y ago
  Disinformation and the rise of computer generated audio, video, and images is going to make this problem even more challenging. I think we may need to come up with ways to sign audio, video, and images that guarantee that the media is captured naturally (or that the media hasn't been tampered with since it was spread by a certain entity). I also think we need to build back the public's trust in institutions. Once they deserve that trust. When anyone with any motive can spread content online that reaches thousands or millions without much of an editorial process, well... it's proven to be disrupting. These are very challenging problems.. I'm counting on Tristan Harris to bring us something.
xwdv 6y ago
I don’t get it. Earlier this year people were screaming this would be impossible. But here we are.
- ywhjaknskkkw 6y ago
  Because Orange man bad don't you know.
- hnracer 6y ago
  Trump was the POTUS, what did you expect from left-wing media?
- tssva 6y ago
  By early June Dr. Fauci was already predicting 200 million doses of a vaccine being available by either the end of the year or early 2021.
- deleted 6y ago
  [deleted]
wyxuan 6y ago
Would like to add that the adcom meeting that happened yesterday wasn't unanimous even though efficacy data was strong because of they were asked to approve it for 17 and 16 year olds as well even though the data for these age groups was lackluster. This likely didn't matter much to FDA because 16 and 17 year olds aren't likely to receive any doses before the full throated approval because they by and large aren't in the people first in line for the vax (1st line workers, vulnerable groups, old people).
- Exmoor 6y ago
  And the concerns about 16-17 weren't that it wasn't effective or safe, but that given that age group has a very low incidence of serious symptoms or death that the bar for risks needed to be much higher since they compromised a relatively small part of the study group.
- cwwc 6y ago
  Interestingly, this seems to also be the case with pregnant women (unless I’m missing something). I’m guessing they’ll be ahead of teens but still low enough in the priority scheme to mostly not receive it?
  - IfOnlyYouKnew 6y ago
    Pregnancy is a "generic" risk factor for any medical intervention, as is young age. There is no reason to believe the vaccine is particular harmful in these groups. But since it's eminently possible to avoid the risk by vaccinating most people around them, that option is (slightly) more attractive.
    - divbzero 6y ago
      The Society for Maternal-Fetal Medicine advocates for the inclusion of pregnant women in vaccine trials and just released a statement applauding FDA’s decision to allow pregnant women access to the vaccine. [1] [2] US FDA’s decision deviates from UK MHRA’s decision to hold off on finalizing their advice for women who are pregnant. [3] [1]: https://www.smfm.org/covidclinical https://www.smfm.org/covidclinical [2]: https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.pdf https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.p... [3]: https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age-pregnant-planning-a-pregnancy-or-breastfeeding https://www.gov.uk/government/publications/covid-19-vaccinat...
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Exmoor 6y ago
I know these threads tend to get bogged down with the various things all COVID related threads do these days, but let's just take a second to savor this moment. The mRNA vaccines were developed in days[0], using only the genetic sequence of the virus. Yes, testing took many months, but science solved what is typically the hard part of the problem overnight. Personally I'm hoping I get the mRNA vaccine not so much because they're currently the most effective, but because it will make me some small part of one of the most impactful scientific works of our lifetimes. We should be seeing another announcement in a week for the Moderna mRNA vaccine as well as their committee review is scheduled for 12/17. [0]https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...
- redisman 6y ago
  Pretty incredible and pretty surreal. I honestly wasn't sure how the utterly incompetent federal response of the US would ever dig itself out of this and I guess the answer is here.
- akkawwakka 6y ago
  It’s worth highlighting that a ton of basic science work went into mRNA vaccine development, starting in the early 1990s: - developing the lipid nanoparticles that the mRNA is delivered in, so your cells could actually take it up intact - figuring out how to get the mRNA to evade the immune system https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-...
  - Rebelgecko 6y ago
    Do you (or anyone else on HN) know why mRNA vaccines haven't been used before COVID? Are they more useful against coronavirii? Or is it just that existing vaccines are good enough, so no one has bothered releasing an mRNA vaccine for the mumps or whatever?
- dot1x 6y ago
  Wow... just wow. You got indoctrinated pretty good hum? You do realize this kind of vaccine never passed animal trials before COVID right? In fact, the company making it never had a successful product before COVID. Yet we're supposed to believe they magically solved the problem in a matter of weeks and all is perfect? Please, submit yourself to be a lab rat, but people like you are the reason why they will force everyone to get the vaccine, freedom be damned.
aberoham 6y ago
Best expert discussion by far, Dr Griffiths on TWiV — https://www.microbe.tv/twiv/twiv-692/ https://www.microbe.tv/twiv/twiv-692/
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jtwaleson 6y ago
Fun fact: most professionals and all official FDA documents use "FDA" and never "The FDA". It's a neat little shibboleth because it is so counterintuitive to omit "the". Use ctrl-f to find the pros in this thread ;)
- momothereal 6y ago
  That's the case with any government agency, right? Even in other countries.
  - jtwaleson 6y ago
    I don't know, but am really curious to find out the rationale! I just noticed it as I started working on FDA approval of a medical device this year and thought it was really odd.
    - garmaine 6y ago
      It’s not off. Sometime you grammatically need a “the”. Sometimes you don’t. Within an in-group, the definite article is often dropped just out of efficiency. We did the exact same thing at NASA when I worked there. When was the last time you heard someone say “The NASA”?
      - jtwaleson 6y ago
        Very interesting! I don't think that grammar is the issue here. "FDA" and "the FDA" are apparently used interchangeably no matter the sentence. With NASA, the difference is that no one spells out N.A.S.A., you say it as one word. With FDA, you spell it out. Please correct me if I'm wrong :)
        kgwgk 6y ago
        > "FDA" and "the FDA" are apparently used interchangeably no matter the sentence “Taxol gains quick FDA approval” “Taxol gains quick the FDA approval” “Three FDA officials say the drug's approval was warranted” “Three the FDA officials say the drug's approval was warranted”
TooCreative 6y ago
Should one do a corona antibody test before getting the vaccine? It does not make sense to get the vaccine if you already have the antibodies from a previous infection, right?
- gotaran 6y ago
  Fauci still recommends getting the vaccinated. It would lengthen your immunity.
  - dot1x 6y ago
    No it won't. Natural antibodies remain in your blood, vaccines need "booster" shots to remain active (if at all). Stop spreading misinformation.
  - tim333 6y ago
    Also the antibody test, at least the one I did, involves sticking a needle in you and paying money. If you are going to get stuck you may as well just stick vaccine in I figure.
blargmaster42_8 6y ago
Normal vaccine takes 10years to develop. Please list what steps was skipped to make this happen in 9 months.
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rapjr9 6y ago
Have any of the vaccines been tested on those actually dying of COVID-19? Would they be likely to have any effect on survival? Seems like those who are actively dying could potentially benefit the most from a vaccine rather than frontline medical workers and the elderly and should be given priority (if it helps). If a vaccine could prevent death then even with few doses available initially it seems possible that no more people would have to die at all (or many fewer). Thinking about this perhaps those who have already experienced organ damage may not be helped much. But perhaps if everyone who was hospitalized was immediately vaccinated the death rate would drop drastically. My guess (and it's just a guess) is that the phase III trials did not try to answer this question directly, and in fact may have excluded anyone who already had a COVID-19 diagnosis (the drug companies want to show maximum effectiveness which would mean vaccinating before being exposed to the disease). That does not mean it would not help prevent deaths in hospitalized cases though. If none of the early doses are given to those hospitalized then it could be a long time before we know the answer to this question. Probably as the vaccines become more widely distributed someone will try it. But trying it early could potentially save the most lives (again, if it works). However, maybe there are good reasons you don't vaccinate someone who already has a disease. Maybe it's a large burden on the body to ramp up the immune system in a different way when the body is already fighting off the infection? I don't know, but I'd like to see more public discussion of this. Here's one article I was able to find that suggests adverse reactions at least are unlikely (seems it's actually been tried a few times): "COVID-19 patients, those with antibodies too may be vaccinated, says Health Ministry" https://www.thehealthsite.com/news/covid-19-patients-those-with-antibodies-too-may-be-vaccinated-says-health-ministry-783571/ https://www.thehealthsite.com/news/covid-19-patients-those-w... Another thing I don't see being discussed much is that while the phase III trials involved tens of thousands of people, only a few hundred people who received the placebo exhibited COVID-19 as far as we know. It would seem that means the vaccines have really only been tried against the disease itself just a few hundred times (and found not to work for about ten of those few hundred). Even if you assume that 10x more people caught COVID-19 but had no symptoms or mild symptoms, that still means very few actual challenges of the vaccine against the disease. It does show that the vaccines are fairly safe since there were few adverse events in the tens of thousands vaccinated, but it does not really seem to show that the vaccines are actually widely effective. The NY Times has a good article about this: "2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean?" https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-e... So it seems possible the vaccines may be much less effective , we won't really know until many, many people are vaccinated. That's no reason not to get vaccinated since the safety seems good from the trials. But it could affect the future dramatically. I guess since we can't know until lots of people have been vaccinated, we just have to wait to find out, nothing more can be done. Presumably data will be being collected so someone (maybe not the public) will have an ongoing readout of effectiveness.

207 points by simonpure 6y ago

What was the point in waiting? What was under the consideration for so long that the FDA needed to wait weeks or months after all of the data has been released?

Fjolsvith 6y ago
Election related.
- rantwasp 6y ago
  i enjoy a conspiracy theory as much as the average joe, but this stuff is getting out if hand
  - Karupan 6y ago
    I used to enjoy harmless ones like aliens or flat earthers, but the ones in 2020 are just outright dangerous.
    - rantwasp 6y ago
      flat earthers were funny until we needed their help to flatten the curve
  - creddit 6y ago
    I highly doubt it's related to the election, but there is a "conspiracy theory" that is entirely plausible to me which is that the paternalistic leaders of the FDA/CDC believe that by taking longer to "validate" the data they are going to be better at convincing anti-vaxxers of the safety of the vaccine. The data analysis here is comically straightforward! This doesn't take 3wks! There's a reason the UK has already approved it! https://marginalrevolution.com/marginalrevolution/2020/12/how-badly-has-the-fda-been-lagging.html https://marginalrevolution.com/marginalrevolution/2020/12/ho...
- DonHopkins 6y ago
  That's what people who don't believe in science and disdain listening to scientists claim.
  - tehjoker 6y ago
    Trump threatened to fire the FDA administrator unless he authorized it today. That's not the hallmark of a careful analysis. https://www.washingtonpost.com/health/2020/12/11/trump-stephen-hahn-fda-covid-vaccine/ https://www.washingtonpost.com/health/2020/12/11/trump-steph... From a personal perspective, I want a safe and effective vaccine as soon as anyone would. I do not want to be propagandized into taking something potentially dangerous just because it lets the business community make money. What I want is a careful, rigorous, and non-politicized decision making process before I can trust the output of an experimental process. This has clearly not happened.
    - ummonk 6y ago
      I hate Trump's bullying tactics as much as the next person, but let's be clear - the FDA had completed its data analysis and released it a few days ago, and then the advisory panel yesterday supported its endorsement. At this point it was clear the vaccine was safe and effective, and an EUA should be rapidly announced by the FDA, whether the Trump would pressure them or not.
      - tehjoker 6y ago
        I don't understand then, why would the FDA need to be threatened? Wouldn't they try to move as fast as possible within the bounds of reason?
        macksd 6y ago
        Trump threatening someone does not imply they needed to be threatened.
        tehjoker 6y ago
- aaomidi 6y ago
  With more platforms taking an anti misinformation stance I wonder if HN is planning to do the same? Even though we have a smaller reach.
ummonk 6y ago
They only released the data 3 days ago. Or are you talking about the marketing release of data, which needed to be properly analyzed?
- ardit33 6y ago
  The application and data was submitted 3 weeks ago... it took 3 weeks for the FDA to drag their feet and just say the obvious... It is like the titanic is burning and these guys are playing violin...
  - roseway4 6y ago
    The FDA reran, in a matter of weeks, the entire analysis undertaken by Pfizer’s pharmacologists and statisticians over a series of months.
    - zaroth 6y ago
      To be fair, this was an extremely basic analysis on a relatively minuscule amount of data, where the form and format of data and the method of analysis has been prescribed months ago. There was no decision that shouldn’t have been made ahead of time. Either it met the predefined criteria or it didn’t.
      - Retric 6y ago
        Regulators need to independently verify more than just raw calculations. The incentives to hide or falsify data can be enormous.
        zaroth 6y ago
        The only thing that couldn’t be verified until the last minute was the unblinded results. Everything else should have been a continuous process of pre-verification up to the point the 128 positive confirmed COVID cases were unblinded. Assume the unblinded results will be good enough, and verify everything else you would normally verify ahead of time. The only thing that remains is to verify the unblinded cases the day they are announced. And not just that but your approval thresholds should already be preset and preregistered, the doses already distributed to point-of-care, and nurses start administering shots the very next day. Yes it’s a big waste of money if it turns out not to work. That’s the whole point. Turns out the vaccine is highly effective 10 days after the first dose. We could have been doing at least a million doses a day since November 19th. Realistically even long before then.
starpilot 6y ago
They needed to wait months to see if the people who received vaccine did not get the virus, and that they also were not harmed by the vaccine. This isn't some binary instantaneous outcome.
- koolba 6y ago
  They’re arguing about analyzing the data more quickly rather than spending three weeks analyzing it. There’s no additional data gleamed in that time period.
ardit33 6y ago
I was wondering as well... the data was submitted about 3 weeks ago... I understand that it is extensive data (for about 44,000 patients), but taking 3 weeks to compile/analyze seems excessive. They should have put in an army of analyzers into it... There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling.... The FDA should be treating this as a war effort, and not drag their feet into pointless bureaucratic 'safety' theater.
- baskire 6y ago
  sadly those extra days gained would do little to even put a dent in that figure.
  - xyzzyz 6y ago
    Alas, UK managed to approve the same vaccine a week ago. A week of delay means extra 15-20 thousands of lives lost.
    - bigyikes 6y ago
      Also the sooner a vaccine is released, the sooner you can dampen the exponential growth, potentially compounding the lives saved. Not sure how significant of an effect this might be, though.
      - addicted 6y ago
        We still don’t know if the vaccine prevents transmission. So that may not even be true.
        bigyikes 6y ago
        I didn’t know that, thanks! I guess I need to learn more about how vaccines work. I thought that vaccine implied immunity which implied that transmission is prevented.
        6y ago
addicted 6y ago
I’d question what was the point of rushing this out? The vaccines are gonna be supply constrained for a while. The same number of people will be vaccinated on Jan 31 (or the day before the next batch of vaccines become available) whether we start today or a few weeks from now. At this point the more important consideration should be not doing anything that might even slightly reduce public faith in the vaccine.
- maxerickson 6y ago
  The first batch of Pfizer vaccine is enough to vaccinate a substantial portion of the vulnerable elderly (after vaccinating healthcare workers). Given that they are the ones that are dying at the highest rates, getting it deployed as fast as possible is likely to extend quite a few lives. It's not like they've executed well on your last point in the meantime.
- nsgi 6y ago
  > The same number of people will be vaccinated on Jan 31 That could still mean a big difference in the number of deaths. Some of those people may die/become seriously ill before Jan 31 before the vaccine gets to them
  - lupire 6y ago
    Not a big difference. A few thousand. A drop in the bucket compared to the 250K and any more ahead killed because many Americans are making a religion of intentionally refusing to limit their spreading of the virus.
scoopertrooper 6y ago
What's the point in rushing? Production is already going at full speed and they're not yet ready to begin the vaccination programme. Rolling this thing out is going to be a massive operation given the delicate conditions it must be stored under and the coordination across thousands of health systems required. All the preparation work is well under way and the timing of this approval doesn't impact it in the slightest.
- creddit 6y ago
  Yeah who cares about the lives being lost in the meantime?
  - scoopertrooper 6y ago
    My point was that none of the work required to prepare to begin the vaccinations was held up by the work of reviewing the studies and granting approval. Furthermore, how many lives would be lost if society didn't have confidence in the approval process and declined vaccination? Russia is suffering this exact problem at the moment. https://www.washingtonpost.com/world/europe/rusisia-vaccine-sputnik-interest/2020/12/10/005917fa-3702-11eb-9699-00d311f13d2d_story.html https://www.washingtonpost.com/world/europe/rusisia-vaccine-...
_Microft 6y ago
They did not 'wait'. The FDA needed the time to do their job. Contrary to what some people would like to believe government agencies are not rubber-stamping factories.
- nottrobin 6y ago
  I know nothing about what goes into approving a vaccine, but I am genuinely curious how come the US FDA was a whole 10 days behind the UK in approving this, and were also beaten by Bahrain and Canada. Is it because they're genuinely more careful? Or is it just bureaucracy?
  - makomk 6y ago
    The UK was unusually aggressive in getting everything in place to roll out this vaccine early - not just the approval process, but other logistics as well. The FDA, on the other hand, was under pressure to delay approval for partisan election-related reasons; the press created the perception that approving the vaccine early would be an evil plot by Trump to win the election. If the trials had reached enough cases to return results earlier, the difference could've been really dramatic because those delaying tactics essentially imposed a minimum length of time the trial had to run for in a slightly stupid way.

Karupan 6y ago

This is good news for everyone. Countries which can’t afford to or don’t have the expertise to thoroughly test and review multiple vaccines can take a cue from the ones that have approved them. Supply is a different issue of course.

mchusma 6y ago

I hope they learned some lessons here and seek to accelerate lifting the ban on the Johnson & Johnson and Astrazeneca vaccines. Work they can do to get those approved in the next few weeks are what can end the pandemic in Q1. In the US, given by Feb, there will have been about 100M infected, It really only takes about 100M vaccines to hit herd immunity. Between Pfizer, Moderna, J&J and Astrazeneca it's reasonable to expect/demand 100M out by Feb. The FDA's approach of "moving slow to give confidence" cost lives and does not actually build confidence. Allowing this vaccine to be taken by the willing was among the easiest decisions ever made, and their pretending otherwise was absurd. It would have built more confidence if they said within 24 hours of the EUA filing "hey public, this was an easy call. We already looked at all this data over months, cut no corners. This isn't a borderline approval, this looks amazing."

tppiotrowski 6y ago
How are you arriving at 100M infected by February? The current case count is at around ~15M with ~250,000 cases being reported yesterday. To reach 100M by February you would need close to ~2M cases a day for every day between today (Dec 11th) and February 1st.
- ceejayoz 6y ago
  https://www.npr.org/sections/coronavirus-live-updates/2020/11/26/939365087/government-model-suggests-u-s-covid-19-cases-could-be-approaching-100-million https://www.npr.org/sections/coronavirus-live-updates/2020/1... > The actual number of coronavirus infections in the U.S. reached nearly 53 million at the end of September and could be approaching 100 million now, according to a model developed by government researchers. > The model, created by scientists at the Centers for Disease Control and Prevention, calculated that the true number of infections is about eight times the reported number, which includes only the cases confirmed by a laboratory test.
- ummonk 6y ago
  Infection count is a lot higher than case count. If you divide the number of deaths by an IFR of 1% you get 30 million infected so far, while with an IFR of 0.5% you get 60 million. There are probably half a million infections every day right now, so 100 million by February doesn't seem that far fetched. Though I see no reason to complain about the FDA dragging its feet, given that the bottleneck to vaccinating the populace is manufacturing, not authorization.

todipa 6y ago

How will the logistics work? Who gets access to this vaccine first?

FlyMoreRockets 6y ago
Generally, health care workers and those most at risk are being granted early access. From a public safety perspective, I wonder if perhaps those most likely to spread the disease should be the first to be innoculated rather than those most likely to have a bad outcome.
- ed25519FUUU 6y ago
  I’ve heard this argument before, I’m still convinced that covering at-risk groups first is the best idea. Even if it still continues to spread for months, we can bring the deaths way down, and give our isolated elderly generation a much-needed opportunity to see family and friends.
  - dehrmann 6y ago
    > give our isolated elderly generation a much-needed opportunity to see family and friends There's concern that elderly people's weaker immune systems won't react as strongly to the vaccine, so it won't be as effective. https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone-dissenter-on-why-long-term-care-residents-shouldnt-receive-covid-19-vaccine-first/ https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone...
- aphextron 6y ago
  >From a public safety perspective, I wonder if perhaps those most likely to spread the disease should be the first to be innoculated rather than those most likely to have a bad outcome. The argument is that the vaccine has not been proven to prevent infection and spread. Only to prevent severe disease in those who do get infected. So administering it to those with comorbidities, for now, is the most effective means of reducing overall mortality based on known evidence.

WalterGR 6y ago

"White House Reportedly Told FDA Head: Approve Vaccine Today Or Resign" https://www.forbes.com/sites/joewalsh/2020/12/11/white-house-reportedly-told-fda-head-approve-vaccine-today-or-resign/ https://www.forbes.com/sites/joewalsh/2020/12/11/white-house... I don't know which sources add new information (if any of these): https://www.cnbc.com/2020/12/11/white-house-threatens-to-fire-fda-chief-unless-covid-vaccine-oked-friday-report.html https://www.cnbc.com/2020/12/11/white-house-threatens-to-fir... https://www.independent.co.uk/news/world/americas/us-politics/covid-vaccine-white-house-fda-resign-b1770296.html https://www.independent.co.uk/news/world/americas/us-politic... https://www.cnn.com/2020/12/11/politics/white-house-fda-chief-approve-covid-vaccine-resign/index.html https://www.cnn.com/2020/12/11/politics/white-house-fda-chie...

r00fus 6y ago
Why now?
- IfOnlyYouKnew 6y ago
  Because they were going to do it anyway, and this makes it look like Trump has something to do with it. It's the same mechanism I use to impress people with my ability to order cats to "come to me or don't, or... go scratch that couch".

ivraatiems 6y ago

The development of a vaccine of this apparent efficacy at this speed is an astonishing scientific achievement, and if it is as good as it appears to be, it is an immense moment for medical science. Plus, the way this vaccine works is absolutely fascinating: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different... In technical terms, it seems to me they're almost like unit testing for the body: You take out everything except the bit you care about most, and subject it to intense scrutiny until you develop a correct response.

ed25519FUUU 6y ago
First time in history when the entire world was working on a single problem.
- deleted 6y ago
  [deleted]
- zaroth 6y ago
  It took roughly 48 hours to develop the vaccine once China published the genetic sequence. The actual study design was nothing particularly impressive. This was by no means a “entire world” effort. I think the untold story of production and distribution could be interesting, but most of that is yet to be written.
  - chemeng 6y ago
    Agreed, we’ve never produced a vaccine of this type at scale nor managed the required supply chain considerations. Making 10K efficacious non-harmful vaccines for a trial may be much easier than making 100M or 1B. Some processes don’t scale easily.
  - divbzero 6y ago
    > The actual study design was nothing particularly impressive. Now that vaccines can be designed so quickly, I wonder what if anything can be done to speed up the testing of their safety and efficacy.

ElHacker 6y ago

This is great news! I'll definitely be in line to get it whenever my turn comes. A thing that keeps worrying me is the amount of people I've seen/chatted with (empirical evidence) that don't trust these vaccines. The most common comments they make are: "I don't want to be guinea pig", "How do I know the government won't control me", and more conspiracy theories. All of these fears seem to come from misinformation on the internet, friends and family get a ton of memes/fake news through WhatsApp highlighting the unproven negative effects of the vaccine. Is there any effective way to control the propagation of misinformation on these platforms? How would one even get started to tackle that problem?

warent 6y ago
I think the best we can do is lead by example in the short term, and in the long term investigate the failure of education systems that bring this about
- lame-robot-hoax 6y ago
  This is what I think too. I try to do my best to talk to these people and alleviate their fears. But as well, I predict that as their family and friends and millions of people in general in front of them receive the vaccine, and end up fine, that it will change their mind. The vaccine will go from being spooky to no big deal.
bt1a 6y ago
Disinformation and the rise of computer generated audio, video, and images is going to make this problem even more challenging. I think we may need to come up with ways to sign audio, video, and images that guarantee that the media is captured naturally (or that the media hasn't been tampered with since it was spread by a certain entity). I also think we need to build back the public's trust in institutions. Once they deserve that trust. When anyone with any motive can spread content online that reaches thousands or millions without much of an editorial process, well... it's proven to be disrupting. These are very challenging problems.. I'm counting on Tristan Harris to bring us something.

xwdv 6y ago

I don’t get it. Earlier this year people were screaming this would be impossible. But here we are.

ywhjaknskkkw 6y ago
Because Orange man bad don't you know.
hnracer 6y ago
Trump was the POTUS, what did you expect from left-wing media?
tssva 6y ago
By early June Dr. Fauci was already predicting 200 million doses of a vaccine being available by either the end of the year or early 2021.
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wyxuan 6y ago

Would like to add that the adcom meeting that happened yesterday wasn't unanimous even though efficacy data was strong because of they were asked to approve it for 17 and 16 year olds as well even though the data for these age groups was lackluster. This likely didn't matter much to FDA because 16 and 17 year olds aren't likely to receive any doses before the full throated approval because they by and large aren't in the people first in line for the vax (1st line workers, vulnerable groups, old people).

Exmoor 6y ago
And the concerns about 16-17 weren't that it wasn't effective or safe, but that given that age group has a very low incidence of serious symptoms or death that the bar for risks needed to be much higher since they compromised a relatively small part of the study group.
cwwc 6y ago
Interestingly, this seems to also be the case with pregnant women (unless I’m missing something). I’m guessing they’ll be ahead of teens but still low enough in the priority scheme to mostly not receive it?
- IfOnlyYouKnew 6y ago
  Pregnancy is a "generic" risk factor for any medical intervention, as is young age. There is no reason to believe the vaccine is particular harmful in these groups. But since it's eminently possible to avoid the risk by vaccinating most people around them, that option is (slightly) more attractive.
  - divbzero 6y ago
    The Society for Maternal-Fetal Medicine advocates for the inclusion of pregnant women in vaccine trials and just released a statement applauding FDA’s decision to allow pregnant women access to the vaccine. [1] [2] US FDA’s decision deviates from UK MHRA’s decision to hold off on finalizing their advice for women who are pregnant. [3] [1]: https://www.smfm.org/covidclinical https://www.smfm.org/covidclinical [2]: https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.pdf https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.p... [3]: https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age-pregnant-planning-a-pregnancy-or-breastfeeding https://www.gov.uk/government/publications/covid-19-vaccinat...

deleted 6y ago

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Exmoor 6y ago

I know these threads tend to get bogged down with the various things all COVID related threads do these days, but let's just take a second to savor this moment. The mRNA vaccines were developed in days[0], using only the genetic sequence of the virus. Yes, testing took many months, but science solved what is typically the hard part of the problem overnight. Personally I'm hoping I get the mRNA vaccine not so much because they're currently the most effective, but because it will make me some small part of one of the most impactful scientific works of our lifetimes. We should be seeing another announcement in a week for the Moderna mRNA vaccine as well as their committee review is scheduled for 12/17. [0]https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...

redisman 6y ago
Pretty incredible and pretty surreal. I honestly wasn't sure how the utterly incompetent federal response of the US would ever dig itself out of this and I guess the answer is here.
akkawwakka 6y ago
It’s worth highlighting that a ton of basic science work went into mRNA vaccine development, starting in the early 1990s: - developing the lipid nanoparticles that the mRNA is delivered in, so your cells could actually take it up intact - figuring out how to get the mRNA to evade the immune system https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-...
- Rebelgecko 6y ago
  Do you (or anyone else on HN) know why mRNA vaccines haven't been used before COVID? Are they more useful against coronavirii? Or is it just that existing vaccines are good enough, so no one has bothered releasing an mRNA vaccine for the mumps or whatever?
dot1x 6y ago
Wow... just wow. You got indoctrinated pretty good hum? You do realize this kind of vaccine never passed animal trials before COVID right? In fact, the company making it never had a successful product before COVID. Yet we're supposed to believe they magically solved the problem in a matter of weeks and all is perfect? Please, submit yourself to be a lab rat, but people like you are the reason why they will force everyone to get the vaccine, freedom be damned.

aberoham 6y ago

Best expert discussion by far, Dr Griffiths on TWiV — https://www.microbe.tv/twiv/twiv-692/ https://www.microbe.tv/twiv/twiv-692/

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jtwaleson 6y ago

Fun fact: most professionals and all official FDA documents use "FDA" and never "The FDA". It's a neat little shibboleth because it is so counterintuitive to omit "the". Use ctrl-f to find the pros in this thread ;)

momothereal 6y ago
That's the case with any government agency, right? Even in other countries.
- jtwaleson 6y ago
  I don't know, but am really curious to find out the rationale! I just noticed it as I started working on FDA approval of a medical device this year and thought it was really odd.
  - garmaine 6y ago
    It’s not off. Sometime you grammatically need a “the”. Sometimes you don’t. Within an in-group, the definite article is often dropped just out of efficiency. We did the exact same thing at NASA when I worked there. When was the last time you heard someone say “The NASA”?
    - jtwaleson 6y ago
      Very interesting! I don't think that grammar is the issue here. "FDA" and "the FDA" are apparently used interchangeably no matter the sentence. With NASA, the difference is that no one spells out N.A.S.A., you say it as one word. With FDA, you spell it out. Please correct me if I'm wrong :)
      - kgwgk 6y ago
        > "FDA" and "the FDA" are apparently used interchangeably no matter the sentence “Taxol gains quick FDA approval” “Taxol gains quick the FDA approval” “Three FDA officials say the drug's approval was warranted” “Three the FDA officials say the drug's approval was warranted”

TooCreative 6y ago

Should one do a corona antibody test before getting the vaccine? It does not make sense to get the vaccine if you already have the antibodies from a previous infection, right?

gotaran 6y ago
Fauci still recommends getting the vaccinated. It would lengthen your immunity.
- dot1x 6y ago
  No it won't. Natural antibodies remain in your blood, vaccines need "booster" shots to remain active (if at all). Stop spreading misinformation.
- tim333 6y ago
  Also the antibody test, at least the one I did, involves sticking a needle in you and paying money. If you are going to get stuck you may as well just stick vaccine in I figure.

blargmaster42_8 6y ago

Normal vaccine takes 10years to develop. Please list what steps was skipped to make this happen in 9 months.

deleted 6y ago

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rapjr9 6y ago

Have any of the vaccines been tested on those actually dying of COVID-19? Would they be likely to have any effect on survival? Seems like those who are actively dying could potentially benefit the most from a vaccine rather than frontline medical workers and the elderly and should be given priority (if it helps). If a vaccine could prevent death then even with few doses available initially it seems possible that no more people would have to die at all (or many fewer). Thinking about this perhaps those who have already experienced organ damage may not be helped much. But perhaps if everyone who was hospitalized was immediately vaccinated the death rate would drop drastically. My guess (and it's just a guess) is that the phase III trials did not try to answer this question directly, and in fact may have excluded anyone who already had a COVID-19 diagnosis (the drug companies want to show maximum effectiveness which would mean vaccinating before being exposed to the disease). That does not mean it would not help prevent deaths in hospitalized cases though. If none of the early doses are given to those hospitalized then it could be a long time before we know the answer to this question. Probably as the vaccines become more widely distributed someone will try it. But trying it early could potentially save the most lives (again, if it works). However, maybe there are good reasons you don't vaccinate someone who already has a disease. Maybe it's a large burden on the body to ramp up the immune system in a different way when the body is already fighting off the infection? I don't know, but I'd like to see more public discussion of this. Here's one article I was able to find that suggests adverse reactions at least are unlikely (seems it's actually been tried a few times): "COVID-19 patients, those with antibodies too may be vaccinated, says Health Ministry" https://www.thehealthsite.com/news/covid-19-patients-those-with-antibodies-too-may-be-vaccinated-says-health-ministry-783571/ https://www.thehealthsite.com/news/covid-19-patients-those-w... Another thing I don't see being discussed much is that while the phase III trials involved tens of thousands of people, only a few hundred people who received the placebo exhibited COVID-19 as far as we know. It would seem that means the vaccines have really only been tried against the disease itself just a few hundred times (and found not to work for about ten of those few hundred). Even if you assume that 10x more people caught COVID-19 but had no symptoms or mild symptoms, that still means very few actual challenges of the vaccine against the disease. It does show that the vaccines are fairly safe since there were few adverse events in the tens of thousands vaccinated, but it does not really seem to show that the vaccines are actually widely effective. The NY Times has a good article about this: "2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean?" https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-e... So it seems possible the vaccines may be much less effective , we won't really know until many, many people are vaccinated. That's no reason not to get vaccinated since the safety seems good from the trials. But it could affect the future dramatically. I guess since we can't know until lots of people have been vaccinated, we just have to wait to find out, nothing more can be done. Presumably data will be being collected so someone (maybe not the public) will have an ongoing readout of effectiveness.