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United States Government Medicine

FDA Approves Pfizer/BioNTech Covid-19 Vaccine For Emergency Use in America (theverge.com) 222

Posted by EditorDavid from the it's-official dept.
Friday night America's Food and Drug Administration finally authorized Pfizer and BioNTech's coronavirus vaccine for emergency use in the United States, reports CNN.

The Verge calls it "a landmark moment in the fight to suppress a virus that has killed nearly 300,000 people in the United States and sickened tens of millions around the world." The vaccine is authorized in the U.S. for people over the age of 16. It was found to be 95 percent effective at preventing symptomatic COVID-19 in clinical trials. "That is extraordinary," Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said in a press conference at the end of November. It's far better than experts had dared hope for. The FDA was prepared to authorize a vaccine as long as it was at least 50 percent effective. "We were shocked," Pfizer's chief executive officer, Albert Bourla, told The New York Times. "We couldn't believe it."

The shot appears to protect people against the most severe forms of the disease. It is also highly effective in people over the age of 65, who are particularly vulnerable to COVID-19. Scientists will continue to monitor the vaccine after it's deployed to see how well it works in the real world.... The Pfizer and BioNTech vaccine has already been authorized by regulatory authorities in the United Kingdom, Canada, and Bahrain.

The authorizations of this vaccine, which have come less than a year after development began, shatter the record for the fastest vaccine developed. The record was previously held by the mumps vaccine, which took four years.
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FDA Approves Pfizer/BioNTech Covid-19 Vaccine For Emergency Use in America More

FDA Approves Pfizer/BioNTech Covid-19 Vaccine For Emergency Use in America

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  • Read the FDA's announcement here (Score:5, Informative)

    by EditorDavid ( 4512125 ) Works for Slashdot on Friday December 11, 2020 @11:02PM (#60821498)
    Here's the complete official text of the agency's announcement [fda.gov] if you want to read it in its full glory.
    • Thanks, Editor David, for the link.

      What does "95 percent effective" mean? What happened to the other 5 percent?

      • What does "95 percent effective" mean?

        It means the vaccinated group had 95% fewer infections than the placebo group.

        So, for example, you vaccinate 10,000 people and give placebos to 10,000 more and 200 people in the placebo group get sick, you would expect 10 people in the vaccine group to get sick.

        What happened to the other 5 percent?

        There is no "other 5%". What there is is R*5% where R is the expected infection rate without the vaccine. But since R is small, that is way less than 5%.

        Vaccinated people who do get sick appear to have mostly mild cases with quick recoveries.

      • Whatever didn't kill the virus in them, made it stronger.

      • Thanks, Editor David, for the link. What does "95 percent effective" mean? What happened to the other 5 percent?

        You can look it up, but the other 5 percent did end up catching the virus. Not one of them however, became seriously ill.

    • Re: (Score:2)

      by Qwertie ( 797303 )

      I've been wondering why the FDA has been bizarrely slow [thedispatch.com] at approving this vaccine which is already being administered to UK residents [cnn.com] and was approved by Canadian authorities 3 days ago. [www.cbc.ca]

      Problems with FDA red tape became apparent in February [independent.co.uk], were widely reported by March (while problems with defective test kits became apparent [washingtonpost.com]), and continued being obstinate throughout the year, e.g. blocking efforts at at-home testing backed by Bill Gates [reuters.com]. So I'm wondering (1) why the FDA behaves this way and (2) why t

  • Probably won't see this until July at the very earliest. Winter is probably more realistic.

    • Probably won't see this until July at the very earliest. Winter is probably more realistic.

      Pfizer says they will have 50 million doses by the end of the year, 20 days from today. They are still ramping up production.

      More vaccines from other manufacturers are already being mass-produced in expectation of approval.

      There are huge financial incentives to push these programs forward quickly.

      • Pfizer says they will have 50 million doses by the end of the year, 20 days from today.

        50 million doses isn't enough to vaccinate 10% of the US population. Remember that each person needs 2 doses.

        They didn't just start manufacturing. Those 50 million doses will have taken many weeks (if not months) to manufacture.

        • Not just to manufacture - we still need to distribute them to medical facilities, and then get people through the doors to get both doses.

          We're having to build the distribution network, because it has to be a robust cold-chain (especially for Pfizer's) that can handle volume. Something like that doesn't exist currently.

          I hope I'm wrong, but I wouldn't be surprised if 40% of the population refuses to get vaccinated. We'll need to wait until 25-50% of them catch it and have a natural immunity before we'll be

      • I think your optimism is very much misplaced.

        Pfizer says they will have 50 million doses by the end of the year...

        Which is what they say, and not what will happen. Not like a company has ever issued an overly rosy forecast for anything....And their distribution is the hardest, because it needs to be the coldest.

        And more importantly, because people need to get two doses, that's enough to vaccinate less than 25m people. I say less than, because not all will get the second dose for various reasons.

        25m people is less than 10% of the number we need to reach the tipping point wher

        • Which is what they say, and not what will happen. Not like a company has ever issued an overly rosy forecast for anything....And their distribution is the hardest, because it needs to be the coldest.

          Imagine if this goes like nvidia's Ampere launch. Sorry about the shortages, it's al unexpected demand guys!

    • That's about what I figure. I'll use my "reverse privilege" (white, male, and rural) to let many others go first and see what the side effects really are.

      Given the difficulty of the super cold shipping of this version, it will probably be the Moderna vaccine anyway.

    • Probably won't see this until July at the very earliest. Winter is probably more realistic.

      The Johnson & Johnson vaccine (assuming it is safe) will be the one most of us get. They are already ramping up production, plan on producing a billion doses in the next year, and (assuming it is safe) should be approved around February.

      Also, it's only a single dose so if you don't like injections, it's twice as good.

    • Re: (Score:2)

      by k6mfw ( 1182893 )
      Reminds me earlier this year when the first groups to get covid-19 tests were major sports teams and celebrities.

    • Re: (Score:2)

      by hey! ( 33014 )

      Winter is a little more pessimistic than experts like Fauci are suggesting; don't forget that when summer arrives we'll have three or four approved vaccines domestically, and probably twice that number will be in use around the world.

      Their big concern for the latter half of 2021 is vaccine refusal.

      Still, it's quite possible that we may see delays as unexpected side effects are found for some vaccines. That's not unheard of, so it's conceivable that the mRNA vaccines might, if we're very unlucky, get with

  • How many doses can they make in a month? (Score:3)

    by khchung ( 462899 ) on Saturday December 12, 2020 @12:08AM (#60821646) Journal

    And how many goes to the US?

    There are roughly 330 million people in the US. General estimate of 60% immunity is needed to bring R0 to less than 1 without lockdown measures.

    How many months until 200 million people in the US got vaccinated? And how many thousands will die until then, with the daily death count just broke 3000?

    • Re:How many doses can they make in a month? (Score:4, Interesting)

      by gravewax ( 4772409 ) on Saturday December 12, 2020 @01:28AM (#60821804)
      Given such a large portion of the US is anti Science or believe Covid is a hoax/scam/conspiracy I would be surprised if the US ever reaches 60%
      • Scientists per capita, and STEM degree holders per capita is larger than any other nation.

        • Re: (Score:2)

          by ghoul ( 157158 )
          A lot of people who would be considered crackpots in other countries are counted as scientists over here.

      • There are MANY Americans who think that the reaction to COVID-19 is excessive, that the policies which are wrapped in a cloak of "science" are in fact not scientific at all, and that many of the policies involving school closures and lockdowns have more politics to them than science-backed sound public safety policy.

        This is NOT the same thing as denying that COVID-19 exists, though some people find it politically convenient to pretend that these two different ideas are one idea.

        People who believe the disea

        • Re: (Score:3)

          by Whibla ( 210729 )

          There are MANY Americans who think that the reaction to COVID-19 is excessive, that the policies which are wrapped in a cloak of "science" are in fact not scientific at all, and that many of the policies involving school closures and lockdowns have more politics to them than science-backed sound public safety policy.

          When a politician says "we're following the science" it's not as a justification for their actions, it's a means of deflecting the blame should their policies turn out to be incorrect. "Well, don't blame me, blame those pesky scientists..."

          If we were truly interested in the Science,

          We'd be the first to admit that it's not clear. Within the scientific and medical community there are numerous different opinions, even if they're rooted in the same evidence. Ironically this is why politicians, politics even, exist. To make the final decision. That most

        • I wish I had mod point for you. Good post.
        • Contrary to some other replies to your post, I don't think it deserves much higher moderation. If you never understood that closing schools was about cutting infection chains and not protecting schoolchildren, you lack insight. Between 1/6 and 1/10 of the workforce is employed in schools and related functions. Your post indeed expresses the thoughts of many who don't agree with the counter measures, and who don't have the capacity of desire to understand what's going on.

      • Despite all the noise antivaxxers get, the USA still has +90% vaccination rate for MMR. (In some parts of the Bay Area the rate is below 50%, though).

    • Re:How many doses can they make in a month? (Score:5, Insightful)

      by mlyle ( 148697 ) on Saturday December 12, 2020 @01:37AM (#60821816)

      Much less than 60% immunized may be necessary.

      1. https://www.cdc.gov/coronaviru... [cdc.gov] About 53 million infected already. (~15%)
      2. 1-1/R0 assumes uniform susceptibility and contact graphs. More detailed modelling suggested that herd immunity thresholds from natural infection (which preferentially infects the most susceptible and connected) may be like 25%. Of course, vaccination will not cluster quite the same, but it will focus on those most likely to die and people closer to the middle of the contact networks for awhile.
      3. Measures short of lockdown lower Rt. I suspect a lot of us are going to be careful for quite some time.

      I believe 20% vaccinated will change the game significantly, and we should be able to be there before late January. Biggest wildcard is whether people get completely reckless (undermining #3) once the vaccine is available but before they are protected.

      • What evidence do you base you "20% vaccination being useful" statement on? 70-80% is "normal" best case scenario figures, even adding your 15% and 20%, you are not even half that. Not that you could add them anyway, as that assumes only people who have not had it, will get a vaccine, which is not going to be the case.

        If Americans were not anti mask and anti lockdown, you may have a point, but they are anti-useful measures, so immunity figures need to be higher, not lower.

        Pretending things will "be alright"

    • Optimistically, we'll have a critical mass of Americans vaccinated by June. The death toll will probably be rather grim at least until March. Expect the total number of deaths to roughly double between now and the point where the pandemic will be "over", so maybe 600K dead Americans. This assumes nothing goes seriously wrong. Of course, if it was politically feasible to impose a hard lockdown then we could be done in a month.

  • as proven by due process in the FDA?

    or was this approved because the whitehouse demanded the resignation of the FDA chief if it wasn't approved by today?

    Even if it happens to be safe, that is some subhuman-level intelligence operating at the whitehouse.
    This abuse of process on a safety evaluation will give the anti-vaxxers the fodder they're looking for.

    Still, never attribute to conspiracy that which is adequately explained by incompetence.

    • Was this approved because safe as proven by due process in the FDA?

      or was this approved because the whitehouse demanded the resignation of the FDA chief if it wasn't approved by today?

      Damn, Trump does one good thing, and you folks with TDS shit all over it anyway.

      Why cares whether this was determined to be safe because of science or political pressure? The important thing is that it was determined to be safe, and we can now give it to all our grandparents and first responders. How can you be so cynical about progress like this?

  • Wait a year to make sure there are no side effects. I am 100% A-OK with vaccines that have been time tested.

    • The vaccine has already been tested for ~10 months. What do you think will be found in two years that wasn't found in one year?

  • There will not be enough people who will take it for herd immunity to work. On the bright? side, it does mean reasonable people (ie those that believe in science and reason) will take it and are less likely to die.

    The US is now accurately compared to Rome in it's last days. The US will wane as a superpower until it is no longer, the likelihood of civil war within those years is high. It didn't have to be this way. It doesn't have to be this way, but those in power are too stricken by greed and ignorance to

    • The US is now accurately compared to Rome in it's last days.

      More accurate than even most realize in that exactly one thing that slid Rome down the tubes was that people became "religious" about politics and they'd give a lot of lip service to the principles of the Republic but in reality were only concerned with their own selfish agendas and willing to put up with populist dictators as long as they seemed to serve their short-sighted short-term goals.

      As just one obvious example, cf how many people were grievously upset by the kneeling during the national anthem, som

  • Democrats had really wished they could have delayed this somehow till the Georgia election. Really difficult to keep blame Trump for a Pandemic when his Operation Warp Speed has generated a vaccine in record time.

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