Pfizer COVID Vaccine is Over 90% Effective and FDA Emergency Authorization Expected Third Week of November

Pfizer and BioNTech, announced positive efficacy results from our Phase 3, late-stage study of our potential COVID-19 vaccine. The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.

The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.

This is a first but critical step in our work to deliver a safe and effective vaccine.

It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.

We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.

Written By Brian Wang,

20 thoughts on “Pfizer COVID Vaccine is Over 90% Effective and FDA Emergency Authorization Expected Third Week of November”

  1. In many states, you would only have to move the needle a tiny bit to make a large impact. Arizona, about 10k votes….?

  2. True, but if we just make sure that all people in the risk groups take the vaccine, then the rest of us could get it without any harm, right? For people not in the risk groups, Covid-19 has a lower lethality than an ordinary flue, is that not correct?

  3. Well, then let's not try Syria for the first few hundred million vials, shall we? Would it not be fair that if the USA pays for the vaccine, it can also have first dibs on it?

  4. Well, could it be that traveling restrictions and restrictions on ordinary citizens are different "animals" and have different consequences?

    Stopping chinese tourists uppset the sensibilities of the liberals but does very little to harm economy or limit the freedoms of the american citizens. Keeping the american public locked into their homes destroys the economy and is a curtailing their freedom.

    So liberals want to keep americans under control whereas conservatives want to lock chine tourists out.

    So to me it is all consistent with their respective ideologies…?

  5. I've already seen graffiti urging people not to accept the vaccine.

    Though I'm not too sympathetic to people who take their medical advice from graffiti. But it affects the whole "herd immunity" thing (which, along with "fomite" are the new words to enter common usage this year).

  6. As to proving that the cold was maintained, that's part of the technology in Pfizer's shipping cases. It's somewhat novel but does not seem particularly challenging, technologically.

    Also, if the vaccine arrives and has warmed but only to conventional refrigerator temperatures, it can still be used – just keep it that cold and use it within 5 days of the warming.

    I presume you mention Syria because it is a war zone. Sure, war makes everything harder, but to the extent that anything can be delivered in a timely fashion, the Pfizer cold cases should work there too. (From the news, the rebels may almost be defeated, ending the war? Not that that affects your point.)

    Human factors may cause bigger complications than the cold chain. First there's the major hurdle of convincing people the vaccine is safe after spending months telling them it is being 'rushed'. And you know someone is going to happen to get a bad cold or the flu just after getting the shot, and they're going to go on the inter-tubes and blame their symptoms on the shot and that'll be blasted all over and people will be saying "I KNEW it wasn't going to be any good – no way I'm going to get it. Don't you be fooled either!"

    More mundanely, the shot will make some people's arms hurt and they won't want to go through that again for the second dose – or it will just be inconvenient and they'll keep putting off the second dose instead of getting it on time. Etc.

  7. Maybe it was when Trump realized that the virus wasn't going to go away soon on its own, and that shutdowns to contain it were going to badly hurt the economy and everyone in it?

    To avoid getting blamed for that, he switched to somewhat minimizing the danger so he could justify leaving the shutdowns to the states, so in turn he could say the country needed to open up to save the economy.

    And of course the Dems could then switch to criticizing Trump for not doing enough – ie. not forcing states to stay shutdown.

  8. Actual public health people have been saying for some time that it will be very difficult to implement a -80C cold chain.

    It's one of those things that: sure, it's actually pretty trivial for someone who knows what they are doing to transport a single case of vials under the right conditions from a lab to a hospital.

    But to transport 600 million vials? Not just maintaining conditions but legally proving that you have maintained conditions? Through train delays and airport strikes and workers getting sick and not turning up that day, and a thousand other things that don't happen when you do something once, but absolutely DO happen when you do something 600 million times?

    And that's just the USA. Now try it in Syria.

  9. Can you answer me this? In early 2020, it was the Republicans who were warning of danger, calling for travel restrictions etc. while the Democrats were saying it was racist to be afraid of foreign plagues.

    Then somehow the two parties swapped stories. It's like the regular monthly emails telling people the current party line got sent to the wrong addresses and everyone just accepted that today we were always at war with East… no I mean Eurasia. Eurasia. Not Eastasia. Only a racist would say that.

    How did that happen? Did some major celebrity swap sides and everyone else copy them?

    This is like if you didn't watch the news for a week and you turned it back on only to find that now the Republicans are chanting for harsher gun laws while the Democrats say this is an attempt to disarm the poor and minorities.

  10. According to their current statements, they can't actually apply for the FDA Emergency Use Authorization until they have all their safety data which isn't until late November.

    Delaying this particular news release (If that actually happened? Cite?) doesn't do anything to delay the timing of late November. They continued gathering the safety data.

    They didn't put the entire trial on hold (which isn't actually technically possible.)

  11. It probably did not change the timeline a bit, though it does look strategic. Honestly, I don't see why anyone should have been surprised by something being just about ready to go. The only big surprise to most is the effectiveness. Though, I was not very surprised by that either.
    I hope there are some other companies near ready too. We have made many doses of the other vaccines as well. The more vaccines we get ready, the more doses will be available.

  12. While elaborate, the cold chain doesn't seem technologically difficult to maintain for developed nations. Delivery requires a well insulated "suitcase" with dry ice inside for shipping, with continuous temperature monitoring.

    Assuming 500M doses distributed over 2021, with maybe 250 doses per container, and assuming each shipping case is used and returned for reuse in a 2 week cycle, they'll need ~80K such cases.

    For local shipping from a distribution center (say a hospital with cryo-storage) to clinics and such (a few hours in transit), pretty much any insulated container with dry ice in it should be adequate.

    Clinics can store it with normal refrigeration for up to 5 days – in fact I'd assume they must let it warm to a temperature suitable for injection. They could store the insulated local shipping containers (with dry ice) in a normal refrigerator to extend clinic storage time by a day or two.

    Areas remote from suitable storage and distribution centers can probably be served by pre-announcing and scheduling vaccination days, and shipping in doses just-in-time.

  13. The thousands who are dead are due to failure to contain the virus while waiting for a vaccine. Announcing the vaccine earlier would not have saved those lives, assuming the timeline would have remained the same for release in December.

    You can lay most of those thousands of deaths at the feet of the lack of leadership in the US. Trump hasn't even bothered to attend the COVID taskforce meetings in months. Meanwhile, compare outcome of the pandemic in Canada vs the US, two very similar countries. The US has 3x the death rate per capita as Canada. In Canada, we managed not to make mask-wearing and physical distancing politically-loaded topics and all major parties supported the response to the pandemic.

  14. Agreed, this was clearly a political delay (originally anticipated to be announced in October, then they mysteriously delayed it a few weeks until post-election). Of course thousands of people have died in the interim, but at least it helped the democrats.

  15. Your politics-fu is stronger than mine.

    Yeah, it looks suspiciously aligned with the election's schedule and outcome.

  16. I imagine he means wrt the presidential election. I'm not convinced this would have moved the needle.

    Deploying this vaccine sounds like quite a challenge. A -80C cold chain is not easy to execute, particularly at scale or in countries with less than excellent infrastructure.

  17. Can you elaborate?

    I can only think of insider trading as a reason, and they probably already (and discreetly) did that.

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