The only danger sign I would foresee that would indicate a rush is if some regulator declines to approve emergency use - but given the data that seems highly unlikely.
They've had some of the data for a while. Pfizer didn't finish their analysis of the Phase 3 data until close to their EUA submission on Nov 20th.
But yes, you are correct, the EMA has specific requirements for it's submission and if they haven't received it until Monday, it's going to take a while to review it, even on an expedited basis.
Having said that, I believe the EMA (EU) also carried out a rolling evaluation, so I'm not sure what the differences are there.
There is absolutely 0% chance at the end the vaccine will not be approved. But 100% chance 20 days will have been wasted.
That's not true, I think it's foolish to 100% trust a company to not make any rushed mistakes, lie, or hide some facts, when there are massive amounts of money involved.
How are they going to check if the manufacturer fudged the report? Run the experiment themselves again in 20 days?
Edit: by the way in the UK they were prepared properly and the vaccine is approved today. Or would you say they are acting irresponsibly?
Site and document inspections.
"Why worry about something that isn't going to happen?"
So looking at it for 20 days isn’t going to help with that. It’s just going to cost 100000 lives.
In reality life is full of gray and often the correct answer is found "in between".
Let’s look at how it turns out in the UK. Mr. Fauci already ate his words of critique and apologized.
The report is about 15000 people who got the vaccine and didn’t get seriously ill. There’s nothing to judge on that you can seriously do in 20 days, in that time frame you can only look at the basics and these are clear: 15000 people got the vaccine, didn’t get seriously ill and mostly became immune.
It’s a waste of time and time is lives.
Delaying vaccines is not ‘just the reality of things’. It’s a political decision with grave consequences. One country makes one choice, another makes another choice. The reality of things is that choice decides wether people live or die. There is no way to shift the blame away from that.
In any case, it's still somewhat unclear why the UK has done so badly with Covid. There are some obvious things the government should have done better - and unless Brexit turns out to be a "titanic success", I can't see how Boris Johnson will remain PM until the next election. But even compared to countries that have implemented weaker measures, slower than we have, or have had their healthcare systems overwhelmed, or struggled with testing - we've suffered much worse. And the reason why is, at this point, unknown.
One argument is we have a less healthy population, either due to lifestyle factors or due to having relatively mild previous flu seasons. Another is our dense, poor housing and service economy. Another is travel and weather. Will be interesting to see what falls out over the analyses over the next few years, and if anything is done to act on the problems (I doubt..).
The factor that these preparedness plans can't account for who is in charge at the time the disaster hits. We might have technically had the best plans, best scientists, best civil service, best procedures - and then the person in charge refused to listen to them. Like Trump and the CDC. Maybe people will vote for competence over bluster next time around? (I doubt..)
What's ridiculous about this situation is that the regulatory authorities are not willing to weigh against the benefit which would come from an early emergency-use authorization (which could have happened as early as August). It's like CPU branch prediction: approve the vaccine for early distribution as fast as it can be made--which would only have been a few hundred million doses globally so far--while the phase 3 studies are going on. The early distribution would be watched as observational studies, of course. If it fails Phase 3, stop distribution and move on to the next vaccine.
If the vaccine works, this strategy would have directly saved tens or hundreds of thousands of lives, and potentially millions from getting sick and whatever long-term complications come from COVID-19. Indirectly, early vaccination of essential workers would work to decrease R0 and therefore cause fewer people to get sick through normal means.
If the vaccine doesn't work, there isn't much money wasted since the manufacturing is already being done pre-approval anyway.
In the worst case if the vaccine primes and adverse immune reaction, that is bad and an argument against early approval. However you have to weigh the added risk (that early vaccinated people have a higher CFR) vs the probability of that happening, which is low.
High likelihood of highly beneficial outcome if it works. Lower possibility of a relatively moderate bad outcome to a smaller population if it doesn't. Certainty of many added deaths if you wait. I don't have the data the regulators have that is necessary to quantify this and make the call.
But for dumb political reasons, this option is off the table. Only Russia and China went ahead with early vaccination; all the other national agencies decided not to even think about early distribution. It was not even an option on the table.
This disease has over a 98% survival rate, and even higher if you're under 40. Many of the "long COVID" studies I've read have been in high risk or elderly people, they were limited case studies and I think a case can be made that most "long COVID" could be nocebo or mass hysteria at this point (or the fact that it could just take the body months to heal from a bad infection).
We've never approved a drug, much less a vaccine, at this speed before. Unless you go back to the days of Jenner where he just stabbed people with Horsepox and there was no real regulation or long term data collection.
I don't know about China, but mass vaccination have not started in Russia yet. It will begin only from the next week starting with medical personnel and teachers. Effectively the Russian vaccine has only finished phase 3 trials (based on 40k volunteers) relatively recently.
Other agencies do not feel that need, realise approval is currently not on the critical path (manufacturing is), and allow themselves two weeks more.
I'm actually rather wondering what's taking the EU so long.
If interested, the FDA release all documentation - search for Drugs@FDA and find a recent medicine, and see just how much review it gets. You'll be surprised!
My mnemonic: the two Ls are like parallel lines.
Source (german):
"Bund und Länder stellen sich darauf ein, dass "bei bestmöglichem Verlauf" noch im Dezember mit ersten Impfstoff-Lieferungen gerechnet werden kann. Gesundheitsminister Jens Spahn sagte heute im Deutschlandfunk, dass Anfang Januar die Ersten aus den Risikogruppen und auch schon Pflegebeschäftigte geimpft sein könnten.", https://www.tagesschau.de/inland/faq-corona-impfstoff-105.ht... , 1. Dezember 2020, 11:00 Uhr
The UK government is in dire need to demonstrate positive aspects of leaving the EU, and being able to independently greenlight this vaccine first is one particularly well suited for PR. The Brits love their NHS system and healthcare in general, so hitting it home on that turf resonates with them.
Ceasing this opportunity is especially important because all the other aspects of Brexit are just about to hurt the Brits big time next year, with the EU transitional period running out at the end of this year, with effectively no trade deal whatsoever in place to replace it, and Trump having been thrown out of office and most of the British prime ministers' hopes for an advantageous and quick trade deal with the US being dumped together with him.
Money Quote: "...because of Brexit we’ve been able to make a decision to do this based on the UK regulator, a world-class regulator, and not go at the pace of the Europeans, who are moving a little bit more slowly."