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How did they approve it that fast? Is the approval process so different and so much more efficient than the one in the EU or USA? Was it extremely rushed to mak
by _Microft 6y ago
How did they approve it that fast? Is the approval process so different and so much more efficient than the one in the EU or USA? Was it extremely rushed to make sure to get doses before they have to compete with other countries for limited supply? I'm pretty curious now. Let's hope for the best, i.e. a good vaccine, a good process and no trust problems, the latter because at least it feels rushed.
- chrisvxd 6y agoMy understanding is that they've been carrying out a rolling evaluation that has been going on for the duration of the trials, which has helped accelerate the normal process. Having said that, I believe the EMA (EU) also carried out a rolling evaluation, so I'm not sure what the differences are there.
- makomk 6y agoThe UK has put a lot of effort into speeding up the roll-out of these vaccinations in general. Enough that it basically leaked the fact some kind of Covid vaccine was coming a few weeks in advance because so many people were involved in the pre-planning and the timescale was so aggressive.
- tinus_hn 6y agoYou make it sound like a bad thing. It was never a secret the vaccines were coming and as each day of delay means 5000 people dying I think putting a lot of effort into speeding up the rollout is pretty well worth it.
- joshuahughes 6y agoUmmm, latest daily UK deaths "with Covid" is 414, not 5000. Ref: https://coronavirus.data.gov.uk https://coronavirus.data.gov.uk
- tinus_hn 6y agoLatest daily EU deaths with COVID is about 5000.
- polytely 6y agoFrom what I remember from the news yesterday the EMA will be done with the evaluation (if they don't find anything that causes concern) by the end of the month, so they aren't that far off
- lbeltrame 6y agoYou are correct. The meeting for the "decision" (rather, it is a recommendation on which the European Commission acts upon) is scheduled to be December 28th at the latest.
- Kliment 6y agoYeah, and given the political pressure they're likely to do it earlier (I believe they meet every 2 weeks, and they received the application documents with the complete data set on monday). Dec 28 is their "no later than" internal deadline. The EC has already said they'd hold an emergency meeting to formally approve immediately after.
- tinus_hn 6y agoYeah, there’s only about 5000 deaths extra for each day of delay. So no rush there!
- polytely 6y agoIf people don't trust that the vaccine is safe, they will not take it, which will basically throw away a year of vaccine development and lower trust in vaccines in general and prolong the pandemic.
- tinus_hn 6y agoDoing the theatrics and vaccinating people are not mutually exclusive. There’s plenty of people who want to get vaccinated now, so they can go first while the people who don’t can wait for this ‘necessary research’ to be done.
- 6y ago
- ascorbic 6y agoUnlikely to be the latter, because they've already prepurchased millions of doses. Unlikely to be the former either. The UK regulatory system is highly-regarded, and until January the EU medicines regulator was based in London. It may just be that they're particularly efficient.
- mattmanser 6y agoLets hope it's not not like our pandemic preparedness, that was highly regarded and turned out to be rotten.
- ascorbic 6y agoThe difference is that the pandemic preparedness was untested, while the MHRA has been working for years
- cameronh90 6y agoIt had actually been identified that our pandemic preparedness was overly focused on influenza. Still, I have no idea whether we'd have fared better in a flu pandemic - maybe the assumption was that we'd be able to get a vaccine quicker in that case? 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..)
- adrianN 6y agoGermany is planning to start vaccinations in December too, it's probably a matter of days before the vaccine gets approval in Germany.
- _Microft 6y agoI read that the approval process might take until end of December and that first vaccinations for people at risk and system-relevant groups was expected for beginning of January. 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.html https://www.tagesschau.de/inland/faq-corona-impfstoff-105.ht... , 1. Dezember 2020, 11:00 Uhr
- ealexhudson 6y agoIt hasn't been approved esp faster than anywhere else - it's just the first out the gate. The regulators have had the data for a while now, you'll see steady approvals over the next couple weeks. 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.
- refurb 6y agoThe regulators have had the data for a while now 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.
- Kliment 6y agoTo be clear, the complete dataset and approval application was not delivered to the EMA by Pfizer until Monday. You can't expect a regulatory approval in two days - it takes longer to even read the complete application.
- refurb 6y agoI have zero insight into what was shared when, but I'm assuming if Pfizer completed their primary analysis in time for the Nov 20th FDA submission, they could have shared that with the EMA at that point. So somewhat of a rolling review (submit data to regulator as it becomes available). 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.
- bluGill 6y agoI would assume the EMA has different forms, and wants the data in a different format. Pfizer as a US company presumably has more experience with FDA formats as well, and more FDA experienced people on staff (this is one of the advantages of the revolving door between industry and regulators - there are disadvantages as well). I'm not sure why the UK got things sooner unless it is because they accepted data sooner there was time to figure out how to submit it while not even knowing if they would submit to the FDA.
- simonbarker87 6y agoI believe a big part of speeding up was parrallelization(spelling?) of the phases rather then the usual running them in series. Also I would imagine that the teams working on these had all the resources they needed, minimal internal delays and no expense spared on budget. I can see how those things combined, coupled with 10 months of “crunch time” work from the teams involved could see a 10x improvement in vaccine production.
- thunderrabbit 6y agoparallelization My mnemonic: the two Ls are like parallel lines.
- djsumdog 6y agoSome things can be done in parallel, yes, but a large chunk of the speed comes from literally skipping some animal testing and ALL long-term longitudinal studies.
- Hamuko 6y agoAs far as I've understood it, the whole COVID-19 vaccine research has been going at a breakneck speed. First vaccine batches were made back in February. https://patrickcollison.com/fast https://patrickcollison.com/fast
- djsumdog 6y agoYea, and honestly, huge money grab for big pharma. Over 100 companies started working on vaccines. They got huge amounts of money, knowing they didn't even have to be successful.
- stjohnswarts 6y agoWho cares in the broader scheme of things? The toll it's taken on the economy is in the trillions, 10 billion to speed it up is literally almost nothing compared to that.
- hannob 6y agoI mean once you have the data it shouldn't be exactly rocket science to check if the trial was done well. Given how clear the data is as far as one has heard until now the decision should be a no-brainer. You already had the trial protocol since several months, so that could've been checked in advance. I'm actually rather wondering what's taking the EU so long.
- boyband6666 6y agoIt is not a trivial process, and these are ferrociously complex. Safety, Quality and Efficacy - each are hard to check. From how people are categorised in trials, how missing data rules are implemented, to how it is manufactured and the stability data. It doesn't take a year for no good reason. Yes this has been sped up massively, but steps have been abbreviated - let's not kid ourselves. 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!
- apsec112 6y agoIt looks like the FDA approval will probably follow in eight days (December 10th). I'd guess the UK just has the edge on administrative efficiency.
- modeless 6y agoPfizer concluded their trial and filed for approval with the FDA almost two weeks ago. People are dying. Why is it not approved yet?
- _Microft 6y agoApproval is like code review. They go over the work and make sure it is sound. Just giving an OK without doing the approval work would be called "rubber-stamping".
- tome 6y ago"LGTM!"
- polytely 6y agoIt is of vital importance that the majority of people feel safe taking the vaccine, because you need herd immunity. If people have doubts that it has been correctly vetted they will be reluctant to get vaccinated which makes the whole investment in the vaccines pointless.
- garmaine 6y agoSafety tests were already completed and approved by regulators months ago. The Phase 3 trials are efficacy trials to show that the vaccine gives immunity. Certainly we learned more about the safety of the vaccines from Phase 3 data, but we already knew that adverse immediate reactions would be very rare. 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.
- Slartie 6y agoGenerally approval of this is fast-tracked everywhere, but the UK being first is a political marketing stunt in my opinion. 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.
- Mauricebranagh 6y agoWell there's a lot of pressure on the government Boris Johnson is facing a lot of pressure from his MP's in particular the red wall (former labour held constituencies in then north)
- Slartie 6y agoTo all the downvoters: they even openly kind-of-admit it, I've now got proof from the mouth of Matt Hancock, UK health secretary: https://www.theguardian.com/world/2020/dec/02/hancock-brexit-helped-uk-to-speedy-approval-of-covid-vaccine https://www.theguardian.com/world/2020/dec/02/hancock-brexit... 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."
- _fizz_buzz_ 6y agoThe EU already clarified that each member state is free to grant emergency approvals. So the UK could have done what they did while inside the EU.
- akadruid1 6y agoThe BBC's fact check column noticed that too and confirmed there was no truth to it: https://www.bbc.co.uk/news/55163730 https://www.bbc.co.uk/news/55163730
- IfOnlyYouKnew 6y agoThey are part of a political system that currently needs to prove itself with PR stunts. Other agencies do not feel that need, realise approval is currently not on the critical path (manufacturing is), and allow themselves two weeks more.
- stjohnswarts 6y agothey did a lot of steps in parallel assuming it was okay and also had nearly infinite resources and money to get it done.