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[flagged] Covid Vaccine Delays – Why? (benwiener.com)
8 points by ishmandoo 2 days ago | hide | past | favorite | 14 comments

"Getting a bit more speculative, why aren’t scientists at Pfizer and Moderna already in conversation with decision makers at the FDA so that the evaluation process can be started based on preliminary data?"

They -are-. The FDA has been in the loop every step of the way.

Still, there is a need for comprehensive review of safety and for everyone to understand the possible risks. You can really only begin to complete this when you have a full application.

I hope the FDA manages to shave a few days off the process from our anticipated mid-December timeline, but it's not like a few days makes very much difference. We'll have approximately the same number of doses produced and administered by December 31st no matter when approval happens; moving forward the timeline a day or two doesn't stop very many cases. Production is the critical path.

On the other hand, fully vetting an application and detecting a substantial gotcha could make a very big difference.

We're already talking of approving this with far less safety and efficacy data, and calendar time, than we're used to. There's not too much fat left to trim in the process. (This is why an initial EUA may be fairly narrowly crafted, too, and not authorize giving the vaccine to all subpopulations... with a few more months opening the door to wider use).

Very interesting and good to hear. So drug companies are sharing early trial data with the FDA?

Trial design and trial data are shared with the FDA underway during an ordinary drug or device trial. But applications subject to FDA Fast-Track authorization processes also undergo "rolling review" where portions of the new drug application are reviewed as they are partially complete. This has narrowed the set of action items that remain.

I'm sure a lot of people are staying up late as the EUA applications come in, and skimming the documents and working to identify remaining weaknesses that can be proactively addressed. But sometime in this, they need to get a good night's sleep, and begin meticulously going through the document and make sure the remaining, necessary (i.e. not waived) conditions for emergency use approval are met.

Could you point me to any sort of reference on this? I'd love to update my post with this info.

Googling 'FDA fast track' yields https://www.fda.gov/patients/learn-about-drug-and-device-app...

Adding 'covid' to this yields https://www.biopharma-reporter.com/Article/2020/11/10/Novava...


There's more information on the process with Europe's regulator, because they're a bit less tight-lipped than the FDA. But data sharing (particularly on adverse events) has been continually happening throughout many jurisdictions and we should see approvals in a similar timeframe between Europe and the US.

Thanks for these links.

I'm seeing that Pfizer and Moderna are participating in a rolling review in Europe, but I haven't yet found anything about that in the US. Is it automatically part of the Fast Track program?

What do press releases like these mean: https://www.pfizer.com/news/press-release/press-release-deta... Are they announcing the _conclusion_ of the application process? It sort of presents the application as an atomic event.

Sure, the application is an "atomic event" in both Europe and the US, even if data has been previously shared and technical assistance from the regulator has been previously offered.

In the end, regulators need to give an emergency authorization or not, based on information at a certain point in time, which is also an atomic event.

Just want to say, I don't mean this as a criticism. Very interested to hear any insights on this.

Look at what happened the last time private industry worked in lockstep with a government regulatory agency (Boeing & the FAA). I'm fine with a small delay to make sure we're doing this right. We can't afford any mistakes.

This is an incredibly weird take.

The process has been incredibly dramatically shortened, but without actually rushing. All of the data required for an EUA is still required. Some timelines have been permitted to be shortened in exchange for dramatically increasing the number of people involved in trials, but they haven't been allowed to be shortened beyond what we know about biological response times. People at press conferences may use general terms like "in a few days," but that's not because they're treating this casually, it's because humans communicate in human ways when talking to other humans. If you're on the FDA, you know the timeline to a T, but if you're part of the general public, "December" and "April" are all you really need.

The FDA has been heavily involved in every step of the trials, which is how things have moved as quickly as they have.

These are the fastest any vaccine has ever been created or approved, by more than four years!

Definitely agree that the vaccine development has been a huge success. Just wondering about (what appears to me to be) slack in the process that could be removed. Another commenter suggests that the drug companies and the FDA are already in close communication including trial data.

That is always the case, yes.

I guess I'm left wondering why you wrote a whole post of your own to ask questions that you could have answered by searching for the large amount of information that is already out there about this process, possibly the most-closely-tracked vaccine development process in history. But hey, it's a free internet, more or less.

I'd be really interested to hear information for the reason behind these delays, especially from insiders. However one thing I appreciate about them is that it gives great ammunition against the widespread belief that the vaccines are being rushed and therefore are unsafe. While obviously it is an Emergency Use Authorization and not a regular approval, and while it seems that they've greatly contracted their normal timelines, it's also abundantly clear that they aren't irresponsibly cutting corners even if the delays are frustrating to we who have a lot of confidence in the process.

I agree

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