A question for you all that I haven't seen asked. So beg my pardon if this has been covered. If this emergency review board at the FDA was put together to quickly review the emergency vaccine request, what takes them 3 weeks to get together for the review. If people are getting sick and dying each day, why does it take 3 weeks to clear the calendar? Assuming approval, it will be about 6 weeks between the publication of the trial results and the first inoculation. Anyone but me take issue with that? Just seems to me they should have been meeting the following week.
I wonder the same thing. I assume they are taking the time to review the data before they meet. But it seems to me that they data should have been packaged by Pfizer (and their outside review board) and that it shouldn't take 3 weeks to review. There is only some much you can do with a data set and a skilled statistician wouldn't take that long to look through everything.
That's part of the difference. My understanding is the UK approval took the company's analysis and reviewed and signed off based on that analysis.
The US review starts at the raw data and does it's own analysis.
The independent board has received the data from the trial and they are currently reviewing. The board is made up of scientists who have the background to review and question the results. They have the time between submission by Pfizer and the meeting to review data, come up with questions and then ask those questions to the Pfizer scientists at the meeting. This isn’t just a rubber stamp, they are supposed to be thoroughly reviewing the data. I think the process is expedited to the extent it can be. Could they have met a week earlier? Maybe, but it wouldn‘t be ethical to just immediately approve. The UK approval is a week and a day earlier than the likely US approval so not a huge amount of time. Yes, a US citizen is dying every minute at this point so even cutting a week off could have potentially saved 10,000 people, but there has to be a balance between speed and a thorough review process.
Close, but not quite. The external (not FDA employees, and people who were not involved in the trials) advisory board doesn't have the data yet. There's a step in between where the FDA will review the raw data and create an analysis. This is sent to the external advisory board about a week before the meeting to give them a week to review the analysis before the meeting. I think we're still in that middle part where the FDA is processing all the raw data to create that analysis. The external reviewers will depend on the FDA analysis while the FDA depends on the raw data. I'm sure those people doing the analysis worked over Thanksgiving and the weekend, and probably long days too.
I wonder if they have the ability to reach out to Pfizer for additional data in this time period. I’m not a scientist so trying to put this in finance terms. When you have an audit the auditors spend a lot of time reviewing data provided by the client and there is a back and forth where the auditors ask questions or ask for additional data. It’s only after all of the data is compiled that the formal audit opinion is given. Maybe I’m way off on this.
In the old days, they would have sent a semi (or several) full of paper to the FDA with all the raw data on it. Now they do it electronically, but it's not any less information, probably more. For every trial participant, every manufacturing step, all the way from where the raw chemicals come from through every step in production, distribution, and trial patient. It's way more than just "did it work?". But, is it repeatable and consistent, and does it work, plus all the impacts. It doesn't help anyone if production batch B is different than A, and A worked but B doesn't. Or, if they both work but B had more side effects. Things that would mean batches A and B were not exactly the same.
I found this quote in article about the process. Not a lot of detail but it does give an idea of the magnitude of the review process...
"An agency spokesperson tells Axios, "The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines. Once the reviews by the various experts are completed, they are then integrated into an overall review.
Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects."
And, this is just for an EUA with a limited scope of the most at risk people likely to be approved to get it. Full approval for general availability to any random person is going to dig even deeper.
Lots of the analysis of drugs in general is weighing the risks vs the thing they're solving. The risk should be lower, much lower, from the drug than the alternative. Healthcare works and seniors in care facilities, the first to likely get approval, are at much higher risk from COVID which means there's more leeway. A perfectly healthy 15 year old with no other risk conditions needs a much higher bar that there's no risk. It's part of what makes vaccine approval so much stronger with less tolerance for impacts. We're giving it to someone who is currently healthy and do not want to change that. In comparison, a cancer drug could have lots of issues but the alternative is cancer kills you, there's lots of room for complications that are less bad than death.