They aren't fighting releasing the data. They are fighting spending the massive amount of money it would take to release it quicker than normal. The requested data includes a lot of protected patient medical information that must be redacted and that isn't even needed to independently check on the government's evaluation and decision making in approving the vaccines.
Why would they have collected that information if it wasn't needed, you might wonder. Simple, it is information that is needed if something bad happens during the trial such as a lot of bad side effects.
If the requestors limited their request to what they actually need for what they are claiming they want to do it would go a lot faster. Instead they are making a massively over broad request in bad faith.
It is hard to tell whether you seriously believe this, or simply want to make an argument. Pfizer said they needed 75 years to redact a particular set of vaccine trial data given the resources they had allocated. They had already released an enormous amount of data, but were subjected to a nuisance suit asking for more. The statement that they wanted 75 years to release vaccine trial data is misleading.
"The alternative being that they reviewed a small portion of said documents, which would render their argument completely moot, since they would only need to release the documents they actually used during their decision"
CFR (code of federal regulations) says:
"“After a license has been
issued, the following data and information in the biological product file are immediately available
for public disclosure unless extraordinary circumstances are shown: (1) All safety and
effectiveness data and information. (2) A protocol for a test or study . . .” 21 C.F.R. § 601.51(e)."
They requested all data that 21 CFR 601.51 authorizes, except for the adverse reaction reports available in the VARS database.
So whether the FDA reviewed or relied on all 329,000 pages, they are requesting all 329,000 pages.
Worse, of course, is that they deliberately ...'d the part that makes it take so long (this will, btw, piss off the judge and clerk who read the brief, since they will go and read that and see immediately that it happened)
In practice, this is just the posturing phase - 90% of what the plaintiffs requested is probably pointless.
The CFR says "
(g) For purposes of this regulation, safety and effectiveness data include all studies and tests of a biological product on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability."
So like, this is probably tens of thousands of pages of blood pressure and heart rate readings for 10,000 anonymous people kind of thing. Along with tens of thousands of pages of blood test results, etc.
And then tens of thousands of pages of purity testing of random vaccine lots ;)
Usually, the judge will tell both sides to try to figure it out, they will get together and the plaintiffs decide "yeah, maybe we only really need 10k pages" and the defendants decide "yeah, we can do 10k pages in 3-4 months" and the case settles.
It would be super unlikely for the judge to order the FDA to produce 329,000 redacted pages of documents in very short order.
We have plenty of data. There were several rounds of trials for each vaccine involving tens of thousands of people over many months. What extra special data are you holding out for that the scientists and various national regulating agencies don't require?
Vaccines require the running of clinical trials during development and approval. Trial data was not stolen in this case (according to the companies), but obviously this is private "vaccine data".
Not on infectiousness or spread, that's the whole point we're making here.
"When the efficacy of the vaccines was so high for preventing serious cases"
They claimed based on trial data 95% efficacy against infection, not just serious cases. That wasn't accurate.
"it would have been a medical ethics problem to delay getting them out to the public while trying to get better data on spread"
They had many months. Regardless even if this wasn't the case, it's easy: make them available and then don't impose any requirements or passporting until such data is available. They didn't do this.
You appear to classify literally any criticism of any process or happening to do with vaccines as "antivax talking points" even though they're precise and specific to this event. Do you realize that for vaccines to be safe and effective, you need a whole lot of people who are willing to be "antivax" in the regulators, pharma companies, doctors surgeries and more? The only reason anyone believes in vaccine safety at all is the assumption of lots of people who will yell stop at the slightest hint of problems. It's clear that this assumption is wrong and the people most afraid of being classed as "anti-vaxxers" are the very people meant to be watching out for safety problems.
Its absolutely ridiculous the level of arrogance to presume you can apply some debate-bro logic and talk your way out of NOT HAVING ANY DATA. NOT HAVING ANY DATA means your product fails. End of story, thanks for playing, nice try, go back to level one and try again. NOT HAVING ANY DATA means we deny you authorization to inject our babies with untested vaccines.
I wonder what the purpose of this is. It would be quite disruptive for a bad actor to start leaking data to discredit the efficacy of the vaccine or to highlight side effects.
I mean the FDA is asking for 55 years to process and release all such public data to the public now.. https://www.reuters.com/legal/government/wait-what-fda-wants... . Which to me is concerning as well the CDC just announcing not to get the J&J shot but the other two.
Early science .. we all jumped in like guniea pigs ... some forced to like myself where Ive already been burned twice (hernia mesh implant recalled causes pain forever and a med I took damaged an organ) by early science/profits over people crap.
Also any media to research where bias (pro or not pro vaccine ... left or right) is.. is hard to believe as truth. Bias clouds the truth always! Im sure any vote on my post is biased based ... pro vaccine or anti. Im in the middle and wanted to wait to see years of data to see/find out which one was the best .. which one was the worst but i wasnt given that opportunity... get vaxed or if not lose everything.
I'd expect that a lot of it is data that is gathered because it might be useful if certain things came to pass that did not come to pass.
For example, suppose in phase 3 they had found that the vaccine provides excellent COVID protection but it also has some terrible side effect in too many people to approve it for general use.
If they have extensive medical records on all the people in the trial they might be able to see some way to tell who is likely to have the bad reaction and who is not. Then they can try to find some way to mitigate that, or go for an approval for the vaccine for people other than those who are likely to react badly.
If things go smoothly on the other hand, there may be no need for anyone to look at much of that data.
What is the right way to collect this data, given that the frontline practitioners are actively discouraging any patients from making a connection for adverse reactions with the vaccine?
Put another way: Isn’t VAERS a necessary solution to ensure that the healthcare system does not misrepresent the safety of the vaccines? Transparency should be a first principle requirement for science.
Transparency is not a "nuisance", it's a requirement. Dismissing people's concerns as immaterial or nuisances is a big reason why people have lost trust in institutions.
As for whether my claim was misleading, are you suggesting that the proposed schedule for releasing the vaccine safety data would not have taken 75 years?
The fact that Pfizer released aggregated data based on their own analyses is immaterial if third parties can't analyze the raw data replicate the results.
If the statistics warrant it then yes, but for a vaccine, even waiting to finish these trials is an incredibly rushed schedule. This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it. I don't think the concern is about fabricating phase III data. The concern is that extreme political pressures mean no matter what the interim results say, the FDA may feel inclined to approve the vaccine. Considering that we need healthy people to willingly take these vaccines to end the pandemic, losing that trust in the process would be devastating. People need to believe that the FDA approved it because the evidence shows the vaccine is most likely effective without safety concerns. If they don't, then they won't take it, and if the vaccine then fails phase III, its not clear how you regain that trust as a regulatory agency.
Why are you so eager to take Pfizer's own statements at face value? Don't you think there's a bit of a conflict of interest here? And suddenly regulatory capture doesn't exist either? The clinical data is effectively a secret between the FDA and Pfizer, both orgs which have their own pressures to approve of the vaccine and possibly downplay adverse events. Not to mention Pfizer has been preemptively absolved of legal responsibility for any harm.
AFAIK both the FDA and the MHRA have been getting data regularly from the various vaccine developers. They didn't have to wait for a final dump of data just to see any of it.
All the experts are concerned too. I work in vaccines (not claiming to be an expert) and I'm concerned too. Long-term safety trials take time, and so the question is how long are you willing to wait for the data? Its a shitty situation all around with the loss of human life, the impact to the economy and the politicization of every damn thing.
I'm concerned, especially in the tech community, that there is so much aggravation toward a group that wants more data before making a decision that could have long term repercussions. The CDC has a page describing past vaccine safety issues, the most recent being 2013[0]. Errors include unexpected side effects or complicates and manufacturing issues.
The treatment being offered is unlike any other mainstream protocol, has not completed the FDA approval process that every other vaccine that's given to the general population (in the US) has gone through.
Add to that counter-intuitive advice being given by medical professionals. When I was young, I had chicken pox. I was never offered the vaccine that my children have received. However, previously infected people are being urged to undergo this treatment. I could do the primary research to determine _why_ that is the case, or those urging everyone to participate can explain clearly why it's different this time.
I don't like the language chosen, which, to me, obscures the idea that what is being offered is like a yearly flu vaccine or any other dead/disabled/controlled viral vaccine. I've read that there are vaccines for SARS-CoV2 that are similar to what normally comes to mind, but they are not available in my country.
mRNA research is awesome. The technique is very cool, but beyond the theoretical best case scenario, what are the failure cases for these treatments? What if the mRNA is damaged along the way. What if there are unknown issue with the delivery mechanism.
Ultimately, I am the primary income for our family and in a not-at-risk category if I were to get infected. At this time, I've decided that is a safer position for my family. I'm hoping that as FDA approval is granted and longer term affects are well known that I'll be comfortable going forward, but at this point I am not.
I'm not anti-vax, but not keen to be an early adopter for new treatment option when I'm not at danger of what I'm being protected from. There's the additional argument about protecting those that can't be vaccinated, but I'm happy to follow other hygiene protocols that have been used in practice for much longer.
Why would they have collected that information if it wasn't needed, you might wonder. Simple, it is information that is needed if something bad happens during the trial such as a lot of bad side effects.
If the requestors limited their request to what they actually need for what they are claiming they want to do it would go a lot faster. Instead they are making a massively over broad request in bad faith.
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