Expecting the public to have confidence in these vaccines is demanding a level of subservience and blind faith that most reasonable people are unwilling to provide.
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.
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.
"It has been clear for a while now that the Pfizer vaccine works and is safe."
Yes, except there is an established process for quantifying "clear for a while now" and it involves sufficient time and control groups. That process isn't being followed and it is concerning for a number of reasons, including the effect of political pressure on expedited drug approvals in the future now that this precedent is being set. The elected leaders capable of bringing such political pressure to bear are invested in the very companies which stand so much to gain by relaxing the time-tested regulatory approval process. This is bad science and bad governance.
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.
Yes, the fact that they are being this cautious is a good thing for public trust. We have other vaccines as well. I rather have this level of transparency then blindly tell people to get JJ and we will figure out edge cases later.
The process has its flaws. Poorly designed drugs make it through the FDA process. Blind following is foolish. Skepticism is healthy. I don't get software updates as soon as available because, even with the testing, peer reviews, flaws still happen.
Further, there were big political and financial reasons to push the vaccines through. Those are all conflicts of interest. Pfizer had millions of doses manufactured before approval. If trial results didn't look good, they certainly had the incentive to "massage" the results to get it approved and get those millions of doses sold rather than a huge loss.
As the original poster shared, it should be a considered a reasonable position to be skeptical of small scale results. Pfizer's position appears to have scaled well (Moderna as well). 100s of millions of doses across diverse populations show its relative safety and efficacy.
With the latest being: EUA approval, and the preemptive purchase of over 100M doses, of the new Pfizer/Moderna omicron vaccine after only being tested in mice.
Sure, its similar to previous iterations which have undergone human testing. Sure, we have a good understanding of how they work, theoretically. The FDA isn't an entirely corrupt and incompetent organization. But without human efficacy and safety data, it feels beyond likely to me that acceptance rates among even the "silent majority" of people will be low.
I get that you’re mad, but I don’t think you’re taking it out on the right people.
The vaccine approval process is really rigorous, it isn’t some joke. We’re currently sitting around waiting because Pfizer is still observing, waiting for the slightest hint of a long term issue. Other vaccine candidates have been paused in the trials. Yes, the risk is nonzero. But there’s no evidence of risk at all and there will be tens of thousands of data points when the results come out.
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.
I have some sympathy to this argument, even though I agree with you in overall that based on what we know from the millions of vaccines being administered, they appear to be very safe. But points in favor of the FDA argument, which is mostly around emergency authorization requiring a lower standard of evidence:
- The pharmaceutical industry is notorious for manipulation of trial data to make their treatments looks as beneficial as possible, as they are incentivized to do so. In the current case Pfizer and others have still not made the trial data public, and probably never will [0][1]
- The main study on the Pfizer vaccine contained safety data for an average of about two months - on this basis the vaccine was declared to be extremely safe. Obviously longer term effects cannot be captured in this timeframe [2]
- Due to the requirements to generate a clear public health message, almost anything that may suggest a risk with vaccines is downplayed. See for example how VAERS data is routinely dismissed (with some reason)[3], whereas data on COVID hospitalization and death rates is largely unquestioned, despite containing some room for interpretation [4].
Again, the the totality of evidence suggests that the vaccine are safe and effective. But it is not crazy or evil, as some would suggest here, to question some of what we are being told and how the data is being presented to us.
I'd say that hiding potential issues with a vaccine, where regulations have already been eased to speed up its rollout, is about as damning as it can be.
I think public trust has been eroded by overconfident statements made by authorities, plus the occasional noble lie.
I wish that public health communication had been more congruent with what was actually known, something like:
"This is a vaccine authorised under emergency conditions and data is still incomplete. It's clearly very beneficial for older citizens but the situation is less clear in the young. We are fairly confident that the rate of serious side effects is quite low" (and then ideally those statements would be followed up by whatever numbers were actually known at the time).
The vaccines were released to the public barely a year ago. There is no way to know exactly how safe or effective they are, supposing they are. We just don't have the data yet. What we have, however, is an aggressive censorship of any information or person critical of the vaccines.
Why did the FDA not hold the expected public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), to review the latest data prior to this approval? The last public meeting was in October 2020. In the intervening 10 months, tens (hundreds?) of millions of doses of EUA vaccine were administered, generating an enormous data set which has not been through VRBPAC review, https://www.bmj.com/content/374/bmj.n2086
> Transparency advocates have criticised the ... (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine ... Kim Witczak ... a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data ... "The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval" ... She warned that without a meeting “we have no idea what the data looks like.”
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed. “Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
... Joshua Sharfstein ... former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence."
It doesn't help that public is too sensitive about this subject. Government can't scrutinize companies like Pfizer enough if they are worried about public reaction. And I'm not too surprised if some companies rush since a lot of money is on the table.
To be fair, this is the best effort we have ever had to develop a vaccine. So I don't think it's fair to blame these companies if their vaccine wasn't effective on new variants as they initially promised. But that doesn't mean that we shouldn't thoroughly scrutinize them.
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.
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.
Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor.
The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence.
Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
Health leaders and politicians entire job is to build and maintain trust. Mistakes like this only reinforce vaccine hesitancy. Those that are hesitant know that the science is settled - until it isn't. The only method to account for unknown unknowns is time.
It would have been entirely possible for Fauci et. al to say "The vaccine data appears to show 95%+ efficacy, but we will be waiting to lift lockdown mandates be sure". That kind of messaging shows both a respect for science and a commitment to everyone's health. However, it was an unpopular political decision, so mandates were lifted.
This isn't the first time they've changed their course after making a decision prematurely. To the vaccine hesitant, why is this FDA approval any different? There's massive political pressure to approve these vaccines.
"FDA set to grant full approval to Pfizer vaccine without public discussion of data": https://www.bmj.com/content/374/bmj.n2086?s=09
Expecting the public to have confidence in these vaccines is demanding a level of subservience and blind faith that most reasonable people are unwilling to provide.
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