FDA responses to FOIA requests on COVID vaccines – not a conspiracy

FDA FOIA

This article about FDA responses to Freedom of Information Act (FOIA) requests by anti-vaccine activists was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In contrast to anti-vaccine claims (and the headline that echoed them), the FDA responses to a broad Freedom of Information Act (FOIA) requests are not evidence of a conspiracy or some kind of unusual problem (though it may reflect some of the general issues with our FOIA system).

In a recent set of posts by anti-vaccine activists, they criticized FDA for, allegedly, wanting 55 years to process a FOIA request for vaccine data. Unfortunately, some media sources repeated the claim uncritically. 

The reality, unsurprisingly, is different. A group that includes several anti-vaccine activists and people who have had anti-vaccine support in the past submitted a very broad request for documents related to the Pfizer-BioNTech vaccine trial.

These documents need to be redacted before being released, to protect interests like patient privacy and trade secrets. The parties are wrangling about the rate at which FDA should process those documents, and the anti-vaccine talking point is basically a misrepresentation of the FDA’s position about the schedule. Here is the report of both parties’ positions to the courts.

FDA explained that this is a very large request, it is one of several hundred they are dealing with, and their FOIA office is small. It wants to provide it at a rate of 500 pages a month, a rate that, from cases cited by FDA, has been repeatedly accepted by courts as reasonable (reflecting standard practice) and has already started providing some of the data. The group is demanding all the information in the next four months. The court will have to decide what is the appropriate rate of release. 

To emphasize — at no point did FDA ask the plaintiffs to wait 55 years for documents. The FDA offered to start releasing documents immediately, and work at a rate of 500 pages a month after December 1, releasing 500 pages to the plaintiffs each month – in order of priorities set by the plaintiffs.

This post will examine numerous issues surrounding FOIA requests to the FDA, and whether the responses by the FDA are reasonable or not.

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Do COVID-19 vaccines cause diabetes? No, just another anti-vax myth

COVID-19 vaccines diabetes

Here we go again, anti-vaxxers are now claiming that COVID-19 vaccines cause type 1 or 2 diabetes. I don’t think I’m over-exaggerating when I say that each new day brings a new claim about COVID-19 vaccines that is easily debunked.

At least I can find the reason, albeit requiring some contortions of logic and science, behind this claim. However, typical of anti-vaxxers, they take it several steps too far.

Anti-vaxxers have tried and failed, to link vaccines with type 1 diabetes. And we know that COVID-19 itself might increase the risk of type 1 diabetes. But is there a link between COVID-19 vaccines either type of diabetes? No.

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Court stays the Biden OSHA COVID vaccine mandate — an analysis

OSHA COVID-19 vaccine mandate

This article about the Court of Appeals stay of President Biden’s OSHA COVID vaccine mandate was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

On November 6, 2021, the US Fifth Circuit Court of Appeals stayed President Biden’s Emergency Temporary Standard (ETS) – the emergency temporary standard by which OSHA required large employers to adopt a COVID-19 vaccine or test mandate – citing grave constitutional and statutory concerns.

On November 12, 2021, the Fifth Circuit published a decision keeping in place its stay and elaborating on the reasons. The decision is concerning — first, the legal analysis does not follow established law in several ways, and the innovations (or misapplications) are not well reasoned. Second, the decision suggests a lack of close reading of the Emergency Temporary Standard the decision is putting on hold. And third, and perhaps most concerning, the decision suggests the panel attributes little to no importance to halting COVID-19, or to the fact that over a thousand people in the United States are dying from COVID-19 every day, or to the fact that the ETS is estimated to save thousands of workers lives and prevent a quarter of a million hospitalizations, under conservative assumptions.

All of these give cause for concern if the Fifth Circuit is the one chosen under the lottery to hear the cases against the mandate. A panel that clearly ascribes little importance to protecting employees from COVID-19 is unlikely to consider the need for a mandate carefully. 

To be clear, the bar for putting out an ETS is high. Another panel may end up not upholding the ETS for not meeting that high bar, and that would be well within the lines of existing jurisprudence. But this decision isn’t it. 

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COVID vaccinated are NOT as likely to spread the virus as unvaccinated

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I keep seeing the anti-vax claim that those who have received the COVID-19 vaccinated are just as likely to spread the virus as unvaccinated individuals. Another day, another myth from anti-vaxxers that must be debunked, because this is utterly ridiculous.

I know, it’s been debunked so many times, it seems fruitless to do it again, but it’s being used as one of the excuses to not get the vaccine. Among all of the dumb claims of the COVID-19 vaccine deniers, this is one of the dumbest.

This claim about those vaccinated against COVID-19 are as likely (or sometimes more likely) to spread the SARS-CoV-2 virus as unvaccinated is not supported by any scientific evidence. Yet, your local Twitter or Facebook anti-vaxxer loves to spread this inane trope, mainly because they can. And because people seem to believe any outlandish claim made about the vaccine.

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Anti-vaccine activists generate and spread misinformation again

anti vaccine misinformation

This article about anti-vaccine misinformation tactics is based on a series of Twitter posts by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

This article are quoted verbatim, except for minor editing changes. We both felt a broader audience for this anti-vaccine tactic to spread misinformation will be useful to understand. In essence, an anti-vaccine group asked the CDC for a single patient record, something the CDC doesn’t keep, and then imply something nefarious is happening because the CDC couldn’t provide that information.

Below, Professor Reiss reviews how this is a cynical tactic to make it appear something is going on with vaccines, when it isn’t.

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COVID vaccine mandates are working

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I know we keep reading about lawsuits and protest about COVID-19 vaccine mandates, but I think we (pro-science, pro-vaxxers) are too focused on the negative. Actual data is showing us that these mandates are working and they are substantially increasing vaccination rates.

There have been a ton of court rulings and public protests about COVID-19 vaccine mandates. Dorit Rubinstein Reiss has written about a few of them, but she is barely keeping up with them. I’m on a mailing list from her, and I swear that it appears that there is a new lawsuit against these mandates every single day. And court rulings have been both positive and negative.

But, as I said above, there is good news. The mandates are actually working. So, let’s take a look at what we know.

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HPV vaccine has decreased cervical cancer rates in England by 90%

HPV vaccine cervical cancer

There is more good news about the HPV vaccine – since being introduced in the UK in 2008, the cervical cancer rate has dropped by 90% according to a recently published peer-reviewed article. Cervical cancer, which kills over 300,000 women a year across the world, is close to being eliminated in countries that recommend the HPV vaccine for women and men.

The HPV vaccine used to be the most hated by anti-vaccine zealots, being surpassed by the COVID-19 vaccine these days, but it is remarkably safe and effective. There are so few ways to prevent cancer, and yet this is one of the best tools that we have in cancer prevention.

Let’s take a look at this new paper, just so we can pile onto the narrative about the overwhelming effectiveness of this vaccine.

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Aluminum in vaccines does not cause type 1 diabetes

aluminum vaccines diabetes

We know that there are no links between vaccines and type 1 diabetes mellitus, and now a new study shows that the aluminum in vaccines also isn’t linked to the disease. I’m sure that Christopher Aluminum Exley and James Lyons-Weiler are crying. Or they will just claim that all other scientists are wrong and they are right.

A lot of the vaccine deniers believe that vaccines cause Type 1 diabetes (or here), based on little evidence. As far as I can tell, this myth is based on the “research” from  J. Barthelow Classen, M.D., who has pushed the idea that vaccines cause type 1 diabetes, through some magical process that has never been supported by other independent evidence.

In another example of the anti-vaccine zealot’s cherry-picking evidence to support their a priori conclusions, they ignore the utter lack of plausibility supporting any link between vaccines and Type 1 diabetes. But once again, real scientific research has found no link between vaccines and diabetes.

And new research has provided robust evidence that there is no link between the aluminum in vaccines and type 1 diabetes mellitus.

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Pfizer COVID-19 vaccine whistleblower – hand waving about clinical trials

laboratory test tubes

And here we go again – a so-called COVID-19 vaccine whistleblower makes vague claims about the Pfizer clinical trials. Predictably, the anti-vaccine world points a trembling, HPV-riddled finger at us, screaming “SHAME. SHAME. SHAME.”

Except, like a lot of these stories, the anti-vaxxers overstate anything critical about the COVID-19 vaccines, while ignoring the vast majority of evidence that support the overwhelming safety and effectiveness of these vaccines. Their confirmation bias is amazing.

Anyway, let’s take a look at this COVID-19 vaccine whistleblower and see if anything they say passes the smell test.

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NFL QB Aaron Rodgers chose homeopathy over vaccines, catches COVID

aaron rodgers covid vaccines

Sometimes my blog posts write themselves. NFL quarterback Aaron Rodgers decided to forgo COVID-19 vaccines and chose homeopathy to build antibodies against it. As you can predict, he tested positive for COVID-19.

Shocking, right?

There are two things here that need to be debunked. First, homeopathy, although I know that almost any scientific skeptic knows that homeopathy is pseudoscience. Second, building antibodies without vaccines – can’t be done, but we’ll get to that.

I’m writing this not for you science geeks out there – nothing I’ll write will cause you to exclaim, “Oh my, and I thought homeopathy worked!” But this is for those who may come here to find out if Aaron Rodgers knows anything about vaccines, COVID-19, or homeopathy. He doesn’t.

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