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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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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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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Supreme Court and Religious Freedom from vaccine mandates – why we should worry

supreme court vaccine mandates

This article about the Supreme Court and how it may use religious freedom against vaccine mandates 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 29 October 2021, the Supreme Court rejected a request to stay – put on hold – Maine’s vaccine mandates for healthcare workers, which did not include a religious exemption. Many people in the immunization community are excited and happy about this decision.

Without wanting to be a downer, I want to explain why this decision – though certainly better than the alternative, staying the mandate – should cause us concern. Basically, three justices on the Court signed onto an opinion that essentially says that public health writ large is not a compelling state interest (in the middle of a deadly pandemic), that thinks that the right comparison is one religious exemption to one medical exemption (rather than consider aggregate effects) and that if other states are less protective of their citizens’ health, a state can’t limit religion to protect its citizens better.

What was not in the decision is any concern about the effects of COVID-19, a disease that is still killing over 1,000 Americans a day. That is highly problematic. But more concerning is the fact that two other justices were not willing to stay the mandate via emergency proceedings, but saying no more, implying that they are open to considering requiring a religious exemption (though they are certainly not saying they would – and these justices probably could use more information on why requiring a religious exemption from vaccines mandates is problematic). 

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Catie Clobes v NBC – problematic anti-vaccine lawsuit against a journalist, Part 2

clobes nbc

This article, part 2 of the Catie Clobes v NBC anti-vaccine lawsuit, 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 part 1, I explained the elements of defamation and why Ms. Clobes will likely be a limited-purpose public figure for her lawsuit against NBC. This lawsuit would require her to prove actual malice, which she has neither alleged nor is likely to be able to show.

In this post, I will explain why Ms. Clobes is also unlikely to be able to prove the claims against NBC in the article are false. As a reminder, “Only false statements of fact can be defamatory. Arguments, characterizations, insults, and aspersions can’t be unless they are premised on explicit or implied false statements of fact.” The claims that large parts of the article being opinion and not fact is essentially negating their case. Any parts of the article that are opinions are not defamation. 

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Catie Clobes v NBC – problematic anti-vaccine lawsuit against a journalist, Part 1

scrabble tiles

This article about the Catie Clobes v NBC lawsuit 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 September 24, 2021, anti-vaccine activist Catelin (Catie) Clobes filed a lawsuit in federal district court in Minnesota against NBC and two of its journalists, Brandy Zadrozny and Aliza Nadi, alleging defamation, emotional distress [sic], and “reasonable care” [sic].

The review of Catie Clobes v NBC is quite long, so this article will be published in two parts, with the second one being available tomorrow.

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Vaccine licensing primer – correcting anti-vaccine misinformation

vaccine licensing

This article about vaccine licensing 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.

Anti-vaccine activists want to claim the Pfizer vaccine is still experimental despite FDA licensing.  They base that claim on a footnote in a document reauthorizing Pfizer’s Emergency Use Authorization (EUA).  FDA is clear that the now fully-licensed vaccine is identical to the EUA vaccine (except of course for the labeling: the EUA vaccine still bears its EUA label), and that both can legally be marketed.  The anti-vaccine claim is being made because the full licensure of the Pfizer vaccine renders moot their claim (not yet decided by a court) that you cannot mandate a vaccine licensed under the EUA. 

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Vaccine informed consent – is it in tension with school mandates?

vaccine informed consent

This article about vaccine informed consent 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.

Several people have asked me whether having school mandates is in tension with the idea of vaccine informed consent. The answer is no. While school mandates have some effect on parental autonomy, the doctrine of informed consent should not be conflated with autonomy.

For a somewhat different reason, imposing sanctions on those who do not vaccinate is also not a violation of informed consent.

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NVICP compensation and autoimmune syndromes – vaccine court review

brown wooden gavel on brown wooden table

This article about NVICP compensation and autoimmune syndromes 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.

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the second of two claims (see first one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on NVICP compensation and autoimmune syndromes.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case, and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

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Vaccine mandates for those with previous COVID infection – policy debate

people woman government health

This article about vaccine mandates for anyone with a previous COVID-19 infection 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 this post, I set out the debates around allowing those with a previous COVID-19 infection to be exempt from U.S. vaccine mandates. 

A quick reminder– the virus is SARS-CoV-2, while the infection with the virus causes the disease, COVID-19 (or just COVID). 

The policy takeaway point is that while, in my view, the choice to allow those with a previous COVID infection an exemption from vaccine mandates can be reasonable, the choice not to allow an exemption also has very good policy reasons behind it.

Since it is a valid policy choice, mandates without such an exemption cannot, in my view, be legally challenged. Those wanting their institution to exempt them because of natural immunity need to convince their institution to do so, and if the institution refuses, do not have viable legal recourse. Under our current law – rightly – in uncertainty, the policymakers have the flexibility to choose the option they think is safer.

I am not a scientist, and I think this is an area of substantial scientific uncertainty. But I have to start by setting out some background, and I will try to summarize what I think we do and do not know.

I will add that my thoughts on this have developed. When I came into this topic, I thought a previous infection should be grounds for exemption. Now, I think there’s an argument both ways, and in fact, the argument against an exemption for the previously infected is stronger – though an institution would still be on solid grounds if it chose to give one, for policy reasons.   

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