FDA, CDC, and COVID-19 vaccines — who does what?

FDA CDC COVID-19 vaccines

This article about the role of the CDC and FDA concerning COVID-19 vaccines 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

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Big supplement profits – making boatloads of money in the name of pseudoscience

big supplement

I occasionally have to defend vaccine profits (or the lack thereof), but everyone seems to ignore Big Supplement profits which are far larger than vaccine profits. And vaccines have real science backing them, which is not a statement you can make about Big Supplement.

Let’s take a moment and look at the revenues and profits of Big Pharma (and a bit of Big Vaccine) and Big Supplement. The former has to work hard and provide evidence of what its drugs do, while the latter basically can sit around and throw darts at various claims, then randomly assign those claims to some new or old supplement.

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Big Pharma drug development — it’s not as easy as everyone thinks it is

big pharma drug development

Doing what I do here, I always get the impression that many people think that Big Pharma drug development is relatively easy. Just invent a drug, test it on some people, and then call up the FDA to get approval to sell it. I know that supplement manufacturers would be so happy if they could do that.

The actual facts are that Big Pharma drug development is so expensive, complicated, time-consuming, and failure-prone that you have got to wonder why anyone would jump into this process. For some drug discoveries, people grow old waiting for final FDA approval.

The myths about Big Pharma drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias,  you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of Big Pharma drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts about Big Pharma drug development.

I have written a similar article about vaccine development, but I wanted to have one that was more about all drugs, except vaccines. Vaccines, and other biological drugs, have slightly different development and regulatory pathways which are not used to bring a standard pharmaceutical to market.

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COVID vaccine development process – how it compares to “normal”

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the COVID-19 vaccine development process, along with the independent controls that make sure that all vaccines are safe and effective.

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Vaccine development process – how it’s usually done

vaccine development process

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.

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ICAN lawsuit against CDC statement that vaccines do not cause autism

vaccines autism

This article about another ICAN lawsuit disputing the CDC statement that vaccines do not cause autism 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On March 31, 2022, a federal district judge dismissed the Informed Consent Action Network‘s (ICAN) lawsuit demanding that CDC remove the statement that vaccines do not cause autism. The judge dismissed the lawsuit because ICAN failed to show that the alleged harms it claimed were caused by anything CDC did, or that removing the statement would fix the problem that they claim they identified. 

The claim never got to be examined on the merits, and for the purpose of dismissal at this early stage, the judge is required to treat ICAN’s claims as true. But it’s worth reminding readers that extensive data shows that vaccines do not cause autism.

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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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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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FDA rejects ICAN petition to revoke of EUAs issued for COVID vaccines

ICAN COVID-19 vaccines

This article about the FDA’s actions on a petition from ICAN to revoke EUAs for COVID-19 vaccines was written by Viridiana Ordonez. Ms. Ordonez has contributed other articles to this website and is aJ.D. candidate at the University of California, Hastings College of Law.

Del Bigtree‘s Informed Consent Action Network (ICAN) submitted a Citizen Petition to the Food and Drug Administration (FDA) on September 27, 2021. In its petition, ICAN requested that the FDA revoke the Emergency Use Authorization (EUA) granted to ModernaTX, Inc. (Moderna) and JNJ Jansen Biotech, Inc. (Janssen) for their COVID-19 vaccines.

ICAN argued that because the FDA has now approved Comirnaty – the COVID-19 vaccine created by Pfizer-BioNTech – the requirements for issuance of the EUA for the other vaccines are no longer met.

The FDA replied to the petition on October 20, 2021, and rejected the request, explaining that ICAN’s petition did not contain facts demonstrating any reasonable grounds for its request. This post summarizes FDA’s response. 

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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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