Peter Doshi and FDA approval of Pfizer COVID vaccine – what now?

Once again, the anti-vaccine shill, Peter Doshi, uses his BMJ blog to complain about the recent Pfizer/BioNTech COVID-19 vaccine approval by the US FDA. I’ve already seen anti-vaccine activists use this as a “peer-reviewed paper that shows that the vaccine is dangerous.” First, it is not peer-reviewed, it is a blog post no different than the one I’m writing right now. Second, it’s an opinion piece, he’s not showing any original or even secondary research to support his wild claims.

BMJ is not a hotbed of anti-vaccine pseudoscience, except for the presence of Peter Doshi. For example, they published a series of articles, written by Brian Deer, about Andrew Wakefield’s despicable deceit, you can read about it herehere, and here. Deer has also written a powerful book about Wakefield’s fraud. I wonder what Mr. Deer thinks of Peter Doshi as an editor at the acclaimed medical journal.

Even though anyone with the least bit of scientific expertise understands that whatever Peter Doshi says about the Pfizer COVID-19 vaccine FDA approval is nonsense, I will endeavor to take apart his ridiculous claims.

Who is anti-vaccine Peter Doshi?

Before we get started, we need to know who is Peter Doshi, and how did he get to be an “expert” on the Pfizer COVID vaccine.

Doshi is a nearly perfect example of false authority, someone who appears to be knowledgeable about vaccines but, in fact, lacks any expertise, education, or experience with those same vaccines.

Doshi received his BA in anthropology from Brown University, MA in East Asian studies from Harvard University, and Ph.D. in history, anthropology, and science, technology, and society from the Massachusetts Institute of Technology. Those would be fine credentials for someone who is going to teach history or anthropology.

But does it make him a vaccine expert? Absolutely not.

For most of us, an authority in vaccines requires actual studies in some, if not all, of the following fields:

  • immunology – the study of the immune system
  • biochemistry – the study of chemical processes in biological systems
  • cell biology – the study of the structure and function of the cell
  • virology – the study of viruses and virus-related diseases
  • microbiology – the study of microorganisms, which include viruses (which is often broken out into a separate field of study), parasites, and bacteria
  • physiology – the study of functions and mechanisms of living systems, generally, in this case, humans
  • epidemiology – the study of patterns and distribution of diseases and medical conditions in a population
  • pharmacology – the study of the mechanism of action of drugs and medications
  • public health – the study of the science of preventing disease and promoting human health through organized efforts
  • statistics – a mathematics discipline that focuses on the collection, organization, analysis, and interpretation of data
  • pediatrics – the branch of medicine that involves the treatment and care of infants, children, and adolescents

At best, and I see no indication of it, Doshi may have some knowledge of statistics, and that’s it. He is not a vaccinologist.

I like making an important point about authorities and false authorities – credentials actually don’t matter, but what does matter is evidence. And we want high quantity and quality of said evidence, something absolutely missing from the claims that Doshi makes.

However, there are substantial reasons why credentials can matter. They imply many things – a broad education in the science of the subject matter, hard work in the minutiae of that field of science, and approval by one’s peers. Getting a Ph.D. in epidemiology is not simply taking classes, but it’s actually doing research in the laboratory and field with a published thesis that is reviewed by numerous peer scientists.

Clearly, Doshi lacks a broad research and publication record in any of those fields that matter to the study of vaccines. He made a statement that claims that “influenza” (a disease caused by influenza viruses) is different than “flu” (a syndrome with many causes, of which influenza viruses appear to be a minor contributor).” That makes me conclude that Doshi actually fails to understand the basic principles of diseases, and, I would dare say, he’s a germ theory denier

And lately, he seems to be on the attack about COVID-19 vaccines.

But let’s get back to Doshi. He is currently an associate professor (non-tenured) of pharmaceutical health services research in the School of Pharmacy at the University of Maryland. This field of study is not basic pharmacological and clinical research of pharmaceuticals – it is economic-based research for drug utilization and other areas. These fields might be interesting if I was writing about pharmaceutical economics, but is nearly irrelevant to understanding vaccines.

Furthermore, Peter Doshi loves his anti-vaccine conspiracy theories. A few years ago, Doshi claimed that the Vaccine Adverse Event Reporting System (VAERS), a system where individuals can report supposed adverse events post-vaccination, to “prove” certain adverse events, was no longer accepting online reports.

But there’s one more important point. The data submitted to the FDA underwent a thorough review by FDA officials and a vaccine expert committee called the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Every drug, including the Pfizer/BioNTech COVID-19 mRNA vaccine, is always reviewed by an expert committee of scientists alongside career FDA scientists. The reviews are generally thorough and deliberate.

For vaccines, VRBPAC, which is made up of approximately 30 experts in vaccines, public health, and statistics. There is also one vaccine industry expert and a consumer representative on the panel. These are the best and brightest individuals in vaccine science.

According to the FDA, the committee is charged with:

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.

The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.

This committee makes recommendations to the FDA director as to whether a drug (including vaccines) should be approved for the EUA (and eventually a full approval, such as what recently happened with the Pfizer COVID-19 vaccine).

Does Peter Doshi think he’s smarter than these experts? Does he arrogantly believe he found a “gotcha” that real scientists did not find? Does he have one thing in his background, other than sniping from the sidelines, that shows any of us that he’s smarter than these people? Well, if he is, why doesn’t he apply to be a member of the committee, it is open to vaccine scientists?

unrecognizable chemist taking liquid with pipette from test tube in modern laboratory
Photo by RF._.studio on Pexels.com

Peter Doshi and the Pfizer COVID-19 vaccine FDA approval

In a BMJ blog post (not a peer-reviewed article), nothing more than an opinion piece, Peter Doshi attacks the recent Pfizer COVID-19 vaccine approval by the US FDA. Now, many of us thought that the FDA approval took too long, especially since it was a reason many people were on the fence about getting the vaccine until that approval showed up.

Doshi’s main line of attack is that we don’t actually know what the effectiveness of the vaccine is because we haven’t waited long enough for the results. He thinks that effectiveness is far below the 95% that was shown in the initial results used to justify the Emergency Use Authorization for the Pfizer vaccine.

Here are just a few criticisms of his distrust of the data:

  1. Doshi cites Israeli reports (not published in peer-reviewed journals) that the effectiveness of the Pfizer COVID-19 vaccine in Israel against the Delta-variant had fallen to 39% where Delta. This is total cherry-picking on his part – there are other articles that have established that the Pfizer vaccine’s effectiveness against the Delta variant is around 66%. Sure, it’s not 95%, but only those who are in love with the Nirvana fallacy understand that number is excellent. And that’s why the CDC and FDA are recommending a booster for the mRNA vaccines.
  2. Doshi claims that there is evidence in the FDA filings that show that the effectiveness wanes. Yes, that happens with vaccines. That’s why we may have to look at vaccines against this virus to need updates annually or more frequently, just like the flu vaccine (which Doshi hates most of all).
  3. Doshi seems to love the old trope that if the vaccine isn’t perfect, it must be horrible. The fact is, even if the vaccine is 66% effective against the Delta variant, that could end up saving thousands, if not millions, of lives. This is what I don’t get about anti-vaxxers – they claim they are worried about lives of children or adults that get the vaccine, but they never look at the benefits – every single day that we wait on bringing this vaccine to everyone in the world is a day where thousands of people will die. Does Doshi want more people to die from COVID-19? I don’t think he’s a sociopath, but nowhere in his opinion piece does he even mention the lives saved. It’s all about attacking the vaccine so that the anti-vaxxers are happy with him.
  4. He complains that only 7% of the participants were still blinded by the endpoint. This happened, because the study managers decided that they had enough data to begin actually vaccinating the group that had received the placebo. They wanted to protect these people because it was clear that the unvaccinated group were going to be harmed by the disease. Again, he shows precisely 0 sympathy for protecting people from hospitalization and death. I’m beyond livid about his thinking.
  5. Doshi then complains that the Pfizer COVID-19 vaccine FDA approval did not include a meeting of VRBPAC to review the data. Well, here’s the thing Mr. Doshi – the evidence in December was sufficient to give the vaccine full approval, and nothing you’ve said indicates that there is new data that would change their mind. Plus, the CDC’s Advisory Committee on Immunization Practices (ACIP) met several times to review the data for these vaccines and continues to endorse it. And like VRBPAC, ACIP is made up of experts in various fields of vaccine research, unlike Doshi the anthropologist/historian.
Doshi Pfizer COVID vaccine
Photo by Min An on Pexels.com

Summary

Not one thing that Doshi presented about the Pfizer COVID-19 vaccine showed me something new about the vaccines – the data was all there in the FDA filings. And his analysis of the data is overwhelmingly amateurish with silly strawman arguments and cherry-picking logical fallacies in an attempt to discredit the approval.

No one is saying the Pfizer vaccine is perfect – I certainly am not. Yes, the effectiveness is lower against the Delta variant of the SARS-CoV-2 virus. We expected that.

But it still protects about ⅔ of the time, keeping people out of the hospital and, better yet, keeping them from dying. I do not understand why he says, “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

In other words, he wants to slow down because he doesn’t understand the science which will lead to more deaths!!! No, thank you, Mr. Doshi.

Why on earth does BMJ continue to give this vaccine denier a stage for his ideas?


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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!