Pfizer COVID-19 mRNA vaccine – FDA approves emergency use authorization

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On 10 December 2020, the Pfizer/BioNTech COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). Unless you were avoiding the internet (and hence, you wouldn’t be reading this), you would know that the review went well, and VRBPAC “approved” the vaccine. On the evening of 11 December, the FDA gave approval for the EUA, the first COVID-19 vaccine available in the USA.

This article will quickly review the major points about the VRBPAC discussion, a review of some of the data, and finally a summary of what we know and don’t know about the Pfizer COVID-19 mRNA vaccine. 

What is VRBPAC?

There is a myth pushed by the anti-vaccine crowd that the FDA summarily approves vaccines without even a cursory review. They think that the FDA trusts anything Big Pharma submits to them without thinking. That couldn’t be further from the truth.

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

For vaccines, the Vaccines and Related Biological Products Advisory Committee, also known as VRBPAC, are made up of experts in vaccines, public health, and statistics. There are around 30 individuals on the committee (although several did not attend nor participated) including one vaccine industry expert (a clinical physician-scientist, not some executive) and one consumer representative, in this case, a respected attorney who concentrates on healthcare issues. 

Also, Dr. Paul Offit, MD, who has been designated a demon Big Pharma shill by anti-vaxxers, is a member of the committee. Dr. Offit is one of the world’s experts on vaccines, who developed one of the rotavirus vaccines that have saved hundreds of thousands of lives across the world every year. 

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.

They aren’t industry shills. They are some of the leading experts in all fields of vaccinology, not babbling anti-vaccine cultists with a 15-minute education on vaccines. VRBPAC is a dignified committee that puts scientific evidence above all else.

What did they say about the Pfizer COVID-19 mRNA vaccine?

The committee looked at just about every aspect of the vaccine. They looked at the raw data and focused on examining the details of each of the significant adverse events that were observed. In every case, they determined that there was no evidence that the event was linked to the vaccine. Of course, this happens all the time, that almost every major adverse event that is listed in a package insert is not actually vaccine-related. 

The VRBPAC seemed to focus on a few important issues:

  1. Individuals with severe allergies, which has become an issue in the UK
  2. 16- and 17-year-olds. There was a lack of good evidence that the vaccine was safe and effective for that age group, so there was a lot of discussion about it. 
  3. Pregnant and lactating women.

The vote on the Pfizer COVID-19 mRNA vaccine was 17-4. Since people will make something out of nothing regarding the 4 negative votes, we don’t officially know why they voted no. The four who voted no were Archana Chatterjee, M.D., Ph.D., Michael Kurilla, M.D., Ph.D., A. Oveta Fuller, Ph.D., and David Kim, M.D., MA. It appears that all four were concerned about the indication of the vaccine for 16- and 17-year-olds, not because they thought the vaccine was either unsafe or ineffective.

However, as votes go, this is a landslide in support of the vaccine.

The committee also required that Pfizer monitor any issues with anaphylaxis with individuals with prior history of allergies. A document published by the FDA on Tuesday said that 0.63 percent of participants who received the vaccine reported potential allergic reactions, compared to 0.51 percent of people who received a placebo. So there is an extremely small increase in the risk of allergic reactions, and I’m not sure that it’s statistically significant. In other words, it might be difficult to determine if it is actually vaccine-related.

Dr. Anthony Fauci, who has been the nation’s frontman for this pandemic and the vaccine, stated that

…the allergic reactions were concerning but most likely rare. If I were a person that had an underlying allergic tendency, I might want to be prepared that I might get a reaction, and therefore be ready to treat it.

The vaccine’s benefits still vastly outweigh the risks, even to those with underlying allergies, and since we can mitigate the risks, it’s clear that the committee wasn’t prepared to make a black box warning or any other type of recommendations for the vaccine for those individuals. 

So what happens next? It goes to the FDA Commissioner, Dr. Stephen Hahn, MD, who will issue the EUA if he agrees with the committee’s findings. Unsurprisingly, Donald Trump has threatened to fire Dr. Hahn if he doesn’t immediately issue the EUA – this is beyond ridiculous. The decision (which is usually pro forma) should be based on science, not on Trump’s personality defects. 

The FDA quickly reviewed the hard work of VRBPAC and gave its approval to the first vaccine available in the USA. However, supplies will be limited, especially since the vaccine requires two doses plus difficult distribution issues because of its low temperature requirements – at this time, the vaccine will mostly be available for healthcare workers along with individuals and staff in long-term healthcare facilities. 

Stay tuned. I’m going to do a further review of some more of the facts about the Pfizer COVID-19 mRNA vaccine in a few days. 

Note

I refer to this vaccine as the Pfizer COVID-19 mRNA vaccine. This isn’t to ignore that the vaccine was actually developed by the German company, BioNTech. However, almost all of the heavy lifting of the clinical trials, FDA submissions, and manufacturing is being done by Pfizer. This happens all of the time with new drugs – one company invents it, but a larger, wealthier partner gets it to market. We owe a big debt to BioNTech, but it’s going to be a Pfizer vaccine from now to the end of this pandemic.



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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!