Moderna COVID-19 vaccine – FDA approves emergency use authorization

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On 17 December 2020, the Moderna COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). VRBPAC gave an overwhelming recommendation for the vaccine, and the FDA issued the EUA today.

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 Moderna 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 Moderna 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. 

Moderna COVID-19 mRNA vaccine facts – science to counter false claims

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.

 Moderna COVID-19 mRNA vaccine discussion

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. 

For the Moderna COVID-19 mRNA vaccine, VRBPAC seemed to focus on a few important issues:

  1. Individuals with severe allergies, which has become an issue in the UK and in the USA with the Pfizer version of the vaccine. 
  2. The wording of the question put to the panel – they settled on “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?” The recommendation for the Pfizer vaccine included 16 and 17-year-olds, which was a point of contention during the deliberation over that vaccine.
  3. Another contentious point was whether individuals in the placebo group should get the vaccine soon. The panel noted that it would be difficult to understand the likelihood of adverse events long-term if they were to get the actual vaccine. Some individuals in the placebo group may eventually get any of the other vaccines that may be available soon, effectively ending their participation as a placebo group member.

The vote for the Moderna COVID-19 mRNA was 20-0, with the four individuals who voted against the Pfizer vaccine voted for the Moderna version because the age cutoff was set at 18 years. There was one abstention, Michael Kurilla, MD, PhD, of the National Institutes of Health, who was concerned that the age range went too low, not because of safety issues, but because the EUA should only be for those who were most at risk of COVID-19 while supplies are short.

However, we shouldn’t focus on the one abstention, because Dr. Kurilla was strongly in support of the vaccine. The 20-0 vote was overwhelming, a literal landslide.

Like with the Pfizer deliberation, the committee also required that Moderna monitor any issues with anaphylaxis with individuals with prior history of allergies. A document published by the FDA stated that “there were no anaphylactic or severe hypersensitivity reactions with close temporal relation to the vaccine.”

Dr. Anthony Fauci, who has been the nation’s frontman for this pandemic and the vaccine, stated this with respect to allergic events:

…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.

Approval!

The FDA quickly reviewed the hard work of VRBPAC and gave its approval to be the second COVID-19 vaccine available in the USA. Like the Pfizer vaccine, it will made available first to frontline healthcare workers along with patients and staff of long-term healthcare facilities.

However, supplies will be limited, especially since the vaccine requires two doses plus, but it it might be easier to distribute because of the easier storage and shipping requirements.

Stay tuned. There will be more vaccines early next year.



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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!