The US Food and Drug Administration (FDA) has announced a Pfizer COVID-19 vaccine review meeting for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 10 December 2020. It is intended to discuss and review the emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine.
What is this Pfizer COVID-19 vaccine review meeting?
As I, and others like Dr. Peter Hotez, have been pushing the FDA to use the Vaccines and Related Biological Products Advisory Committee to utilize that group to review any request for an emergency use authorization for a new COVID-19 vaccine.
In case you don’t know, VRBPAC is a specialized group of scientists who review the data for new vaccine applications to the FDA. The FDA describes them as:
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 are experts in all areas of vaccine science and public health related to vaccines. VRBAC being the cornerstone of the Pfizer COVID-19 vaccine review meeting allays some of my fears that the EUA for the vaccine would be a political rather than a scientific decision. Of course, Donald Trump being crushed in the election is another reason to be confident that politics will be less important.
VRBAC is not made up of a bunch of political hacks who want to make someone look good in approving the vaccine. They will thoroughly examine the data on safety and effectiveness from phase 3 clinical trials before giving their assessment to the FDA commissioner.
Remember, this Pfizer COVID-19 vaccine review is for an emergency use authorization of the vaccine – this will include providing vaccines to healthcare workers and individuals in nursing homes or long-term treatment locations.
This will not be an “approval” for widespread use. The FDA will review the whole New Drug Application (NDA) for the vaccine, which should include another meeting of VRBPAC, before issuing final clearance for the vaccine. Although it has been officially announced, we can assume that other COVID-19 vaccines will undergo a similar level of review if they request an emergency use authorization.
Although there are several reports that the vaccine might be available by mid-December, the FDA stated:
While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.
As I wrote before, the first doses of the vaccines are not going to go to the vast bulk of humans. They will go to healthcare workers whom we have to keep alive to treat those of you who refuse to take the most basic of steps like wearing a damn mask.
Nevertheless, I’m breathing a sigh of relief – at this point, it appears that the FDA is going to use science to determine if a vaccine is safe and effective, not pressure from the President.
In addition, the Advisory Committee on Immunization Practices (ACIP) will be meeting on 23 November 2020 to discuss the various COVID-19 vaccines. Although ACIP does not “approve” vaccines (despite various misinformation about what it does), they will be setting the priority list as to who gets the vaccine first, especially with limited supplies.
So, there’s good news that we will have a Pfizer COVID-19 vaccine review by an independent and unbiased review committee. There’s no reason to believe that they would refuse to allow an emergency use authorization, but they might see some data that would require extra analyses from Pfizer, BioNTech, and the researchers.
But we should know more in the next few weeks.