FDA Meeting Today to Discuss Booster Doses

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be meeting today to address the FDA supplemental Biologics License Application (sBLA) for the booster dose of the BNT162b2 (Comirnaty) Pfizer-BioNTech vaccine that was submitted in late August.

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, said in a statement about the Pfizer-BioNTech booster dose.

During today’s meeting, the VRBPAC committee will vote to either recommend the booster dose or vote against it. Generally speaking, the FDA listens intently to the VRBPAC’s recommendations, and it could play a large role in the immediate future with the booster strategy that public health officials and the Biden Administration are looking to roll out this month.

The meeting could set the tone for the Biden Administration’s COVID-19 plan, which has been meeting to discuss a strategy that largely includes booster shots for people who have been vaccinated earlier this year and the rollout of the booster doses beginning on Monday.

The Medical Community’s Messaging

Certainly there is some commentary coming from public health officials this past week that can lead to the general public’s confusion or indecision on whether to get a booster dose. Although it is important to present all the data and opposing information, it can lead to inertia by the general public who do not know what to do with the varying, conflicting messages.

Earlier this week, a group of scientists came out against booster doses after reviewing the current data from randomized controlled trials and observational studies. The scientists included people from the World Health Organization (WHO) and the Food Drug Administration (FDA).

Their review, published in The Lancet, summarized the currently available evidence published in peer-reviewed journals and pre-print servers.

“The vaccines that are currently available are safe, effective, and save lives. Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society. These high-stakes decisions should be based on robust evidence and international scientific discussion,” co-author Soumya Swaminathan, MBBS, MD, chief scientist WHO, said.

The National Institutes of Health is one example of promoting the other side of the issue. Anthony S. Fauci, MD, director of the National Institution of Allergy and Infectious Diseases (NIAID), and chief medical advisor to the Biden Administration did not agree with the assessment made by the aforementioned group and said there is waning immunity against COVID-19 infection and evidence a booster dose is warranted.

No matter the outcome of today’s VRBPAC vote or the eventual FDA decision to either approve or not approve booster doses, one thing remains: COVID-19 and the continuation of the pandemic as it continues to create pain and suffering to patients, and a huge burden on the medical infrastructure in some areas.