FDA Discusses 3rd mRNA Vaccination Dose for Teenagers

The U.S. FDA Vaccine Advisory Committee's 167th meeting for September 17, 2021, has released the agenda and presentation materials. 

The Vaccines and Related Biological Products (VRBPAC) committee will meet in an open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for the mRNA Comirnaty vaccine to administer a third dose, or “booster” dose, in individuals 16 years of age and older.

The U.S. FDA currently approves Comirnaty as a two-dose regimen. Countries such as Israel launched 3rd dose programs in late July 2021.

Additional discussing are also planned. Materials for this meeting will be available on the VRBPAC Committee meeting's page.

All meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

The Lancet published a Viewpoint on September 13, 2021, co-authored by former U.S. FDA staff and other immunologists, explaining their suggestion regarding receiving a third COVID-19 vaccination.

These vaccine researchers stated, 'Current evidence does not appear to show a need for boosting in the general population, in which efficacy against severe COVID-19 remains high. Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently.'

Note: The U.S. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.