FDA Vaccine Committee Scheduled COVID-19 Vaccine Booster Reviews
The U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) scheduled meetings to review new information regarding COVID-19 on October 14-15, 2021.
The VRBAC digital meeting presentations will be heard, viewed, captioned, and recorded through a teleconferencing platform.
Under Topic 1, the committee will meet in open session to discuss the Emergency Use Authorization (EUA) of the ModernaTX Inc. SpikeVax COVID-19 vaccine for the administration of an additional dose, or “booster” dose, following completion of the primary series, to individuals 18 years of age and older.
On October 15, 2021, under Topic II, the committee will meet in an open session to discuss the EUA of the Janssen Biotech Inc. COVID-19 vaccine for administering an additional dose, or “booster” dose to individuals 18 years of age and older.
Interested persons may present data, information, or views on issues pending before the committee, orally or in writing. The FDA established the meeting docket number: FDA-2021-N-0965. Federal eRulemaking Portal: https://www.regulations.gov.
And individuals interested in making formal oral presentations should notify [email protected].
The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters.