FDA to meet on booster doses and COVID-19 vaccines for younger children
The U.S. Food and Drug Administration (FDA) announced two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines
The FDA also said it anticipates receiving a request from Pfizer to amend its emergency use authorization (EUA) to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA scheduled an advisory committee meeting on October 26 to discuss that request.
On Oct. 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
Additionally, on Oct. 15, the committee will hear a presentation from the National Institute of Health’s National Institute of Allergy and Infectious Diseases on the heterologous use of booster doses following the primary series of the three currently authorized or approved COVID-19 vaccines.
During the meeting, the committee will hear presentations from the companies on the data for their respective vaccines. The FDA will also present its own analyses of each of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an opportunity to provide comments.
