VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters

On Oct. 14 and 15, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) 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).

On Oct. 14, the committee will discuss an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.

On Oct. 15, the VRBPAC will discuss amending the emergency use authorization of Johnson and Johnson’s Janssen COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.

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.

The FDA intends to make background materials for both VRBPAC meetings available to the public, including the meeting agendas and committee rosters, no later than two business days before each meeting.

The FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page.