FDA schedules meetings about COVID-19 booster shots in adults and primary series in children

Oct. 4, 2021

The U.S. Food and Drug Administration (FDA) has scheduled a series of meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss granting emergency use authorizations (EUA) for booster doses of the COVID-19 vaccines from Moderna and Johnson & Johnson.

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.

Meanwhile, on October 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Johnson & Johnson 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 vaccination.

Additionally, on October 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.

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