FDA to hold meetings discussing emergency-use vaccines, boosters
The FDA announced two upcoming meetings with its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday to discuss available data for COVID-19 vaccinations.
The meetings will be held on Thursday, Oct. 14 and Friday, Oct. 15 respectively, and will discuss booster shots for the Moderna and Johnson & Johnson vaccines, as well as available data on the use of a booster of a different vaccine than the one used for the primary series.
On Oct. 14, the committee with discuss an amendment to the emergency-use authorization of the Moderna vaccine for the administration of a booster dose in individuals 18 and over.
On Oct. 15, the committee will discuss an amendment to the emergency-use authorization of the Johnson & Johnson vaccine for the administration of a booster dose in individuals 18 and over.
In addition, the committee will hear a presentation from the National Institute of Health's National Institute of Allergy and Infectious Disease on the heterologous use of booster shots following the primary series of the three authroized COVID-19 vaccines.
During the meeting, the committee will hear presentations from the companies on the data of their respective vaccines. The FDA will also present its own analyses of each manufacturer's data.
There will be an open public hearing each day, in which the public will be given an opportunity to provide comments.
The FDA is also anticipating a request from Pfizer to amend its emergency-use authorization to allow the use of its vaccine in children aged 5-11. In anticipation of this request, the FDA is moving forward with scheduling an advisory committee meeting on Tuesday, Oct. 26 to inform the agency's decision making.