USA: Pandemic Update U.S. FDA to Hold Meeting for Discussing EUA for Covid-19 Vaccine
On December 17, the U.S. Food and Drug Administration (U.S. FDA) has plans to conduct an advisory committee meeting in order to discuss the emergency use authorisation (EUA) for Moderna’s Covid-19 vaccine.
USA – The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 17 to discuss the request for emergency use authorisation (EUA) for a Covid-19 vaccine from Moderna.
“In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA understands there is tremendous public interest regarding vaccines for Covid-19. We remain committed to keeping the public informed about the evaluation of the data of a potential Covid-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”
The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a Chair, members with scientific and public health expertise, and a consumer, industry, and sometimes a patient representative. Additional experts with specific expertise may be added for individual meetings as needed.
Although the VRBPAC members provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorise the vaccine for emergency use are made by the FDA. In terms of timing of the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.
The FDA intends to issue a Federal Register notice as soon as possible with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted. These comments will be reviewed by the FDA.
The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.