- For immediate release:
The United States Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biologics Advisory Committee (VRBPAC) on December 17 to discuss the Emergency Use Authorization (EUA) application for a Moderna Inc.’s COVID-19 vaccine
“In line with the FDA’s commitment to ensure full transparency, dialogue and efficiency, the Advisory Committee on Vaccines and Related Biologics, comprised of outside scientific and public health experts from across the country, will meet to discuss the totality of safety and efficacy. data provided by Moderna for submission to EUA, “said FDA Commissioner Stephen M. Hahn, MD.” The FDA understands that there is enormous public interest in COVID-19 vaccines. We remain committed to keeping the public informed of the data assessment of a potential COVID-19 vaccine, so that once available, the public and the medical community can have confidence and confidence in receiving the vaccine for our families and ourselves.
The FDA intends to make background documents, including the meeting agenda and list of committees, publicly available no later than two business days before the meeting. Typically, 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 can be added for one-on-one meetings, if required.
Although VRBPAC members provide advice to the agency, which may include advice on safety and efficacy data submitted in the EUA application, final decisions on whether or not to authorize the vaccine for use in emergency are taken by the FDA. In terms of the schedule of the VRBPAC meeting after submission of the EUA application, this time frame will allow the FDA to thoroughly assess the data and information submitted in the EUA application prior to the meeting and prepare for an in-depth public discussion with the members of the advisory committee.
The FDA intends to issue a Federal Register notice with the details of the meeting as soon as possible, which will include information on a public registry for comment. At that time, public comments can be submitted. These comments will be reviewed by the FDA.
The FDA intends to webcast the VRBPAC meeting live on the agency’s YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.