For immediate release:

The U.S. Food and Drug Administration has scheduled a meeting of the Advisory Committee on Vaccines and Related Biological Products (VRBPAC) on December 17 to discuss Moderna Inc.’s application for an Emergency Use Authorization (EUA) for COVID-19 vaccine.

“In line with the FDA’s commitment to full transparency, dialogue, and efficacy, the Advisory Committee on Vaccines and Related Biological Products, composed of external scientific and public health experts from across the country, discusses safety and efficacy as a whole. the data submitted by Moderna for the submission of the EUA, ”said FDA Commissioner Stephen M. Hahn,“ The FDA is aware that there is a huge public interest in COVID-19 vaccines. We remain committed to keeping the public informed about the evaluation of data on a potential COVID-19 vaccine so that the public and the medical community, once available, can be confident that they will receive the vaccine for our family and ourselves.

The FDA intends to disclose background materials, including the agenda of the meeting and the committee schedule, 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 representative of consumers, industry, and sometimes patients. Additional experts can be added to individual meetings as needed.

Although members of the VRBPAC provide advice to the agency, which may include advice on the safety and efficacy data submitted in the EUA application, the FDA will make the final decision on whether to allow vaccination for emergency use. Given the timing of the VRBPAC meeting following the submission of an EUA application, this time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA application prior to the meeting and to prepare for a strong public discussion with the Commission. members of the Advisory Committee.

The FDA will publish a notice of the federal registry as soon as possible that includes details of the meeting, which will include comments on public documents. Public comments can then be submitted. These comments will be reviewed by the FDA.

The FDA intends to broadcast 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 U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, as well as medical devices. The agency is also responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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