The US Food and Drug Administration (FDA) announced that its advisory committee will meet to discuss the authorization of one of the COVID-19 vaccines, The meeting was scheduled for December 10 and will be broadcast live on various digital platforms.
FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for next December 10 in order to discuss the application for authorization of Emergency Use (USA) of COVID-19 Vaccine from Pfizer, Inc. in association with BioNTech Manufacturing GmbH.
“The FDA recognizes that transparency and dialogue are essential for the public to have confidence in COVID-19 vaccines,” says the statement issued by the FDA.
“I want to assure the American people that the FDA process and the evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn.
An application for emergency approval of the covid-19 vaccine developed by the Pfizer / BioNTech alliance was submitted on Friday in the United States and Europe .
For his part, Albert Bourla, CEO of Pfizer, added his estimates on when vaccination may begin in the US: in December to health employees, in the first quarter of 2021 to risk groups and then to the rest of the population .
“The FDA has been preparing for the US review for COVID-19 vaccines for several months and is ready to do so as soon as a US application is submitted. While we cannot predict how long the review will take, we will review the application as quickly as possible, while continuing to do so in a comprehensive and science-based manner, so that we can help make available a vaccine that the American people deserve. as soon as possible ”says the organization’s statement.
The United States and Europe could authorize it by December: in the first fortnight the FDA, according to estimates by the US government, and in the second the European Medicines Agency, according to the president of the European Commission, Ursula von der Leyen.
“A discussion of the safety and efficacy of the Pfizer and BioNTech vaccine with this committee, comprised of outside public health experts and scientists from around the country, will help ensure a clear public understanding of the scientific data and information that the FDA will evaluate to make a decision on whether to authorize a vaccine for emergency use for the prevention of COVID-19 “added the administration.
FDA intends to make the background materials, including the meeting agenda and committee roster, available to the public 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 experience for individual meetings can be added as required.
Although the VRBPAC members provide advice to the agency, which may include advice on the safety and efficacy data presented in the US application, the FDA makes the final decisions on whether to authorize the vaccine for emergency use.
Regarding the timing of the VRBPAC meeting after the EUA application is submitted, this amount of time will allow FDA to thoroughly evaluate the data and information presented in the EUA application prior to the meeting and be prepared. for a robust public discussion with the advisory committee members.
The week of November 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information on a public docket for comment. At that time, public comments can be submitted. These comments will be reviewed by the organization.
FDA intends to broadcast the VRBPAC meeting live on the agency’s YouTube, Facebook, and Twitter channels; the meeting will also be webcast from your website.
The FDA is an agency within the US Department of Health and Human Services that is responsible for protecting public health by guaranteeing the safety, efficacy and safety of drugs, vaccines and other biological products for human use and medical devices. for human and veterinary use.
The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products in the United States.