The U.S. Food and Drug Administration announced on Friday that it has scheduled a meeting of its external advisory panel to discuss Pfizer and BioNTech’s application for emergency use approval for a coronavirus vaccine.
The Advisory Committee on Vaccines and Allied Biological Products (VRBPAC) will meet on December 10th.
The companies submitted their application for an EUA on Friday. It is the first application for FDA approval for a coronavirus vaccine.
“The FDA recognizes that transparency and dialogue are critical to public confidence in Covid-19 vaccines. I want to reassure the American people that the process and evaluation of the data for a potential Covid-19 vaccine is ongoing the FDA will be as open and open as possible, “said FDA Commissioner Dr. Stephen Hahn in a statement.
“The FDA has been preparing to review EUAs for Covid-19 vaccines for several months and is ready to do so as soon as an EUA application is filed. Although we cannot predict how long the FDA review will take the FDA will review it. ” submit the request asap, but still thorough and science-based so that we can get a vaccine available as soon as possible that the people of America deserve. “
The FDA should post the VRBPAC meeting schedule on the Federal Register at least two weeks in advance. The agency has promised to take full account of the contributions of the committee, composed of vaccine experts and others, with no ties to the companies submitting vaccines for FDA approval or approval.
“A discussion of the safety and effectiveness of the Pfizer and BioNTech vaccine with this committee, comprised of external science and public health experts from across the country, will help ensure a clear public understanding of the scientific data and information, which the FDA will evaluate in the correct order will make a decision on whether to approve an emergency vaccine for the prevention of Covid-19, “said Hahn.
The FDA announced that it will broadcast the VRBPAC meeting live on the agency’s YouTube, Facebook and Twitter channels, as well as on the FDA website.