The U.S. Food and Drug Administration has set a public meeting on Dec. 10 to discuss approving Pfizer and BioNTech’s experimental COVID-19 vaccine and will livestream it on YouTube, Facebook and Twitter.
The companies asked the federal agency Friday for emergency use authorization after its research indicated that the vaccine candidate is 95% effective in preventing the coronavirus.
It’s the first vaccine request before the FDA that could serve as a major weapon in the fight to end the worsening global pandemic.
“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines,” FDA Commissioner Stephen Hahn said. “I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible.”
The FDA’s Vaccines and Related Biological Products Advisory Committee will hold the meeting on Dec. 10. Members of the committee will discuss the safety and the effectiveness of the potential vaccine in hopes of gaining the public’s trust, according to the agency.
The FDA intends to livestream the meeting on its website in addition to social media platforms, and the agency said it will make the meeting agenda and additional background materials available to the public prior to the meeting.
Hahn said he doesn’t know how long it will ultimately take to review the emergency use authorization request, but he vowed that the FDA will move as quickly as possible.
“The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted,” Hahn said. “While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”
The committee will report back to the FDA, and the agency will make the final decision.
“A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19,” Hahn said.
Pfizer executives said if approved, the long-awaited vaccine could begin to be rolled out in “hours.”
Distributing the two-dose vaccine will be left up to individual countries, although most agree that first responders and other at-risk health care workers should get the first injections.
Medical experts said it could be several more months before the vaccine is widely available to the public.
This story was reported from Los Angeles.