This paves the way for FDA to authorize the shot and within 24 hours of an emergency use authorization, the vaccine could be shipped out to distribution sites across the US
Medical experts advising the US Food and Drug Administration (FDA) have recommended the emergency approval of Pfizer-BioNTech’s coronavirus vaccine. The question that members had to vote for or against was, “Based on the totality of scientific evidence available, do the benefits of the Pfizer/BioNTech Covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?” After nearly nine hours of deliberations on December 10, 17 members of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from across the US, voted yes, four voted no and one abstained. The decision came as Covid-19 cases continued to surge across the US with deaths setting an all-time, one-day record of more than 3,000 on December 9.
This paves the way for the FDA to authorize the shot for a nation that has lost more than 290,000 lives to the Covid-19 pandemic. While the FDA does not have to follow the group’s recommendation, it is widely expected to do so.
The meeting on December 10 was an important step in the process, allowing outside scientific experts an opportunity to provide valuable advice and input for the agency to consider as part of its final review, noted FDA Commissioner Dr Stephen M Hahn.
“Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDA’s career officials in the Center for Biologics Evaluation and Research. After the VRBPAC meeting, FDA career staff will take the committee’s input into account as they continue their review of the EUA request to determine whether it has met the standards for safety and effectiveness for issuance of EUA. I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it,” tweeted Dr Hahn.
Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDA’s career officials in the Center for Biologics Evaluation and Research.
— Dr. Stephen M. Hahn (@SteveFDA) December 10, 2020
The agency emphasized that its staff feels the responsibility to move as quickly as possible through the review process. “However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come. Brinkwire Brief News.