FDA panel recommends Pfizer coronavirus vaccine for emergency use, here's what will happen next
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 to expect," added Dr Hahn.
Ahead of the meeting, the FDA had also released a 53-page analysis, stating that the data submitted in Pfizer’s EUA request were “consistent with the recommendations set forth in the FDA guidance on EUA for vaccines to prevent Covid-19 and met the prespecified success criteria established in the protocol".
What happened at the meeting?
The open discussion with the committee was conducted live. The final vote was not without dissent and seems to have been influenced by one narrow issue: the inclusion of 16- and 17-year-olds in the proposed emergency use authorization. Four members voted against issuing an emergency use authorization after a late debate about whether to remove 16- and 17-year-olds from it. Some experts stated the data on this subgroup was ‘insufficient’ to say whether the vaccine carries more benefit than risk for them, arguing that they are at relatively low risk of severe disease and death from coronavirus. Once the voting got over, the group adjourned, leaving no time for members to explain why they voted the way they did.
The panel also discussed concerns raised by reports of serious allergic reactions among vaccine recipients in the UK. Paul Offit, a vaccinologist from Children’s Hospital of Philadelphia and a panelist, pointed out that this is a potentially big problem. He feared that statements by British regulators could lead “tens of millions” of people with severe allergies to reject the vaccine. While Offit did not think this should stand in the way of EUA, he urged continued studies to learn more about the potential for allergic reactions to the vaccine and to reassure those who have severe allergies in general. “(The matter needs) careful observation to prove that this is not going to be a problem. You’ve got tens of millions of people who are not going to get this vaccine because of the comments that were made (by health officials in the UK). We need to offer people some solace. This issue is not going to die until we have better data,” said Offit.
The FDA informed the panel that it had asked Pfizer to include allergic reactions in its safety tracking plan. Experts also advised that more information about the vaccine’s effects on pregnant women, young children and those who are severely immunocompromised will be needed.
What happens now?
Officials from Operation Warp Speed, the federal government’s vaccine distribution program, have said they will start shipping the vaccine to distribution sites across the US within 24 hours of FDA authorization. About 2.9M doses will be sent in an initial shipment.
"Our goal is to make sure that we can ensure the vaccine is delivered in a timely manner, is to be delivered safely, securely, and it's ready to be utilized to start administering the vaccine as soon as possible,” explained Army General Gustave F Perna, who serves as the chief operating officer of Operation Warp Speed. The drug alone is not enough for ensuring the distribution of vaccines across the US, Perna said. Additional supplies are also needed to administer a drug, and the general noted those supplies are on the way to the 636 locations across 64 jurisdictions where the vaccine will be sent.
The VRPBAC is scheduled to meet again on December 17 to discuss Moderna's EUA application. "As we've discussed, based on current production schedules, we expect to have enough doses to vaccinate 20 million Americans by the end of this year, 50 million total by the end of January, and at least 100 million total by the end of the first quarter," Alex M Azar, Secretary for the Department of Health and Human Services (HHS) informed.
While the EUA allows shipping to begin, but shots still cannot be administered until the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) recommends that the vaccine be deployed for use. The ACIP has a meeting scheduled for December 11 and expects to vote during another meeting that is scheduled for December 13. As interim guidance, the ACIP had earlier recommended that both healthcare personnel and residents of long-term care facilities be offered the Covid-19 vaccine in the initial phase of the vaccination program.