December 11, 2020

A panel just recommended FDA authorize Pfizer's coronavirus vaccine. Here's what happens next.

Daily Briefing

    An FDA advisory panel on Thursday recommended that the agency authorize the emergency use of Pfizer's and BioNTech's coronavirus vaccine candidate—a decision which makes it likely the inoculation will receive an emergency use authorization (EUA) within the next few days.

    FDA panel backs authorization of vaccine candidate

    On Thursday, members of FDA's Vaccines and Related Biological Products Advisory Committee met to determine whether there is enough evidence to support an EUA for the vaccine candidate. In a 17-4 vote, with one abstention, the committee concluded the vaccine appears to be safe and effective and recommended FDA authorize the vaccine's emergency use in adults and teenagers 16 and older.

    The four committee members who voted against recommending the vaccine's authorization—Archana Chatterjee, Rosalind Franklin University's VP of medical affairs; Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan; David Kim, director of vaccines and immunization in HHS' Office of Infectious Disease and HIV/AIDS Policy; and Michael Kurilla, the National Center for Advancing Translation Sciences' director of clinical innovation—as well as the one panelist who abstained—Cody Meissner, Tufts University' director of pediatric infectious diseases—raised concerns about:

    • The vaccine causing serious allergic reactions in certain patients;
    • The lack of evidence supporting the inoculation's safety and effectiveness in women who are pregnant and lactating, as well as in teenagers ages 16 and 17;
    • The absence of data showing the vaccine prevents viral shedding, which occurs when a virus is released from an infected person; and
    • The effect of the vaccine's EUA on the vaccine's ongoing clinical trials.

    Specifically, panelists during Thursday's meeting cited recent reports of two health care workers experiencing severe allergic reactions after receiving the vaccine in the United Kingdom, where regulators on Dec. 2 authorized the inoculation for people ages 16 and older. The news prompted regulators in the United Kingdom and Canada, where the vaccine received an authorization on Wednesday, to issue warnings that people with a history of anaphylactic allergic reactions to medications and foods should not get the vaccination.

    Marion Gruber, director of FDA's Office of Vaccines Research and Review, said FDA has been in communication with U.K. regulators about the two incidents and is seeking additional information. In addition, FDA said it asked Pfizer to track allergic reactions to its vaccine candidate and noted the vaccine would include a warning in its instructions. Specifically, she noted that a warning had been added to the draft EUA cautioning people with an allergy to any of the vaccine's individual components not to receive it and that providers should have readily available equipment necessary to treat a severe allergic reaction wherever the vaccine is administered.

    Paul Offit, a member of the committee and professor of pediatrics at the Children's Hospital of Philadelphia, recommended Pfizer conduct a study to evaluate whether people with a known history of severe peanut and egg allergies develop severe reactions to the vaccine. Offit, although voting in favor of authorization, said that study may assuage concerns people may have about getting the vaccine if they have a known history of allergies.

    "You're going to have tens of millions of people who are going to not get that vaccine because of the comments that were made both by" U.K. regulators and Operation Warp Speed Chief Science Advisor Moncef Slaoui about the two documented cases severe allergic reactions to the vaccine, Offit said. "I just think it's a practical solution because this issue is not going to die until we have better data."

    According to STAT News, some panelists requested FDA rephrase the proposed EUA to exclude people younger than 18, but FDA declined to do so—a decision that in turn resulted in some of the "no" votes. For instance, during an interview on CNN's "OutFront," Chatterjee, who called on Pfizer and BioNTech to provide additional data on the vaccine candidate, said she "fully" supports the vaccine's EUA "for use in adults 18 years and older" but had an issue with the limited data on younger patients.

    Panelists also wanted more data on the vaccine's effect on viral shedding, which is key to herd immunity. Pfizer's Katherine Jansen, head of vaccine research and development, said the company is conducting a study to evaluate whether the vaccine prevents people from contracting the virus, current data show efficacy against Covid-19, the disease caused by the new coronavirus.

    In addition, panelists said the vaccine's broad EUA could affect Pfizer's and BioNTech's ongoing clinical trials. Specifically, some panelists said trial participants who received a placebo should be offered the vaccine once FDA issues an EUA, but others said the move could affect the trial's long-term results.

    What's next?

    Although FDA is not required to follow to the committee's recommendations, the agency usually does. People familiar with the agency's plans told the New York Times that FDA is expected to issue an EUA for the vaccine candidate on Saturday, but that "legal or bureaucratic requirements" may delay the agency's announcement to Sunday or later.

    According to the Times, the vaccine's authorization would set off a complex distribution plan coordinated by large hospitals, pharmacy chains, the federal government, and local governments.

    Federal officials said the first 6.4 million doses of the vaccine would leave warehouses within 24 hours of FDA's issuance of an EUA, the Times reports. About half of the doses would be shipped across the country and the other half would be reserved for people to receive their second dose of the vaccine.

    Meanwhile, according to the Times, Pfizer will continue its clinical trial if and when it receives the EUA, with a goal of applying for the vaccine's full approval in April 2021—at which point the company will have six months of safety data. If it receives full approval, Pfizer will be permitted to sell the vaccine directly to health systems and other providers, the Times reports.

    America's surging coronavirus epidemic

    Amid the vaccine developments, U.S. officials on Thursday reported about 223,570 new cases of the novel coronavirus, according to data compiled by the Times. As of Friday morning, U.S. officials had reported a total of about 15.6 million cases of the virus since America's epidemic began—up from about 15.4 million cases reported as of Thursday morning.

    According to the Times, the United States' average daily number of newly reported coronavirus cases over the past week was 211,127—which is up by 28% when compared with the average from two weeks ago.

    As of Friday morning, data from the Times showed that the rates of newly reported coronavirus cases were "staying high" in Puerto Rico; the U.S. Virgin Islands; Washington, D.C.; and 40 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and West Virginia.

    Meanwhile, the Times' data showed that, as of Friday morning, the daily average number of newly reported cases over the past seven days was "going down" in nine states that had been seeing comparatively higher rates of coronavirus transmission. Those states are Illinois, Iowa, Montana, Nebraska, New Mexico, North Dakota, South Dakota, Wisconsin, and Wyoming.

    In Guam and Hawaii, meanwhile, rates of newly reported coronavirus cases were "staying low" as of Friday morning, the Times' data showed.

    Meanwhile, U.S. hospitalizations for Covid-19, the disease caused by the novel coronavirus, grew to a new high for the 13th consecutive day on Thursday, according to data from The Atlantic's COVID Tracking Project. The data showed that 107,258 Americans with Covid-19 were hospitalized for treatment on Thursday, including 21,023 who were receiving care in an ICU and 7,442 who were on a ventilator.

    On Thursday, U.S. officials also reported about 2,923 new deaths tied to the novel coronavirus. As of Friday morning, U.S. officials had reported a total of about 292,747 U.S. deaths linked to the virus since the country's epidemic began, up from about 289,531 deaths reported as of Thursday morning.

    (Wang, Inside Health Policy, 12/10 [subscription required]; Thomas et al., New York Times, 12/10; STAT News, 12/10; Neergaard/Perrone, Associated Press, 12/10; Choi, The Hill, 12/10; New York Times, 12/11; "The COVID Tracking Project," The Atlantic, accessed 12/11).

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