December 18, 2020

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

Daily Briefing

    An FDA advisory panel on Thursday recommended the agency authorize the emergency use of Moderna's coronavirus vaccine candidate—a decision which makes it likely the inoculation will receive an emergency use authorization (EUA) as early as Friday.

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    FDA panel backs authorization of Modern's 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 Moderna's coronavirus vaccine candidate. In a 20-0 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 people ages 18 and older.

    The vote came after FDA on Tuesday released its first scientific evaluation of Moderna's coronavirus vaccine candidate and confirmed the inoculation's effectiveness. Overall, FDA scientists found that data showed Moderna's two-shot vaccine regimen was safe and "highly effective" at preventing Covid-19 among participants of all ages, races, and genders. In addition, FDA said the data suggested the vaccine candidate may prevent both symptomatic and asymptomatic infections from the novel coronavirus. And in terms of safety, FDA scientists wrote that their analysis "supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an" EUA.

    As with Pfizer's vaccine, committee members on Thursday raised questions about:

    • The Moderna vaccine candidate's potential side effects, including whether it has been linked to severe allergic reactions;
    • Whether Moderna's vaccine candidate 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.

    Ultimately, the panelists largely agreed that the data Moderna submitted from its clinical trials on the vaccine candidate showed the benefits of the experimental vaccine outweigh the risks for use in people 18 and older and support recommending an EUA. Hayley Gans, an infectious disease specialist at Stanford University's Lucile Packard Children's Hospital, said, "I think this is a really opportune time to move science forward, and I would say that the evidence—which has been studied in great detail—on this vaccine highly outweighs any issues that we've seen."

    The one panel member who abstained from the committee's vote—Michael Kurilla, director of clinical innovation at NIH's National Center for Advancing Translational Sciences—said he was concerned that the committee was recommending Moderna's coronavirus vaccine candidate be used too widely. "A blanket statement for individuals 18 years and older is far too broad," Kurilla said.

    Instead, Kurilla said he would have preferred to recommend that FDA implement an expanded access protocol for the vaccine candidate that would apply only to individuals ages 18 and older who are at high risk of developing a severe case of Covid-19, the disease caused by the novel coronavirus. According to STAT News, expanded access to the vaccine candidate in such a manner essentially would function as a "big clinical trial" for the experimental vaccine.

    According to STAT News, it's worth noting that the advisory panel's vote in favor of an EUA for Moderna's coronavirus vaccine candidate "is numerically more positive than its vote on Pfizer's [and BioNTech's] vaccine last week, which totaled 17 in favor, four opposed, and one abstaining." However, as STAT News explains, "that has more to do with procedure than preference. Pfizer requested an emergency use for people over the age of 16, despite having a small amount of data on the vaccine's benefits for those under 18, which was off-putting to a few panelists. By contrast, Moderna's application covered only those over 18, so there was no dissent about teenage vaccination."

    What's next?

    Although FDA is not required to follow to the committee's recommendations, the agency usually does. According to the Washington Post, FDA in a statement issued Thursday said the agency will "rapidly work toward" making a decision on whether to issue an EUA for Moderna's vaccine.

    If FDA chooses to issue the EUA, the United States would have a total of two coronavirus vaccines authorized for use in the country. Experts expect that FDA will issue the EUA for Moderna's coronavirus vaccine candidate in the same way the agency issued its EUA for Pfizer's and BioNTech's vaccine. FDA scientists released a positive assessment of Pfizer's and BioNTech's vaccine last Tuesday, and an FDA advisory panel last Thursday endorsed the vaccine candidate's EUA. FDA then issued its EUA for the vaccine candidate last Friday, and the federal government began shipping out doses of the vaccine over the weekend. By Monday, health care facilities had started administering the first doses of the vaccine to frontline health care workers.

    On Monday, Gen. Gustave Perna—COO of Operation Warp Speed, the federal government's coronavirus vaccine initiative—said the federal government is preparing to distribute nearly six million doses of Moderna's vaccine candidate to 3,285 locations in the first week following the inoculation's EUA. "It will be a very similar cadence that was executed this week with Pfizer, where we're hitting initial sites on Monday, follow on Tuesday and Wednesday," Perna said.

    Moderna's vaccine candidate is easier to ship and can be distributed more widely than Pfizer's vaccine, because Moderna's candidate does not have to be stored at temperatures as cold as Pfizer's vaccine. Experts have said that factor could make it easier to get Moderna's vaccine to rural and low-income areas, where health care providers are less likely to have the deep freezers needed to store Pfizer's vaccine.

    In North Carolina, for instance, Mandy Cohen, the state's secretary of health and human services, this week said, "Moderna can go to more places. … We hope to be in all 100 counties with some amount of vaccine—small allocations at first—by the end of next week, assuming Moderna gets [authorized] this week and we get our allocations delivered over the course of next week."

    America's coronavirus epidemic continues to surge

    As the New York Times reports, progress on authorizing and distributing coronavirus vaccines in the United States "couldn't come soon enough," as America continues to see persistently high rates of newly reported coronavirus cases, as well as record-high numbers of related hospitalizations and deaths.

    U.S. officials on Thursday reported about 238,189 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 17.2 million cases of the virus since America's epidemic began—up from about 17 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 213,165—which is up by 18% 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 37 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, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin.

    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 12 states that had been seeing comparatively higher rates of coronavirus transmission. Those states are Alaska, Colorado, Iowa, Kentucky, Michigan, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Utah, and Wyoming.

    Hawaii has had comparatively low case rates, but it was seeing those rates "going up" as of Friday morning, according to the Times. In Guam, meanwhile, rates of newly reported coronavirus cases were "staying low" as of Friday morning, the Times' data showed.

    U.S. hospitalizations for Covid-19 grew to a new high for the 20th consecutive day on Thursday, according to data from The Atlantic's COVID Tracking Project. The data showed that 114,237 Americans with Covid-19 were hospitalized for treatment on Thursday, including 21,900 who were receiving care in an ICU and 7,847 who were on a ventilator.

    U.S. officials on Thursday also reported about 3,293 new deaths linked to the virus. As of Friday morning, U.S. officials had reported a total of about 310,935 U.S. deaths linked to the virus since the country's epidemic began, up from about 307,642 deaths reported as of Thursday morning.

    (STAT News, 12/17; Grady et al., New York Times, 12/17; Wang, Inside Health Policy, 12/17 [subscription required]; Owermohle, Politico, 12/17; McGinley/Johnson, Washington Post, 12/17; New York Times, 12/18; "The COVID Tracking Project," The Atlantic, accessed 12/18).

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