November 30, 2020

Coronavirus vaccine roundup: Moderna to seek EUA for coronavirus vaccine

Daily Briefing

    Below we round up the latest news on new coronavirus vaccine efforts.

    • The Advisory Committee on Immunization Practices, which is a panel of outside experts who make recommendations to CDC regarding vaccine use, last week said that essential workers should receive any authorized vaccine against the novel coronavirus before adults 65 and older and those with medical conditions that place them at high risk of developing severe Covid-19. As Axios reports, "Many essential workers don't have the option to social distance, unlike some older or sicker Americans." Beth Bell, a global health expert at the University of Washington who is a member of the committee, said, "These essential workers are out there putting themselves at risk to allow the rest of us to socially distance. And they come from disadvantaged situations, they come from disadvantaged communities" (Branswell, STAT News, 11/23; Owens, Axios, 11/24).
    • Experts have expressed confusion over recent results from clinical trials evaluating AstraZeneca's and Oxford University's coronavirus vaccine candidate, the New York Times reports. The early data showed that the experimental vaccine was 90% effective in participants who initially—and unintentionally—received half a dose of the vaccine, followed by a full dose of the vaccine at a later date. The early data also showed that the vaccine candidate was 62% effective in participants who initially received one full dose, followed by another full dose at a later date. According to an article published in Nature, it's possible that smaller doses of a vaccine could be more effective at triggering specific parts of the immune system when compared with a larger dose. However, according to the Times, it's also possible that "other factors, like the size and makeup of the groups that got different doses, may also be at play." For example, Moncef Slaoui—an official with Operation Warp Speed, the federal government's coronavirus vaccine initiative—noted that the higher efficacy group for AstraZeneca's and Oxford's vaccine did not include any participants older than 55 (Zimmer/Robbins, New York Times, 11/24; Owens, "Vitals," Axios, 11/25; Callaway, Nature, 11/23; Lauerman/LaVito, Bloomberg, 11/24; Callaway, Nature, 11/23).
    • Gen. Gustave Perna, head of logistics for Operation Warp Speed said the federal government intends to send 6.4 million doses of Pfizer's coronavirus vaccine candidate to U.S. states within 24 hours of the company receiving an emergency use authorization from FDA, if that occurs. Public health experts expect that the federal government will make the first set of authorized coronavirus vaccine doses available to health care and other frontline workers, followed by groups who are at high risk for developing severe Covid-19. Perna said state and local officials have been informed of their estimated dose allocations, which are based on population. He added that the federal government is on track to distribute 40 million doses of coronavirus vaccine candidates by the end of this year (Sun, Washington Post, 11/24; Robbins, New York Times, 11/24; Spalding/O'Donnell, Reuters, 11/24; Huang, "Shots," NPR, 11/24).
    • Moderna earlier this month announced that initial data from Phase 3 clinical trial on its coronavirus vaccine candidate shows that the experimental vaccine is 94.5% effective at preventing Covid-19. For its clinical trial, Moderna recruited 30,000 participants, including 6,000 who identified as Hispanic or Latinx and more than 3,000 who identified as Black or African American. In addition, 7,000 participants were older than 65 and 5,000 had chronic diseases that place them at high-risk for severe Covid-19. Early data from the trial shows that 90 participants in the study's placebo group and five participants in the vaccine group developed Covid-19, which the company said indicated a 94.5% effectiveness rate at preventing the disease completely. In addition, Moderna said no one in the vaccine group developed a severe case of Covid-19, while 11 individuals in the placebo group developed severe cases. Moderna said it plans to file an emergency authorization request with FDA "in the coming weeks." The company also said it plans to distribute the first 20 million doses of the vaccine in the United States, and that it expects to do so by the end of 2020. Moderna said it expects to make 500 million to one billion doses that could be distributed worldwide in 2021 (Palca, "Shots," NPR, 11/16; DeAngelis, Boston Business Journal, 11/16; Weintraub, USA Today, 11/16; Budryk/Sullivan, The Hill, 11/16; Deutsch, Politico, 11/16; Loftus, Wall Street Journal, 11/16; Johnson, Washington Post, 11/16; Grady, New York Times, 11/16).
    • Moderna on Monday announced it will seek emergency use authorization (EUA) from FDA for its coronavirus vaccine candidate, which according to the company has a 94.1% efficacy rate in preventing Covid-19 and a 100% efficacy rate against severe Covid-19 cases. If authorization is granted, Moderna's vaccine could begin to be administered as soon as Dec. 21, according to Moderna CEO Stéphane Bancel. Bancel added that the company was "on track" to manufacture 20 million doses by the end of the year, and between 500 million and 1 billion doses next year.
      The announcement makes Moderna the second company, after Pfizer, to seek an EUA for a coronavirus vaccine candidate—an announcement, which, according to Axios, "potentially pav[es] the way for the U.S. to have two Covid-19 vaccines in distribution by the end of the year" (Grady,
      New York Times, 11/30; Axios, 11/30).
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