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September 2, 2022

Covid-19 roundup: FDA authorizes updated boosters for fall vaccination campaign

Daily Briefing

    Covid-19 vaccines will transition to the private market in January 2023, a biotechnology company has developed a Covid-19 vaccine in pill form, and more in this week's roundup of Covid-19 news.

    Your top resources on the Covid-19 vaccines

    • FDA on Wednesday authorized updated Covid-19 boosters from Pfizer-BioNTech and Moderna ahead of the United States' expected fall booster campaign. Pfizer-BioNTech's booster is authorized for individuals 12 and older, while Moderna's booster is authorized for all adults 18 and older. The boosters are bivalent vaccines, which target both the original coronavirus variant and omicron subvariants BA.4 and BA.5. "As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent Covid-19 vaccine to provide better protection against currently circulating variants," said FDA Commissioner Robert Califf. According to Peter Marks, head of FDA's vaccines division, the updated vaccines are expected to better match future variants that could evolve this winter. "In terms of trying to stave off serious outcomes and symptomatic disease, one needs to refresh the immune system with what is actually circulating," he said. On Thursday, CDC's Advisory Committee on Immunization Practices (ACIP) recommended both booster shots—Pfizer-BioNTech's for people 12 years and older and Moderna's for people 18 years and older . Since CDC Director Rochelle Walensky signed off on ACIP's recommendation, vaccinations with the updated boosters could begin as early as the day after Labor Day. (Hopkins/Whyte, Wall Street Journal, 8/31; Weiland/LaFraniere, New York Times, 8/31; Fiore, MedPage Today, 8/31; AP/Modern Healthcare, 8/31; Reed/Bettelheim, Axios, 9/1; Herper, STAT, 8/31)
    • Vaxart, a biotechnology company based in San Francisco, reported promising Phase 2 clinical trial data for its Covid-19 vaccine that would be delivered in pill form instead of a shot. According to company officials, the two-dose vaccine was "safe and well tolerated" and generated immune responses against the original coronavirus strain, as well as subsequent variants and subvariants, including omicron, in a small trial of 66 people. In addition, the vaccine showed a mucosal antibody response, which can add another layer of protection against infection. "We believe that the positive findings for multiple immunologic responses may ultimately translate to enhanced protection against infection with, and/or transmission of, SARS-CoV-2," said Sean Tucker, Vaxart's founder and chief scientific officer. Ultimately, the company said it believed that its Covid-19 vaccine pill could be "groundbreaking" for global delivery of vaccines and help get ahead of potential new variants. Currently, Vaxart is working on new omicron-based vaccine candidates, with plans to move forward with clinical trials in the first half of 2023. (Reed, Axios, 9/1)
    • The Biden administration on Tuesday said it plans to shift Covid-19 vaccine coverage to the private market as soon as January 2023—a sign that the United States is moving out of the "acute emergency phase" of the pandemic. Already, the administration has begun transitioning some Covid-19 treatments, such as monoclonal antibodies, to the private market, and more are expected to follow in the coming months. Although the administration had always planned to transition Covid-19 products to commercial purchasing, the process has been accelerated due to a lack of new pandemic funding from Congress. "We have always intended to transition this work to the commercial market and have been planning for that transition for some time now," said Dawn O'Connell, an assistant secretary in HHS. "Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work." According to O'Connell, Covid-19 vaccines are expected to move to the private market by January 2023, and Pfizer's antiviral Covid-19 treatment Paxlovid could make the transition by mid-2023. However, even as Covid-19 vaccines and treatments move to commercial purchasing, additional funds are still "needed for a range of critical response needs, including the development of next-generation vaccines, therapeutics, and tests," O'Connell said. (Sullivan, The Hill, 8/30)
    • Plasma SARS-CoV-2 nucleocapsid antigen levels were associated with pulmonary illness severity and outcomes in hospitalized Covid-19 patients, according to a cross-sectional study published in the Annals of Internal Medicine. For the study, researchers analyzed data from 2,540 patients in 10 countries who were enrolled in the Therapeutics for Inpatients with Covid-19 platform trial between August 2020 and November 2021. At enrollment, 81% of participants were not vaccinated, and 57% had elevated plasma antigen levels (>= 1,000 ng/L). In addition, 25% of patients were breathing room air, 11% required noninvasive ventilation, and most required supplemental oxygen. Overall, the researchers found that baseline severity of pulmonary illness was strongly associated with plasma antigen level. On average, patients who required noninvasive ventilation had 3.1-fold higher plasma antigen levels compared to those breathing room air. Antigen levels were also 2.88-fold higher for patients who needed 4 L or more of oxygen supplementation and 1.77-folder higher for those who needed less than 4 L. Compared to patients with lower antigen levels, those with high antigen levels had a greater likelihood of worsened pulmonary status at day 5, and their length of hospital stay was almost twice as long (median seven days vs. four). According to the researchers, antigen levels could be a useful biomarker for designing trials for Covid-19 antivirals. "You can't eyeball patients and say, that patient is a good candidate for antivirals," said Angela Rogers, one of the study's authors from Stanford University. "In big trials, we treat all patients the same," even though there is "huge heterogeneity." (Hein, MedPage Today, 8/30)
    • Almost 80% of children in the United States have had Covid-19, according to new CDC estimates. As part of an ongoing national lab survey, CDC tests for antibodies against the coronavirus in collected commercial lab samples. Out of more than 26,000 lab samples, 79.7% show evidence of coronavirus antibodies. This suggests that 56,977,000 U.S. children have had at least one Covid-19 infection. Overall, the prevalence of coronavirus antibodies was relatively similar across age groups. The group with the highest prevalence in test samples was children ages five to 11 years old at 82.5%. In comparison, children between the ages of six months and four years old had a 74% prevalence rate for coronavirus antibodies. (Twenter, Becker's Hospital Review, 8/30)


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