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March 18, 2022

Covid-19 roundup: Moderna asks FDA to authorize second booster shot for all adults

Daily Briefing

    Moderna requests FDA authorization of an additional booster shot of its Covid-19 vaccine for all adults, children were hospitalized for Covid-19 at significantly higher rates during the omicron surge than the delta surge, and more in this week's roundup of Covid-19 news.

    Your top resources on the Covid-19 vaccines

    • Moderna on Thursday announced that it has requested FDA authorization of a second booster shot of the company's Covid-19 vaccine for all adults, a broader request than the one submitted by Pfizer and BioNTech earlier this week, which asked FDA to authorize a second booster shot for adults ages 65 and older. In a statement, Moderna said the FDA request "was made to provide flexibility" to CDC and health care providers so they can determine the "appropriate use" of a second booster shot, "including for those at higher risk of Covid-19 due to age or comorbidities." Moderna president Stephen Hoge on Monday said his company would "strongly recommend and encourage" a fourth Covid-19 shot "[f]or those who are immune-compromised, those who are older adults, over the age of 50 or at least 65," but said he doesn't expect "any kind of recommendations that would be across the board for everyone." (Lim/Gardner, Politico, 3/17; Dam, Axios, 3/17; Miller, Associated Press, 3/18)
    • The White House on Tuesday said the country's Covid-19 response will be significantly reduced if Congress does not approve new pandemic funding soon. Previously, the Biden administration had requested $22.5 billion in Covid-19 funding as part of a broad government spending bill, but the funding was ultimately removed before the bill was passed. According to administration officials, state allocations of monoclonal antibodies will be reduced by 30% starting next week, and no new orders, including one planned for March 25, will be made without new funding. The government will also be unable to purchase more oral antiviral pills, such as Pfizer's Paxlovid, as well as more vaccine doses. Testing capacity and a program to pay for testing and treatment for uninsured individuals will also be negatively affected by a lack of funding. "With cases rising abroad, scientific and medical experts have been clear that in the next couple of months we could see rising cases of Covid-19 here in the United States as well," wrote White House Covid-19 coordinator Jeff Zients and director of the Office of Management and Budget Shalanda Young in a letter to Congress. "Waiting to provide funding until we're in a surge will be too late." According to NPR, Democrat lawmakers have said they will try to pass a standalone Covid-19 funding bill in the near future, but some Republicans oppose the plan, with some senators requesting a full accounting of how previous Covid-19 funding was spent before approving new funds. (Keith/Snell, NPR, 3/15; Reed, Axios, 3/15; Sullivan, The Hill, 3/15; Plescia, Becker's Hospital CFO Report, 3/16; Haslett/Gittleson, ABC News, 3/15)
    • The omicron subvariant BA.2, which has been referred to as "stealth omicron," now makes up almost a quarter of new Covid-19 infections in the United States, according to CDC estimates published Tuesday—up from 11.6% the week ending March 5. Currently, the subvariant is most prevalent in the Northeast, making up 39% of all coronavirus circulation in the region of New York and New Jersey and 38.6% in New England. According to CBS News, these new estimates come as the subvariant has become dominant in several countries worldwide, including those that are now facing a resurgence in cases. However, it is not currently clear whether the subvariant will also cause a new surge in cases in the United States. "Although BA.2 does seem to be growing as a proportion of sub-lineages in the United States, it's not nearly as quickly as we've seen in some other countries. The doubling time in the United States actually seems to be slowing down," said Deborah Dowell, CDC's CMO for Covid-19 response. "The speculation I've seen is that it may extend the curve going down of case rates of omicron, but is unlikely to cause another surge the way we've seen, that we saw initially with omicron." (Tin, CBS News, 3/15)
    • The American College of Cardiology (ACC) on Wednesday published guidance for the evaluation and treatment of patients with long Covid and cardiovascular symptoms. Under the new guidance, patients with post-acute sequelae of SARS-CoV-2 infection (PASC) should be divided into two groups: those with documented cardiovascular disease and those with "cardiovascular syndrome," which includes a wide variety of symptoms that cannot be explained by testing. For those with PASC-cardiovascular syndrome, the predominant symptom should be the focus of evaluation and management. For example, people with unexplained tachycardia and exercise intolerance should avoid cardiovascular deconditioning and continue physical activity through seat instead of upright exercises. "There appears to be a 'downward spiral' for long Covid patients. Fatigue and decreased exercise capacity lead to diminished activity and bedrest, in turn leading to worsening symptoms and decreased quality of life," said Nicole Bhave, the co- chair of the writing group from Michigan Medicine. In addition to its long Covid guidance, the ACC offered recommendations for post-infection or vaccination myocarditis as well as potential cardiac testing for athletes recovering from Covid-19. (Lou, MedPage Today, 3/16)
    • Immunome will begin human testing of its Covid-19 antibody cocktail after FDA last week lifted a clinical hold on the company's testing plan. The antibody cocktail, which is called IMM-BCP-01, consists of three monoclonal antibodies that bind to nonoverlapping regions of the coronavirus's spike protein. It was developed from memory B cells taken from patients who successfully recovered from Covid-19 to identify an antibody combination that would be broadly protective against the coronavirus. "We believe in the potential of IMM-BCP-01 and its ability to aid in the ongoing fight against [Covid-19], especially as the new variants continue," said Immunome CEO Purnanand Sarma. "We are pleased to report the clinical hold has now been lifted. We look forward to advancing the program into the clinic." (George, Philadelphia Business Journal, 3/11)
    • According to a new CDC report, young children were hospitalized for Covid-19 at much higher rates during the omicron surge than the delta surge. For the report, researchers analyzed data from over 2,500 children aged 0-4 years who were hospitalized from March 2020 to mid-February 2022. The study was divided into three periods based on the prominent coronavirus variant at the time: pre-delta, delta, and omicron. Overall, the researchers found that children between six months and four years were hospitalized five times more during the omicron surge than the delta surge. In addition, infants under six months were hospitalized six times more during the omicron surge than the delta surge. Of the children hospitalized during the omicron surge, 63% had no underlying medical conditions. However, the proportion of hospitalized children in the ICU was smaller in the omicron wave than the other two periods, suggesting that omicron did not cause more severe infections compared with previous variants. "The bigger picture here is that Covid can be a severe disease, even in young children and even in otherwise healthy children," said William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, who was not involved in the study. "Although the risk of severe disease is higher in older adults than in children, children are not spared Covid-19, and even otherwise healthy children without underlying health conditions can be hospitalized." (Shepherd, Washington Post, 3/16; Wu, MedPage Today, 3/15)

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