FDA panel recommends changing Covid shots to fight omicron this fall - CNBC

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The Food and Drug Administration's panel of independent vaccine experts on Tuesday voted 19 to 2 to recommend new Covid-19 shots that target the omicron variant this fall, when public health officials are expecting a new wave of infections.
It is the first time the panel has proposed that vaccine makers modify the shots to target a different variant.
However, the panel did not make a recommendation on which omicron subvariant the shots should target.
The omicron variant is the most dramatic example yet with more than 30 mutations.
Limited data, limited time

FDA panel recommends changing Covid shots to fight omicron this fall - CNBC

The Food and Drug Administration's panel of independent vaccine experts on Tuesday voted 19 to 2 to recommend new Covid-19 shots that target the omicron variant this fall, when public health officials are expecting a new wave of infections. It is the first time the panel has proposed that vaccine makers modify the shots to target a different variant. The FDA will likely accept the committee's recommendation and authorize a vaccine change. However, the panel did not make a recommendation on which omicron subvariant the shots should target. Pfizer, Moderna, Novavax and Johnson & Johnson all developed their vaccines against the original Covid strain that first emerged in Wuhan, China, in 2019. But as the virus has rapidly evolved over the course of the pandemic, the vaccines have become less effective at protecting against infection and mild illness, though they are still generally protecting against severe disease. A healthcare worker prepares a syringe with the Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the COVID-19 pandemic in Manhattan in New York City, January 29, 2021. Mike Segar | Reuters The vaccines target the spike protein the virus uses to invade human cells. However, the shots have trouble recognizing and attacking the spike the more it mutates away from the original version of the virus. The omicron variant is the most dramatic example yet with more than 30 mutations. That is one of the central reasons why omicron caused such a massive wave of infections last winter despite the fact that masses of people were fully vaccinated. Fall booster campaign Omicron continues to mutate into more contagious subvariants. Dr. Peter Marks, who heads the FDA's vaccine division, said the U.S. faces a Covid outbreak this fall and winter as the virus evolves, vaccine immunity wanes and people spend more time indoors where Covid can spread much easier than outdoors. "For that reason, we have to give serious consideration to a booster campaign this fall to help protect us," Marks told the committee. "The better the match of the vaccine to the circulating strain, we believe may correspond to improved vaccine effectiveness and potentially to a better durability of protection." Justin Lessler, an epidemiologist at University of North Carolina Chapel Hill, said 95,000 additional people could die in the U.S. from Covid by March 2023 in the most optimistic projections from a team of scientists who are developing models of the pandemic's trajectory. In the most pessimistic scenario, 211,000 people could perish from the virus by March of next year, he said. However, Lessler cautioned that there is a lot of uncertainty in those projections. Three doses from the current vaccines are just 19% effective at preventing infection from omicron among adults ages 18 and older 150 days or more after administration, according to data presented by the Centers for Disease Control and Prevention. This low protection against infection is likely due to omicron evolving into the more contagious BA.2 and BA.2.12.1 subvariants, CDC official Dr. Ruth Link-Gelles said. A third dose was 55% effective at preventing hospitalization from these subvariants among adults 120 days or more after receiving the shot, according to the data. Limited data, limited time
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