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FDA advisers recommend updating COVID booster shots to better match newer coronavirus variants

At least some U.S. adults may receive up-to-date vaccines for COVID-19 this fall, as government advisers voted Tuesday that it was time to adjust booster doses to better match the latest versions of the virus.

Food and Drug Administration advisers have struggled with how to modify doses now, when there is no way to know how the rapidly mutating virus will develop by the fall – especially as people taking the current boosters remain strongly protected from the worst. results of COVID-19.

Finally, the FDA panel voted 19-2 that the COVID-19 amplifiers must contain some version of the superconducting micron variant in order to be ready for an expected fall boost campaign.

“We will be behind the eight balls if we expect more,” said Dr. Mark Sawyer of the University of California, San Diego.

The FDA will have to decide on the exact prescription, but expect a combination vaccine that adds protection either to the micron or to some of its younger relatives in the original vaccine.

“None of us have a crystal ball” to know the next threatening variant, said FDA chief vaccine expert Dr. Peter Marks. But “we can at least bring the immune system closer to being able to respond to what is circulating” now much older strains of the virus.

It is not clear to whom a customized souvenir would be offered – they may only be encouraged for older adults or people at high risk for the virus. However, the FDA is expected to decide to change the prescription within days and then Pfizer and Moderna will have to seek approval for properly updated doses, time for health authorities to come up with a drop strategy.

Current vaccines for COVID-19 have saved millions of lives worldwide. With a booster dose, those used in the US maintain strong protection against hospitalization and death, but their ability to prevent infection was significantly reduced when omicron appeared. And the mutated micron caused by the winter wave has been replaced by its genetically distinct relatives. Omicron’s two youngest cousins, named BA.4 and BA.5, now make up half the cases in the United States, according to the Centers for Disease Control and Prevention.

Pfizer and Moderna were already making amplifiers that add protection to the first mutant micron. Their combination vaccines, what scientists call “divalent” vaccines, have substantially increased antibody levels capable of fighting this variant, rather than just giving another dose of the current vaccine.

Both companies found that the modified shots also offered some cross-protection against these disturbing BA.4 and BA.5 mutants, but not so much.

Many scientists support the combined approach because it retains the proven benefits of the original vaccines, which include some cross-protection against other mutants that appeared during the pandemic.

The question facing the FDA is the right prescription change. Both companies said they would have several complex omicron-targeted downloads by October, but Moderna said switching to targeting newer omicron relatives could delay its release by another month.

Complicating the decision further is that only half of all vaccinated Americans have received this very important first souvenir. And while the CDC says health care has declined for the elderly, a second booster recommended for people 50 and older seems to be restoring it. But only a quarter of those eligible for the special amplifier have received one.

Marks said that by modifying the shots, “we hope we can persuade people to take this booster to boost their immune response and help prevent another wave.”

The logistics will be challenging. Many Americans have not yet had their first vaccinations, including young children who have just become eligible – and it is unclear whether the modified amplifiers could eventually lead to a change in the main vaccine. But FDA advisers said it was important to go ahead and study up-to-date vaccine prescriptions in children as well.

And one more complexity: A third company, Novavax, is awaiting FDA approval for a more traditional type of COVID-19 vaccine, the protein-based vaccine. Novavax said on Tuesday that a booster of its regular vaccine promised a good immune response against the new mutant microns without a prescription change.

World Health Organization advisers recently said that micron-adapted shots would only be more useful as reinforcements, as they would have to increase the scope of cross-protection of people against multiple variants.

“We do not want people to lose confidence in the vaccines currently available,” said Dr Kanta Subbarao, a virologist who chairs the WHO committee.

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The Associated Press Department of Health and Science receives support from the Department of Education Sciences of the Howard Hughes Medical Institute. The AP is solely responsible for all content.

Copyright © 2022 by the Associated Press. All rights reserved.

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FDA advisers recommend updating COVID booster shots to better match newer coronavirus variants Source link FDA advisers recommend updating COVID booster shots to better match newer coronavirus variants

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