Analysis-Upcoming COVID recalls will likely be updated for Omicron

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By Michael Erman

NEW YORK (Reuters) – COVID-19 vaccines this fall are likely to be based on the Omicron variant of the coronavirus rather than the original strain, although some experts suggest they may only offer significant benefits to older people and immunocompromised.

Moderna, Pfizer and Novavax have tested vaccines based on the first BA.1 Omicron variant that became mainstream last winter, leading to a massive increase in infections.

On Wednesday, Moderna said its updated vaccine worked well against newer Omicron subvariants and was moving forward with plans to seek approval from regulators.

Vaccines that can bridge the gap between the original version of the coronavirus and the Omicron variant would likely be “much, much better” for the fall, says Trevor Bedford, a University of Washington biologist who has closely tracked SARS mutations. – coV-2 virus.

Bedford said it would take too long to meet regulatory requirements to adapt the next vaccine to versions of Omicron that are spreading rapidly now.

“Catching up with one of the Omicrons is really important,” he said, noting the huge increase in the number of mutations from the original strain that emerged in China to Omicron on the spike protein part of the virus targeted by the vaccines.

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The World Health Organization (WHO) plans to evaluate the effectiveness of vaccines designed for Omicron, as do national health regulators like the US Food and Drug Administration.

A group of WHO advisers said last week that an Omicron-based vaccine could broaden immunity after the Omicron variant evaded much of the protection against infection generated by vaccines designed for the original virus, a view shared by other experts. FDA scientific advisers will meet on June 28 to make a recommendation on the matter.

Important questions remain, including whether vaccines designed for the variants circulating last winter will work well against significantly different subvariants that may emerge. Experts also want to know whether the new vaccines will increase protection against serious illness and death for younger, healthier people or just provide a few months of extra protection against mild infections.

Scientists who have questioned the value of booster shots for young, healthy people say a massive campaign is also unnecessary with an updated shot.

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BILLIONS OF DOLLARS AT PLAY

Unlike the annual adjustments for flu shots that manufacturers are allowed to try to align with circulating strains, regulators have required companies to conduct clinical trials to prove their new COVID vaccines work better.

But nearly three years into the pandemic, vaccine makers are pushing for a flu-like model that would allow them to quickly revamp their vaccines to fight new variants.

At stake, billions of dollars in contracts with countries around the world. Moderna is already manufacturing the plans, with agreements signed in some countries.

Moderna is asking regulators to greenlight a version of their COVID-19 vaccine targeting both the BA.1 Omicron variant and the original version of the virus, armed with new evidence that it could be effective against the subvariants circulating more recently. “The challenge we have is that the virus continues to evolve very rapidly,” Moderna President Stephen Hoge said in an interview, noting that millions of doses of the updated vaccine could be ready by August.

If the drugmaker still needs to tweak the vaccine and restart manufacturing, new vaccines might not be available until the middle of the fourth quarter, he said.

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Pfizer and its partner BioNTech are testing variant-tailored COVID-19 vaccines but have not yet released data. Novavax, whose vaccine is not yet authorized in the United States, launched a trial of its own Omicron-based vaccines at the end of May.

Dr. Jesse Goodman, a professor at the Georgetown School of Medicine and a former top FDA scientist, said unlike the flu, regulators don’t have enough experience with COVID vaccines to match them to strains. circulating without clinical trials.

Dr. Luciana Borio, former acting chief scientist of the FDA, said science generally supports the idea that it would be better to have vaccines that more closely match the virus currently circulating.

“We see this with people who have hybrid immunity against vaccination and infection,” Borio said. “The immune response that is generated is very rich.”

Still, Borio and others aren’t convinced that everyone should be vaccinated again.

“There is no evidence that a healthy 27-year-old should be revaccinated,” Borio said.

(Reporting by Michael Erman; Editing by Caroline Humer and Bill Berkrot)

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