The FDA has put together a strategy for COVID-19 vaccines that are less effective against new viral variants-Technology News, Firstpost

New York TimesFebruary 5, 2021 1:12:55 pm

Faced with the potential for coronavirus variants that may circumvent current vaccines, treatments, and viral testing, the Food and Drug Administration is preparing action plans in the coming weeks. Pfizer and Modana vaccines have been shown to be effective against known variants of the coronavirus, but less potent against the first mutants identified in South Africa. The variant has so far been confirmed in only three people in the United States, but national scrutiny is weak and may have missed other cases.

As of Thursday, all but seven of the 618 coronavirus mutant cases identified so far in the United States were the first rapidly spreading mutants observed in the United Kingdom, according to data from the Centers for Disease Control and Prevention. Is related to.

Janet Woodcock, deputy director of the authorities, said in a call to reporters Thursday that “if an unprevented, ineffective vaccine variant emerges, it needs to be changed quickly.” Stated. New versions of vaccines need to be manufactured, tested and distributed quickly.

Pfizer and Moderna officials say the vaccine is ready to be fine-tuned as needed and the process can be completed in just six weeks.

Vials of Moderna’s COVID-19 vaccine in Mount Pleasant, Texas, December 21, 2020. The lack of vaccination against yellow fever, polio and other illnesses has created innovative solutions even in very poor countries. (Cooper Neil / New York Times)

Dr. Woodcock refused to reveal details of how the FDA would evaluate fine-tuned vaccines, but would probably require smaller and shorter trials than the original trials conducted by Pfizer and Moderna. Said that it would be.

“You can’t pass the test for more than 30,000 patients,” she said, if the current vaccine turns out to be ineffective against the new variant. “It may not be sufficient to conduct a full-scale efficacy study that can be used to shift or perhaps add ingredients to existing vaccines.”

Dr. Woodcock said the plan will be announced for comment from scientists before it is implemented. Authorities may also turn to an advisory board to help guide changes to existing vaccines.

The FDA will also release guidance documents for monoclonal antibody therapy and viral testing. According to a recent study, one of two antibodies, a monoclonal antibody made by Eli Lilly and a cocktail made by Regeneron, is powerless against mutants prevalent in South Africa.

“I knew from the beginning that monoclonal antibodies were vulnerable to this type of strain shift,” she said.

Laboratory tests for coronavirus that rely on a technique called PCR appear to detect new mutants accurately, but if they change, they can easily change, Dr. Woodcock said. I am. However, determining for mutations in mass-produced antigen tests is “much more complicated.”

Ndambiri. c.2021 The New York Times Company

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