FDA to the public: We will be nimble in response to omicron

The Food and Drug Administration assured the public Tuesday it is “actively working” with drugmakers and global partners to understand whether the omicron variant of the coronavirus can puncture existing defenses and if updated products are needed.

Specifically, regulators are studying how the variant first detected in South Africa impacts diagnostic tests, treatments and vaccines.

“We are closely monitoring the situation and are committed to communicating with the public as we learn more,” said acting FDA Commissioner Janet Woodcock. “Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.”

Dr. Woodcock said the FDA requires drugmakers to be on the lookout for dangerous variants and evaluate their impact as a condition of emergency use authorizations governing their market access.

Vaccine makers have said they are exploring whether booster shots will be able to combat omicron or if new, specially tailored shots are needed to deal with mutations in the new variant.

Companies said they will get a handle on the situation within two weeks but it could take at least three months to develop a special shot.

“If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly,” Dr. Woodcock said. “The FDA is committed to continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts, to arm ourselves with the best available diagnostics, and life-saving therapeutics and vaccines to fight this virus.”

The FDA‘s statement comes one day after President Biden said omicron is cause for concern but not alarm. He said drugmakers and regulators must be nimble.

“We do not yet believe that additional measures will be needed. But so that we are prepared if needed, my team is already working with officials at Pfizer, Moderna, and Johnson & Johnson to develop contingency plans for vaccines or boosters if needed,” Mr. Biden said. “And I will also direct the FDA and the CDC to use the fastest process available — without cutting any corners for safety — to get such vaccines approved and on the market if needed.”

For more information, visit The Washington Times COVID-19 resource page.

Health, The New York Today

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