CDC Director Confirms FDA in Talks to Streamline Omicron-Specific Vaccine Authorization – .

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CDC Director Confirms FDA in Talks to Streamline Omicron-Specific Vaccine Authorization – .


The director of the Centers for Disease Control and Prevention confirmed on Sunday that the Food and Drug Administration was in talks to streamline the authorization of a vaccine specific to omicron.
“You know, one of the things about a recall – about a variant specific recall – I know Moderna, Pfizer, Johnson and Johnson say they can all do it pretty quickly in three months. . But then you have the FDA approval. Is there a world where you can see it go a lot faster given that we’ve been through this before? “This Week” co-host Martha Raddatz asked CDC director Rochelle WalenskyRochelle Walensky Sunday Shows Sneak Peek: Several States Detect Cases of Omicron Variant CDC Strives to Tighten Testing Requirements for International Travelers Overnight Health Care – Brought to you by March of Dimes – Omicron triggers wave of MORE responses on ABC.

“Yeah, you know, I should defer it to the FDA, but they’re already discussing the rationalization of the authorization of that, of an omicron-specific vaccine, in part because a much of the vaccine is actually exactly the same and really, it would just be that mRNA code that would have to change, ”Walensky replied.

“So these conversations are going on, and certainly the FDA will act quickly and the CDC will act quickly right after,” she added.

Walensky’s comments follow a Wall Street Journal report last week that said the Food and Drug Administration was considering measures for a rapid review of drugs and vaccines specific to the omicron variant in case new tools specific to the omicron variant. variant would be needed.

Among some of the considerations the FDA would consider, it would allow drug manufacturers to study, in the case of vaccines, to examine hundreds of people and their immune responses in relation to COVID-19 test trials that rely on it. waiting for COVID-19. detected and include thousands of participants, according to the newspaper.

In response to an investigation of the Journal report, the FDA pointed to a statement last week by Acting Commissioner Janet Woodcock for “FDA’s latest thoughts on developing vaccines to treat the variants” in addition to the authorization for emergency use of the agency’s vaccines. guide last updated in February.

“Historically, the work of getting the genetic information and patient samples for the variants and then performing the tests necessary to assess their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks, ”said Woodcock. the week.



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