CDC director confirms FDA in talks to streamline authorization of omicron-specific vaccine

The director of the Centers for Disease Control and Prevention (CDC) confirmed on Sunday that the Food and Drug Administration (FDA) was in discussions to streamline the authorization of an omicron-specific vaccine.

“You know, one of the things about a booster — about a variant-specific booster — I know Moderna, Pfizer, Johnson and Johnson say they can all do this fairly quickly, within three months. But then you have FDA approval. Is there any world where you can see that moving much faster given we’ve already been through this?” “This Week” co-anchor Martha Raddatz asked CDC Director Rochelle Walensky on ABC.

“Yeah, you know, much of that I would have to defer to the FDA, but they’re already in conversations about streamlining the authorization of this, of an omicron-specific vaccine, partially because much of the vaccine is actually exactly the same, and, really, it would just be that mRNA code that would have to change,” Walensky answered.

“So those conversations are ongoing, and, certainly, FDA will move swiftly, and CDC will move swiftly right thereafter,” she added.

Walensky’s comments follow a report by The Wall Street Journal last week that indicated the Food and Drug Administration was eyeing steps for a rapid review of drugs and vaccines specific to the omicron variant in the event that new variant-specific tools were needed.

Among some of the considerations the FDA is reportedly eyeing would be allowing drugmakers for studies, in the case of vaccines, to examine hundreds of people and their immune responses in comparison to COVID-19 test trials that rely on waiting for COVID-19 to be detected and include thousands of participants, according to the newspaper.

In response to an inquiry about the report by the Journal, the FDA pointed to a statement last week by the acting commissioner, Janet Woodcock, for the “​​FDA’s latest thinking on vaccine development to address variants” in addition to the agency’s vaccine emergency use authorization guidance last updated in February.

“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,” Woodcock said last week.