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

17:08  05 december  2021
17:08  05 december  2021 Source:   thehill.com

Omicron Variant: Germany, Czech Republic Report Suspected Cases After U.K. Confirmation

  Omicron Variant: Germany, Czech Republic Report Suspected Cases After U.K. Confirmation Several countries, including the U.S., Japan and Israel, have announced travel restrictions to avoid the mass spread of the latest COVID variant.Germany's Hessian Ministry for Social Affairs and Integration said Saturday that an individual who traveled to Germany from South Africa is suspected to be infected with the Omicron variant.

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

CDC director confirms FDA in discussion to streamline authorization of omicron-specific vaccine © Julia Nikhinson CDC director confirms FDA in discussion to streamline authorization of 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.

Scotland Officials Concerned Omicron Variant Has Community Spread as 6 Cases Confirmed

  Scotland Officials Concerned Omicron Variant Has Community Spread as 6 Cases Confirmed Countries throughout the world are taking action to prevent a proliferation of the variant as scientists are still working to determine the danger it poses. Some nations like Japan have decided to block any foreign visitors in an effort to stop the highly mutated variant from entering its borders even as cases began popping up around the globe, AP reported.For more reporting from the Associated Press, see below.New cases in Portugal and Scotland might already point toward local spread of the variant outside of southern Africa.

"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.

Americans face at least 2 weeks of uncertainty as scientists work to answer 3 key questions about the new Omicron variant

  Americans face at least 2 weeks of uncertainty as scientists work to answer 3 key questions about the new Omicron variant Americans face at least two weeks of uncertainty before major questions may get answered about the Omicron variant of the coronavirus. © Steve Pfost/Newsday/Getty Images Stony Brook, N.Y.: Robert Baird, of Centereach, New York is given a booster shot as members of the community are administered the COVID-19 vaccination and booster at Stony Brook University Research and Development Park in Stony Brook, New York on Nov. 17, 2021.

Among some of the considerations that 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.

Rhode Island reports first case of omicron variant .
Rhode Island has reported its first case of the omicron variant, making it one of the dozens of states to have detected the new COVID-19 strain. Gov. Dan McKee (D) and the Rhode Island Department of Health (RIDOH) announced the omicron case in a joint statement on Saturday. The infected individual is in their 20s and recently traveled from New York to Providence, according to the statement. The individual was fully vaccinated, but did not have a booster shot. "We fully expected that Omicron would eventually be detected in Rhode Island as it has been in our neighboring states. I want to be clear: Rhode Island is prepared. This is not cause for panic," McKee said. Video: U.K.

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