Slaoui: Moderna will request an emergency use authorization for the vaccine



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  • Moderna, the biotech company that announced the results of its COVID-19 vaccine last week, will apply to the Food and Drug Administration for an emergency use authorization before the end of the month, Moncef Slaoui, head of Operation House White “Speed ​​Warp” said Sunday.
  • Pfizer, which also said last week that it had successfully developed a vaccine to prevent transmission of COVID-19, applied for emergency use authorization on Friday.
  • A panel of outside experts is scheduled to meet Dec. 10 to discuss the Pfizer vaccine, and Slaoui said a panel would meet Dec. 17 to discuss the Moderna vaccine in what he called a “parallel” process.
  • Slaoui also said Sunday that he was hopeful that the Pfizer vaccine could be given to people in the United States starting Dec. 11.
  • Visit the Business Insider home page for more stories.

Moderna will seek emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine by the end of the month, said Moncef Slaoui, head of Operation “Warp Speed,” the White House effort to develop and administer the vaccine. during an appearance on ABC News’s “This Week.”

Pfizer, which also announced last week that it had developed a vaccine to prevent the transmission of COVID-19, the disease caused by the new coronavirus, applied for emergency use authorization on Friday. A panel of outside experts advising the FDA is expected to meet on December 10 to discuss Pfizer’s request for an emergency use authorization.

Slaoui, a former GlaxoSmithKline executive and Moderna board member, also said Sunday that the Pfizer vaccine could be distributed to some people in the U.S. Starting December 11, if it received a clearance on the same day as the panel. meets to discuss it.

As Business Insider previously reported, the majority of people in the U.S. are not likely to receive a vaccine this year, as a launch is likely to prioritize high-priority people, including healthcare workers from frontline, essential workers, people over 65 and people with pre-existing conditions. .

Moderna announced on November 16 that its vaccine had been successful in clinical trials, demonstrating 94.5% efficacy in preventing the transmission of COVID-19. On November 18, Pfizer announced that its COVID-19 had been 95% effective during clinical trials.

“The two companies are working 24 hours a day, 7 days a week, preparing their files,” Slaoui said Sunday during an appearance on ABC News’ “This Week.” “As you know, Pfizer already submitted the application yesterday. Moderna plans to submit the application by the end of this month. The FDA will review the files.”

Slaoui said the FDA will review the Moderna vaccine on Dec. 17, a week after an expert panel is expected to review the Pfizer vaccine in what he described as a “parallel” process. It’s unclear how long it will take the FDA to approve the vaccines after the experts make their recommendation.

Sloui added that he was “concerned” by public perception and hesitancy around the vaccine.

“Vaccines have been developed as thoroughly and scientifically as ever,” he told ABC News. “I have been doing this for over 30 years. The development of this vaccine is no different than any other, except that we have gone incredibly fast with incredible resources and incredible commitment from all parties.”

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