President Trump Praises Operation Warp Speed As Moderna’s Vaccine Candidate Heads Into FDA Review



 

FILE – In this July 27, 2020, file photo, nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y. Moderna Inc. says it will ask U.S. and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection. (AP Photo/Hans Pennink, File)

Lt. Gen. Paul Ostrowski of Operation Warp Speed said 100 percent of Americans will have the opportunity to take a COVID-19 vaccine by June of 2021. He made those remarks Monday while speaking to reporters.

However, that’s not the only development on the vaccine front. In a press release the same day, biotech company Moderna said it plans to apply for Emergency Use Authorization from the FDA.

“We’re going to be filing (today) around the world, first regulatory approval for the product for regulators to review it and the FDA has told us an advisory meeting is likely to be meeting on December 17,” stated Moderna CEO Stephane Bancel. “It is highly possible that between the 17th and Christmas, the product is approved.”

It’s the latest candidate to reach that stage following Pfizer and BioNTech, which both have a vaccine already under regulatory review. If Moderna is granted authorization, its vaccine could be available as soon as December 21.

In light of the news, President Trump urged the FDA to “act quickly.” He added, “Operation Warp Speed has been a great modern day miracle.”

Moderna has received $1 billion under Operation Warp Speed to fund its vaccine research. The company has also already taken a $1.5 billion order from the U.S. for the pre-manufacturing of 100 million doses of its vaccine, which the company said is 94.1 percent effective and expected to cost about $25 per dose.

Moving forward, the vaccine may be approved as soon as Christmas in which case it would likely be distributed to high priority groups first, including frontline medical workers and likely residents of nursing homes.




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