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The Trump administration has exercised an option in its contract with Moderna, the pharmaceutical company seeking approval for a COVID-19 vaccine funded as part of Operation Warp Speed, to obtain an additional 100 million doses of its vaccine in the second quarter of 2021 should it ultimately be approved for emergency use by the FDA.
Under the updated contract with the U.S. government, Moderna will supply 200 million vaccines to Americans by the end of June 2021 should the FDA grant emergency use authorization. The Trump administration has previously committed to providing vaccines to Americans who want them at no personal cost.
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said Health and Human Services Secretary Alex Azar in a statement Friday afternoon. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
The U.S. government can still exercise additional contract options to secure up to 300 million more doses of the Moderna vaccine candidate.
The Moderna vaccine was developed using mRNA technology, and like the Pfizer vaccine, has shown promise for receiving an emergency use approval before 2021. Moderna has already applied for an emergency use authorization, and Pfizer is reportedly expected to receive emergency approval from the FDA on Friday evening.
General Gustav F. Perna, chief operating officer for Operation Warp Speed, said Wednesday that the U.S. government expects 2.9 million Pfizer vaccines to be distributed within a week of approval, should the vaccine ultimately be approved. Pfizer recently said that it can provide 25 million vaccines to the U.S. by the end of the year, and 100 million vaccines by the end of March 2021, according to The New York Times.
Between the two mRNA vaccine candidates, the American public could have enough vaccines for 150 million Americans to receive the two-shot regimen by the end of June. The FDA said earlier this week that Pfizer’s vaccine was 95% effective against COVID-19, and Moderna has said its data shows their vaccine is 94.1% effective against COVID-19.
“We appreciate the confidence that the U.S. government continues to have in mRNA-1273, our COVID-19 vaccine candidate, demonstrated by this increased supply agreement,” said Moderna CEO Stéphane Bancel in a statement Friday. “We continue to scale up our manufacturing capability in the U.S. and outside of the U.S.”
The FDA will hold an advisory meeting for the Moderna vaccine candidate on Thursday, December 17 to discuss whether or not to recommend the vaccine candidate for use in people 18-years-old or older. The Pfizer vaccine was recently recommended 17-4 by an FDA advisory committee for usage in people 16-years-old or older, and that vaccine candidate has already been authorized for use among the general public by Canada, the United Kingdom, and Bahrain.
A couple of advisory panelist members have since said that they didn’t vote in favor of recommending the vaccine because of the language allowing minors aged 16 and 17 to receive it, as they didn’t believe there was sufficient data to allow for that recommendation.