The FDA has approved Pfizer’s COVID-19 vaccine through an emergency use authorization, clearing the way for Americans to receive inoculations against COVID-19 for the first time since the pandemic was declared in March, according to multiple reports.
Under the emergency authorization, high-priority Americans will begin receiving the first of two inoculations against COVID-19, possibly within hours, according to previous remarks made by Pfizer CEO Albert Bourla. The CDC expects Pfizer to have 25 million doses available this month.
The approval was first reported by The New York Times, which cited “two people with knowledge of the decision who spoke on condition of anonymity because they were not authorized to discuss it.” The Washington Post and The Associated Press subsequently corroborated the FDA’s decision.
FDA regulators recently said that the two-dose regimen of the Pfizer vaccine is 95% effective against COVID-19, corroborating the initial efficacy claims that made headlines in November when Pfizer said its vaccine candidate was over 90% effective.
With respect to the coming months, Pfizer has agreed to provide the U.S. with 100 million doses of COVID-19 vaccine before the end of March 2021. The U.S. holds contract options to purchase additional doses of the vaccine at a later point, but it’s unclear whether it will follow through on that option, or instead rely on the other vaccine candidates in the works.
Moderna’s vaccine candidate, which uses mRNA technology just like the Pfizer vaccine, is currently in the regulatory review pipeline. The FDA plans to hold an advisory meeting next week on whether the vaccine candidate should be approved for adults.
Should the Moderna vaccine be approved, the U.S. government expects to have an additional 15 million doses of the vaccine in December 2020, according to Stat News. When combined with the Pfizer vaccine, Americans could expect to have access to 40 million doses of vaccine — enough for 20 million people — before the start of 2021.
In the first months of 2021, Moderna has agreed to provide 100 million doses of its vaccine to the American public, should it be approved. The U.S. government announced Friday it would exercise an option in its contract to purchase an additional 100 million doses of the vaccine to be distributed by no later than the end of June 2021.
“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 an additional 300 million doses of the Moderna vaccine candidate — on top of the 200 million already agreed upon. It’s not clear when these vaccines would be distributed.
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