The FDA authorization came a day after an advisory commission for the agency provided an upbeat assessment of the two companies’ vaccine. The agency is also coordinating with the CDC and the Operation Warp Speed team to ensure rapid vaccine distribution.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Dr. Stephen M. Hahn.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” Hahn said in a news release.
White House Chief of Staff Mark Meadows had reportedly instructed Hahn to allow emergency use of the COVID-19 vaccine by the end of the day today or submit his resignation, according reports from media outlets including the Washington Post and CNN, which cited anonymous sources.
The granting of an EUA to the Pfizer-BioNTech vaccine and the vaccine candidate from Moderna potentially as soon as next week likely will not be enough to curb the pandemic in the U.S. soon, according to Kasey Fu, director of epidemiology at GlobalData. “Vaccines are coming, but they will not be available to the general public for months, and if the current outbreak situation is not controlled in the coming weeks, many more lives will be lost before the vaccines are made available,” she said.
GlobalData’s current data models suggest that approximately 20% of the U.S. population will be infected by May 2021. “At the current 1.8% case fatality rate, that’s equivalent to over 1.2 million deaths,” Fu said. “To put that in perspective, the estimated deaths would make up 50% of all-cause mortality reported in the U.S. for 2018. That’s about the same as death from heart disease, cancer and unintentional injuries combined.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is optimistic about the long-term impact of COVID-19 vaccines. If 75%–80% of U.S. the public gets a vaccine by the second quarter of the year, herd immunity could be possible by fall, Fauci said in an event from the Harvard T.H. Chan School of Public Health.
A handful of countries, including the U.K., Canada and Bahrain, have already permitted the use of the vaccine. But the FDA’s decision will likely pave the way for other countries to follow in their footsteps. “Hundreds of thousands, and likely millions, of vaccine doses around the world, are waiting to be delivered to millions of people following the FDA’s EUA approval,” said Dr. Noam Tau, a physician at Sheba Medical Center in Ramat Gan, Israel.
While the Pfizer-BioNTech vaccine could be among the first to win widespread use across the world, no single vaccine can stem the pandemic alone. “This means that the approval of the EUA for Pfizer’s vaccine is not the beginning of the end, but merely an important step toward the end of the beginning of the pandemic,” Tau said. “There is a long way to go yet before we are out of the woods, both locally in the U.S. and globally.”
Executive editor Chris Newmarker contributed to this report. Original article updated with news of FDA authorization.
Filed Under: Drug Delivery, Infectious Disease