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Moderna reported that submitted its application to the US Food and Drug Administration (FDA). to obtain emergency use authorization for your updated Covid-vaccine booster-19 for use in people over 18 years.
This, just one day after Pfizer and BioNTech submitted their US application for their Covid booster-19 updated for people over 12 years old.
“We have worked closely with the FDA to ensure that Americans have access to Moderna’s updated bivalent booster, which, if authorized, can offer higher, broader and longer-lasting protection against covid-19 compared to the actual reinforcement orally authorized,” he said. Stephane Bancel, CEO of Moderna.
During the next few days, the FDA will evaluate the data from Moderna and Pfizer and decide whether to authorize the injections.
“The FDA will use the totality of available evidence to authorize the fall bivalent boosters,” FDA spokeswoman Abigail Capobianco said in a statement emailed to CNN last week.
These Covid vaccines could be available in mid-September
Dr. Ashish Jha, COVID Response Coordinator-19 of the White House, said that updated reinforcements should be available to the public in early to mid-September, but ultimately it is up to the FDA when the vaccine will be given the green light.
Dr. Peter Marks, director of the Ce The FDA’s Biological Evaluation and Research Center said in an interview with the New York Times on Tuesday that the agency will not convene its independent panel of vaccine experts to seek a recommendation on whether to authorize the Covid-19. Marks told the Times that the FDA has “extremely good” data that it is “extremely confident” that shows the injections are safe and effective, even though the formulations for the updated boosters have not been tested in humans.
Independent experts advising the US Centers for Disease Control and Prevention (CDC) on their vaccine recommendations, discuss the updated vaccines against covid-19 during the meetings next week. CDC Advisory Committee on Immunization Practices meetings are scheduled for Thursday, September 1 and Friday, September 2.
U.S. Government bought 105 million booster doses of the bivalent Covid-vaccine 19 of Pfizer and others 66 Millions of updated shots from Moderna.
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