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Law360 (March 22, 2021, 2:00 PM EDT) -- AstraZeneca said Monday that its COVID-19 vaccine is "highly effective" at treating the disease that has caused millions of deaths across the globe, adding that it was preparing to ask the U.S. Food and Drug Administration for emergency approval of the treatment soon.
The company said trials showed its vaccine was 100% effective in combating the most severe cases of COVID-19 and at preventing cases that would require hospitalization. AstraZeneca also said it saw a 79% effective rate for "preventing symptomatic COVID-19."
On top of those strong numbers, AstraZeneca said there were no safety issues with the vaccine, according to an independent data safety monitoring board. The company said that "in the coming weeks" it will be filing to get the FDA to give the treatment the green light for emergency use.
"These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups," Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in a statement. "We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus."
The FDA said in a statement to Law360 on Monday that "while encouraged by the results reported by AstraZeneca, these data are reported from an interim analysis of the data, so that FDA will not be in a position to comment until the full data are submitted to and reviewed by the agency."
AstraZeneca's announcement came as about 2.7 million deaths have resulted from COVID-19 globally, according to data from Johns Hopkins University.
The FDA has previously given emergency authorization to coronavirus vaccines from Pfizer, Moderna and Johnson & Johnson.
On Dec. 10, the FDA gave its first stamp of approval to a COVID-19 vaccine when it signed off on an emergency use authorization request from Pfizer and its German partner BioNTech. The first doses of that vaccine were administered to front-line health care workers in the U.S. later that month.
The Pfizer-BioNTech two-dose vaccine is about 95% effective.
Moderna filed its emergency authorization request in late November. The FDA approved its vaccine, which is 94% effective at preventing infection among individuals 18 and older, in mid-December.
J&J submitted its application for emergency use authorization to the FDA on Feb. 4 and received approval later that month.
--Additional reporting by Dave Simpson, Hailey Konnath and Britain Eakin. Editing by Marygrace Murphy.
Update: This story has been updated with additional information.
For a reprint of this article, please contact reprints@law360.com.
