Pharmaceutical giant Johnson & Johnson (J&J) submitted its single-shot COVID-19 vaccine to U.S. regulators for emergency use authorization after the vaccine produced positive results in their global trial.
According to their trial, the vaccine was 66% effective at preventing moderate and severe COVID-19.
In the U.S. portion of the trial, the vaccine was found to be 72% effective.
“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said J&J CSO Paul Stoffels.
If the vaccine receives regulatory clearance from the Food and Drug Administration (FDA) it would be the third authorized shot in the United States after Moderna and Pfizer’s.
Because the vaccine has not been peer-reviewed, it would require research from FDA scientists and an external panel of experts.
“The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines so that the American public and medical community have trust and confidence in FDA-authorized vaccines,” said Janet Woodcock, M.D., acting FDA commissioner.
The FDA said it would discuss its approval publicly on Feb. 26.
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