Isai RochaJohnson & Johnson submitted a request to the U.S. Food and Drug Administration for emergency use of their single-dose COVID-19 vaccine, Thursday.
On Jan. 29, the company announced that the phase 3 vaccine trials produced an overall efficacy rate of 66% against moderate to severe COVID-19 symptoms, a number that jumped up to 72% in U.S. trials.
“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,” J&J’s chief scientific officer, Dr. Paul Stoffels, said in a statement. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,”
The vaccine must meet the FDA’s criteria and be publicly debated by an independent panel before it can be approved for use in the U.S.
These requests were made by both Pfizer and Moderna before they got approval for the vaccines the U.S. is currently administering.
If approved, it would be the first single-shot vaccine being used in the U.S., as Moderna and Pfizer both require two doses for maximum effectiveness.
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