The pharmaceutical giant announced its application in a statement on Thursday, stating if approved it expects to supply 100 million doses of the vaccine to the United States during the first half of the year.
Paul Stoffels, chief scientific officer at Johnson & Johnson, said the submission for emergency use authorization “is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
The FDA said in a statement it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Feb. 26 to discuss the application.
The meeting was scheduled to provide the FDA with three weeks to evaluate the data and information Johnson & Johnson provided in its application, the federal agency said, adding that it cannot predict how long after the meeting before it makes its decision but it will “review the request as expeditiously as possible.”
“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 Acting FDA Commissioner Janet Woodcock.
The application announcement came a week after Johnson & Johnson released late-stage clinical trial results of the one-shot vaccine that said it was 72% effective at preventing moderate to severe COVID-19 infection in the United States, 66% in Latin America and only 57% in South Africa where a fast-spreading variant of the virus has been surging.
Overall, the company said its drug has a 85% efficacy rate in preventing severe disease and has “demonstrated complete protection against COVID-19 related hospitalization and death” after 28 days.