Johnson & Johnson asks FDA to approve COVID-19 vaccine

3 weeks ago

Feb. 5 (UPI) — Johnson & Johnson has submitted an application to the Food and Drug Administration for regulators to give its coronavirus vaccine emergency use authorization.

The pharma company announced the move Thursday. If the request is approved, Johnson & Johnson expects to supply 100 million doses of the vaccine to the United States during the first half of this year.


The vaccine is being developed and manufactured by Janssen, a subsidiary of Johnson & Johnson.

Chief scientific officer Paul Stoffels said the FDA application “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 in a statement.

“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 its vaccines committee has scheduled a meeting for Feb. 26 to evaluate the application.

The meeting was scheduled to allow the FDA three weeks to evaluate data and information. The FDA said it can’t predict when it might make a decision about the vaccine, but noted that 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.

A week ago, Johnson & Johnson said late-stage clinical trial results for the one-shot vaccine showed that it was 72% effective at preventing moderate to severe COVID-19 infection in U.S. volunteers, 66% in Latin America and 57% in South Africa.

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.

The company said the vaccine was tested against a variant strain of the disease in South Africa, which is part of the reason for its lower efficacy there. Health experts have said existing vaccines will be effective against mutant strains, but likely not as effective as they are against the original coronavirus.

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