Johnson & Johnson COVID-19 Vaccine was Submitted for EUA

Johnson & Johnson submitted its single-shot COVID-19 vaccine to U.S. regulators recently for emergency use authorization after the vaccine was shown to be effective against illness and preventing severe disease and death.

According to a statement by Paul Stoffels, chief scientific officer of Johnson & Johnson, the submission is “a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”

If the vaccine is approved by the FDA, it would be the third authorized shot in the U.S. FDA officials announced outside experts would discuss the vaccine at a public meeting February 26.

The company announced its vaccine was 66% effective overall at preventing moderate to severe illness in a global clinical trial in a release last week. It also said J&J's vaccine offered the best protection against severe cases of disease, proving 85% effective.

Stoffels added the company would be ready to ship doses immediately upon authorization but did not specify the number. In a report by the Washington Post, government officials told them doses could be in the single-digit millions.

It's also been reported the J&J vaccine can be stored at refrigerator temperatures for several months.

In the meantime to approval, the FDA said it will propose draft guidelines on how manufacturers of COVID-19 vaccines, therapeutics and diagnostic tests should deal with new variants of the virus.

Janet Woodcock, the FDA’s acting commissioner, pledged to pursue streamlined processes to get updated products to health-care personnel. She said the FDA would not “create obstacles” to authorizing tools that could be useful.

Woodcock said in a statement that the FDA has anticipated the emergence of variants and does not believe there will be “the need to start at square one with any of these products.”