Johnson & Johnson shot cleared in U.S.

NEW YORK—Johnson & Johnson’s coronavirus vaccine was cleared for use in the U.S., making a third shot available that could plug gaps in the country’s immunization campaign as concern grows over an influx of virus variants.

The U.S. Food and Drug Administration said in a statement on Saturday that it had granted an emergency-use authorization for the single-dose vaccine for people 18 and older.

The decision comes after the U.S. hit a sad milestone with 500,000 Americans dead from the virus, and at a time when health officials are raising alarms that recent declines in the number of new cases may be stalling.

The J&J shot is highly effective at preventing severe COVID-19, with no serious side effects, agency staff said in a report Wednesday. On Friday, a committee of outside advisers to the FDA voted unanimously that the vaccine’s benefits outweigh any risks. In the week ahead, J&J is prepared to ship 3 million to 4 million doses, Biden administration officials have said.

“We’re in a race between the virus mutating — new variants coming out that could cause further disease — and stopping it,” said Jay Portnoy, director of the division of allergy, asthma and immunology at Children’s Mercy Hospital, who supported an emergency authorization.

The clearance marks another milestone in an unprecedented global scientific sprint. Since the World Health Organization declared the coronavirus a pandemic nearly a year ago, numerous vaccines have been deployed around the world, including shots developed in China and Russia. Worldwide, more than 231 million doses have been administered in 100 countries, according to data collected by Bloomberg.