Johnson & Johnson seeks FDA approval of COVID-19 booster shot

NEW BRUNSWICK, N.J. - Johnson & Johnson said Tuesday it has asked the U.S. Food and Drug Administration to authorize a booster shot for its single-dose COVID-19 vaccine as the government looks to expand its booster program.

The company said in a statement that it submitted data to the agency, seeking to receive authorization for Americans 18 and up who previously received the J&J vaccine.

While J&J said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.

"Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent," said Dr. Mathai Mammen, global head of Janssen research and development. "We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters."

Mammen continued: "At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population."

FILE - A physician's assistant draws up a shot of Johnson & Johnson's COVID-19 vaccine in a primary care physician's office. (Photo by Wolfgang Kumm/picture alliance via Getty Images)

J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the U.S. But its research also shows a booster dose at either two to six months increased immunity even further.

An FDA advisory panel will convene next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention.

If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.

"Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible," Mammen said.

The FDA has already authorized booster shots of Pfizer’s vaccine for those who are immunocompromised, Americans 65 and up, and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.

Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 15 million Americans got the J&J shot.

Because the J&J vaccine only requires one shot, it was considered an important tool in fighting the pandemic when it received an emergency use authorization by the FDA on Feb. 27. But its rollout was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.

Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided the benefits of the shot still outweighed those uncommon risks.

J&J said it also plans to submit data to other world regulators.

This story was reported from Cincinnati. The Associated Press contributed.