J&J requests FDA emergency approval for COVID-19 booster shot

Company findings indicated the shot was 94% effective against moderate-to-critical COVID-19

Johnson & Johnson requested emergency approval of its COVID-19 vaccine booster shot for individuals 18 years and older, the company announced Tuesday.

J&J also submitted recent data from a late-stage trial indicating the booster bolstered protection against moderate-to-severe COVID-19 disease to 94% in the U.S., and reported a "substantial increase in immune response" when the booster was administered six months following the initial shot.

Additional data suggests a ninefold increase in antibody levels following administration of the booster, ramping up to twelvefold four weeks later, and the shot was reported as generally well-tolerated.


"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%. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters," said Dr. Mathai Mammen, head of research at J&J's Janssen unit, in a statement Tuesday. "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."

The Food and Drug Administration last month approved a booster shot for many who received the Pfizer-BioNTech vaccine, and is expected to make a similar decision regarding the Moderna shot. The FDA's expert advisory committee is expected to meet to consider the Johnson & Johnson request on Oct. 15.

The vaccine from the New Brunswick, N.J., company was considered an important tool in fighting the pandemic because it requires only one shot. 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.

The Associated Press contributed to this report.