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
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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.
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"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.
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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.
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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.