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 company research shows a booster dose at either two or six months revved up immunity even further. Data released last month showed giving a booster at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet released clinical data on a six-month booster shot.
FDA's advisers will review studies from the company and other researchers next Friday and vote on whether to recommend boosters.
The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company's data. Companies normally submit their requests well in advance of meeting announcements. A J&J executive said the company has been working with FDA on the review.
“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,” said Dr. Mathai Mammen, head of research for J&J's Janssen unit.
The vaccine from the New Brunswick, New Jersey, 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.
Rival drugmakers 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.
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