The FDA says it is wrestling with whether and when recipients of the single-shot Johnson & Johnson Covid-19 vaccine need another dose — at 6 months or as early as 2 months.
Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from Covid-19. But amid signs that protection against milder infections may be waning, the government already hasfor certain people starting at six months after their last shot.
Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months. FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit,” while pointing to only small numbers of people who got another shot at six months instead.
Overall, the J&J vaccine “still affords protection against severe Covid-19 disease and death,” the FDA’s reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80 percent effective against hospitalizations in the U.S.
J&J’s single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a
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