FDA Questions Timing Of J&J Booster Shot For COVID Vaccine
The Food and Drug Administration said Wednesday it was undecided on when and if recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose — at six months or even as two months.
In an online review, FDA scientists didn’t reach a solid conclusion, pointing to the shortcomings with J&J’s data, including lack of information on protection against the highly contagious delta variant.
The review comes ahead of meetings Thursday and Friday when an FDA advisory panel will make its recommendation on whether to support booster doses of both the J&J and Moderna vaccines. A single step in the government’s vaccine review process. Next week, the FDA will make a final decision regarding the authorization of those boosters, if approved the Centers for Disease Control and Prevention will decide criteria for who should get them.
Health authorities claim all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. However, there are signs that protection against milder infections may be becoming less effective, the government previously approved booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.
The goal being for uniform recommendations, Moderna has asked the FDA to clear its booster dose at six months. However, J&J complicated the decision by proposing a second shot with a parameter of two to six months.
FDA reviewers wrote that data from the study of the two-month booster plan indicates “there may be a benefit,” while citing 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 concerning its effectiveness “are consistently less” than that in Pfizer and Moderna shots.
J&J presented data to the FDA from a real-world study indicating its vaccine remains approximately 80% effective against hospitalizations in the U.S.
J&J’s single-dose vaccine was attractive for its one-and-done formulation. But it was hindered by a series of problems including manufacturing issues and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In the end, regulators decided the shot’s benefits outweighed those risks.
Pfizer and Moderna comprise the vast majority of U.S. COVID-19 vaccines received in the U.S., more than 170 million Americans have been fully vaccinated with one of those companies’ two-dose shots with less than 15 million Americans getting the J&J single dose shot.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.