U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson's COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.
prioritizing Moderna and Pfizer shots over J&J's because of its safety issues. Previously, U.S. officials had treated all three vaccines similarly because they'd each been shown to offer strong protection.
Federal scientists identified 60 cases, including nine that were fatal, as of mid-March. That amounts to one blood clot case per 3.23 million J&J shots administered, the FDA said Thursday. The vaccine will carry a starker warning about potential"long-term and debilitating health consequences" of the side effect.
A J&J spokesman said in an emailed statement:"Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine."Despite the restriction, FDA's vaccine chief Dr. Peter Marks said J&J's vaccine"still has a role in the current pandemic response in the United States and across the global community.
The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J's one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned., believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they're made.
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