麻豆传媒

Use of Johnson and Johnson's (J&J) COVID-19 vaccine should only be limited to certain adults, .

Due to an updated analysis of the rare cases of thrombosis with thrombocytopenia syndrome (TTS), which typically occur 1 to 2 weeks after vaccination, use of the J&J vaccine should be restricted to those for whom mRNA vaccines are "not accessible or clinically appropriate," or who would not get vaccinated if not for the J&J vaccine, the agency said.

"Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in a statement.

FDA and CDC initially paused use of the vaccine in April 2021, following 15 cases of TTS. Through March 18 of this year, the agencies have confirmed 60 TTS cases and nine deaths.

"The reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered," the FDA said in its announcement. The greatest risk is among women ages 30 to 49 years (about 8 cases per million doses).

Additional reasons for this action included that the risk factors for TTS were "unknown," that an individual with TTS may deteriorate rapidly "despite prompt diagnosis and treatment," and that TTS may have "long-term and debilitating" health consequences.

The FDA added that they have included a warning statement at the beginning of the J&J vaccine for healthcare providers "for prominence," summarizing the risks of TTS.

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