The Advisory Committee on Immunization Practices voted 15 to 0 to make the recommendation Thursday after hearing updates from Centers for Disease Control and Prevention officials on reports of J&J vaccine recipients experiencing blood clots combined with low blood-platelet levels.
The updated position is likely to deal another blow to the use of the J&J shot, whose uptake had been hurt by manufacturing issues and earlier reports of the blood-clotting condition.
There have been at least 54 cases of the condition, thrombosis with thrombocytopenia syndrome, or TTS, among J&J vaccine recipients, including nine resulting in deaths, CDC officials said Thursday.
The rate of cases is higher than previously estimated in both men and women, and in a wider age range, the officials said.
“The additional TTS cases and reported deaths are concerning,” said Dr. Helen Keipp Talbot, an infectious-disease specialist at Vanderbilt University Medical Center and member of the ACIP.
Earlier this year, federal health authorities paused the use of J&J’s vaccine while they investigated the condition TTS. Use of the vaccine resumed in April after health authorities concluded its benefits still outweighed the risks.
The ACIP, which advises the CDC on vaccine policy, voted in April to resume use of J&J’s vaccine, after meeting twice to discuss the issue. Warnings about the risk were added to fact sheets given to vaccine providers and recipients, including that the risk appeared highest among women ages 30 to 49.
At that time, a total of 15 cases of TTS had been reported among nearly 7 million vaccine doses administered. All of the cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Symptoms developed between six and 15 days after vaccination.
As of Aug. 31, CDC officials said at the advisers’ meeting, about 3.8 cases of TTS were reported for every million doses of J&J vaccine administered, across all recipients. The rate was highest among women ages 30 to 39, at 10.6 per million doses.
CDC officials also said that among those who develop TTS, the fatality rate was about 15%. The people who died deteriorated quickly after being admitted to the hospital, officials said.
CDC officials said getting J&J’s vaccine was still superior to not getting vaccinated, but the balance between the benefits and risks for the messenger RNA vaccines from Pfizer-BioNTech and Moderna was superior to J&J’s. And the current supply of mRNA vaccines in the U.S. is adequate, unlike earlier in the year.
Some committee members said that the J&J vaccine should remain available for people who aren’t able to take the mRNA vaccines.
Partly because of the safety concerns, J&J’s single-dose vaccine has been used much less than the two-dose vaccines from Moderna Inc. MRNA -0.44% and Pfizer Inc. with its partner BioNTech SE.
About 16.1 million people in the U.S. have received J&J’s vaccine, according to the CDC. About 870,000 booster doses of J&J’s vaccine have been administered.
J&J said in a statement Thursday it recently updated the fact sheet for its vaccine to say that it shouldn’t be administered to people who previously experienced TTS after receiving a prior dose of either the J&J vaccine or other vaccines with a similar adenovirus-based design.
Other shots with a similar design include AstraZeneca PLC’s Covid-19 vaccine, which is available outside the U.S. but not in the U.S.
Write to Peter Loftus at [email protected]
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