FDA Lifts Pause On J&J COVID Vaccine Following Panel Vote

The U.S. Food and Drug Administration said Friday evening that use of the Johnson & Johnson COVID-19 vaccine should resume after “a thorough safety review” was conducted during a 10-day pause to investigate a rare but serious side effect.

The lift followed a vote by members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, that determined the benefits of the vaccine outweigh the small risk to mostly women under 50 of developing rare but serious blood clots.

CDC Director Rochelle Walensky said that health and safety led the move to press pause on the J&J vaccine, as well as to lift it.

“Our vaccine safety systems are working. We identified exceptionally rare events — out of millions of doses of the Janssen COVID-19 administered — and we paused to examine them more carefully,” Walensky said in a statement. “As we always do, we will continue to watch all signals closely as more Americans are vaccinated.”

On April 13th, the J&J vaccine was paused to further investigate six cases of a type of blood clot called cerebral venous sinus thrombosis.

The CDC has since identified 15 total cases out of nearly 8 million doses administered of what it’s calling TTS, or thrombosis with thrombocytopenia syndrome. All of the identified cases have occurred in women ages 18-64, with all but two of those cases appearing in women under 50.

Resuming the J&J vaccine for all adults 18 and older would result in 26 cases of TTS, but would prevent 1,435 deaths and 2,236 intensive care unit admissions in 9.8 million vaccinations. Meanwhile, resuming the vaccine only for those 50 and older would cause two cases of TTS, while preventing 257 deaths and 779 ICU admissions over 3.6 million inoculations.

There is currently talk among public health officials on how to best approach TTS warnings to the affected demographic.

Law360: https://www-law360-com.libproxy2.usc.edu/productliability/articles/1378381/fda-lifts-pause-on-j-j-covid-vaccine-following-panel-vote

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