J&J’s Covid shot restricted by FDA on rare clotting disorder

Bloomberg: Johnson & Johnson’s Covid-19 vaccine was limited to use only in US adults for whom other shots aren’t appropriate after an investigation of rare and potentially deadly clotting disorder that occurs in some recipients.

The Food and Drug Administration limited the use of the vaccine to people 18 and older for whom other shots aren’t accessible or clinically appropriate, and those who would otherwise not get immunized against the virus. J&J’s single-shot vaccine has been noted for its convenience compared to two-shot vaccines, especially in remote areas and in populations like the homeless who may be difficult to give repeat immunizations.

Uptake of the J&J vaccine has paled in comparison to those made by Pfizer Inc. and Moderna Inc., which require two doses for a full regimen. Hundreds of millions of their messenger RNA shots have been administered. While some 18.7 million doses of J&J’s vaccine have been administered to US adults, according to the Centers for Disease Control and Prevention, almost 31 million doses have been delivered to vaccine sites, suggesting a surplus of unused shots.

The agency decided to limit the authorized use of J&J’s shot after conducting an investigation and analysis of reported cases of blood clots in combination with low levels of blood platelets, known as thrombosis with thrombocytopenia syndrome, or TTS, that occurred one to two weeks following administration of the shot.

The findings of that analysis “warrants limiting the authorized use of the vaccine,” the FDA said in the statement, suggesting that potential benefits only outweigh risks for those for whom other the vaccines aren’t accessible.

J&J is collaborating with the FDA and health authorities around the world “to ensure health-care professionals and individuals are warned and fully informed about reports of TTS, enabling correct diagnosis, appropriate treatment, and expedited reporting,” according to an emailed statement.

Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said the J&J vaccine still has a role to play in the U.S. pandemic response and across the globe.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” Marks said, noting that the agency has closely monitored the J&J shot and cases of TTS, and will continue to evaluate it.

Last month, J&J suspended its full-year Covid vaccine sales forecast, citing uncertainty around demand. The shot is sold on a not-for-profit basis and produced $5.9 billion in 2021 sales.

Joaquin Duato, J&J’s new chief executive officer, told Bloomberg in an interview in late April that the company’s vaccine was “still highly needed” and would continue being produced.