- The Washington Times - Thursday, May 5, 2022

The Food and Drug Administration said Thursday it is limiting the use of the COVID-19 vaccine from Johnson & Johnson to adults who cannot access another version or might face a medical issue if they take another type.

Regulators cited the risk of a rare but severe blood-clotting condition that’s been linked to the J&J vaccine, with 60 known cases and nine deaths.

It is another setback for the J&J vaccine, which showed promise as an efficient one-shot option earlier in the pandemic, but faced manufacturing hiccups and questions about safety and efficacy versus the messenger RNA vaccines from Pfizer-BioNTech and Moderna that have become the dominant options.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of [thrombosis with thrombocytopenia syndrome] following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, referring to the J&J division that makes the vaccine.

Fewer than 20 million of the J&J shots have been administered in the U.S., and it accounts for less than 4% of primary vaccinations in the U.S. It also accounts for a small fraction of booster shots.

The vaccine has been part of the trinity of vaccines used in the U.S. since early 2021, but it was paused for a time in early 2021 as regulators investigated the rare clotting issue, or TTS.

It also faced manufacturing problems due to a mix-up at a Baltimore plant, and regulators previously said the mRNA vaccines were preferable to the J&J vaccine because of lingering concerns about TTS.

The FDA on Thursday said it took even stricter action because it feared rates of TTS were not trailing off.

“The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine,” the agency said.

In a statement, J&J said Thursday’s update to a fact sheet for medical providers is consistent with the FDA‘s decision in December, in which regulators said they preferred people to receive an mRNA vaccine.

However, the company said its vaccine remains an important tool and is a better option than remaining unvaccinated, given the low rates of blood clots.

“Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults when compared with no vaccine,” the company said.

“Johnson & Johnson continues to collaborate with health authorities and regulators around the world to ensure healthcare professionals and individuals are warned and fully informed about reports of TTS, enabling correct diagnosis, appropriate treatment, and expedited reporting.”

The company said its shot is critical to the global vaccination campaign and will be made available “where people are most in need.”

For more information, visit The Washington Times COVID-19 resource page.

• Tom Howell Jr. can be reached at thowell@washingtontimes.com.

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