FDA limits use of Johnson & Johnson’s Covid-19 vaccine, citing clotting risk

The Food and Drug Administration on Thursday announced it was limiting access to Johnson & Johnson’s Covid-19 vaccine because of the risk of a blood clotting disorder that was discovered weeks after the vaccine was first put into use in the spring of 2021.

Going forward, the single-dose vaccine will only be available to people 18 and older who cannot take one of the other available vaccines for medical reasons, or who simply will not agree to be vaccinated with one of the messenger RNA vaccines made by Moderna and by Pfizer and its partner BioNTech.

Peter Marks, the FDA’s vaccines lead, told STAT the agency reached its decision after a recent review of the data on the vaccine revealed another person in this country had died after receiving it — the ninth such death — in the first quarter of the year. The vaccine is made by J&J’s vaccines division, Janssen.

“If we see deaths and there is an alternative vaccine that is not associated with deaths but is associated with similar efficacy … we felt it was time at this point to make a statement on the [product’s] fact sheet that this was not a first-line vaccine,” said Marks, who is director of the FDA’s Center for Biologics Evaluation and Research.

The clotting disorder, called thrombosis with thrombocytopenia or TTS, is rare, occurring at a rate of about 3.25 cases per million doses administered. But the condition can be fatal or life-altering if an individual survives. With one death for every 2 million doses given in this country, the FDA decided that is a risk most people don’t need to take, Marks said.

The prospect of a single-dose vaccine held enormous promise when J&J announced its approach. The vaccine doesn’t require the complicated cold chain needed for the mRNA vaccines. A single-dose product is attractive to people who don’t like to be vaccinated, and cheaper to use for low- and middle-income countries.

But the level of protection the vaccine offered was not as high as that induced by the messenger RNA and in the U.S., people who received the J&J vaccine have since been urged to get mRNA boosters. When the clotting risk was identified in mid-April of 2021, the FDA paused use of the vaccine. Though the pause was lifted 10 days later, confidence in the vaccine had been shaken and demand for it plummeted.

In December, the independent panel that advises the Centers for Disease Control and Prevention on vaccines issued a preferential recommendation for the mRNA vaccines over the J&J product.

Of the 577 million doses of Covid vaccine administered in the United States, only 18.7 million were the J&J vaccine.

The company said it has updated its product sheet to reflect the FDA’s restrictions. In a statement, it said data continue to show that the benefits of the vaccine outweigh its risks, when compared to going unvaccinated.

“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,” it said.

Marks stressed that people who received the J&J vaccine in the past do not need to worry. TTS, when it occurs, develops a week or two after vaccination. People who were vaccinated months ago are not in danger of developing the condition, he said.

He acknowledged the latest announcement won’t change much on the ground in the United States, where few vaccination sites stock the J&J vaccine at this point. But it could have implications abroad, where countries still struggling to vaccinate their populaces could be influenced by the U.S. decision.

“In the United States, this is probably not going to have that much of an effect,” Marks said. “We’re trying to be cautious and we’ve informed our global partners at [the World Health Organization] for instance, about this and tried to work with them because we don’t want our global partners to be panicked.”

“We’re not saying that it’s a bad vaccine. We’re just saying that for our population, where there’s an alternative, we feel that the alternative should be used.”