The Food and Drug Administration (FDA) announced on May 5 that it will restrict the use of the Johnson & Johnson COVID-19 vaccine to adults who can’t receive mRNA vaccines, because of the risk of potentially life-threatening side effects with the J&J shot.
The agency said the COVID-19 vaccine can now only be administered to people aged 18 years of age and older who can’t receive either the Moderna or Pfizer vaccines, both of which are two-dose vaccines and use mRNA technology. J&J’s single-shot vaccine uses adenovirus technology.
People 18 and older who want to receive the J&J vaccine “because they would otherwise not receive a COVID-19 vaccine” can also get it, according to the FDA’s statement. The agency didn’t elaborate.
Over the past several months, the FDA and other federal agencies have increasingly recommended that Americans get either the Moderna or Pfizer vaccines over the J&J vaccine. In December, for example, the Centers for Disease Control and Prevention (CDC) issued a recommendation that prioritized the Moderna and Pfizer vaccines over the J&J vaccine because of safety issues.
FDA officials said in the statement that they made the decision to restrict J&J’s vaccine after reevaluating the data on the risk of life-threatening blood clots that may occur within two weeks of vaccination.
“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”
TTS refers to thrombosis with thrombocytopenia syndrome, a rare form of blood clotting.
After an analysis, the FDA found that the risk of TTS in combination with low levels of blood platelets between one and two weeks after the J&J vaccine is administered warrants placing limitations on the use of the vaccine, according to the statement.