WASHINGTON (AP) — U.S. regulators on Thursday strictly limited who can receive the COVID-19 vaccine developed by Johnson & Johnson because of the lingering risk of rare but serious blood clots.
The US Food and Drug Administration (FDA) announced that the vaccine should only be administered to adults who cannot receive another or specifically request the J&J vaccine. For months, federal officials have recommended that people get the vaccines developed by Pfizer or Moderna instead of the one from J&J.
Dr. Peter Marks, the FDA’s immunization chief, said the agency decided to restrict the vaccine after re-examining data on the risk of life-threatening blood clots and concluding that they have only been detected in people vaccinated with the vaccine. from J&J.
“If there is an alternative that appears to be just as effective in preventing serious outcomes from COVID-19, we would prefer that people choose it,” Marks said. “But we’ve been careful to say that — compared to no vaccine — this is still a better option.”
If they appear, the clots appear in the first two weeks after receiving the vaccine, so he added: “If you had the vaccine six months ago, you can sleep peacefully tonight knowing that this is not a problem.”
The FDA licensed J&J’s vaccine in February of last year for adults 18 and older.
Initially, J&J’s was considered an important tool in the fight against the pandemic because it is a single dose. But that option turned out to be less effective than the two doses of the Pfizer and Moderna vaccines.
In December, the Centers for Disease Control and Prevention recommended prioritizing Pfizer and Moderna over J&J because of their safety concerns. Before that, US authorities had treated the three vaccines similarly because each had been shown to offer strong protection.
But follow-up studies have consistently shown less effectiveness of the J&J vaccine. And while the blood clots seen with J&J’s are rare, officials say they still happen.
Federal scientists identified 60 cases, including nine that were fatal, as of mid-March. That’s one case of thrombosis for every 3.23 million doses of the J&J vaccine administered, the FDA said Thursday. The vaccine will carry a stronger warning about the possible “long-term and debilitating health consequences” of the side effect.
Under new FDA guidance, the J&J vaccine may continue to be given to people who have had a severe allergic reaction to one of the other vaccines and are unable to receive an additional dose. It could also be an option for people who refuse to receive messenger RNA vaccines from Pfizer and Moderna, and would therefore remain unvaccinated, according to the agency.
“Data continue to support a favorable benefit-risk profile for Johnson & Johnson’s COVID-19 vaccine in adults, when compared to no vaccine received,” a J&J spokesperson said in an emailed statement.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
