The Food and Drug Administration (FDA) announced Thursday that it has limited the use of the Johnson & Johnson (J&J) coronavirus vaccine to adults for whom other COVID-19 vaccines are not “accessible or clinically appropriate.”
The change in the FDA’s recommendation for the J&J vaccine follows an updated analysis of its association with a rare blood clot disorder, per the FDA press release.
“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release.
Marks continued, “The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
The J&J vaccine will also remain available to adults who elect to receive it and who would otherwise not get vaccinated.
The FDA said that after “conducting an updated analysis, evaluation, and investigation” of the reported blood clot cases, its findings warranted limiting the use of the J&J vaccine.
However, the FDA determined that the benefits of receiving the J&J vaccine outweigh its potential risks for individuals who cannot receive any of the other shots or who choose to receive the J&J vaccine.
Last year, according to Axios, the FDA temporarily called for an immediate halt to the J&J vaccine after six women developed the blood clot disorder within two weeks of receiving their shots.
Just over a week later, the pause was lifted after regulators determined that the benefits of the Johnson & Johnson COVID vaccine outweighed the risk of the rare blood clot disorder.