Janssen COVID-19 Vaccine Limited

FDA limits Janssen COVID-19 vaccine to certain populations

(RxWiki News) Because of risks associated with the Janssen COVID-19 vaccine, the US Food and Drug Administration (FDA) has limited its use in certain people.

The vaccine is now only recommended for those:

  • 18 years of age and older
  • For whom other authorized or approved COVID-19 vaccines are not available or clinically appropriate
  • Who have decided to get the Janssen vaccine and otherwise would not receive a COVID-19 vaccine

The reason for this limitation? Health risks seen with the vaccine.

More specifically, this vaccine poses a risk of thrombosis with thrombocytopenia syndrome (TTS). This is a rare syndrome that involves blood clots and low levels of blood platelets, which is potentially life-threatening.

However, according to the FDA, the benefits of the Janssen vaccine outweigh the risk for the populations listed above.

The fact sheet for the vaccine has been updated to include the limitations and a warning statement regarding the risks.

“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 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. "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. 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 authorization for emergency use of the Janssen COVID-19 vaccine happened in February of 2021. However, before the two-month mark, the FDA and the Centers for Disease Control and Prevention (CDC) issued a recommendation to not administer the vaccine until they looked into six reported cases of TTS.

Ten days later, the agencies removed the recommendation to pause administration.

The good news is that other vaccines are available to the public, and these COVID-19 vaccines work in different ways than the Janssen shot.

In fact, last December, the Advisory Committee on Immunization Practices (ACIP) recommended that those who are 18 years or older get a mRNA COVID-19 vaccine over the Janssen COVID-19 vaccine.

The available mRNA COVID-19 vaccines include Pfizer-BioNTech's and Moderna's two-dose series.

Speak with your local pharmacist if you have any questions.