FDA updates its guidance on who should take the Johnson & Johnson COVID-19 vaccine

The Johnson & Johnson (Janssen) vaccine was approved by the U.S. Food and Drug Administration (FDA) in February 2021 under an Emergency Use Authorization for the over-18s. 

However, following further research and analysis of reported side effects, the agency has made the decision to limit the authorization of the vaccine to two groups of people. 

According to the FDA’s investigations, the Johnson & Johnson COVID-19 vaccine comes with an elevated risk of thrombosis with thrombocytopenia syndrome (TTS). This is a rare condition, but it can have serious effects, including blood clots. 

In light of this, the FDA’s guidance says that the vaccine is suitable for: 

• Over-18s that are unable to take another approved COVID-19 vaccine for medical reasons or problems with accessibility;
• Over-18s who choose to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.

In a statement, Peter Marks, M.D., Ph.D., and director of the FDA’s Center for Biologics Evaluation and Research said: “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. 

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.”

He added that the FDA will continue to carefully monitor the safety of the Johnson & Johnson vaccine, and if any new safety information emerges, this will be evaluated. 

Johnson & Johnson has now updated its U.S. COVID-19 vaccine fact sheet. The company says that the purpose of these changes is to make sure people are aware of the thrombosis risks. 

In a press release, the company said: “Our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine. Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults when compared with no vaccine.”