US limits Johnson & Johnson vaccine to ‘life-threatening blood clots’

The U.S. Food and Drug Administration restricts the emergency use approval of the Johnson & Johnson vaccine

The U.S. Food and Drug Administration restricts emergency use approval of Johnson & Johnson’s vaccine (Image: Getty Images)

US regulators are restricting the use of Johnson & Johnson’s one-shot coronavirus vaccine because an investigation found it increases the risk of developing life-threatening blood clots.

The Food and Drug Administration (FDA) is restricting emergency use authorization of the Johnson & Johnson vaccine to people aged 18 and over who are uneligible for or unable to receive other Covid-19 vaccines. The FDA also allows its use for people who refuse to take other brands of vaccines.

Thursday’s decision is due to the risk of a dangerous and rare blood-clotting condition called thrombosis with thrombocytopenic syndrome (TTS) that could result from the vaccine, the FDA said. The updated approval also applies to booster vaccinations.

“We recognize that Janssen’s Covid-19 vaccine still has a role to play in the current response to the pandemic in the United States and throughout the global community,” said Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our security monitoring systems and our commitment to ensuring that science and data guide our actions.”

More than 18.7 million doses of the Johnson & Johnson vaccine had been administered in the United States as of Thursday, according to the Centers for Disease Control and Prevention (CDC). However, only 7.7% of the fully vaccinated population received the Johnson & Johnson vaccine.

The CDC’s immunization advisory committee issued an updated recommendation in December, stating that there was a “preferred recommendation for the use of mRNA COVID-19 vaccines over Janssen’s adenoviral COVID-19 vaccine in all persons aged ≥ 18 years in the United States”. These include the jabs from Pfizer and Moderna.

Committee members also expressed TTS concerns at the time.

The CDC and FDA previously recommended pausing the Johnson & Johnson vaccine due to the cases of blood clotting. When the break was lifted, authorities issued a warning about the incident.

Johnson & Johnson said at the time it was aware of this and “we have worked closely with medical experts and public health authorities, and we strongly support the open sharing of this information with healthcare professionals and the public.”

The FDA’s updated fact sheet states that as of March 18, it has registered 60 TTS cases, nine of which resulted in death. This corresponds to 15% of the confirmed TTS cases.

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Justin Scacco

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