US regulators are limiting the use of Johnson & Johnson’s one-shot coronavirus vaccine due to an investigation revealing it increases the risk of developing life-threatening blood clots.
The Food and Drug Administration (FDA) is limiting the emergency use authorization of the Johnson & Johnson vaccine to people 18 years and older who are not suited to or cannot receive other Covid-19 jabs. The FDA is also allowing its use for people who refuse to take other vaccine brands.
Thursday’s decision is owed to the risk of a dangerous and rare blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS) that could result from receiving the jab, the FDA said. The updated authorization also applies to booster shots.
‘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,’ stated Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
‘Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.’
More than 18.7million doses of the Johnson & Johnson vaccine have been administered in the US as of Thursday, according to the Centers for Disease Control and Prevention (CDC). Still, only 7.7% of the fully vaccinated population received the Johnson & Johnson jab.
The CDC’s vaccine advisory committee in December issued an updated recommendation stating it made a ‘preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged ≥18 years in the United States’. Those include the Pfizer and Moderna jabs.
Committee members at the time also cited TTS concerns.
The CDC and the FDA previously recommended a pause of the Johnson & Johnson vaccine due to the blood clotting cases. When the pause was lifted, the agencies issued a warning around the occurrence.
Johnson & Johnson at the time stated it was aware and ‘we have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public’.
The FDA’s updated fact sheet states that it has recorded 60 TTS cases through March 18, with nine of them leading to deaths. That represents 15% of the confirmed TTS cases.
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