In an announcement issued Thursday, the FDA stated the J&J vaccine ought to solely be given to individuals who don’t have entry to another vaccines or for whom different vaccines will not be clinically acceptable.
The FDA stated the choice was made after extra info was shared concerning the prevalence of a uncommon blood clotting situation, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after individuals obtained the J&J vaccine. The discovering “warrants limiting the authorized use of the vaccine,” the FDA stated.
“We acknowledge that the Janssen COVID-19 vaccine nonetheless has a task within the present pandemic response within the United States and throughout the worldwide neighborhood,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, stated within the assertion.
“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 CDC says 16.9 million persons are absolutely vaccinated with the J&J vaccine, in comparison with 76.5 million with Moderna and 126.3 million with Pfizer.
Through March 18, the CDC and FDA have detected 60 confirmed circumstances of TTS, together with 9 deadly circumstances.
The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it might assist unfold vaccines throughout the nation as a result of it solely required one preliminary dose and didn’t must be saved at extraordinarily chilly temperatures, in contrast to the two-dose Pfizer and Moderna vaccines.
But 2 months after authorization, the federal government paused its use for 10 days due to experiences of TTS. Last December, the CDC’s Advisory Committee on Immunization Practices stated the Pfizer and Moderna vaccines had been most popular over J&J as a result of J&J carried the uncommon threat of blood clots and bleeding within the mind.
Uganda has obtained 15.8 million doses of J&J and the bulk had been administered in hard-to-reach locations, based on the Ministry of Health.
At least 9.5 million doses of the vaccine for which the federal government paid Shs37b to amass, have been dispatched to districts.