The US has resumed the use of the Johnson & Johnson (Janssen) Covid-19 vaccine, after the Food and Drug Administration and the US Centers for Disease Control and Prevention lifted their earlier call for a temporary pause.
The pause had been recommended after reports of six cases of a rare and severe type of blood clot in individuals were reported in recipients of the Janssen vaccine.
But the latest decision to resume use follows a safety review that included two meetings of the CDC’s Advisory Committee on Immunization Practices, the US FDA said.
During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.
Teams from these authorities also reached out to providers and clinicians to ensure they were made aware of the potential for these adverse events and could manage and recognise these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome, the note said.
The two agencies have determined that the use of the vaccine be resumed as they had confidence in its effectiveness in preventing Covid-19, the note said. Besides, the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older, it added.
In India, J&J vaccine has applied for permission to conduct local trials, as a pre-curser to bring in the vaccine. It has a production alliance with Hyderabad’s Biological E.