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EMA calls for warning of ‘very rare side-effects’ on J&J vaccine

Our Bureau Mumbai | Updated on April 21, 2021

Being a one-dose vaccine, J&J’s product has elicited global interest   -  FREDERIC J. BROWN

Similar ‘blood clot’ cases were reported with AstraZeneca vaccine

The Pharmacovigilance Risk Assessment Committee (PRAC), the safety committee of the European Medicines Agency (EMA), has called for a warning about unusual blood clots with low blood platelets on the “product information” that goes with the Johnson and Johnson (Janssen) Covid-19 vaccine. These events need to be listed as “very rare side-effects”, it added.

Being a single-dose vaccine, J&J’s product has elicited much global interest.

The reports on rare blood clots come on the heels of similar reports involving the AstraZeneca-Oxford University vaccine.

Pointing out that Covid-19 was associated with a risk of hospitalisation and death, the regulator said the overall benefits of the vaccine Janssen, in preventing Covid-19, outweighed the risks of the side-effects.

Major cases in women

Explaining the EMA directive, it said, the committee took a decision to include a warning after consideration of all evidence including the eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome.

As on April 13, over 7 million people had received Janssen’s vaccine in the United States, the EMA said. “All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, the specific risk factors have not been confirmed,” it added.

J&J in India

In India, J&J has approached the Drug Controller General of India (DCGI) to undertake local trials on the vaccine, a precursor to launching in India.

The EMA’s PRAC noted that the blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

“The cases reviewed were very similar to the cases that occurred with the Covid-19 vaccine developed by AstraZeneca, Vaxzevria,” it added.

Published on April 21, 2021

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