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Adverse Events Seen in J&J Covid Vaccine Rollout

12.04.2021 - Johnson & Johnson has joined AstraZeneca in the negative spotlight, giving the latter some likely welcome relief. After studying a spate of usually rare blood-clotting issues in people receiving the Anglo-British drugmaker’s Covid-19 vaccine, the European Medicines Agency (EMA) is now looking at similar incidents with the US healthcare group’s single-dose shot.

The J&J product has not reached the EU due to delivery problems echoing those of AstraZeneca – most recently, both were hit by an apparent mix-up at a US plant owned by Emergent BioSolutions, in which an estimated 15 million doses were ruined. This gives the European drugs regulator additional time before fears of adverse events become a problem in the  European rollout.

To date, the EMA has tracked three cases of unusual blood clots with low blood platelets following vaccination with J&J’s shot, the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) said on Apr. 9. An additional incident was recorded in the Phase 3 trial. PRAC said it is currently unclear whether the event, which has been identified as capillary leak syndrome, a condition in which blood vessels leak into muscles and body cavities, were related to the vaccine.

The government of India is said to be studying investigating whether there have been any domestic cases of blood clotting, even mild ones, as a side effect of the two Covid vaccines being administered there – in addition to the AstraZeneca shot this includes a product developed by the country’s Bharat Biotech, marketed as Covaxin.

In the US, at least two vaccination sites in the states of Colorado and North Carolina were temporarily closed late last week after adverse reactions in a limited number of recipients. It was not clear whether any of these involved the capillary syndrome. Press reports pointed to initial dizziness and nausea, and at least one case of severe eczema.

J&J is currently facing rollout issues in its home market, acccording to the Wall Street Journal, The newspaper said only 700,000 doses were due to be distributed this week, down from 4.9 million a week earlier.

Some 14.5 million J&J doses had been delivered to US states by the end of last week, and 4.9 million doses had been administered, the Centers for Disease Control and Prevention calculated.

Author: Dede Williams, Freelance Journalist