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Warning About Blood Clots Should be Added to Labels for Johnson & Johnson’s Covid Vaccine, Says E.U.’s Medicines Regulator

by Michael Curzon
20 April 2021 5:17 PM

There is a “possible link” between the Johnson & Johnson (J&J) Covid vaccine and blood clots, according to the European Medicines Agency (EMA). The regulator says that a warning should be added to labels for the vaccine. Sky News has the story.

The EMA says it has found a possible link between the J&J Covid vaccine and very rare cases of unusual blood clots.

European regulators say that unusual blood clots with low blood platelets should now be listed as “very rare” side effects of the vaccine.

But they stressed that the “overall benefits of the vaccine in preventing Covid outweigh the risks of side effects”.

The new warning is based on eight “serious” cases in the U.S., one of which resulted in the person dying.

All eight people were under the age of 60 and developed clots within three weeks of vaccination, the EMA said, with the majority of cases being women.

They were “very similar to the cases that occurred with the Covid vaccine developed by AstraZeneca”, it added.

The Guardian has more on the next steps for the J&J vaccine.

The EMA has said a warning about very unusual blood clots should be added to labels for J&J’s Covid vaccine…

J&J advised European governments to store their doses until the E.U. drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.

The delay is a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems, and concerns over blood clots from those who have received the AstraZeneca vaccine.

The Sky News report is worth reading in full.

Tags: European Medicines AgencyJohnson & JohnsonVaccine

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