The Johnson & Johnson coronavirus vaccine is possibly linked to rare blood clots, but the benefits of using it outweigh the risks, the European Medicines Agency announced Tuesday.
The regulator’s safety committee PRAC concluded that a warning about unusual blood clots with low blood platelets should be added to the product information, and that “these events should be listed as very rare side effects of the vaccine.”
PRAC has been reviewing data since April 9 on eight cases of thrombosis in combination with thrombocytopenia that followed vaccination in the U.S. — one of which was fatal — after authorization. As of April 13, over 7 million people had received the jab in the U.S. All of these cases occurred before the EU had received any deliveries of the vaccine.
All cases occurred in people under 60 years within three weeks of vaccination, the majority in women, the EMA said. No specific risk factors have been confirmed.
The committee also noted that the blood clots occurred mostly at unusual sites such as in veins in the brain, abdomen and in arteries, together with low levels of blood platelets and sometimes bleeding. They were “very similar” to cases seen after vaccination with the Oxford/AstraZeneca jab, it added.
On April 13, U.S. regulators recommended suspending the rollout of the jab “out of an abundance of caution” after six further cases of the rare blood clots were reported in younger women. At that time, the U.S. had administered 6.8 million doses of the single-shot viral vector jab.
The news came as the first batches were arriving in EU countries, a month after it was approved for use in the bloc.
Taking a cautious approach, the drugmaker advised EU countries to wait for the EMA’s decision from its review before rolling out the vaccine. It also announced it was “proactively” delaying deliveries over the concerns in the U.S.
However, without the EMA’s advice to this effect, most EU countries have opted to administer the doses they had received. Only a handful, including Belgium and the Netherlands, chose to pause their rollout.
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