EU agency says blood clot ‘rare’ J&J side effect

Europe’s medicines regulator said on Tuesday that blood clots should be listed as a “very rare” side effect of Johnson & Johnson’s COVID-19 vaccine, but that the benefits of the shot still outweigh the risks.

The United States is also expected to announce its decision on the single-shot J&J vaccine by Friday, as nations around the world urgently try to accelerate inoculation campaigns and revive their pandemic-ravaged economies.

The European Medicines Agency (EMA) assessment came as an EU official promised to have enough doses available to vaccinate 70% of European adults by the summer — a boon for the continent’s sluggish rollout.

Europe’s Johnson & Johnson campaign was delayed after U.S. health regulators said the shot should be paused over blood clot fears.

After conducting a review of isolated cases of clotting among people who received the vaccine, EMA’s safety committee said it found a “possible link” between the jab and the medical condition.

The regulator said its safety committee “concluded that a warning about unusual blood clots with low blood platelets should be added to the product information” for the J&J shot.

“These events should be listed as very rare side effects of the vaccine,” it said in a statement.

Only two countries had started administering the J&J shot before it was paused — the United States and South Africa — with more than seven million doses given out so far.

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Printable version | May 13, 2021 6:23:41 PM |

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