US regulator suspends use of J&J vaccine due to ‘extremely rare’ side effects

The US Food and Drug Administration (FDA) said on Tuesday that it is asking US states to temporarily halt use of Johnson & Johnson’s COVID vaccine, after six people were reported to have developed blood clots.

While making the recommendation, the FDA said that the adverse effects appear to be “extremely rare”, and that it made the call out of an “abundance of caution”.

The regulator said that as of Monday, 6.8 million doses of the vaccine had been administered in the US, and that, in collaboration with the US Centers for Disease Control and Prevention (CDC), it is reviewing data involving six reported cases of a “rare and severe type of blood clot” in recipients.

All six cases occurred in women aged between the age of 18 and 48, with symptoms developing six to 13 days after receiving the shot.

In a statement, Johnson & Johnson said that “no causal relationship” has been identified between the blood clots and the vaccine.

This development comes as the vaccine produced by the company was reported to have arrived in the EU on Monday. Malta has reserved 250,000 doses of the vaccine, and the EU is expected to receive 55 million doses of the single-shot vaccine by June.

Additionally, in recent months, the vaccine produced by AstraZeneca was roiled in controversy after a small number of fatal blood clots were reported in recipients.

Subsequently, the Europeans Medicines Agency issued a statement saying that blood clots are an “extremely rare side effect” of the vaccine, now rebranded as the Vaxveria vaccine.