EMA Reviews Link Between Blood Clots and Johnson & Johnson Vaccine
The Johnson & Johnson COVID-19 vaccine.

The European Medicines Agency is reviewing the cases of four people who developed blood clots after receiving Johnson & Johnson’s (J&J) COVID-19 vaccine, the regulator announced on Friday

“Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with COVID-19 Vaccine Janssen. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the USA. One of them was fatal,” the regulator said in a statement after a meeting of its Pharmacovigilance Risk Assessment Committee (PRAC) ended on Friday.

The vaccine is currently being used in the USA under an emergency use authorisation, and in South Africa as an implementation trial to vaccinate health workers.

It was authorised in the EU on 11 March and member states were expected to start rolling it out in the next few weeks. 

“These reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions,” said the EMA. “PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.”

PRAC is also investigating a bleeding disorder linked to AstraZeneca. 

“Five cases of this very rare disorder, characterised by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure, were reported in the EudraVigilance database,” according to the EMA, although it said no causal relationship had been established between the condition and the vaccine.

PRAC has also concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of AstraZeneca.

Both AstraZeneca and Johnson & Johnson vaccines use the same viral vector technology. 

Image Credits: Johnson & Johnson.

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