The European Medicines Agency (EMA) announced, on Friday 9 April, that an investigation had been opened by its safety committee (PRAC) to assess the risks of thromboembolic events linked to the Covid-19 vaccine produced by the pharmaceutical company Janssen Pharmaceutica NV, a Belgian subsidiary of the US group Johnson & Johnson.
The PRAC “has started a review of a safety signal”: in other words, the reports it has received about these thromboembolic events (blood clots, leading to the blockage of a vessel).
In total, the EMA reports four serious cases of “unusual blood clots with low blood platelets” following inoculation with the Johnson & Johnson vaccine.
“One case occurred in a clinical trial and three cases occurred during the roll-out of the vaccine in the USA. One of them was fatal”, the agency said.
“But it is currently not clear whether there is a causal association” between the product and these effects, it insists. On Wednesday, however, the agency confirmed the link between similar adverse events and the AstraZeneca vaccine (see EUROPE 12693/1).
The Johnson & Johnson product is currently only used in the US and is expected to be used in the EU in the coming weeks. The European Commission authorised it at the beginning of March (see EUROPE 12676/1) and expects a delivery of 55 million doses in the second quarter.
Expanded review for AstraZeneca. Also on the basis of a ‘safety signal’, the PRAC is continuing to investigate the Anglo-Swedish vaccine.
It is now looking into reports of a syndrome of “leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure“, which may be linked to the AstraZeneca product.
Production assessment for Sputnik V. Regarding the Russian vaccine, which is currently under a rolling review, EMA Executive Director Emer Cooke confirmed to the press on Wednesday that a “good clinical practice inspection in Russia” was also being conducted.
Ms Cooke said that this was an assessment of “the way the trials were conducted”, and said that this was a “standard procedure” followed by the EMA for many products.
Reacting to the recent statement by the Slovak Medicines Agency that the doses of Sputnik V it had received differed from those examined by EMA, MEP Vlad Gheorghe (Renew Europe, Romania) nevertheless called on the European Agency to give the vaccine “maximum attention”.
“I call for a specific analysis by EMA of the doses in question and I ask Slovakian authorities to facilitate their delivery to the European drug regulator”, he wrote on Friday in a letter to Ms Cooke, the Slovak Minister and the European Commissioner for Health.
To see the letter: https://bit.ly/320vKLT Original version in French by (Agathe Cherki)