PANDEMIC: This opinion was eagerly awaited by the fifteen European countries which suspended vaccination with AstraZeneca, including France.
The AstraZeneca vaccine against the coronavirus is “safe and effective” and “is not associated” with a higher risk of blood clots, the European Medicines Agency (EMA) announced on Thursday.
“The committee came to a clear scientific conclusion: this is a safe and effective vaccine,” EMA Executive Director Emer Cooke said in a video conference. “Its benefits in protecting people against Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks,” she added.
The European regulator, based in Amsterdam, “also concluded that the vaccine was not associated with an increase in the overall risk of thromboembolic events or blood clots,” said the director. “If it was me, I would get the vaccine tomorrow,” she said.
The EMA, however, said further investigation was needed in a number of rare cases including low platelet counts. “During the investigation and review, we started to see a small number of rare and unusual but very serious cases of bleeding disorders, which then triggered a more focused review,” said Emer Cooke. . “Based on the available evidence, and after days of in-depth analysis” of the data, “we still cannot definitively rule out a link between these cases and the vaccine,” she stressed.
494 cases out of 20 million vaccinated
Therefore, the EMA recommends adding these potential risks to the product information. This will “bring attention to these possible rare diseases” to help healthcare professionals and patients “stop and lessen any possible side effects,” said Emer Cooke.
There have been 469 cases of blood clots reported in 20 million people vaccinated in the European Economic Area (EEA) – EU, Norway, Iceland and Liechtenstein – and the UK, the EMA said in a separate statement. Of them, 191 were from the EEA, according to the agency.
By comparing this figure to cases reported in the general population, the EMA determined that there was no increased overall risk of a blood clot. Only 25 rare cases involving low platelet counts have been identified. They mostly concern women under 55, said the EMA, even if “there are still concerns related in particular to these rare cases” among the youngest. The agency also found that there was “no evidence of a problem” with specific batches of the vaccine or specific manufacturing sites.