EU agency to confirm AstraZeneca blood clot link, official says

A top official at the European Medicines Agency says in an interview there is a causal link between AstraZeneca’s coronavirus vaccine and rare blood clots, but that it’s still unclear what the connection is and the benefits of taking the vaccine outweigh the risks of getting COVID-19.

Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, tells Rome’s Il Messaggero newspaper that the EU medicines regulator is preparing to make a more definitive statement this week.

Based on the evidence to date, Cavaleri says there’s a clear association between the AstraZeneca vaccine and the dozens of rare blood clots that have been reported worldwide amid the tens of millions of vaccine jabs that have been given out.

Last month, more than a dozen countries, including Germany, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said the benefits of the vaccine outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended the vaccine’s leaflet be updated to inform doctors and patients about the rare clots.

“It is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of (blood) platelets,” Cavaleri is quoted as saying.

He says he appreciates the need for an unequivocal European recommendation on the safety of the vaccine for particular age groups but says he doesn’t expect the EMA to be able to provide that now.

People wait to receive a dose of the AstraZeneca/Oxford vaccine at the SSE Arena which has been converted into a temporary COVID-19 vaccination center, in Belfast, Northern Ireland on March 29, 2021. (Paul Faith / AFP)

“Certainly the information about the product will be updated, affirming that these adverse events are linked to the vaccine. It will be declared in a very clear way,” he is quoted as saying.

Any further doubts about the AstraZeneca vaccine would be a setback for the shot, which is critical to Europe’s immunization campaign and a linchpin in the global strategy to get vaccines to poorer countries. The AstraZeneca vaccine is cheaper and easier to use than rival vaccines from Pfizer and Moderna and has been approved for use in over 50 countries and groups, including by the 27-nation EU and the World Health Organization. US authorities are still in the process of evaluating the vaccine.

Most European Union countries, including Italy, resumed using the AstraZeneca vaccine on March 19.