The European Medicines Agency gave the green light to resume administration of the AstraZeneca vaccine. During a press conference, Emer Cooke, Executive Director at EMA, presented the results of the Pharmacovigilance Risk Assessment Committee (PRAC) review, affirming that “the vaccine is not associated with an increase in the overall risk of thrombosis or blood clots” and “there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites”. Therefore, the AstraZeneca vaccine is a “safe and effective vaccine. Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the possible risks.”
“However, ‒ Cook adds – on the basis of available evidence and after days of in-depth analysis of clinical reports, autopsies and additional information from clinical trials, the vaccine may be associated with very rare cases of blood clots and thrombocytopenia, including rare cases of clots in the vessels draining blood from the brain (CVST)”. Hence the recommendation to “update the package leaflet”, so as to include these additional warnings.
Indeed, the PRAC recommended raising awareness of possible risks related to the Anglo-Swedish product, on one hand by stressing the rare conditions that can occur and, on the other, providing clear information to healthcare professionals as well, in view of “identifying and reducing any possible side effects”.
EMA’s approval comes after several European countries decided to suspend the vaccine roll out as a precautionary measure following a number of suspicious deaths linked to its administration.
According to Antonella Viola, immunologist at the University of Padua, this measure is “useful to bring clarity and let people know that the Government takes the safety of vaccines into the highest consideration”.
Nevertheless, the suspension generated strong repercussions in terms of public confidence, prompting political representatives and scientists to publicly endorse their own administration of AstraZeneca to reassure the population. The same EMA director Emer Cooke said she was “ready to vaccinate tomorrow”, as are Presidents of Liguria, Giovanni Toti, and Emilia Romagna, Stefano Bonaccini: “I will also vaccinate with AstraZeneca”. Microbiologist Andrea Crisanti took the same stance and added “I also recommended people close to me to get vaccinated with AstraZeneca”.
The first dose is also ready for the French Prime Minister Jean Castex, the Slovenian Prime Minister Janez Jansa and President Borut Pahor, and the British Prime Minister Boris Johnson, who recalled that “the Oxford injection is safe, the Pfizer injection is safe. What is not safe is taking Covid’.