Aifa. Vaccino AstraZeneca: sicuro senza limiti di età | Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco

Following the decision of the PRAC of EMA, the Director General of AIFA and the president of the CSS Franco Locatelli
held a press conference to clarify EMA's decision, ratified by AIFA, to the public.

While the press conference is underway in Italy, the French High Authority for Health has recommended the use of the AstraZeneca vaccine only for those over 55 years old.

This age restriction is explained by the fact that the serious cases of blood clotting problems that had motivated the suspension of the vaccine were observed only in people under the age of 55, specified the French health authority.

For the AstraZeneca vaccine, this is a rather surprising decision, considering that, when it was opened to the public, just 3 months ago, it was reserved for those under 65 years of age. “Age – explained Dominique Le Guludec, the president of the HAS – is the main risk factor that exposes people to developing serious forms” of Covid.

Italy has not chosen this path: “National regulatory authorities have their own degree of autonomy to decide restrictions on use. We have evaluated and do not believe that there are reasons to proceed with a restriction on the use of the AstraZeneca vaccine under the age of 55 as decided in France "said the president of the CSS Franco Locatelli during the press conference at the ministry, underlining that the majority of vaccinations with AstraZeneca were done in this age group and it is therefore consequential that the rare events reported occurred in this group. (Huffingtonpost – March 19, 2021)

AIFA. AstraZeneca COVID-19 vaccine: benefits continue to outweigh risks despite a possible link with rare cases of blood clots associated with low blood platelet levels

Update on the methods of use of the COVID-19 vaccine VACCINE ASTRAZENECA and the interim recommendations on the target groups of the anti-SARS-CoV-2 / COVID-19 vaccination [0.38 Mb] >

Use of the COVID-19 Vaccine AstraZeneca vaccine in subjects over 65 years of age [0.35Mb] >

Summary of product characteristics

Avis n° 2021.0018/AC/SEESP du 19 mars 2021 du collège de la Haute Autorité de santé sur la place du vaccin AstraZeneca dans la stratégie vaccinale suite à l'avis de l'agence européenne des médicaments concernant des évènements indésirables survenus dans plusieurs pays Europeans chez des personnes vaccinées