Italian Medicines Agency Agenzia Italiana del Farmaco

After EMA’s opinion, vaccinations with AstraZeneca to resume tomorrow - After EMA’s opinion, vaccinations with AstraZeneca to resume tomorrow

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After EMA’s opinion, vaccinations with AstraZeneca to resume tomorrow

The recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), in the meeting held today, 18 March 2021, confirmed the favourable benefit/risk balance of the AstraZeneca anti-Covid19 vaccine, excluding an association between cases of thrombosis and the COVID19 vaccine. Based on available data, it also ruled out problems related to quality and production.

Having heard the Minister of Health, the Directorate General for Prevention and the Consiglio Superiore di Sanità (CSS), the Italian Medicines Agency announces that the reasons no longer apply for the precautionary ban on use of the vaccine batches, issued on 15 March 2021.

Therefore, tomorrow, as soon as the Committee for Medicinal Products for Human Use (CHMP) releases its opinion, AIFA will revoke the ban on use of the AstraZeneca vaccine, thus allowing complete resumption of the vaccination campaign, starting from 15.00.

We also inform you that a press conference will be held tomorrow at 12.00 at the headquarters of the Ministry of Health, Lungotevere Ripa 1, which will be attended by AIFA Director General Nicola Magrini, by the Director General for Prevention Giovanni Rezza and by the President of the CSS Franco Locatelli.

Published on: 18 March 2021

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