Given the opinion of the Technical Scientific Committee of the Italian Medicines Agency-AIFA Agenzia Italiana del Farmaco (reference no. STDG P 128960 of 4 November 2021), following the opinions expressed by the Permanent Monitoring Group on SARS-CoV-2 infection of the Italian Health Council-CSS Consiglio Superiore di Sanità on 1 September 2021 and the Technical Scientific Committee under the Order of the Head of the Civil Protection Department (O.C.D.P.C.- Ordinanza del Capo Dipartimento Protezione Civile) no. 751 of 2021 during the session of 3 September 2021, it is noted that, within the anti-SARS-CoV-2/Covid-19 vaccination campaign, subjects vaccinated abroad with a Covid-19 vaccine not authorized by the European Medicine Agency-EMA are allowed to receive a booster shot with a m-RNA vaccine according to the authorized booster doses (30 mcg in 0,3 mL for Comirnaty by Pfizer/BioNTech; 50 mcg in 0,25 mL for Spikevax by Moderna) starting from 28 days and up to a maximum of 6 months (180 days) from the completion of the primary vaccine course.
The completion of this integrated vaccination course is recognized as equivalent pursuant to the Law Decree no. 52 art. 9, paragraph 1, lett. b) of 22 April 2021, converted with amendments by the Law no. 87 of 17 June 2021.
After the maximum term of 6 months from the primary course completion with a vaccine not authorized by EMA, as well as in the event of failure to complete it, the procedure with a complete primary vaccination course with m-RNA vaccine is possible according to the relevant authorized doses.