Below is a circular from the Ministry of Health with indications for the booster dose in subjects vaccinated abroad with a vaccine not authorized by the EMA.
SUBJECT: instructions regarding the booster dose for those vaccinated abroad with a vaccine which has not been authorized by EMA.
As advised by the CTS and the AIFA, in the registered document no. STDG P 128960 of 11/4/2021, which follows on from the opinions expressed by the “Gruppo permanente sull’infezione da SARS-CoV-2” and the” Consiglio Superiore di Sanità” on 01/09/2021 and by the “Comitato Tecnico Scientifico “ referred to in the O.C.D.P.C. no. 751 of 2021 in the session of 03/09/2021, it should be noted that, as part of the anti-SARS-CoV-2/COVID-19 vaccination campaign, those vaccinated abroad with a vaccine which has not been authorized by EMA may receive a booster dose with m-RNA vaccine in dosages authorized for the "booster" (30 mcg in 0.3 mL for Comirnaty ( Pfizer BioNTech); 50 mcg in 0.25 mL for Spikevax (Moderna) starting from 28 days and up to a maximum of 6 months (180 days) from completion of the primary cycle. The completion of this integrated vaccination course is recognized as equivalent pursuant to article 9, paragraph 1, letter b) of the decree no.52 of 22 April 2021, converted with amendments ( law no.87 of June 17, 2021). It is possible to proceed with a complete primary vaccination cycle with m-RNA vaccine, in the authorized dosages, after 6 months from completion of (or after having partially completed) a vaccination cycle which has not been authorized by EMA.