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Anti-SARS-CoV-2 / COVID-19 booster shot: indications for the booster dose in subjects vaccinated abroad with a vaccine not authorized by EMA.

With the Circular letter dated 04/11/2021, the Ministry of Health clarified that subjects vaccinated abroad with a vaccine NOT authorized by EMA can receive a booster dose with m-RNA vaccine in the dosages authorized for the “booster” ( 30 mcg in 0.3 mL for Pfizer / BioNTech’s Comirnaty; 50 mcg in 0.25 mL for Moderna’s Spikevax) starting from 28 days and up to a maximum of 6 months (180 days) from completion of the primary course. The completion of this integrated vaccination cycle is recognized as equivalent to the certification issued by the health authorities in charge after the vaccination is validated by EMA.

After the maximum term of 6 months from the completion of the primary course with a vaccine not authorized by EMA, as well as in case of failure to complete the same, it is possible to proceed with a complete primary vaccination course with m-RNA vaccine, in the related authorized dosages.