AIFA’s Scientific Technical Committee (CTS), at its meeting on 7-9 September 2021, expressed its opinion on the administration of additional doses of vaccine against COVID-19, answering the questions posed by the Ministry of Health. The CTS notes that the priority of the vaccination campaign remains the achievement of high vaccination coverage with the completion of the vaccination courses currently authorised to reduce the circulation of the virus, the development of variants and to effectively prevent the onset of serious disease and deaths.

The CTS deems it appropriate, pending EMA's authorisation, to make the Comirnaty and Spikevax vaccines available:

• as an additional dose of COVID-19 vaccine, at least 28 days after the last administration, to complete the vaccination course in adults and adolescents aged>12 years (Comirnaty vaccine) or >18 years (Spikevax vaccine) in clinically relevant immunosuppression conditions. Solid organ transplant recipients and comparably immune compromised subjects (based on clinical evaluation) fall into this category;
• as a booster dose, in order to maintain an effective immune response to the vaccine after completion of the vaccination course, at least 6 months after the last administration, in the elderly (>80 years) and in patients hospitalised in nursing homes. This option can also be made available to healthcare professionals, depending on the level of exposure to the infection, the individual risk of developing severe forms of COVID-19 and in accordance with the general strategy of the vaccination campaign.

As for the additional dose, it is planned to administer one of the two mRNA vaccines authorised in Italy (Comirnaty and Spikevax).

AIFA’s Board of Directors, meeting in extraordinary session on 9 September 2021, approved the inclusion of the additional dose of the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines in the list of medicines provided for by Law 648/96.

The provision shall be effective from the day following its publication in the Official Gazette.