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Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA approves booster dose with Comirnaty and Spikevax bivalent vaccines - AIFA approves booster dose with Comirnaty and Spikevax bivalent vaccines

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AIFA approves booster dose with Comirnaty and Spikevax bivalent vaccines

Press release no. 696 - On 5 September 2022, AIFA’s Scientific-Technical Committee (CTS) gave the green light to the use of the Comirnaty and Spikevax bivalent vaccines, recently approved by the EMA as booster doses for people aged 12 years and above.

According to the CTS, these vaccines have proved effective at triggering an antibody response greater than the original monovalent vaccine against both the Omicron BA.1 variant and the BA.4 and BA.5 variants.

In terms of safety, available data do not differ from the original monovalent vaccine.

The booster dose is available for all people covered by the authorized indication and can be administered after at least three months from completion of the primary vaccination course or from any booster dose already received. 

The CTS stressed that the booster dose is strongly recommended to the population at higher risk of developing serious disease, namely people who have risk factors and those over 60.

All other people can still get vaccinated with the booster dose on medical advice or as an individual choice.


Published on: 05 September 2022

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