Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA authorises Comirnaty Original bivalent vaccine for Sars-Cov-2 Omicron BA.4-5 variants - AIFA authorises Comirnaty Original bivalent vaccine for Sars-Cov-2 Omicron BA.4-5 variants

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AIFA authorises Comirnaty Original bivalent vaccine for Sars-Cov-2 Omicron BA.4-5 variants

Press release no. 697 - On 14 September 2022 the AIFA Scientific-Technical Committee (CTS) decided to make available the use of the Comirnaty Original/Omicron BA.4-5 bivalent vaccine, approved by the EMA, as a booster dose for all people covered by the authorised indication.

The CTS stresses that the booster dose is strongly recommended to the population at higher risk of developing a 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.

According to the CTS, there are currently no elements to express a preferential judgment towards the different bivalent vaccines available (original strain BA.1 and BA.4-5): they all increase the protection against different variants and help to maintain an optimal protection against COVID-19. In fact, even the bivalent BA.1 vaccine has been shown to trigger a higher antibody response against the BA.5 variant than the original vaccine.

In conclusion, both BA.1 and BA.4-5 vaccines can be primarily recommended as a booster dose for all people over the age of 60 or with risk factors.


Published on: 14 September 2022

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