This is what is foreseen by the new Ministry circular that regulates the use of the two bivalent vaccines (the first against the Omicron Ba.1 variant and the second against the Ba.4-Ba.5 variants). Then clarified that the new vaccines can indiscriminately “expand the protection against different variants and can help maintain optimal protection against the COVID-19 disease”. THE CIRCULAR
23 SEPT –
Green light on request for the possibility for all over 12 to be able to request the fourth dose with the new bivalent vaccines and ok also at the fifth dose for the immunosuppressed (for which the primary course was three doses and they have already received the fourth). These are the main innovations of the new circular of the Ministry of Health which regulates the use of the two bivalent vaccines (the first against the Omicron Ba.1 variant and the second against the Ba.4-Ba.5 variants)
“Following the authorization by EMA and AIFA of the original / BA.4-5 bivalent formulation of the Comirnaty vaccine, two formulations are now available as part of the anti-SARS-CoV-2 / COVID-19 vaccination campaign bivalents of m-RNA vaccines (original / omicron BA.1 by Spikevax and Comirnaty, and original / BA.4-5 by Comirnaty). As specified by the AIFA CTS, at the moment, there is no evidence to be able to express a judgment of preferential use of one of the different bivalent vaccines available today, believing that all of them can expand the protection against different variants and can help maintain optimal protection against the COVID-19 disease.
The recommendations on the use of the original / omicron BA.1 formulation are therefore also extended to the original / BA.4-5 formulation, without any distinction ”explains the circular which then identifies the categories to which they may be administered.
Specifically, the use of bivalent m-RNA vaccine formulations is recommended as a priority:
– as a second booster dose in favor of all persons aged ≥ 60 years, persons with high frailty motivated by concomitant / pre-existing pathologies aged ≥ 12 years (Annex 1), health workers, guests and operators of residential facilities and pregnant women, in the manner and timing provided for the same;
– as a second booster dose, upon evaluation and specialist clinical judgment, to subjects with marked impairment of the immune response, for causes related to the underlying disease or pharmacological treatments and to subjects undergoing haematopoietic or solid organ transplantation (Annex 2), who have already received a primary course of three doses (standard primary course plus additional dose at least 28 days after the last dose) and a subsequent first booster dose, at least 120 days after the last dose;
– as the first booster dose, in the manner and timing provided for the same, in favor of subjects aged ≥ 12 years who have not yet received it, regardless of the vaccine used to complete the primary course.
These vaccines, taking into account the indication of use authorized by EMA and AIFA, may, however, be made available upon request of the interested party, as a second booster dose, for the vaccination of subjects of at least 12 years of age, who have already received the first booster dose for at least 120 days.
September 23, 2022
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