EMA, green light for Pfizer bivalent for Omicron 4 and 5

EMA green light for Pfizer bivalent for Omicron 4 and

(Finance) – The European drug agency Ema recommends the authorization of Pfizer Biontech’s new ‘booster’ vaccine (booster) against Covid, also adapted to the Omicron Ba.4 and Ba.5 subvariants, in addition to the original SarsCov2 strain. The new adapted Comirnaty vaccine is intended for people aged 12 and above. This was announced yesterday by the EMA in a note.

The recommendation of the EMA, explains the European agency, “will further extend the arsenal of available vaccines to protect people against Covid-19 as the pandemic continues and new waves of infections are expected in the cold season. “The new vaccine is indicated for people 12 years of age and older who have received at least one course of vaccination against Covid The vaccine adapted to that of Original Pfizer-Biontech mRna was evaluated. EMA’s Drug Committee evaluated all data from adapted Comirnaty vaccines.

Clinical studies have shown that the adaptato against Omicron 1 is more effective in triggering an immune response against the subvariant compared to the original vaccine, presenting comparable side effects. The opinion for adaptation against Omicron BA.4-5 considers that “immunogenicity data (the ability of the vaccine to trigger an immune response) from laboratory (non-clinical) studies have provided supporting evidence” that it offers immunity against i strains of the covid it targets.

In the meantime, clinical studies are continuing on the Comirnaty adapted also for Omicron Ba.4-5 and the EMA committee will receive them as they become products.

(Photo: EPA / Biontech)

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