Swissmedic approves bivalent COVID-19 booster vaccine from Pfizer

Bern, 10.10.2022 - Swissmedic has temporarily authorised Comirnaty Bivalent Original / Omicron BA.1 (tozinameran / riltozinameran), containing messenger ribonucleic acid (mRNA) against two coronavirus variants. A booster vaccination with this vaccine showed higher antibody concentrations against Omicron variant BA.1 than one with original Comirnaty in studies. The side effects profile in the study was similar to that of the original vaccine.

A review of the data packages submitted on an ongoing basis showed that the vaccine applied for meets the safety, efficacy and quality requirements. It is administered as a single dose of 0.3 mL (30 micrograms). It contains 15 micrograms of mRNA (tozinameran; original Comirnaty) and 15 micrograms of mRNA that targets the Omicron variant BA.1 (riltozinameran).

The bivalent vaccine contains mRNA both for the spike protein of the Wuhan strain and for that of the Omicron variant BA.1. The modified composition promises to be more effective against the Omicron variant BA.1 of the SARS-CoV-2 coronavirus.

The protective effect of the bivalent vaccine against the original SARS-CoV-2 virus (Wuhan type) measured in the antibody concentration is equivalent to the effect of the original vaccine (Comirnaty).

The side effects profile of Comirnaty Bivalent Original / Omicron BA.1 was similar to that seen following administration of the second dose or the booster (30 micrograms) of the original vaccine. No new safety signals were found.

The data currently available to Swissmedic regarding the recently submitted application for authorisation for the bivalent vaccine Comirnaty Original/Omicron BA.4-5 are not yet sufficient for a decision.

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