Swissmedic has approved the adapted bivalent vaccine “Comirnaty Original / Omicron BA.4-5” (tozinameran / famtozinameran). It covers the Omicron subvariants BA.4 and BA.5 in addition to the original SARS-CoV-2 strain.
Swissmedic approves bivalent Pfizer Ltd. COVID-19 Original / Omicron BA 4-5 booster dose for adults aged 12 and over
Bivalent Original / Omicron BA.4-5 mRNA vaccine (tozinameran / famtozinameran) approved
The vaccine 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 variants BA.4 and BA.5 (famtozinameran).
“Comirnaty Original / Omicron BA.4-5” is intended for adults aged 12 and over who have already been administered Comirnaty Original as basic vaccination or a first booster dose. The approved vaccine is an adapted version of Pfizer Ltd. COVID-19 vaccine Comirnaty.
The ready-to-use dispersion for injection contains both messenger RNA (mRNA) from the original COVID-19 vaccine and mRNA coding for the spike protein of Omicron variants BA.4 and BA.5. Swissmedic assessed all available data on Comirnaty Original/Omicron BA.4-5.
The vaccine has been adapted to better match the circulating variants of SARS-CoV-2. The protective effect of the bivalent vaccine against Omicron variants BA.4 and BA. 5 of the SARS-CoV-2 virus measured in the antibody concentration is higher than the effect of the original vaccine (Comirnaty).
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 safety profile of the adapted vaccine is comparable with the original mRNA vaccines, whose safety profile is already well known. No new safety signals were found.