Covid-19: Swissmedic approves adapted vaccine
Swissmedic has approved the adapted bivalent vaccine "Comirnaty Original / Omicron BA.4-5". It covers the original SARS CoV-2 strain as well as the Omicron BA.4 and BA.5 subvariants.
The vaccine is administered in a dose of 0.3 ml (30 micrograms). It contains 15 micrograms of mRNA (tozinameran; original Comirnaty) and 15 micrograms of mRNA targeting omicron variants BA.4 and BA.5 (famtozinameran), such as Swissmedic writes.
"Comirnaty Original / Omicron BA.4-5" is intended for people 12 years of age and older who have received basic immunization with Comirnaty Original or a first booster vaccination with Comirnaty Original, according to the statement. The approved vaccine is an adapted version of Pfizer AG's Comirnaty Covid 19 vaccine, it said.
The ready-to-use injection dispersion contains messenger RNA (mRNA) of the original Covid 19 vaccine as well as messenger RNA encoding the spike protein of Omikron variants BA.4 and BA.5. Swissmedic had reviewed all available data on Comirnaty Original/Omicron BA.4-5.
According to Swissmedic, the vaccine is adapted to better match the circulating variants of SARS-CoV-2. The protective effect of the bivalent vaccine against the omicron variants BA.4 and BA.5 of the SARS-CoV-2 virus, as measured by antibody concentration, is higher than the effect of the original vaccine (Comirnaty).
The protective effect against the original SARS-CoV-2 virus (Wuhan type) measured by the antibody concentration of the bivalent vaccine was equivalent to the effect of the original vaccine (Comirnaty). The safety profile of the adapted vaccine was comparable to that of the original mRNA vaccines, for which the safety profile was well known. No new safety signals were detected, Swissmedic concluded.
Source: Swissmedic
