Swissmedic has issued an unlimited authorisation* for the bivalent vaccine Spikevax bivalent Original / Omicron BA.4-5. It covers the Omicron subvariants BA.4 and BA.5 in addition to the original SARS-CoV-2 strain.
Swissmedic issues unlimited authorisation* for booster dose of Moderna's bivalent COVID-19 Original / Omicron BA.4-5 vaccine
Spikevax bivalent Original / Omicron BA.4-5 mRNA vaccine authorised for people aged 18 and over
The vaccine is administered as a single dose of 0.5 ml. It contains 25 micrograms of mRNA Original Spikevax and 25 micrograms of mRNA that targets the Omicron variants BA.4 and BA.5. “Spikevax Original / Omicron BA.4-5” is intended for persons aged 18 and over, who have received a primary vaccine cycle and/or previous booster dose of Spikevax or another authorised vaccine.
The 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 took the clinical data on Spikevax Original / Omicron BA.4-5 into consideration in its decision.
The vaccine has been adapted to better match the 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. The safety profile of the adapted vaccine is comparable with that of the original mRNA vaccines. No new safety signals have been detected abroad following administration of the adapted vaccine.
Different authorisation methods
The vaccines against BA.4 / BA.5 variants have already been authorised abroad. Authorisation in these countries was based on extrapolated data and not on clinical studies. In addition, international decisions can also be determined by factors such as taking into account the local pandemic situation or the different legal framework. This therefore enables emergency authorisation, even if the pandemic situation is no longer precarious. The legislators who formulated the Therapeutic Products Act (TPA) did not explicitly provide for these authorisation methods which are possible abroad.
They specified in the TPA that the review of medicinal products for authorisation must be based on clinical studies. Swissmedic reviews applications to determine whether the efficacy, safety and quality of the medicinal product can be proven. This authorisation method was also taken into consideration when reviewing the vaccines against BA.4 / BA.5 variants. Consequently, the review period for authorisation in Switzerland may be longer than in other countries.
* Supplemented on 14.03.2023: Ordinary procedure pursuant to Art. 11 and 16 TPA