Moderna’s vaccine, approved by Swissmedic on January 12, 2021, is an mRNA vaccine, as was Pfizer/BioNTech’s candidate BNT162, approved in December. The Swiss federal government has secured 7.5 million cans. The estimated vaccine efficacy against SARS-CoV-2 infection is 94%.
Swissmedic announced that the vaccine, which is based on an mRNA platform, is now available for use in Switzerland following a temporary marketing authorization based on a thorough review of all submitted data on the safety, efficacy, and quality of the vaccine [1]. In addition to the internal review, the approval decision is based on an assessment of the benefit-risk ratio by the independent expert panel HMEC (Human Medicines Expert Committee).
High efficacy after second dose
The pivotal study showed a high efficacy of 94% 14 days after the second vaccination. Swissmedic Director Dr. Raimund Bruhin is confident: “The rapid and at the same time conscientious assessment in the rolling procedure has proved very successful. This is another important step so that a large part of the population in Switzerland can now be rapidly vaccinated against COVID-19”. Moderna’s COVID-19 vaccine may be administered to persons 18 years of age and older in accordance with the drug information and official federal vaccination recommendations. Vaccination consists of two doses administered intramuscularly by trained medical personnel to vaccinees one month apart [1]. According to clinical studies, vaccinated individuals are reliably protected 14 days after the second dose. Based on current data, Swissmedic recommends adherence to the vaccination interval and not postponing the second vaccination dose, as stated in the drug information. In addition, different vaccines should not be combined because no data are available on the interchangeability of COVID-19 vaccines. One multi-dose vial of COVID-19 vaccine contains ten doses of vaccine. The preparations are stored frozen between -25°C and -15°C. The ampoules are thawed before first use and can be stored at refrigerator temperature (2°C-8°C) for up to 30 days. After the first dose is withdrawn, the vial should be stored between 2°C and 25°C and discarded after six hours.
Monitoring of side effects
As with all medicines that are new to the market, Swissmedic closely monitors the safety of vaccines [1]. The most common documented side effects are comparable to those after influenza vaccination. Swissmedic requires the marketing authorization holder to continue to collect continuous information on the safety, efficacy and quality of its vaccine. The other applications for pandemic vaccines will continue to be evaluated on a rolling basis, using all resources with high priority. Swissmedic will decide on further authorizations of pandemic vaccines as soon as sufficient data are available and will also exchange information with partner authorities at short intervals.
Production facilities also in Switzerland
The Swiss company Lonza is carrying out the construction of four production lines for Moderna vaccine, three of which are located in the canton of Valais (Visp) and one in the USA [2]. These four sites are expected to produce enough vaccine for up to 400 million doses. The active ingredients are manufactured by Lonza. The vaccine is then shipped to so-called “fill-and-finish partners” selected by Moderna. These include the companies Catalent in the USA and ROVI in Spain. It is not yet clear how high the filling and refining capacities are. Marketing authorization holders assume responsibility for the quality of their drugs and for monitoring them.
Literature:
- “Swissmedic grants marketing authorization for Moderna’s Covid-19 vaccine,” Swissmedic, Jan. 12, 2021.
- “Covid-19 vaccine: why we still have a long wait ahead,” www.swissinfo.ch/ger/covid-19-impfstoff–warum-wir-noch-eine-lange-wartezeit-vor-uns-haben/46231102
HAUSARZT PRAXIS 2021; 16(1): 37 (published 1/27-21, ahead of print).
