Following a thorough review of all the submitted data on safety, efficacy and quality, Swissmedic has today temporarily authorised the Moderna vaccine (COVID-19 mRNA Vaccine Moderna), which is based on an mRNA platform, for use in Switzerland. This means that a second COVID-19 vaccine has satisfied the strict requirements for safety, efficacy and quality and can be used with immediate effect in Switzerland. The authorisation studies have demonstrated a high efficacy rate of 94 percent 14 days after the second injection of the vaccine.
Second COVID-19 vaccine authorised in Switzerland
Supplementing its own internal review, Swissmedic granted temporary authorisation for the COVID-19 vaccine from Moderna after the independent Human Medicines Expert Committee (HMEC) had corroborated Swissmedic's appraisal of the benefit/risk profile during its extraordinary meeting on 8 January 2021.
"The rapid, but at the same time conscientious, review in the rolling procedure has proved very successful. This is another important step forward in enabling a large proportion of the population in Switzerland to be vaccinated quickly against COVID-19," says Swissmedic Executive Director Raimund Bruhin confidently.
Do not defer second dose
The COVID-19 vaccine from Moderna may be administered to those aged 18 and over according to the product information and the official government recommendations. Vaccination involves two doses, which are given to the vaccine candidates as intramuscular injections 1 month apart by trained healthcare personnel. According to the clinical trials, vaccinated individuals are reliably protected 14 days after the second dose.
In line with the latest data, Swissmedic recommends keeping to this vaccination interval and not deferring the second dose of the vaccine as mentioned in the product information. Moreover, different vaccines should not be combined since there is no information at all on the interchangeability of COVID-19 vaccines.
Establishment licence granted in Switzerland
The establishment licence, a prerequisite for the authorisation, was granted to Moderna Switzerland GmbH on 9 January 2021, after the company had provided the necessary documentation. "After receiving an establishment licence, the marketing authorisation holders assume responsibility for the quality and monitoring of their medicines", explained Philippe Girard, Deputy Executive Director of Swissmedic and Head of Licensing. Swissmedic granted the licence partly on the basis of a successful inspection of Moderna's Swiss site.
Safety: focus on side effects
As with all medicines newly launched on the market, Swissmedic closely monitors the safety of vaccines. The side effects documented most frequently are comparable with those after a flu vaccination. As a condition of authorisation, Swissmedic will require the marketing authorisation holder to continue submitting information on the safety, efficacy and quality of its vaccine on an ongoing basis.
The authorisation applications for pandemic vaccines will continue to be processed with high priority in the rolling procedure using all the available resources. Swissmedic will decide on further authorisations of pandemic vaccines as soon as sufficient data become available. To this end, Swissmedic also shares information with partner authorities at short intervals.