Emergency approval of vaccines is not legally possible in Switzerland, according to Swissmedic, Switzerland’s drug approval body.
However, Swissmedic says it is working closely with international partner authorities and is urgently reviewing all applications for Covid-19 vaccines and processing the information as it becomes available.
Emergency approvals for the use of vaccines fall short of regular authorisations. it said. Even in countries where laws allow for emergency approval, investigations continue beyond approval.
Unlike in the US, in Switzerland there is no legal basis for emergency approval that would allow use of a Covid-19 vaccine while investigations are ongoing.
Swissmedic is fast-tracking all applications connected with the Covid-19 pandemic, assigning extra staff to this task so that content checks are not compromised. Based on the information received so far Swissmedic has submitted further questions to vaccine applicants.
“We hope we will soon receive answers regarding the safety of the individual vaccines”, said Raimund Bruhin, the Executive Director of Swissmedic. “As soon as the data allow a preliminary risk-benefit assessment will be made and Swissmedic will decide very quickly on an authorisation”.
As with any authorisation, restrictions for certain age or risk groups may be imposed if these groups were underrepresented in the clinical trials. An authorisation may also be limited in duration and include conditions such as the need to provide further study data.