Benefits and risks of Covid-19 vaccines: rapid authorisations are possible, but premature vaccinations are not the answer for Switzerland

The regulatory authority in the United States, the FDA, will shortly decide on an emergency approval (Emergency Use Authorisation) for the use of the coronavirus vaccine from Pfizer/BioNTech. An emergency approval for vaccines is not a legal option in Switzerland. Swissmedic works closely with international partner authorities and reviews all applications for COVID-19 vaccines as a matter of urgency and in a “rolling” procedure. The companies supplied further details on their COVID-19 vaccines. This enables authorisations to be issued quickly once sufficient data on safety, efficacy and quality are available.

Emergency approvals for the use of vaccines fall short of regular authorisations. Even in countries that possess the legal instruments for placing them on the market earlier than usual, the investigations are still ongoing. In Switzerland, there is no legal basis for the emergency use of COVID-19 vaccines while the authorisation applications are still being processed. Parliament and the Federal Council have decided that, for the protection of the public, the regulatory authority (Swissmedic) should review the submitted documentation carefully according to scientific criteria.

Safety and speed

For a conditional or regular market authorisation, the applicants must provide sufficient and meaningful data on the safety, efficacy and quality of their vaccines and answer any queries promptly. 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. With rolling submission, Swissmedic has created an instrument to be used in the pandemic for the immediate review of data submitted by the pharmaceutical companies on an ongoing basis. The companies supplied further details on their COVID-19 vaccines and Swissmedic has submitted some further questions to the applicants.

"We hope we will very soon receive answers regarding the safety of the individual vaccines", explains Raimund Bruhin, the Executive Director of Swissmedic. "As soon as the data allow a preliminary benefit-risk assessment to be made, Swissmedic will decide very quickly on an authorisation".

A COVID-19 vaccine is authorised in a nuanced process. 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 can also be limited in duration and include conditions requiring the subsequent delivery of study data.