Swiss drugs regulator authorises Pfizer/Biontech COVID-19 vaccine
Swiss drugs regulator Swissmedic has authorised the COVID-19 vaccine from Pfizer and partner BioNTech, the agency said on Saturday, calling it the world’s first such approval under a standard procedure.
Two months after receiving the application, Swissmedic granted authorisation for the vaccine in a rolling review of documents being submitted.
Other countries have already approved it for emergency use to help curb the global coronavirus pandemic.
“The data available to date showed a comparable high level of efficacy in all investigated age groups, thus meeting the safety requirements,” it said on its website.
“The safety of patients is an essential prerequisite, especially where the authorisation of vaccines is concerned”, Swissmedic Director Raimund Bruhin said.
“Thanks to the rolling procedure and our flexibly organised teams, we … managed to reach a decision quickly – while also fully satisfying the three most important requirements of safety, efficacy and quality.”
Swissmedic is also reviewing applications for COVID-19 vaccines made by Moderna and AztraZeneca.