(Adds details and background)
ZURICH, Dec 19 (Reuters) - 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.
(Reporting by Michael Shields, Editing by William Maclean)