* Swissmedic calls approval a world first as standard
procedure
* Vaccinations to start within days - health minister
* No shortcuts taken on road to approval - agency
(Adds Pfizer comment, health minister)
By Michael Shields
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," Swissmedic 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.
"We commend Swissmedic for its careful assessment of our
COVID-19 vaccine and timely action to help protect the people of
Switzerland," Sabine Bruckner, Pfizer's head of Swiss
operations, said in a statement, calling Swiss approval "a
historic moment in the fight against this deadly disease".
Swiss vaccinations will start within days, Health Minister
Alain Berset said in a video posted on Twitter. First priority
for the voluntary jabs will be vulnerable people, including the
elderly and those with medical conditions.
Swissmedic will require Pfizer to continue submitting
information on the safety, efficacy and quality of its vaccine
on an ongoing basis, it said.
(Reporting by Michael Shields, Editing by William Maclean and
Ros Russell)