Last checked at 
* 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 Swissmedic comment, health agency, background)
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 for people aged 16 and
older after 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.
"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 nevertheless 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".
The vaccine has been authorised or approved for emergency
use in more than 15 countries, the partners said. Swissmedic's
Bruhin said he expected EU regulators to approve it soon.
Swiss vaccinations will start within days, Health Minister
Alain Berset said on Twitter. The first priority for the
voluntary jabs will be vulnerable people, including the elderly
and those with medical conditions.
The Swiss health agency said on Saturday a nationwide
vaccination programme could start from Jan. 4 with an initial
batch of around 100,000 doses.
Swissmedic will require Pfizer to continue submitting
information on the safety, efficacy and quality of its vaccine,
it said.
"We will take immediate action if necessary should safety
signals emerge," Bruhin told a news conference.
Switzerland has a contract with Pfizer and BioNTech
to deliver 3 million doses of the vaccine, it has
said, enough for 1.5 million people to get two jabs three weeks
apart.
COVID-19 cases in Switzerland and neighbouring Liechtenstein
have surpassed 400,000 and the death toll has topped 6,000,
prompting the government on Friday to close restaurants for a
month and urge people to stay home.
(Reporting by Michael Shields, Editing by William Maclean and
Ros Russell)
