(Adds AstraZeneca comment)
By John Miller
ZURICH, Feb 3 (Reuters) - Switzerland has withheld approval
for AstraZeneca's COVID-19 vaccine, drugs regulator
Swissmedic said on Wednesday, demanding more efficacy and
quality data before greenlighting a shot that won European Union
approval last week.
The country separately announced it had ordered millions
more COVID-19 vaccine doses from other manufacturers.
Switzerland, which has already ordered 5.3 million doses
from AstraZeneca, said it was awaiting results from trials of
the shot in North and South America involving tens of thousands
of people, after earlier trials did not produce clear data
including on efficacy in older people.
"As soon as the results have been received, a temporary
authorisation according to the rolling procedure could be issued
at very short notice," Swissmedic said in a statement, adding it
was necessary to get additional data about safety, efficacy and
quality.
"The data currently available do not point to a positive
decision regarding benefits and risks," it said.
AstraZeneca reiterated that its vaccine was being reviewed
on a rolling basis by Swissmedic, to speed up the approval
process, and that it would share information with the regulator
as quickly as it became available.
"We are confident that our vaccine is effective,
well-tolerated, and can have a real impact on the pandemic," the
company said.
AstraZeneca and its partner, Oxford University, have
defended their vaccine that is approved in about 50 countries,
saying it had 76% efficacy against symptomatic infection for
three months after a single dose, which increased if the second
shot is delayed.
However, some European countries are restricting it to
certain age groups, citing a lack of data in particular in older
people.
The Swiss government said it had signed a deal with
Germany's Curevac and the Swedish government for the
delivery of 5 million vaccine doses, a preliminary pact with
U.S. vaccine maker Novavax for 6 million doses, and
secured a further 6 million doses from Moderna.
These new orders bring total Swiss vaccine orders to more
than 30 million doses, enough to vaccinate its 8.6 million
population about twice over under a two-dose regimen.
Further talks with additional developers are taking place
for even more shots, the government said.
"The idea behind procuring vaccines from different
manufacturers is to make sure that sufficient doses of an
approved vaccine are available to the public even if there are
delivery problems," the Federal Health Ministry said.
(Reporting by John Miller in Zurich and Alistair Smout in
London; Editing by Michael Shields, Kirsten Donovan and Barbara
Lewis)