(Adds details)
ZURICH, Nov 13 (Reuters) - Switzerland has begun a rolling
review of Moderna's, COVID-19 vaccine candidate so it
can give it a speedy approval should it pass muster in clinical
trials, the country's drug regulator said on Friday.
Regulator Swissmedic is already scrutinizing the progress of
experimental vaccines being developed by AstraZeneca as
well as Pfizer and BioNTech SE in similar
rolling reviews.
So-called rolling reviews allow drug companies to submit
applications for COVID-19 medicinal products before development
work is concluded and prior to the availability of complete
supporting documentation.
U.S. drugmaker Moderna said this week that it has enough
data for a first interim analysis of its late-stage COVID-19
vaccine trial, raising hopes that initial results will be
released soon.
Interim trial data from Pfizer and BioNTech released on
Monday indicated that its vaccine candidate was more than 90%
effective.
"Swissmedic can thus obtain an initial picture of the
benefit-risk profile of the vaccine candidates before the
authorisation studies are completed," Swissmedic said in a
statement about the rolling review.
"This accelerates the review process while at the same time
preserving the same level of careful checking of all
requirements relating to safety, efficacy and quality."
As part of the review, Swissmedic said it was working with
other drug regulators around the world.
Switzerland has already set aside 400 million Swiss francs
($437 million) to buy COVID-19 vaccines and reserved a total of
about 16 million doses of the shots being developed by Moderna,
AstraZeneca and Pfizer/BioNTech.
($1 = 0.9148 Swiss francs)
(Reporting by John Miller; Editing by Michael Shields and David
Clarke)