(Adds details, background)
By John Miller
ZURICH, April 20 (Reuters) - Switzerland's drug regulator is
still awaiting data needed to consider AstraZeneca's
COVID-19 vaccine candidate for approval, a Swissmedic official
said on Tuesday, adding the information "unfortunately" had yet
to be submitted.
AstraZeneca was the first vaccine maker to seek approval
back in early October 2020, but has since been surpassed by
three vaccines that have won Swissmedic's blessing from Pfizer
, Moderna and Johnson & Johnson. Another
candidate, from Germany's CureVac, this week submitted
a rolling application, in hopes of a speedy OK.
Claus Bolte, Swissmedic's head of approvals, said
AstraZeneca's approval process had dragged on as part of a
"curious" situation, marked by the British-Swedish company's
release of initial, optimistic efficacy data in March that drew
a U.S. officials' rebuke, before days later issuing slightly
worse numbers.
"We're waiting, just like the U.S. Food and Drug
Administration, for the results of clinical trials in Latin
America and North America," Bolte said during a virtual press
conference from Bern.
"It was announced four weeks ago, but it has unfortunately
not yet been submitted," he said. "We want to decide on an
approval. Right now, however, it's not possible."
Also at the press conference, Swiss vaccines czar Nora
Kronig said that Moderna's COVID-19 vaccine deliveries
had experienced some hiccups and delays, but the Swiss
government still anticipated the U.S. company would fulfill its
commitments to Switzerland for the second quarter.
Moderna told Reuters last week that its second-quarter
deliveries to Britain and Canada would be delayed, but that
Swiss and European Union shipments would hit target ranges.
Switzerland expects to get eight million doses combined from
Moderna and Pfizer and its German partner BionTech in
April, May and June.
(Reporting by John Miller, editing by John Revill and Silke
Koltrowitz)
Astrazeneca (AZN)
