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By Andreas Rinke
FRANKFURT, June 8 (Reuters) - The European Medicines Agency
(EMA) does not expect to make a decision on the approval of
German biotech group CureVac's COVID-19 vaccine before
August, an official at Germany's health ministry familiar with
the matter told Reuters.
The source said German health minister Jens Spahn had
provided the update on the EMA's view on the timing of the
review on Monday in a call with his regional state counterparts.
The health ministry declined to comment. CureVac did not
immediately respond to a request for comment, while the EMA said
it would not comment on the timing of ongoing reviews.
In what has so far been CureVac's only major confirmed
supply deal, the European Union secured up to 405 million doses
of the vaccine in November last year, of which 180 million are
optional.
That was followed by a memorandum of understanding with
Germany for another 20 million doses. Both deals are dependent
on EMA approval.
CureVac has previously had to climb down from a more
optimistic outlook on the speed at which its vaccine is being
developed, pushing out to June its guidance on the timing of
initial results from a late-stage trial from as early as May
previously.
The company said on May 28 that the late-stage trial
involving about 40,000 volunteers in Europe and Latin America
had reached a first interim analysis at 59 COVID-19 cases, but
that more data would be necessary for statistically reliable
efficacy numbers.
The stakes for CureVac and its prospective European
customers rose after age limits were imposed on the use of
Johnson & Johnson and AstraZeneca's
vaccines.
Shortfalls in AstraZeneca's and J&J's supply chains have
also knocked the European vaccination campaign.
But with EU vaccinations nonetheless picking up speed,
mainly thanks to higher deliveries from BioNTech and
Pfizer, the focus could turn to how CureVac's product
can help in low and middle-income countries, which have fallen
behind in the global immunisation drive.
Business Insider earlier reported Spahn's update to regional
ministers.
(Writing by Ludwig Burger; Editing by Sabine Wollrab and Jan
Harvey)
