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EU regulator does not expect approval for CureVac vaccine before August - source

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)

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