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CureVac says well on track to request vaccine approval as planned

Wed, 5th May 2021 15:54

* Says infections rate within trial population is high

* Some doses aimed for production in '21 to be delivered in
'22

* Trial result will also offer unique view on spread of
variants

By Ludwig Burger

FRANKFURT, May 5 (Reuters) - Germany's CureVac is
on track to file for European approval of its COVID-19 vaccine
as early as this month because high infection rates among trial
participants are bringing a read-out on efficacy within closer
reach.

"The cases are coming in fast," Chief Executive Franz-Werner
Haas told Reuters.

Since starting out in 2000, the biotech firm has focused on
so-called messenger RNA (mRNA), a drug and vaccine technology
that has also become the recent focus of the European union's
procurement negotiations.

The mRNA approach has been validated by the wide use of
coronavirus vaccines developed by pioneers BioNTech
and its partner Pfizer, as well as by Moderna,
in Europe and North America.

But more volumes will be needed to boost lagging
immunisation coverage in Europe and potentially for repeated
booster shots.

The group's late stage trial involves more than 37,000
volunteers in Europe and Latin America, half of whom are
receiving a placebo.

An interim analysis is due when 56 and then 111 volunteers
across both groups have fallen ill with COVID-19.

CureVac has not publicly determined at which checkpoint it
would publish first results but has said it expects to file for
European authorization in late May or early June.

Current infection rates in participating country Peru, in
particular, have put CureVac well on track to meet its
timetable, Haas said.

As CureVac's only major supply deal, the European Union in
November last year secured up to 405 million doses of the shot,
of which 180 million are optional.

The Nasdaq-listed firm, which is backed by investor Dietmar
Hopp, GlaxoSmithKline as well as the German government,
has said it aims to produce up to 300 million doses of the
vaccine in 2021 and up to 1 billion in 2022.

The CEO, which has flagged equipment and material supply
issues due to the U.S. Defense Production Act, confirmed the
production target, but said that some volumes may not be cleared
for delivery before the first quarter of 2022.

This is due to "validation by regulators" that is needed for
the release of the produced volumes to customers, which may
require additional time, he said.

For the trial read-out expected later this month, CureVac
will publish details on its primary goal of preventing COVID-19
across all virus variants.

It also aims to disclose efficacy data specifically on the
variant known as B117 that was first detected in Britain, as
well as on the initial variant that emerged in Chinese city of
Wuhan.

All infections in the trial will undergo genetic sequencing
of any variant, offering a unique picture of the variations of
the pathogen in Europe and Latin America.

"We'll have the only study that will offer real-world data
on the current distribution of variants," said Sarah Fakih, the
firm's head of investor relations.
(Editing by Keith Weir)

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