The US pharmaceutical company Moderna wants to apply for approval for its corona vaccine in the EU on Monday.
At the same time, an emergency license is to be applied for in the USA.
The US pharmaceutical company
Moderna
has developed a
vaccine
against the
coronavirus *
.
On Monday, the company wants to
apply for
approval
in the
EU
.
The
Corona vaccine *
According to Moderna has an
efficiency of 94.1 percent
.
New York - The US pharmaceutical company
Moderna
wants to be the first company to
apply for approval for a corona vaccine
in the
EU
.
The application for a conditional approval should be submitted to the European Medicines Agency EMA on Monday, the company said.
At the same time, an
application
for
emergency approval is
to be
submitted
to the US
FDA
.
Corona vaccine: Moderna wants to apply for approval in Europe
With the application for approval at the EMA, a
corona *
vaccination is
also
getting closer
in
Germany
.
Last week, EU Commission chief
Ursula von der Leyen announced
that
a framework contract for
up to 160 million vaccine doses
had been concluded
with
Moderna
.
Accordingly, 80 million cans are to be delivered initially, with the option of 80 million more units.
According to Moderna, the product could be
delivered
in the EU
as early as December
, provided it receives approval.
We just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, our COVID-19 vaccine candidate and that today, we plan to request an Emergency Use Authorization from the US FDA & conditional approval from the EMA.
Read more: https://t.co/90FbcVHdWN pic.twitter.com/36tpY0QeFl
- Moderna (@moderna_tx) November 30, 2020
A
so-called
rolling review process is
already running at the EMA for
the
Corona vaccine *
from
Moderna
, which is intended to accelerate the approval process.
Manufacturers can submit individual parts on the quality, safety and effectiveness of a preparation even before the complete application for approval.
Moderna corona vaccine: 94.1 percent effectiveness
The
Moderna vaccine mRNA-1273
has an
effectiveness of 94.1 percent
, the company said.
This emerges from the latest analysis of data from the
Phase III clinical trial
, in which 30,000 people in the
United States are
participating.
Half of the participants receive the vaccine, the other half a placebo.
For full vaccination protection, two doses are necessary at intervals.
A total of
196 cases of
the disease
Covid-19 * have been
confirmed
among the test persons so far
.
11 of these cases were in the vaccine group and 185 in the placebo group.
This results in an
effectiveness of 94.1 percent
.
The new results roughly correspond to the preliminary data that
Moderna published in
mid-November.
The company also announced that the total of
30 severe Covid 19 courses
in the study
only
affected
the placebo group
.
The
effectiveness
of mRNA-1273 was similar across all age groups, according to Moderna.
(ph / dpa) * Merkur.de is part of the Ippen digital editorial network