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Corona vaccine: Moderna wants to apply for approval in Europe today

2020-11-30T17:26:13.074Z

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 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

Source: merkur

All news articles on 2020-11-30

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