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Corona vaccine: Biontech and Pfizer apply for approval in the EU

2020-12-01T21:05:36.000Z


The Mainz-based company Biontech and the US pharmaceutical group Pfizer applied for approval of their corona vaccine in the EU and the USA on Monday.


The Mainz-based company Biontech and the US pharmaceutical group Pfizer applied for approval of their corona vaccine in the EU and the USA on Monday.

  • The German company

    Biontech

    and its US partner

    Pfizer

    have developed a

    corona vaccine *

    .

  • On Monday, the companies

    applied for

    approval

    in the

    EU

    .

  • The

    Biontech / Pfizer vaccine *

    has an

    effectiveness of 95 percent

    , according to the company

    .

Mainz / New York - Mainz-based company

Biontech

and its US partner

Pfizer

have applied to the European Medicines Agency


(EMA) for

approval of their corona vaccine

in the

EU

.

The application for a conditional marketing authorization was submitted on Monday, announced Biontech and Pfizer on Tuesday.

On Monday, the US company

Moderna also

submitted a corresponding application for its vaccine to the EMA.

Corona vaccine: Biontech / Pfizer apply for approval in the EU and the USA

The

EMA

must now examine the applications.

How long this would take was initially unclear.

If the authority recommends conditional approval, the vaccine could

still be used in December

,

announced Biontech *

.

The final decision is made by the EU Commission, which usually follows the EMA recommendation.

Biontech had announced that it would

be able to start

delivering the first vaccines

immediately after approval

.

Biontech / Pfizer and Moderna have also

filed for

emergency

approval

with the

US Food and Drug Administration

.

For the

Biontech / Pfizer vaccine *

with the designation

BNT162b2

, extensive test series showed an

effectiveness

that

offers

95 percent protection

against the disease

Covid-19 *

,

according to the companies

.

The vaccine worked similarly well across all age groups and other demographic differences and showed

practically

no serious side effects

, the companies said after the final analysis.

The

vaccination protection

for people who are over 65 years old is over

94 percent

.

It

is not yet clear to

what extent the vaccine also protects against

infection

and possible transmission of the

coronavirus *

.

We have submitted a formal Application for Conditional Marketing Authorization to @EMA_News for #mRNA vaccine candidate # BNT162b2 against # COVID19.

It will be assessed according to # EMA's normal stringent standards for quality, safety and efficacy.

https://t.co/Sn1n4oJZ6S pic.twitter.com/2sadnJJLp9

- BioNTech SE (@BioNTech_Group) December 1, 2020

Corona vaccine: Germany and EU with a framework agreement for the purchase of up to 300 million doses

"As a company based in the heart of Europe, today's

milestone

is immensely important to us as we continue to strive to enable global distribution after the potential approval of BNT162b2," said Biontech CEO and co-founder

Ugur Sahin *

.

“We want to continue to work with

regulatory agencies

around the world

to enable

rapid global distribution of

our

vaccine if

approved

.

We would like to contribute to the global efforts to fight the virus in order to return to

normal

. "

Germany

and the

EU

have already signed a framework agreement * for the purchase of

up to 300 million doses of the corona vaccine

.

Based on delivery

forecasts

,

Biontech

assumes that

up to 50 million vaccine

doses

will be

shipped

worldwide this year

and

up to 1.3 billion doses

will be manufactured

next year

.

(ph / dpa) * Merkur.de is part of the Ippen digital editorial network

Source: merkur

All news articles on 2020-12-01

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