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
.
Update from December 1, 1:05 p.m.:
The European Medicines Agency
EMA
wants to
decide
in December on an
approval
recommendation
for the
corona vaccine from
the Mainz company
Biontech
and the US pharmaceutical
company Pfizer
.
The agency announced on Tuesday in Amsterdam that the results of the examination should be available
by
December 29th
.
A decision is
expected by
January 12th
on the application of the US company
Moderna
for approval of its vaccine
.
Biontech
could
deliver
the
corona vaccine
"within a few hours" after approval by the authorities.
That said Biontech CFO
Sierk Poetting
on Tuesday at a joint press conference with Research
Minister
Anja Karliczek
(CDU).
"We have been producing in stockpiles and everything that is there can then really be distributed within a few hours."
Corona vaccine: Karliczek seeks trust in connection with the rapid development
Karliczek
has again sought
trust
in connection with the
rapid development
of corona vaccines.
Despite all the speed, the
test standards
remained
at the high level that is otherwise applied to the approval of vaccines, she said.
"A Covid-19 vaccine has to be safe and effective - just like any other vaccine." Karliczek announced an information campaign.
The
federal government
will do everything
possible to educate
citizens about the
benefits
of vaccination - but also about possible
side effects
that vaccinations could have.
“And to be clear once again:
the vaccination remains voluntary
.
Those who get vaccinated not only protect themselves, they also do something for the community, ”added the minister.
Corona vaccine: Biontech / Pfizer apply for approval in the EU and the USA
First report from December 1:
Mainz / New York - The Mainz 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.
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