- New stability data show vaccine can be stored at -25°C to -15°C
for a total of two weeks and support decentralized distribution
plans for vaccination at general practitioners’ offices
- Label update offers greater flexibility for distributing,
storing and administering the vaccine within the European
Union
New York and Mainz, Germany,
March 26, 2021 — Pfizer Inc.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the
European Medicines Agency (EMA) approved storage of COMIRNATY® at
-25°C to -15°C for a total of two weeks based on data showing the
stability at these temperatures in standard pharmaceutical
freezers. The new data is a testament to the companies’ ongoing
commitment to developing this vaccine further and collecting data
in order to support broader and more flexible vaccine distribution
and inoculation. With this approval, the COMIRNATY vials can be
stored in all 27 European Union (EU) member states at these updated
temperatures for a total of two weeks alternatively to the storage
at ultra-low temperatures. It marks an important milestone in the
vaccine roll-out, as it could allow storage in pharmacies to
support vaccinations at local practices/doctors’ offices. By
enabling more individuals to store and administer the vaccine, the
approval will help broaden access, while limiting strain on larger
vaccination centers.
“From the beginning our goal was to make our
vaccine broadly available to people around the world. This approval
by the EMA will enable us to access important additional channels
to distribute and administer our vaccine,” said Ugur Sahin,
CEO and Co-founder of BioNTech. “It comes at an important
point in time, as governments now have more flexibility to move
from inoculations in vaccination centers to a more decentralized
vaccine roll-out through local doctors and general practitioners to
accelerate our path out of the pandemic.”
“We appreciate the collaboration with the EMA
and other regulatory agencies around the world as we work to ensure
our vaccine can be shipped and stored under increasingly flexible
conditions,” said Albert Bourla, Chairman and Chief
Executive Officer, Pfizer. “This new storage option in
Europe will help make the vaccine even more accessible to people
across the continent, another important step as we continue our
global fight against this virus.”
The vaccine, which is based on BioNTech’s
proprietary mRNA technology, was developed by both BioNTech and
Pfizer. BioNTech is the Marketing Authorization Holder in the
European Union, and the holder of emergency use authorizations or
equivalent in the United States, United Kingdom, Canada and other
countries in advance of a planned application for full marketing
authorizations in these countries.
AUTHORIZED USE IN THE
EU:COMIRNATY® ▼ (the Pfizer-BioNTech COVID-19 vaccine) has
been granted conditional marketing authorisation by in the EU to
prevent coronavirus disease 2019 (COVID-19) in people from 16 years
of age. EMA’s human medicines committee (CHMP) has completed its
rigorous evaluation of COMIRNATY®, concluding by consensus that
sufficiently robust data on the quality, safety and efficacy of the
vaccine are now available.
IMPORTANT SAFETY INFORMATION:
- Events of anaphylaxis have been reported. Appropriate medical
treatment and supervision should always be readily available in
case of an anaphylactic reaction following the administration of
the vaccine.
- The efficacy, safety and immunogenicity of the vaccine has not
been assessed in immunocompromised individuals, including those
receiving immunosuppressant therapy. The efficacy of COMIRNATY® may
be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY® may not
protect all vaccine recipients. Individuals may not be fully
protected until 7 days after their second dose of vaccine.
- In clinical studies, adverse reactions in participants 16 years
of age and older were injection site pain (> 80%), fatigue (>
60%), headache (> 50%), myalgia and chills (> 30%),
arthralgia (> 20%), pyrexia and injection site swelling (>
10%) and were usually mild or moderate in intensity and resolved
within a few days after vaccination. A slightly lower frequency of
reactogenicity events was associated with greater age.
- There is limited experience with use of COMIRNATY® in pregnant
women. Administration of COMIRNATY® in pregnancy should only be
considered when the potential benefits outweigh any potential risks
for the mother and fetus.
- It is unknown whether COMIRNATY® is excreted in human
milk.
- Interactions with other medicinal products or concomitant
administration of COMIRNATY® with other vaccines has not been
studied.
- For complete information on the safety of COMIRNATY® always
make reference to the approved Summary of Product Characteristics
and Package Leaflet available in all the languages of the European
Union on the EMA website.
The black equilateral triangle denotes that
additional monitoring is required to capture any adverse reactions.
This will allow quick identification of new safety information.
Individuals can help by reporting any side effects they may get.
Side effects can be reported to EudraVigilance or directly to
BioNTech using email medinfo@biontech.de, telephone +49 6131 9084
0, or via the website
www.biontech.de. About
Pfizer: Breakthroughs That Change Patients’ LivesAt
Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe
information contained in this release is as of March 26, 2021.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking
information about Pfizer’s efforts to combat COVID-19, the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine, the BNT162 mRNA vaccine program, the mRNA platform and
regulatory pathway and COMIRNATY®, the Pfizer-BioNTech COVID-19
Vaccine (BNT162b2) (including a label update to the EU Prescribing
Information which would enable the vaccine to be stored at -25°C to
-15°C, standard freezer temperature, for a total of two weeks,
qualitative assessments of available data, potential benefits,
expectations for clinical trials, the anticipated timing of
regulatory submissions, regulatory approvals or authorizations and
anticipated manufacturing, distribution and supply) involving
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
risks associated with preclinical and clinical data (including the
in vitro and Phase 3 data), including the possibility of
unfavorable new preclinical, clinical or safety data and further
analyses of existing preclinical, clinical or safety data; the
ability to produce comparable clinical or other results, including
the rate of vaccine effectiveness and safety and tolerability
profile observed to date, in additional analyses of the Phase 3
trial and additional studies or in larger, more diverse populations
upon commercialization; the ability of BNT162b2 to prevent COVID-19
caused by emerging virus variants; the risk that more widespread
use of the vaccine will lead to new information about efficacy,
safety, or other developments, including the risk of additional
adverse reactions, some of which may be serious; the risk that
preclinical and clinical trial data are subject to differing
interpretations and assessments, including during the peer
review/publication process, in the scientific community generally,
and by regulatory authorities; whether and when additional data
from the BNT162 mRNA vaccine program will be published in
scientific journal publications and, if so, when and with what
modifications and interpretations; whether regulatory authorities
will be satisfied with the design of and results from these and any
future preclinical and clinical studies; whether and when a
Biologics License Application for BNT162b2 may be filed in the U.S.
and whether and when other biologics license and/or emergency use
authorization applications may be filed in particular jurisdictions
for BNT162b2 or any other potential vaccines that may arise from
the BNT162 program, and if obtained, whether or when such emergency
use authorization or licenses will expire or terminate; whether and
when any applications that may be pending or filed for BNT162b2
(including a potential Biologics License Application in the U.S.)
or other vaccines that may result from the BNT162 program may be
approved by particular regulatory authorities, which will depend on
myriad factors, including making a determination as to whether the
vaccine’s benefits outweigh its known risks and determination of
the vaccine’s efficacy and, if approved, whether it will be
commercially successful; decisions by regulatory authorities
impacting labeling or marketing, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of a vaccine, including development of
products or therapies by other companies; disruptions in the
relationships between us and our collaboration partners or
third-party suppliers; risks related to the availability of raw
materials to manufacture a vaccine; challenges related to our
vaccine’s ultra-low temperature formulation, two-dose schedule and
attendant storage, distribution and administration requirements,
including risks related to storage and handling after delivery by
Pfizer; the risk that we may not be able to successfully develop
other vaccine formulations; the risk that we may not be able to
create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with
global demand for our vaccine, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether
and when additional supply agreements will be reached;
uncertainties regarding the ability to obtain recommendations from
vaccine technical committees and other public health authorities
and uncertainties regarding the commercial impact of any such
recommendations; uncertainties regarding the impact of COVID-19 on
Pfizer’s business, operations and financial results; and
competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About BioNTechBiopharmaceutical
New Technologies is a next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
The Company exploits a wide array of computational discovery and
therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells,
bi-specific checkpoint immuno-modulators, targeted cancer
antibodies and small molecules. Based on its deep expertise in mRNA
vaccine development and in-house manufacturing capabilities,
BioNTech and its collaborators are developing multiple mRNA vaccine
candidates for a range of infectious diseases alongside its diverse
oncology pipeline. BioNTech has established a broad set of
relationships with multiple global pharmaceutical collaborators,
including Genmab, Sanofi, Bayer Animal Health, Genentech, a member
of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit www.BioNTech.de.
BioNTech Forward-looking
StatementsThis press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, statements
concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine; our expectations regarding the potential characteristics
of BNT162b2 in our clinical trials and/or in commercial use based
on data observations to date; the ability of BNT162b2 to prevent
COVID-19 caused by emerging virus variants; the expected time point
for additional readouts on efficacy data of BNT162b2 in our
clinical trials; the nature of the clinical data, which is subject
to ongoing peer review, regulatory review and market
interpretation; the timing for submission of data for, or receipt
of, any marketing approval or Emergency Use Authorization; our
contemplated shipping and storage plan, including our estimated
product shelf life at various temperatures; and the ability of
BioNTech to supply the quantities of BNT162 to support clinical
development and market demand, including our production estimates
for 2021. Any forward-looking statements in this press release are
based on BioNTech current expectations and beliefs of future
events, and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to: the
ability to meet the pre-defined endpoints in clinical trials;
competition to create a vaccine for COVID-19; the ability to
produce comparable clinical or other results, including our stated
rate of vaccine effectiveness and safety and tolerability profile
observed to date, in the remainder of the trial or in larger, more
diverse populations upon commercialization; the ability to
effectively scale our productions capabilities; and other potential
difficulties.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report for the Three and
Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its
Current Report on Form 6-K filed with the SEC on November 10, which
is available on the SEC’s website at www.sec.gov. All information
in this press release is as of the date of the release, and
BioNTech undertakes no duty to update this information unless
required by law.
Pfizer Contacts:
Media RelationsAndrew Widger+44 1737
330909Andrew.Widger@Pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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