NEW YORK and MAINZ, GERMANY, May 28,
2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) today announced that the Conditional Marketing Authorization
(CMA) for COMIRNATY® in the European Union (EU) has been expanded
to include individuals 12 to 15 years of age. This follows the
European Medicines Agency’s (EMA) Committee for Medicinal Products
for Human Use (CHMP) positive opinion to authorize the vaccine in
this age group. The extended indication for the CMA for COMIRNATY®
is valid in all 27 EU member states.
COMIRNATY® was the first COVID-19 vaccine to
receive authorization in the EU and is the first to have its CMA
extended to adolescents. Distribution and administration of
COMIRNATY® by the EU member states will continue to be determined
according to the populations identified in the EU and per national
guidance.
“Today’s extension of our COVID-19 vaccine
authorization in the European Union is another critical milestone
in our collective effort to broaden vaccination programs to as many
people as possible,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. “Making vaccines available to
adolescents will help re-open schools and support the return to a
normal day-to-day life.”
“This is a meaningful moment for adolescents,
parents and entire families who are seeking protection from this
virus and a return to normalcy,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “We
appreciate the agency’s thorough and efficient review of the data
from our clinical trial, and look forward to seeing more people
across Europe immunized as a result of today’s decision.”
The EU decision is based on data from a pivotal
Phase 3 clinical trial, which enrolled 2,260 participants aged 12
to 15 years. Participants received two 30 μg doses of the COVID-19
vaccine. Results from this trial, which were published in The New
England Journal of Medicine on May 27, 2021, showed a vaccine
efficacy of 100% in participants with or without prior SARS-CoV-2
infection and robust antibody responses. In the trial, the vaccine
was also generally well tolerated. Participants will continue to be
monitored for long-term protection and safety for an additional two
years after their second dose.
In addition, the pediatric study evaluating the
safety and efficacy of the COVID-19 vaccine in children 6 months to
11 years of age is ongoing. Pfizer and BioNTech expect to have
definitive readouts and, subject to the data generated, submit for
an Emergency Use Authorization (e.g., in the U.S.) or a variation
to Conditional Marketing Authorizations (e.g., in the EU) for two
cohorts, including children 2-5 years of age and 5-11 years of age,
in September. The readout and submission for the cohort of children
6 months to 2 years of age are expected in the fourth quarter.
The Pfizer-BioNTech COVID-19 vaccine, which is
based on BioNTech 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 equivalents in the United States (jointly with
Pfizer), 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 the by the European Commission to
prevent coronavirus disease 2019 (COVID-19) in people from
12 years of age. The European Medicines Agency’s (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.
-
Syncope (fainting) may occur in association with administration of
injectable vaccines, in particular in adolescents. Procedures
should be in place to avoid injury from fainting.
-
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.
-
The overall safety profile of COMIRNATY® in adolescents 12 to 15
years of age was similar to that seen in participants 16 years of
age and older. The most frequent adverse reactions in clinical
trial participants 12 to 15 years of age were injection site pain
(> 90%), fatigue and headache (> 70%), myalgia and
chills (> 40%), arthralgia and pyrexia
(> 20%).
-
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
The Pfizer-BioNTech COVID-19 vaccine has not
been approved or licensed by the U.S. Food and Drug Administration
(FDA), but has been authorized for emergency use by FDA under an
Emergency Use Authorization (EUA) to prevent Coronavirus Disease
2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age
and older. The emergency use of this product is only authorized for
the duration of the declaration that circumstances exist justifying
the authorization of emergency use of the medical product under
Section 564 (b) (1) of the FD&C Act unless the declaration is
terminated or authorization revoked sooner. Please see Emergency
Use Authorization (EUA) Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) and Full EUA
Prescribing Information available
at www.cvdvaccine-us.com.
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 Notice The
information contained in this release is as of May 28, 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 and COMIRNATY®, the
Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative
assessments of available data, potential benefits, expectations for
clinical trials, the potential of BNT162b2 for adolescents 12 to 15
years of age, 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 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 following 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 the rolling
submission of a Biologics License Application for BNT162b2 in the
U.S. (the BLA) will be accepted for review and whether and when
other biologics license and/or emergency use authorization
applications or amendments to any such 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 the BLA or any requested
amendments to the emergency use or conditional marketing
authorizations) 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, clinical trial sites or third-party suppliers; the risk
that demand for any products may be reduced or no longer exist;
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, booster
doses or new variant-specific vaccines; 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 advisory or technical committees and other public health
authorities and uncertainties regarding the commercial impact of
any such recommendations; challenges related to public vaccine
confidence or awareness; 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 BioNTech
Biopharmaceutical 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
Statements This 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 (including a potential second booster dose of BNT162b2
and/or a potential booster dose of a variation of BNT162b2 having a
modified mRNA sequence); the potential of BNT162b2 for adolescents
12 to 15 years of age, evaluation of BNT162b2 in children 6 months
to 11 years old, anticipated timing of regulatory submissions,
regulatory approvals or authorizations and anticipated
manufacturing, distribution and supply); 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;
the risk that demand for any products may be reduced or no longer
exist; the ability of BioNTech to supply the quantities of BNT162
to support clinical development and market demand, including our
production estimates for 2021; and challenges related to public
vaccine confidence or awareness. Any forward-looking statements in
this press release are based on BioNTech’s 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 Annual Report on Form 20-F for the
Year Ended December 31, 2020, filed with the SEC on March 30, 2021,
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 Relations
Andrew Widger +44 1737 330909 Andrew.Widger@Pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:Media
RelationsJasmina Alatovic+49 (0)6131 9084 1513
Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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