NEW YORK and MAINZ, Germany,
November 25, 2021—Pfizer Inc.
(NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”)
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) issued a positive
opinion on the administration of the companies’ COVID-19 vaccine
COMIRNATY® in children 5 to under 12 years of age. The European
Commission (EC) will review the CHMP recommendation and is expected
to make a final decision on a variation to the Conditional
Marketing Authorization in the near future. If the EC grants the
variation regarding a vaccination in this age group, the decision
will be immediately applicable to all 27 EU member states. If
approved, COMIRNATY will be the first COVID-19 vaccine authorized
in the European Union for individuals 5 to under 12 years of
age.
The positive opinion adopted by the CHMP is
based on scientific evidence shared by the companies, including
results from a Phase 2/3 randomized, controlled
trial that included ~4,500 children 5 to under 12 years of age
(2,268 from the original group and 2,379 from the supplemental
safety group). Participants in this age group received a two-dose
regimen of 10-µg doses administered 21 days apart, as compared to
the 30-µg doses used in individuals 12 years and older. This dose
level was carefully selected for use in the trial based on safety,
tolerability and immunogenicity data evaluated as part of a
dose-ranging study. The Phase 2/3 trial showed a favorable safety
profile, robust immune responses and a vaccine efficacy rate of
90.7% in participants without prior SARS-CoV-2 infection, measured
from 7 days after the second dose, during a period when Delta was
the prevalant strain. The Data Monitoring Committee for the study
has reviewed the data and has not identified any serious safety
concerns related to the vaccine.
Pfizer and BioNTech continue to supply the
vaccine, including sufficient volume for pediatric doses, under
their existing supply agreement with the EC. The companies do not
expect the introduction of pediatric doses in the United States and
the European Union, if authorized, to impact the existing supply
agreements in place with governments and international health
organizations around the world.
Pfizer and BioNTech have submitted requests for
authorization of their COVID-19 vaccine in this age group to other
regulators around the world. The companies expect initial pivotal
data from their ongoing clinical trial in 2 to under 5 years of age
this quarter, and in 6 month to under 2 years of age in the first
quarter 2022, with full data readouts to follow.
COMIRNATY, which is based on BioNTech’s
proprietary mRNA technology, was developed by both BioNTech and
Pfizer. BioNTech is the Marketing Authorization Holder in the
United States, the European Union, the United Kingdom, Canada and
other countries, and the holder of emergency use authorizations or
equivalents in the United States (jointly with Pfizer) and other
countries. Submissions to pursue regulatory approvals in those
countries where emergency use authorizations or equivalent were
initially granted are ongoing.
AUTHORIZED USE IN
THE EU:COMIRNATY® ▼ (the
Pfizer-BioNTech COVID-19 vaccine) has been granted conditional
marketing authorization (CMA) by the European Commission to prevent
coronavirus disease 2019 (COVID-19) in people from 12 years of age.
The vaccine is administered as a 2-dose series, 3 weeks apart. In
addition, the CMA has been expanded to include a booster dose
(third dose) at least 6 months after the second dose in individuals
18 years of age and older. For immunocompromised individuals, the
third dose may be given at least 28 days after the second dose. 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.
- Very rare cases of
myocarditis and pericarditis have been observed following
vaccination with Comirnaty. These cases have primarily occurred
within 14 days following vaccination, more often after the second
vaccination, and more often in younger men. Available data suggest
that the course of myocarditis and pericarditis following
vaccination is not different from myocarditis or pericarditis in
general.
- Anxiety-related
reactions, including vasovagal reactions (syncope),
hyperventilation or stress‐related reactions (e.g. dizziness,
palpitations, increases in heart rate, alterations in blood
pressure, tingling sensations and sweating) may occur in
association with the vaccination process itself. Stress-related
reactions are temporary and resolve on their own. Individuals
should be advised to bring symptoms to the attention of the
vaccination provider for evaluation. It is important that
precautions are 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
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 November 25, 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 (COVID-19
Vaccine, mRNA) (BNT162b2) (including the potential in children 5
through <12 years of age and a positive CHMP opinion on the
administration in children 5 through <12 years of age in the EU,
studies in children 6 months to 5 years of age, qualitative
assessments of available data, potential benefits, expectations for
clinical trials, the anticipated timing of data readouts,
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 2/3 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
submissions to request emergency use or conditional marketing
authorizations for BNT162b2 for pediatric populations, a potential
booster dose and/or 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 submission for a variation to the Conditional Marketing
Authorization in the EU for children 5 through <12 years of age,
potential submissions for younger pediatric populations, a
potential booster dose or any other 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 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 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 including the program to
develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA)
(BNT162b2) (including qualitative assessments of available data,
potential benefits, expectations for clinical trials, the potential
of BNT162b2 for children 5 through 11 years of age (also referred
to as 5 to <12 years), evaluation of BNT162b2 in children 6
months to <5 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 ability of BioNTech to supply the quantities of BNT162 to
support clinical development and market demand, including our
production estimates for 2021; whether and when additional supply
agreements will be reached; challenges related to public vaccine
confidence or awareness; and uncertainties regarding the impact of
COVID-19 on BioNTech’s trials, business and general operations. 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 Annual Report as 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.
CONTACTS
Pfizer:Media Relations+44
1737332335eupress@pfizer.com
Investor Relations+1 (212) 733-4848IR@pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49
(0)6131 9084 1513 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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