- In participants aged 12-15 years old, BNT162b2 demonstrated
100% efficacy and robust antibody responses, exceeding those
reported in trial of vaccinated 16-25 year old participants in an
earlier analysis, and was well tolerated
- The companies plan to submit these data to the U.S. Food and
Drug Administration (FDA) and the European Medicines Agency (EMA)
as soon as possible to request expansion of the Emergency Use
Authorization (EUA) and EU Conditional Marketing Authorization for
BNT162b2
- The companies also provided an update on the Phase 1/2/3 study
of BNT162b2 in children aged 6 months to 11 years
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced that, in a Phase 3 trial in adolescents 12 to 15 years of
age with or without prior evidence of SARS-CoV-2 infection, the
Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100%
efficacy and robust antibody responses, exceeding those recorded
earlier in vaccinated participants aged 16 to 25 years old, and was
well tolerated. These are topline results from a pivotal Phase 3
trial in 2,260 adolescents.
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“We share the urgency to expand the authorization of our vaccine
to use in younger populations and are encouraged by the clinical
trial data from adolescents between the ages of 12 and 15,” said
Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We
plan to submit these data to FDA as a proposed amendment to our
Emergency Use Authorization in the coming weeks and to other
regulators around the world, with the hope of starting to vaccinate
this age group before the start of the next school year.”
“Across the globe, we are longing for a normal life. This is
especially true for our children. The initial results we have seen
in the adolescent studies suggest that children are particularly
well protected by vaccination, which is very encouraging given the
trends we have seen in recent weeks regarding the spread of the
B.1.1.7 UK variant. It is very important to enable them to get back
to everyday school life and to meet friends and family while
protecting them and their loved ones,” said Ugur Sahin, CEO and
Co-founder of BioNTech.
About the Phase 3 Data from Adolescents 12-15 Years of
Age
The trial enrolled 2,260 adolescents 12 to 15 years of age in
the United States. In the trial, 18 cases of COVID-19 were observed
in the placebo group (n=1,129) versus none in the vaccinated group
(n=1,131). Vaccination with BNT162b2 elicited
SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of
1,239.5, demonstrating strong immunogenicity in a subset of
adolescents one month after the second dose. This compares well
(was non-inferior) to GMTs elicited by participants aged 16 to 25
years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2
administration was well tolerated, with side effects generally
consistent with those observed in participants 16 to 25 years of
age.
The companies plan to submit these data to the FDA and EMA for a
requested amendment to the Emergency Use Authorization of BNT162b2
and the EU Conditional Marketing Authorization for COMIRNATY® to
expand use in adolescents 12-15 years of age as quickly as
possible. All participants in the trial will continue to be
monitored for long-term protection and safety for an additional two
years after their second dose.
Pfizer and BioNTech plan to submit the data for scientific peer
review for potential publication.
Update on the Phase 1/2/3 Study in Children 6 months to 11
years old
Last week, Pfizer and BioNTech dosed the first healthy children
in a global Phase 1/2/3 seamless study to further evaluate the
safety, tolerability, and immunogenicity of the Pfizer-BioNTech
COVID-19 vaccine in children 6 months to 11 years of age. The study
is evaluating the safety, tolerability, and immunogenicity of the
Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule
(approximately 21 days apart) in three age groups: children aged 5
to 11 years, 2 to 5 years, and 6 months to 2 years. The 5 to 11
year-old cohort started dosing last week and the companies plan to
initiate the 2 to 5 year-old cohort next week.
The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, 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) for use in individuals 16 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) including Full EUA
Prescribing Information available at www.cvdvaccine.com.
The vaccine, which is based on BioNTech proprietary mRNA
technology, was developed by both BioNTech and Pfizer. BioNTech is
the Marketing Authorizations 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 U.S.: The Pfizer-BioNTech COVID-19
Vaccine is authorized for use under an Emergency Use Authorization
(EUA) for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) in individuals 16 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE
AUTHORIZATION PRESCRIBING INFORMATION:
- Do not administer Pfizer-BioNTech COVID-19 Vaccine to
individuals with known history of a severe allergic reaction (e.g.,
anaphylaxis) to any component of the Pfizer-BioNTech COVID-19
Vaccine
- Appropriate medical treatment used to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of
Pfizer-BioNTech COVID-19 Vaccine
- Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the
occurrence of immediate adverse reactions according to the Centers
for Disease Control and Prevention guidelines
(https://www.cdc.gov/vaccines/covid-19/)
- Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
the Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect all
vaccine recipients
- In clinical studies, adverse reactions in participants 16 years
of age and older included pain at the injection site (84.1%),
fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills
(31.9%), joint pain (23.6%), fever (14.2%), injection site swelling
(10.5%), injection site redness (9.5%), nausea (1.1%), malaise
(0.5%), and lymphadenopathy (0.3%)
- Severe allergic reactions, including anaphylaxis, have been
reported following the Pfizer-BioNTech COVID-19 Vaccine during mass
vaccination outside of clinical trials. Additional adverse
reactions, some of which may be serious, may become apparent with
more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer-BioNTech COVID-19 Vaccine administered
to pregnant women are insufficient to inform vaccine-associated
risks in pregnancy
- Data are not available to assess the effects of Pfizer-BioNTech
COVID-19 Vaccine on the breastfed infant or on milk
production/excretion
- There are no data available on the interchangeability of the
Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to
complete the vaccination series. Individuals who have received one
dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second
dose of Pfizer-BioNTech COVID-19 Vaccine to complete the
vaccination series
- Vaccination providers must report Adverse Events in accordance
with the Fact Sheet to VAERS at
https://vaers.hhs.gov/reportevent.html or by calling
1-800-822-7967. The reports should include the words
“Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section
of the report
- Vaccination providers should review the Fact Sheet for
Information to Provide to Vaccine Recipients/Caregivers and
Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine
Administration Under Emergency Use Authorization
- Please see Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including Full EUA Prescribing Information available at
www.cvdvaccine-us.com
About Pfizer: Breakthroughs That Change Patients’ Lives
At 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 March 31, 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 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, evaluation of
BNT162b2 in children 6 months to 11 years old, 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 data outlined in this release),
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
(including the data outlined in this release) 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 (including the
data outlined in this release) 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 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 a
potential Biologics License Application in the U.S. or any
requested amendments to the emergency use authorization) 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 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); 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 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.
View source
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Pfizer Contacts:
Media Relations Jerica Pitts +1 (347) 224-9084
Jerica.Pitts@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
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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