Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the initiation of a Biologics License Application (BLA)
with the U.S. Food and Drug Administration (FDA) for approval of
their mRNA vaccine to prevent COVID-19 in individuals 16 years of
age and older. Data to support the BLA will be submitted by the
companies to the FDA on a rolling basis over the coming weeks, with
a request for Priority Review. The Prescription Drug User Fee Act
(PDUFA) goal date for a decision by the FDA will be set once the
BLA is complete and formally accepted for review by the agency.
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The Pfizer-BioNTech COVID-19 Vaccine is currently available in
the U.S. under an Emergency Use Authorization (EUA) granted by the
FDA on December 11, 2020. Since then, the companies have delivered
more than 170 million doses of the vaccine across the U.S.
Submission of a BLA, which requires longer-term follow-up data for
acceptance and approval, is the next step in the rigorous FDA
review process.
“We are proud of the tremendous progress we’ve made since
December in delivering vaccines to millions of Americans, in
collaboration with the U.S. Government,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “We look forward to
working with the FDA to complete this rolling submission and
support their review, with the goal of securing full regulatory
approval of the vaccine in the coming months.”
“Following the successful delivery of more than 170 million
doses to the U.S. population in just a few months, the BLA
submission is an important cornerstone of achieving long-term herd
immunity and containing COVID-19 in the future,” said Ugur Sahin,
M.D., CEO and Co-founder of BioNTech. “We are pleased to work with
U.S. regulators to seek approval of our COVID-19 vaccine based on
our pivotal Phase 3 trial and follow-up data.”
Pfizer and BioNTech initiated the BLA by submitting the
nonclinical and clinical data needed to support licensure of the
COVID-19 vaccine for use in individuals 16 years of age and older.
This includes the most recent analyses from the pivotal Phase 3
clinical trial, where the vaccine’s efficacy and favorable safety
profile were observed up to six months after the second dose. The
companies will submit the required manufacturing and facility data
for licensure in the coming weeks to complete the BLA.
Pfizer and BioNTech also have submitted an application to expand
the current EUA for their COVID-19 vaccine to include individuals
12 to 15 years of age. The companies intend to submit a
supplemental BLA to support licensure of the vaccine in this age
group once the required data six months after the second vaccine
dose are available.
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
equivalent in the United States (together with Pfizer), United
Kingdom, Canada and other countries in advance of a planned
application for full marketing authorizations in these
countries.
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)
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) and Full EUA
Prescribing Information available at www.cvdvaccine-us.com.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 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.htmlor 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 May 7, 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 the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)
(including qualitative assessments of available data, potential
benefits, expectations for clinical trials, a rolling submission of
a Biologics License Application (BLA) with the FDA for BNT162b2,
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 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 the submission of the BLA for BNT162b2 in the U.S. will be
completed and 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 the BLA for BNT162b2 in the U.S. and
any other applications that may be pending or filed for BNT162b2
(including 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, including the Biologics License Application, 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, including the Biologics License Application, 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.
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Pfizer Contacts: Media Relations Amy Rose +1 (212)
733-7410 Amy.Rose@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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