NEW YORK and MAINZ, GERMANY, NOVEMBER
16, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced that the companies have initiated a
Phase 1 study to evaluate the safety, tolerability and
immunogenicity of a next generation COVID-19 vaccine candidate that
aims to enhance SARS-CoV-2 T cell responses and potentially broaden
protection against COVID-19. This candidate, BNT162b4, is composed
of a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins
that are highly conserved across a broad range of SARS-CoV-2
variants and will be evaluated in combination with the companies’
Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. These
non-spike proteins have been chosen based on BioNTech's proprietary
target prioritization platform and were designed into a vaccine
candidate with the purpose of enhancing and broadening T cell
immunity and potentially extending durability of protection against
COVID-19.
BNT162b4 will be evaluated in a U.S.-based study
(NCT05541861) enrolling approximately 180 healthy individuals
between 18 and 55 years of age, who have received at least three
doses of an mRNA-based COVID-19 vaccine. The trial will explore
different dose levels of BNT162b4 administered in combination with
a 30-µg dose of the companies’ Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine and will be compared to the administration of a
30-µg dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine as a booster.
This study is part of the companies’ long-term
and multi-pronged scientific strategy to generate more robust,
longer-lasting, and broader immune responses against SARS-CoV-2
infections and associated COVID-19. As part of this approach the
companies are developing multiple vaccine candidates with the aim
of delivering a potential pan-SARS-CoV-2 vaccine.
The Pfizer-BioNTech COVID-19 Vaccines
(COMIRNATY®) and BNT162b4 are based on BioNTech’s proprietary mRNA
technology and were developed by both BioNTech and Pfizer. BioNTech
is the Marketing Authorization Holder for BNT162b2 Wild Type and
BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) 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 planned.
U.S. Indication & Authorized
Use
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)
AUTHORIZED USEPfizer-BioNTech
COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is
FDA-authorized under Emergency Use Authorization (EUA) for use in
individuals 5 years of age and older as a single booster dose
administered at least 2 months after either:
- completion of primary vaccination with any authorized or
approved monovalent* COVID-19 vaccine; or
- receipt of the most recent booster dose with any authorized or
approved monovalent COVID-19 vaccine.
*Monovalent refers to any authorized and
approved COVID-19 vaccine that contains or encodes the spike
protein of only the Original SARS-CoV-2 virus
COMIRNATY® (COVID-19 Vaccine,
mRNA)
INDICATIONCOMIRNATY® (COVID-19
Vaccine, mRNA) is a vaccine approved for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12
years of age and older.
AUTHORIZED USECOMIRNATY®
(COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use
Authorization (EUA) to provide:
Primary Series
- a third primary series dose to individuals 12 years of age and
older who have certain kinds of immunocompromise
Pfizer-BioNTech COVID-19
Vaccine
AUTHORIZED USES Pfizer-BioNTech
COVID-19 Vaccine is FDA authorized under Emergency Use
Authorization (EUA) for use in individuals 6 months and older to
provide:
Primary Series
- a 3-dose primary series to individuals 6 months through 4 years
of age
- a 2-dose primary series to individuals 5 years of age and
older
- a third primary series dose to individuals 5 years of age and
older with certain kinds of immunocompromise
EMERGENCY USE
AUTHORIZATIONEmergency uses of the vaccines have not been
approved or licensed by FDA but have been authorized by FDA under
an Emergency Use Authorization (EUA) to prevent Coronavirus Disease
2019 (COVID-19) in individuals aged 6 months and older for the
Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are
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.
IMPORTANT SAFETY
INFORMATION
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY® (COVID-19
Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine
Tell your vaccination provider about all
of your medical conditions, including if you:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the
immune system
- are pregnant, plan to become pregnant, or are
breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- The vaccine may not protect everyone
- You should not get COMIRNATY (COVID-19
Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe
allergic reaction after a previous dose of COMIRNATY or the
Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these
vaccines
- There is a remote chance that these vaccines could cause a
severe allergic reaction. A severe allergic reaction would usually
occur within a few minutes to 1 hour after getting a dose of the
vaccine. For this reason, your vaccination provider may ask you to
stay at the place where you received the vaccine for monitoring
after vaccination. If you experience a severe allergic reaction,
call 9-1-1 or go to the nearest hospital
Seek medical attention right away if you
have any of the following symptoms:
- difficulty breathing, swelling of the face and throat, a fast
heartbeat, a bad rash all over the body, dizziness, and
weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received COMIRNATY® (COVID-19 vaccine, mRNA)
or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher
among adolescent males and adult males under 40 years of age than
among females and older males, and the observed risk is highest in
males 12 through 17 years of age. In most of these people, symptoms
began within a few days following receipt of the second dose of
vaccine. The chance of having this occur is very low
Side effects that have been reported
with these vaccines include:
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or
swelling of the face
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the
heart)
- Injection site pain
- Tiredness
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Arm pain
- Fainting in association with injection of the vaccine
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Unusual and persistent cool, pale skin
These may not be all the possible side effects
of the vaccine. Call the vaccination provider or healthcare
provider about bothersome side effects or side effects that do not
go away.Individuals should always ask their healthcare providers
for medical advice about adverse events.
Report vaccine side effects to the US Food and
Drug Administration (FDA) and the Centers for Disease Control and
Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).
The VAERS toll-free number is 1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html. In addition, individuals can
report side effects to Pfizer Inc. at www.pfizersafetyreporting.com
or by calling 1-800-438-1985.
COMIRNATY® Full Prescribing Information and EUA
Fact Sheets for Vaccination Providers and Recipients and Caregivers
Fact Sheets:
EUA Fact Sheet for Vaccination Providers (12 Years & Up),
BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 Years),
BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Orange
Cap COMIRNATY® Full Prescribing Information (12 years of age and
older), DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination
Providers (12 years of age and older), DO NOT DILUTE, Gray Cap EUA
Fact Sheet for Vaccination Providers (6 months through 4 years of
age), DILUTE BEFORE USE, Maroon Cap EUA Fact Sheet for Vaccination
Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange
Cap EUA Fact Sheet for Recipients and Caregivers (12 years of age
and older) EUA Fact Sheet for Recipients and Caregivers (5 through
11 years of age) EUA Fact Sheet for Recipients and Caregivers (6
months through 4 years of age)
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 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 16, 2022.
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, also known as COMIRNATY (COVID-19 Vaccine, mRNA)
(BNT162b2) (including the Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5), a next generation
COVID-19 vaccine candidate, BNT162b4, which will be evaluated in
combination with the companies’ Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine, the companies’ long-term scientific COVID-19
strategy and next generation vaccine candidates, qualitative
assessments of available data, potential benefits, expectations for
clinical trials, potential regulatory submissions, 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 Phase 1/2/3 or Phase
4 data), including the data for BNT162b2, the next generation
vaccine candidates, any monovalent, bivalent or variant-adapted
vaccine candidates or any other vaccine candidate in the BNT162
program in any of our studies in pediatrics, adolescents, or adults
or real world evidence, 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, in real world data studies or in larger, more diverse
populations following commercialization; the ability of BNT162b2,
the next generation vaccine candidates, any monovalent, bivalent or
variant-adapted vaccine candidates or any future vaccine 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 in additional populations, for a
potential booster dose for BNT162b2, the next generation vaccine
candidates, any monovalent or bivalent vaccine candidates or any
potential future vaccines (including potential future annual
boosters or re-vaccinations), 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,
the next generation vaccine candidates, any monovalent or bivalent
vaccine candidates or any other potential vaccines that may arise
from the BNT162 program, including a potential variant-based,
higher dose, or bivalent vaccine, and if obtained, whether or when
such emergency use authorizations or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including any requested amendments to the
emergency use or conditional marketing authorizations), the next
generation vaccine candidates, any monovalent or bivalent vaccine
candidates, 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
which may lead to reduced revenues or excess inventory; risks
related to the availability of raw materials to manufacture a
vaccine; challenges related to our vaccine’s formulation, dosing
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
potential future annual boosters or re-vaccinations or new
variant-based or next generation vaccines; the risk that we may not
be able to maintain or scale up manufacturing capacity on a timely
basis or maintain access to logistics or supply channels
commensurate with global demand for our vaccines, which would
negatively impact our ability to supply the estimated numbers of
doses of our vaccines within the projected time periods; 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, 2021 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, bispecific
immune checkpoint 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, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
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)
(BNT162b) (including a bivalent mRNA vaccine candidate, BNT162b4,
including a Phase 1 study to evaluate the safety, tolerability, and
immune response of BNT162b4, the Companies’ long-term scientific
COVID-19 strategy, 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); our expectations regarding the potential characteristics
of BNT162b2, BNT162b4, any monovalent or bivalent vaccine
candidates or any future vaccine in our clinical trials and/or in
commercial use based on data observations to date; the ability of
BNT162b2, BNT162b4, any monovalent or bivalent vaccine candidates
or any future vaccine, to prevent COVID-19 caused by emerging virus
variants; 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 Phase 1/2/3 or Phase 4 data), including
the data discussed in this release for BNT162b2, BNT162b4, any
monovalent or bivalent vaccine candidates or any other vaccine
candidate in BNT162 program in any of our studies in pediatrics,
adolescents, or adults or real world evidence, including the
possibility of unfavorable new preclinical, clinical or safety data
and further analyses of existing preclinical, clinical or safety
data; 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; the expected time
point for additional readouts on efficacy data of BNT162b2 or
BNT162b4 in our clinical trials; 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 nature of the clinical
data, which is subject to ongoing peer review, regulatory review
and market interpretation; whether and when submissions to
request emergency use or any marketing approval for BNT162b4,
BNT162b2 in additional populations, , any monovalent, bivalent or
variant-adapted vaccine candidates or any potential future vaccines
(including potential future annual boosters or re-vaccination),
and/or other biologics license and/or emergency use authorization
applications or amendments to any such applications may be filed in
particular jurisdictions for BNT162b4, BNT162b2, any monovalent or
bivalent vaccine candidates or any other potential vaccines that
may arise from the BNT162 program, including a potential
variant-based, higher dose, or bivalent vaccine, and if obtained,
whether or when such emergency use authorizations or licenses will
expire or terminate; whether and when any applications that may be
pending or filed for BNT162b2, BNT162b4, any monovalent, bivalent
or variant-adapted vaccine candidates, 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; 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, BNT162b4, any monovalent or bivalent vaccine candidates or
any future vaccine, to support clinical development and market
demand, including our production estimates for 2022; that demand
for any products may be reduced or no longer exist which may lead
to reduced revenues or excess inventory; the availability of raw
materials to manufacture a vaccine; our vaccine’s formulation,
dosing schedule and attendant storage, distribution and
administration requirements, including risks related to storage and
handling after delivery by Pfizer; the ability to successfully
develop other vaccine formulations, booster doses or potential
future annual boosters or re-vaccinations or new variant-based
vaccines; the ability to maintain 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; 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; 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 Quarterly Report as Form 6-K for the
three and nine months ended September 30, 2022, filed with the SEC
on November 7, 2022, 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 +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@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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