NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer
Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the
companies have received Fast Track Designation from the U.S. Food
and Drug Administration (FDA) for their mRNA-based combination
vaccine candidate for influenza and COVID-19, which aims to help
prevent two respiratory diseases with a single injection. Fast
Track is a process designed to facilitate the development and
expedite the review of new drugs and vaccines intended to treat or
prevent serious conditions and address unmet medical need.1
Pfizer and BioNTech previously announced the
start of a Phase 1 trial to examine the safety, tolerability, and
immunogenicity of their combined influenza and COVID-19 candidate
vaccine among healthy adults.
The vaccine candidate is based on BioNTech’s
proprietary mRNA platform technology and contains mRNA strands
encoding the wild-type spike protein of SARS-CoV-2 and the spike
protein of the Omicron sublineages BA.4/BA.5, as well as mRNA
strands encoding the hemagglutinin of four different influenza
strains, recommended for the Northern Hemisphere 2022/23 by the
World Health Organization.
A combined vaccine for influenza and COVID-19
has the potential to simplify immunization practices against two
severe respiratory diseases caused by evolving viruses that require
vaccine adaptation.
About Respiratory DiseasesSARS-CoV-2 led
to a global pandemic with more than 6.5 million deaths2 and a high
socio-economic burden worldwide.3 While vaccinations can help
address the disease, COVID-19 is expected to continue circulating,
and vaccines will likely require continual adjustments to address
new variants of concern. Influenza is another respiratory disease
that also requires repeated vaccinations due to continuous
mutations in the surface hemagglutinin protein. Influenza accounts
for up to 12,000 to 52,000 deaths in the United States every year4
and causes substantial morbidity and mortality globally each
year.5
U.S. INDICATION & AUTHORIZED
USE
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent, (Original and Omicron
BA.4/BA.5)
AUTHORIZED USE
Pfizer-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 an FDA-approved COVID-19 vaccine 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
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 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
Pfizer-BioNTech COVID-19 Vaccine and
Pfizer-BioNTech COVID-19 Vaccine, Bivalent
AUTHORIZED USES
Pfizer-BioNTech COVID-19
Vaccine and Pfizer-BioNTech COVID-19 Vaccine,
Bivalent are FDA authorized under Emergency Use
Authorization (EUA) for use in individuals 6 months to 4 years of
age to provide:
Primary Series
- a 3-dose primary series as follows:
- Dose 1: Pfizer-BioNTech COVID-19 Vaccine
- Dose 2: Pfizer-BioNTech COVID-19 Vaccine
- Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent
EMERGENCY USE AUTHORIZATION
Emergency 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. 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
INFORMATIONPfizer-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
- Dizziness
These may not be all the possible side effects
of these vaccines. 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:COMIRNATY® Full Prescribing
Information (12 years of age and older), DO NOT DILUTE, Gray CapEUA
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 CapEUA Fact Sheet for Vaccination Providers (12
years of age and older), DO NOT DILUTE, Gray CapEUA Fact Sheet for
Vaccination Providers (5 through 11 years of age), DILUTE BEFORE
USE, Orange CapEUA Fact Sheet for Vaccination Providers (6 months
through 4 years of age), DILUTE BEFORE USE, Maroon CapEUA 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 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 December 9, 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 and
influenza, the collaboration between BioNTech and Pfizer to develop
a COVID-19 vaccine and a combination vaccine candidate for
influenza and COVID-19, mRNA technology, the BNT162b2 mRNA vaccine
program, a combination vaccine candidate for influenza and COVID-19
and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY
(COVID-19 Vaccine, mRNA), including the Pfizer-BioNTech COVID-19
Vaccine, Bivalent (Original and Omicron BA.4/BA.5 (BNT162b2)
(including 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 data for the combination
vaccine candidate for influenza and COVID-19, BNT162b2, 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, including the risk that additional data
against newer Omicron sublineages could differ from the previous
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, any monovalent,
bivalent or variant-adapted vaccine candidates, the combination
vaccine candidate for influenza and COVID-19 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 the combination vaccine candidate for influenza
and COVID-19, BNT162b2 in additional populations, a potential
booster dose for BNT162b2, 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 the combination vaccine candidate for influenza
and COVID-19, 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
the combination vaccine candidate for influenza and COVID-19,
BNT162b2 (including any requested amendments to the emergency use
or conditional marketing authorizations), 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 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 and influenza; the collaboration between BioNTech and
Pfizer including the program to develop a COVID-19 vaccine and a
combination vaccine candidate for influenza and COVID-19, mRNA
technology, the BNT162b2 mRNA vaccine program, a combination
vaccine candidate for influenza and COVID-19 and the
Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19
Vaccine, mRNA), including the Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5 (BNT162b2)
(including a combination vaccine candidate for influenza and
COVID-19, 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); our expectations regarding
the potential characteristics of a combination vaccine candidate
for influenza and COVID-19,BNT162b2 in our clinical trials and/or
BNT162b2 in commercial use based on data observations to date; the
ability of a combination vaccine candidate for influenza and
COVID-19, BNT162b2, 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 a combination vaccine
candidate for influenza and COVID-19, BNT162b2, 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; the
expected time point for additional readouts on efficacy data of
a combination vaccine candidate for influenza and COVID-19,
BNT162b2 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; 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 a combination
vaccine candidate for influenza and COVID-19, BNT162, 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; a combination vaccine candidate for influenza and
COVID-19, BNT162, any monovalent or bivalent vaccine candidates or
any future vaccine, 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-adapted 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 vaccines, 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.
For a discussion of these and other risks and
uncertainties, see BioNTech’s quarterly report on Form 6-K for the
quarter 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
1 U.S. Food and Drug Administration Fast Track. Available
at https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm2
World Health Organization Coronavirus (COVID-19) Dashboard.
Available at https://covid19.who.int/3 Delardas O, Kechagias KS,
Pontikos PN, Giannos P. Socio-Economic Impacts and Challenges of
the Coronavirus Pandemic (COVID-19): An Updated Review.
Sustainability. 2022; 14(15):9699.
https://doi.org/10.3390/su14159699 4 Centers for Disease
Control and Prevention. Disease Burden of Flu. Available at
https://www.cdc.gov/flu/about/burden/index.html 5 World Health
Organization. Fact Sheet on Seasonal Influenza (Flu). Available at
http://www.who.int/mediacentre/factsheets/fs211/en/
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