NEW YORK and MAINZ, Germany, July 27,
2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)
today announced that the companies have initiated a randomized,
active-controlled, observer-blind Phase 2 study to evaluate the
safety, tolerability, and immune response of an enhanced COVID-19
mRNA-based vaccine candidate at a 30 µg dose level. This
next-generation bivalent COVID-19 vaccine candidate, BNT162b5,
consists of RNAs encoding enhanced prefusion spike proteins for the
SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The
enhanced spike protein encoded from the mRNAs in BNT162b5 has been
modified with the aim of increasing the magnitude and breadth of
the immune response that could better protect against
COVID-19.
This is the first of multiple vaccine candidates
with an enhanced design which the companies plan to evaluate as
part of a long-term scientific COVID-19 vaccine strategy to
potentially generate more robust, longer-lasting, and broader
immune responses against SARS-CoV-2 infections and associated
COVID-19.
BNT162b5 will be evaluated in a U.S.-based study
enrolling approximately 200 participants aged between 18 and 55 who
have received one booster dose of a U.S.-authorized COVID-19
vaccine at least 90 days prior to their first study visit.
Participants will be stratified by the number of months since their
last dose of COVID-19 vaccine received prior to entering the study
(three to six months or more than six months). The study does not
include a placebo (injection with no active ingredient). For more
information about this study please visit www.clinicaltrials.gov on
this link.
The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2,
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
planned.
U.S. Indication & Authorized Use
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under
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 6
months of age and older.
Pfizer-BioNTech COVID-19 Vaccine is FDA
authorized 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
Booster Series
-
a single booster dose to individuals 5 through 11 years of age who
have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine
-
a first booster dose to individuals 12 years of age and older who
have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
-
a first booster dose to individuals 18 years of age and older who
have completed primary vaccination with a different authorized or
approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
-
a second booster dose to individuals 50 years of age and older who
have received a first booster dose of any authorized or approved
COVID-19 vaccine
-
a second booster dose to individuals 12 years of age and older with
certain kinds of immunocompromise and who have received a first
booster dose of any authorized or approved COVID-19
vaccine
COMIRNATY® 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.
-
COMIRNATY® is administered as a 2-dose primary
series
COMIRNATY® AUTHORIZED
USESCOMIRNATY® (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 with certain kinds of immunocompromise
Booster Dose
-
a first booster dose to individuals 12 years of age and older who
have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
-
a first booster dose to individuals 18 years of age and older who
have completed primary vaccination with another authorized or
approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
-
a second booster dose to individuals 50 years of age and older who
have received a first booster dose of any authorized or approved
COVID-19 vaccine
-
a second booster dose to individuals 12 years of age and older with
certain kinds of immunocompromise and who have received a first
booster dose of any authorized or approved COVID-19 vaccine
Emergency Use Authorization Emergency
uses of the vaccine 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
6 months of age 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.
INTERCHANGEABILITYFDA-approved COMIRNATY®
(COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine
FDA authorized for Emergency Use Authorization (EUA) for
individuals 12 years of age and older can be used interchangeably
by a vaccination provider when prepared according to their
respective instructions for use.
The formulations of the Pfizer-BioNTech COVID-19
Vaccine authorized for use in individuals 6 months through 4 years
of age, 5 through 11 years of age, and 12 years of age and older
are different and should therefore not be used interchangeably. The
Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6
months through 11 years of age should not be used interchangeably
with COMIRNATY® (COVID-19 Vaccine, mRNA).
IMPORTANT SAFETY INFORMATION
Tell your vaccination provider about all of
the vaccine recipient’s medical conditions, including if the
vaccine recipient:
- has any allergies
- has had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or are on a blood thinner
- is immunocompromised or are on a medicine that affects the
immune system
- is pregnant, plan to become pregnant, or are breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
(COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
-
The vaccine recipient should not receive Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if the vaccine
recipient has had a severe allergic reaction to any of its
ingredients or had a severe allergic reaction to a previous dose of
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
-
There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY® (COVID-19 Vaccine, mRNA) 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 the vaccine was administered for monitoring after
vaccination. If the vaccine recipient experiences a severe allergic
reaction, call 9-1-1 or go to the nearest hospital
Seek medical attention right away if the
vaccine recipient has 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 the vaccine, more commonly in males
under 40 years of age than among females and older males. In most
of these people, symptoms began within a few days following receipt
of the second dose of the vaccine. The chance of having this occur
is very low
Seek medical attention right away if the
vaccine recipient has any of the following symptoms after receiving
the vaccine, particularly during the 2 weeks after receiving a
vaccine dose:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding
heart
- Fainting
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Persistent vomiting
- Persistent pain in the abdomen
- Unusual and persistent cool, pale skin
- Fainting can happen after getting
injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY® (COVID-19 Vaccine, mRNA). Sometimes people who faint can
fall and hurt themselves. For this reason, your vaccination
provider may ask the vaccine recipient to sit or lie down for 15
minutes after receiving the vaccine
- Some people with weakened immune
systems may have reduced immune responses to Pfizer-BioNTech
COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- Additional side effects include
rash, itching, hives, swelling of the face, 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, and fainting in association with
injection of the vaccine and irritability
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.
-
You should always ask your 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. You can also report
side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by
calling 1-800-438-1985
Click for Fact Sheets and Prescribing
Information for individuals 6 months of age and older:Recipients
and Caregivers Fact Sheet (6 months through 4 years of
age)Recipients and Caregivers Fact Sheet (5 through 11 years of
age)Recipients and Caregivers Fact Sheet (12 years of age and
older)COMIRNATY® Full Prescribing Information (12 years of age and
older), DILUTE BEFORE USE, Purple CapCOMIRNATY® Full Prescribing
Information (12 years of age and older), DO NOT DILUTE, Gray CapEUA
Fact Sheet for Vaccination Providers (6 months through 4 years of
age), DILUTE BEFORE USE, Maroon CapEUA Fact Sheet for Vaccination
Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange
CapEUA Fact Sheet for Vaccination Providers (12 years of age and
older), DILUTE BEFORE USE, Purple CapEUA Fact Sheet for Vaccination
Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
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 www.facebook.com/Pfizer.
Pfizer Disclosure NoticeThe
information contained in this release is as of July 27, 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 an enhanced mRNA-based vaccine candidate,
BNT162b5, including a Phase 2 study to evaluate the safety,
tolerability, and immune response of BNT162b5 at a 30-µg dose
level, the companies’ long-term scientific COVID-19 strategy,
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 any data for BNT162b2, BNT162b5,
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, BNT162b5, 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
BNT162b5, BNT162b2 in additional populations, for a potential
booster dose for BNT162b2, 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 BNT162b5, 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 BNT162b5, BNT162b2 (including any requested
amendments to the emergency use or conditional marketing
authorizations), 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; 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 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, 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,
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, 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)
(BNT162b2) ( including a bivalent mRNA vaccine candidate, BNT162b5,
including a Phase 2 study to evaluate the safety, tolerability, and
immune response of BNT162b5 at the 30-µg dose level, 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, BNT162b5, 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, BNT162b5, 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,
BNT162b5, 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
BNT162b5 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 BNT162b5,
BNT162b2 in additional populations, for a potential booster dose
for BNT162b2, 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 BNT162b5, 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, BNT162b5, 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, BNT162b5, 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 Annual Report as Form 20-F for the
Year Ended December 31, 2021, filed with the SEC on March 30, 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)
733-7410PfizerMediaRelations@pfizer.com
Investor Relations+1 (212) 733-4848IR@pfizer.com
BioNTech:Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084
1074Investors@biontech.de
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