- 105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4
2022, with an option for the U.S. Government to purchase up to 195
million additional doses
NEW YORK and MAINZ, GERMANY, JUNE 29,
2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) today announced a new vaccine supply agreement with the U.S.
government to support the continued fight against COVID-19. Under
the agreement, the U.S. government will receive 105 million doses
(30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted
COVID-19 vaccines, subject to authorization from the U.S. Food and
Drug Administration (FDA). The doses are planned to be delivered as
soon as late summer 2022 and continue into the fourth quarter of
this year.
The U.S. government will pay the companies $3.2
billion upon receipt of the first 105 million doses. Under this
agreement, the U.S. government also has the option to purchase up
to 195 million additional doses, bringing the total number of
potential doses to 300 million.
“As the virus evolves, this new agreement will
help ensure people across the country have access to vaccines that
may provide protection against current and future variants,” said
Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “Vaccines have been and will remain critical to
protecting people of all ages against COVID-19. We remain proud of
our long-term partnership with the U.S. government in helping to
address this pandemic, and of the ongoing impact of vaccination
efforts in the U.S. and around the world.”
“This agreement will provide additional doses
for U.S. residents and help cope with the next COVID-19 wave.
Pending regulatory authorization, it will also include an
Omicron-adapted vaccine, which we believe is important to address
the rapidly spreading Omicron variant,” said Sean Marett,
Chief Business and Chief Commercial Officer of BioNTech.
“We appreciate the continued partnership of the U.S. government in
our shared goal to help end this pandemic.”
On June 25, 2022, Pfizer and BioNTech reported
pivotal data demonstrating the safety, tolerability and
immunogenicity of two Omicron-adapted vaccine candidates. These
data have been shared with regulators, including the FDA, and a
request for U.S. Emergency Use Authorization is planned. The
companies have begun manufacturing the Omicron-adapted vaccine
candidates at risk so that they can begin deliveries rapidly upon
authorization or approval and subsequent recommendation by the U.S.
Centers for Disease Control and Prevention’s (CDC), if received,
and as directed by the U.S. government. Eligible U.S. residents
will continue to receive the vaccine for free, consistent with the
U.S. government’s commitment for free access to COVID-19
vaccines.
The Pfizer-BioNTech COVID-19 Vaccine, 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 16 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 2-dose primary series to individuals 12 through 15 years of
age
- 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.
IMPORTANT SAFETY
INFORMATION
Tell your vaccination provider about all
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 bleeding disorder or is on a blood thinner
- is immunocompromised or is 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 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 the vaccine
recipient 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
adolescent males and adult 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 or difficulty breathing
- 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, feeling weak or lack of energy, 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, 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 (16 years of age and
older), DILUTE BEFORE USE, Purple CapCOMIRNATY® Full Prescribing
Information (16 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 Facebook.com/Pfizer.
Pfizer Disclosure Notice The
information contained in this release is as of June 29, 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 BNT162b2 mRNA vaccine program, and the
Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19
Vaccine, mRNA) (BNT162b2) (including a supply agreement with the
U.S. government and planned deliveries thereunder, two
Omicron-adapted COVID-19 vaccine candidates (one monovalent and one
bivalent), planned regulatory submissions, 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 discussed in this release, for BNT162b2, any
monovalent or bivalent 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, any monovalent or
bivalent 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, any monovalent or bivalent
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 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 (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 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.de.
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 supply agreement with the U.S. government
and planned deliveries thereunder, two Omicron-adapted COVID-19
vaccine candidates (one monovalent and one bivalent), planned
regulatory submissions, 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, 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, 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 previously published for
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 BNT162b2, any monovalent or bivalent
vaccine candidates or any future vaccine, in our clinical trials;
the nature of the clinical data, which is subject to ongoing peer
review, regulatory review and market interpretation; 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; whether
and when submissions to request emergency use or conditional
marketing authorizations for BNT162b2 in additional populations,
for a potential booster dose for BNT162b2, any monovalent or
bivalent 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 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; 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 BNT162, any monovalent or bivalent
vaccine candidates or any future vaccine, to support clinical
development and market demand, including our production estimates
for 2022; disruptions in the relationships between us and our
collaboration partners, clinical trial sites or third-party
suppliers; reduction in the demand for any products, 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 BioNTech; our ability to successfully
develop other vaccine formulations, booster doses or potential
future annual boosters or re-vaccinations or new variant-based
vaccines; our 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; our 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) 733-7410
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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