- 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
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.
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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® INDICATION COMIRNATY® (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 USES COMIRNATY® (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.
INTERCHANGEABILITY
FDA-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 Cap
COMIRNATY® Full Prescribing Information (16 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
Vaccination Providers (12 years of age and older), DILUTE BEFORE
USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 years
of age and older), DO NOT DILUTE, Gray Cap
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice The information contained in
this release is as of 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 BioNTech Biopharmaceutical New Technologies is a
next generation immunotherapy company pioneering novel therapies
for cancer and other serious diseases. The Company exploits a wide
array of computational discovery and therapeutic drug platforms for
the rapid development of novel biopharmaceuticals. Its broad
portfolio of oncology product candidates includes individualized
and off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Genentech, a member of the
Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For
more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements This press release
contains “forward-looking statements” of BioNTech within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements may include, but may not be
limited to, statements concerning: BioNTech’s efforts to combat
COVID-19; the collaboration between BioNTech and Pfizer 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.
Category: Vaccines
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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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