Pfizer And BioNTech to Provide U.S. Government an Additional 50
Million Pediatric Doses of COVID-19 Vaccine to Support Further
Preparedness for Future Needs
Doses expected to be delivered by April 2022
NEW YORK and MAINZ, GERMANY, October 28,
2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)
today announced that the U.S. government has purchased 50 million
more doses of the companies’ COVID-19 vaccine. The U.S. will
receive these additional doses to continue to support preparedness
for pediatric vaccinations, including securing vaccines for
children under 5 years of age, should they receive regulatory
authorization. The companies expect to deliver all these doses by
April 30, 2022.
With this order, the U.S. government has
exercised its final purchase option under its existing U.S. supply
agreement with the companies, bringing the total number of
Pfizer-BioNTech COVID-19 Vaccine doses secured under the agreement
since the start of the pandemic to 600 million – spanning doses for
adults and adolescents, and children. Separately, Pfizer and
BioNTech have agreed to provide a total of 1 billion doses to the
U.S. government at a not-for-profit price for donation to low- and
lower-middle-income countries.
“We are extremely proud to provide enough doses
of our vaccine to help protect every U.S. child under 12 from
COVID-19, if authorized by the FDA,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “As we await the
agency’s review of our application for emergency use of the vaccine
in children 5 to under 12 years of age, and clinical trial results
in children under 5, we are working with the U.S. government to
help ensure communities across the country have access to pediatric
doses as soon as possible. The introduction of doses for young
children will be another critical milestone in addressing this
public health crisis.”
“From the very beginning, it has been our goal
to provide access to a highly effective vaccine to as many people
as possible. This supply agreement will help to offer a vaccine to
all children younger than 12 years of age in the United States,”
said Ugur Sahin, CEO and Co-founder of BioNTech. “We would
like to thank the U.S. government for its trust in us and our
vaccine.”
Pfizer and BioNTech submitted a request earlier
this month to the U.S. Food and Drug Administration (FDA) for
Emergency Use Authorization of their COVID-19 vaccine in children 5
to <12 years of age. The dosage strength for this age group (10
µg) was carefully selected as the preferred dose for safety,
tolerability and immunogenicity, and differs from the dosage
strength for individuals 12 years and older (30 µg). If authorized
and subsequently recommended by the U.S. Centers for Disease
Control and Prevention’s (CDC) Advisory Committee on Immunization
Practices (ACIP), the companies expect to then begin shipping 10-µg
pediatric doses immediately, 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 to free
access to COVID-19 vaccines.
In addition to the U.S. FDA, the companies have
submitted data to the European Medicines Agency to support the
vaccination of children 5 to <12 years of age. Further
submissions for this age group are planned or underway with other
regulatory agencies around the world. Initial data from the other
two age cohorts in the ongoing Pfizer-BioNTech clinical trial in
children – those 2 to <5 years of age and those 6 months to
<2 years of age – are expected as soon as fourth quarter 2021 or
early first quarter 2022.
Commitment to Global Vaccine Access In
total, Pfizer and BioNTech expect to manufacture 3 billion doses of
their COVID-19 vaccine worldwide in 2021, which includes pediatric
doses. In 2022, the companies expect to manufacture 4 billion doses
of the Pfizer-BioNTech COVID-19 Vaccine worldwide, which also
includes pediatric doses. The companies do not expect the
introduction of pediatric doses in the U.S. to impact the existing
supply agreements in place with governments and international
health organizations around the world.
To date, Pfizer and BioNTech have shipped more
than 1.8 billion COVID-19 vaccine doses to 149 countries and
territories. The companies are firmly committed to working toward
equitable and affordable access for COVID-19 vaccines and have
pledged to provide 2 billion doses to low- and middle-income
countries in 2021 and 2022 – at least 1 billion each year.
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 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 or ongoing.
U.S. INDICATION & AUTHORIZED USE
HOW IS THE VACCINE GIVEN?The vaccine will be
given as an injection into the muscle.
Primary Series: The vaccine is administered as a
2-dose series, 3 weeks apart. A third dose may be administered at
least 4 weeks after the second dose to individuals who are
determined to have certain kinds of immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at
least 6 months after completion of a primary series to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
- A single booster dose of the vaccine may be administered to
certain individuals who have completed primary vaccination with a
different authorized COVID-19 vaccine. Individuals should check
with their healthcare provider regarding eligibility for, and
timing of, the booster dose.
WHAT IS THE INDICATION AND AUTHORIZED USE?The
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the
FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use
Authorization (EUA) have the same formulation and can be used
interchangeably to provide the COVID-19 primary vaccination series
or a booster dose.
COMIRNATY® (COVID-19 Vaccine, mRNA) is an
FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
-
It is approved as a 2-dose series for prevention of COVID-19 in
individuals 16 years of age and older.
-
It is also authorized under EUA to provide:
-
-
a two-dose primary series in individuals 12 through 15 years
-
a third primary series dose in individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise
-
a single booster dose to the following individuals who have
completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY®:
-
65 years of age and older
-
18 through 64 years of age at high risk of severe COVID-19
-
18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
-
a single booster dose to eligible individuals who have completed
primary vaccination with a different authorized COVID-19 vaccine.
Booster eligibility and schedule are based on the labeling
information of the vaccine used for the primary series.
The Pfizer-BioNTech COVID-19 Vaccine has
received EUA from FDA to provide:
-
a two-dose primary series in individuals 12 years of age and
older
-
a third primary series dose for individuals 12 years of age and
older who have been determined to have certain kinds of
immunocompromise
-
a single booster dose to the following individuals who have
completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY®:
-
65 years of age and older
-
18 through 64 years of age at high risk of severe COVID-19
-
18 through 64 years of age with frequent institutional or
occupational exposure to SARS-CoV-2
-
a single booster dose to eligible individuals who have completed
primary vaccination with a different authorized COVID-19 vaccine.
Booster eligibility and schedule are based on the labeling
information of the vaccine used for the primary series.
EUA StatementEmergency 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 12 years 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. Please see EUA Fact Sheet at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATIONIndividuals
should not get the vaccine if they:
-
had a severe allergic reaction after a previous dose of this
vaccine
-
had a severe allergic reaction to any ingredient of this
vaccine
Individuals should tell the vaccination provider
about all of their medical conditions, including if they:
-
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.
Side effects reported with the vaccine
include:
-
There is a remote chance that the vaccine could cause a severe
allergic reaction
-
A severe allergic reaction would usually occur within a few minutes
to one hour after getting a dose of the vaccine. For this reason,
vaccination providers may ask individuals to stay at the place
where they received the vaccine for monitoring after
vaccination
-
Signs of a severe allergic reaction can include difficulty
breathing, swelling of the face and throat, a fast heartbeat, a bad
rash all over the body, dizziness, and weakness
-
If an individual experiences a severe allergic reaction, they
should call 9-1-1 or go to the nearest hospital
-
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. 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.
Individuals should seek medical attention right away if they have
any of the following symptoms after receiving the vaccine:
-
chest pain
-
shortness of breath
-
feelings of having a fast-beating, fluttering, or pounding
heart
-
Side effects that have been reported with the vaccine 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
-
These may not be all the possible side effects of the vaccine.
Serious and unexpected side effects may occur. The possible side
effects of the vaccine are still being studied in clinical trials.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go
away
Data on administration of this vaccine at the
same time as other vaccines has not yet been submitted to FDA.
Individuals considering receiving this vaccine with other vaccines,
should discuss their options with their healthcare provider.
Patients should always ask their healthcare
providers for medical advice about adverse events. Individuals are
encouraged to report negative side effects of vaccines to the US
Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or
call 1‐800‐822‐7967. In addition, side effects can be reported to
Pfizer Inc. at www.pfizersafetyreporting.com or by calling
1-800-438-1985.
Please click here for full Prescribing
Information (16+ years of age). Please click here for Fact Sheet
for Vaccination Providers (12+ years of age). Please click here for
the Recipients and Caregivers Fact Sheet (12+ years of age).
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 October 28, 2021. 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 COMIRNATY (COVID-19
Vaccine, mRNA) (BNT162b2) (including the potential in children 5 to
<12 years of age, a study in children 6 months to 5 years of
age, qualitative assessments of available data, potential benefits,
expectations for clinical trials, supply to the U.S. government and
the timing of delivery of doses thereunder, 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 the Phase 2/3 data), 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 or in larger, more diverse
populations following commercialization; the ability of BNT162b2 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 younger pediatric populations,
applications for a potential booster dose 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 or any other potential vaccines that may
arise from the BNT162 program, and if obtained, whether or when
such emergency use authorization or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including the submission to request emergency
use for children 5 to <12 years of age, potential submissions
for younger pediatric populations, a potential booster dose or any
other requested amendments to the emergency use or conditional
marketing authorizations) 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;
risks related to the availability of raw materials to manufacture a
vaccine; challenges related to our vaccine’s formulation, two-dose
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
new variant-specific vaccines; the risk that we may not be able to
create 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, 2020 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, Bayer Animal Health,
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 to develop
a COVID-19 vaccine (including the potential in children 5 to <12
years of age, a study in children 6 months to 5 years of age,
qualitative assessments of available data, potential benefits,
expectations for clinical trials, 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 BNT162b2 in our clinical trials and/or in commercial use based
on data observations to date; the ability of BNT162b2 to prevent
COVID-19 caused by emerging virus variants; the expected time point
for additional readouts on efficacy data of BNT162b2 in our
clinical trials; 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 risk that we may
not be able to create 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, including our production estimates for 2021;
and whether and when additional supply agreements will be reached.
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, 2020, filed with the SEC on March 30, 2021,
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
PfizerMedia Relations+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848IR@Pfizer.com
BioNTech Media RelationsJasmina Alatovic+49 (0)6131 9084
1513 Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084
1074Investors@biontech.de
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