- Omicron-adapted monovalent candidate given as a fourth booster
dose elicited a 13.5 and 19.6-fold increase in neutralizing
geometric titers against Omicron BA.1 at 30 µg and 60 µg dose
levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold
increase against Omicron
- Geometric mean ratios for Omicron neutralizing antibody
response consistent with regulatory requirement of superiority
- Preliminary laboratory studies demonstrate both Omicron-adapted
candidates neutralize Omicron BA.4 and BA.5 though to a lesser
extent than they do for BA.1
- Both vaccine candidates demonstrated a favorable safety and
tolerability profile similar to the Pfizer-BioNTech COVID-19
Vaccine
- Data to be discussed with regulators with goal of rapidly
introducing adapted booster to address current and future
variants
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced positive data evaluating the safety, tolerability, and
immunogenicity of two Omicron-adapted COVID-19 vaccine candidates:
one monovalent and the other bivalent, a combination of the
Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting
the spike protein of the Omicron BA.1 variant of concern. Data from
the Phase 2/3 trial found that a booster dose of both
Omicron-adapted vaccine candidates elicited a substantially higher
immune response against Omicron BA.1 as compared to the companies’
current COVID-19 vaccine. The robust immune response was seen
across two investigational dose levels, 30 µg and 60 µg.
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“As we’ve said since the early days of the pandemic, we will
follow the science and adapt our own approaches as needed to help
address COVID-19 as the virus evolves,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “Based on these data,
we believe we have two very strong Omicron-adapted candidates that
elicit a substantially higher immune response against Omicron than
we’ve seen to date. We look forward to discussing these data with
the scientific community and health authorities so we may rapidly
introduce an Omicron-adapted booster as soon as possible if
authorized by regulators.”
“The data show the ability of our monovalent and bivalent
Omicron-adapted vaccine candidates to significantly improve
variant-specific antibody neutralization responses,” said Prof.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Omicron has
newly evolving sublineages that have outcompeted BA.1 and exhibit a
trend of increasing potential for immune escape. We will therefore
remain vigilant and are prepared to rapidly adapt our
Omicron-adapted vaccine candidates to emerging sublineages if
epidemiological and laboratory data suggest.”
The Omicron adapted vaccine candidates (30 µg and 60 µg) studied
in the Phase 2/3 trial in 1,234 participants 56 years of age and
older elicited substantially higher neutralizing antibody responses
against Omicron BA.1 when compared to the companies’ current
COVID-19 vaccine. The pre-specified criterion for superiority was
measured by the ratio of neutralizing geometric mean titers (GMR)
with the lower bound of the 95% confidence interval >1. The
geometric mean ratios (GMRs) for the monovalent 30 µg and 60 µg
vaccines compared to the current COVID-19 vaccine were 2.23 (95%
CI: 1.65, 3.00) and 3.15 (95% CI: 2.38, 4.16), respectively. The
GMRs for the bivalent 30 µg and 60 µg vaccines compared to the
current COVID-19 vaccine were 1.56 (95% CI: 1.17, 2.08) and 1.97
(95% CI: 1.45, 2.68), respectively. The monovalent Omicron-adapted
vaccine 30 µg and 60 µg achieved a lower bound 95% confidence
interval for GMR of >1.5, consistent with the regulatory
requirement of super superiority. Demonstration of superiority
against Omicron and safety are regulatory requirements for
potential emergency use authorization of a variant-adapted
vaccine.
One month after administration, a booster dose of the
Omicron-adapted monovalent candidates (30 µg and 60 µg) increased
neutralizing geometric mean titers (GMT) against Omicron BA.1 13.5
and 19.6-fold above pre-booster dose levels, while a booster dose
of the Omicron-adapted bivalent candidates conferred a 9.1 and
10.9-fold increase in neutralizing GMTs against Omicron BA.1. Both
Omicron-adapted vaccine candidates were well-tolerated in
participants who received one or the other Omicron-adapted
vaccine.
In a SARS-CoV-2 live virus neutralization assay tested on sera
from participants over 56 years of age and older, sera efficiently
neutralized BA.4/BA.5 with titers approximately 3-fold lower than
BA.1. Pfizer and BioNTech will continue to collect additional study
data on Omicron BA.4/BA.5 over the coming weeks.
These results are being shared with the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) in advance
of upcoming discussions with the FDA Vaccines and Related
Biological Products Advisory Committee (VRBPAC) on June 28 and with
the International Coalition of Medicines Regulatory Authorities
(ICMRA) on June 30. The companies have also submitted additional
data from their ongoing COVID-19 booster studies, including data on
an additional dose of their current COVID-19 vaccine and Beta
candidate, to further demonstrate the flexibility and potential
benefit of mRNA-based 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 either 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 formulation 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 5
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 skim
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 5 years 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 25,
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 study
evaluating two Omicron-adapted COVID-19 vaccine candidates: one
monovalent and the other bivalent, a combination of the
Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting
the Omicron variant of concern, 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 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 study
evaluating two Omicron-adapted COVID-19 vaccine candidates: one
monovalent and the other bivalent, a combination of the
Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting
the Omicron variant of concern, 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 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 discussed in this release 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 in our clinical trials; the
risk that more widespread use of the vaccine will lead to new
information about efficacy, safety, or other developments,
including the risk of additional adverse reactions, some of which
may be serious; the nature of the clinical data, which is subject
to ongoing peer review, regulatory review and market
interpretation; the timing for submission of data for, or receipt
of, any marketing approval or Emergency Use Authorization; our
contemplated shipping and storage plan, including our estimated
product shelf life at various temperatures; the ability of BioNTech
to supply the quantities of BNT162, any monovalent or bivalent
vaccine candidates or any future vaccine, to support clinical
development and market demand, including our production estimates
for 2021; 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; 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; 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; 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.
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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