- Bivalent booster elicited approximately 4-fold higher
neutralizing antibody titers against Omicron BA.4/BA.5 sublineages
compared to the original COVID-19 vaccine in individuals older than
55 years of age
- One-month after a 30-µg booster dose of the bivalent vaccine,
Omicron BA.4/BA.5-neutralizing antibody titers increased 13.2-fold
from pre-booster levels in adults older than 55 years of age and
9.5-fold in adults 18 to 55 years of age, compared to a 2.9-fold
increase in adults older than 55 years or age who received the
original booster vaccine
- Safety and tolerability profile of bivalent booster remains
favorable and similar to the original COVID-19 vaccine
NEW YORK and MAINZ, GERMANY, November 4,
2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) today announced updated data from a Phase 2/3 clinical trial
demonstrating a robust neutralizing immune response one-month after
a 30-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)). Immune responses
against BA.4/BA.5 sublineages were substantially higher for those
who received the bivalent vaccine compared to the companies’
original COVID-19 vaccine, with a similar safety and tolerability
profile between both vaccines. These results reinforce the
previously reported early clinical data measured 7 days after a
booster dose of the bivalent vaccine, as well as the pre-clinical
data, and suggest that a 30-µg booster dose of the Omicron
BA.4/BA.5-adapted bivalent vaccine may induce a higher level of
protection against the Omicron BA.4 and BA.5 sublineages than the
original vaccine.
“As we head into the holiday season, we hope
these updated data will encourage people to seek out a COVID-19
bivalent booster as soon as they are eligible in order to maintain
high levels of protection against the widely circulating Omicron
BA.4 and BA.5 sublineages,” said Albert Bourla, Chairman
and Chief Executive Officer, Pfizer. “These updated data
also provide confidence in the adaptability of our mRNA platform
and our ability to rapidly update the vaccine to match the most
prevalent strains each season.”
“These data demonstrate that our
BA.4/BA.5-adapted bivalent vaccine works as conceptually planned in
providing stronger protection against the Omicron BA.4 and BA.5
sublineages,” said Prof. Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. “In the next step and as part of
our science-based approach we will continue to evaluate the
cross-neutralization of the adapted vaccine against new variants
and sublineages. Our aim is to provide broader immunity against
COVID-19 caused by SARS-CoV-2, including Omicron and other
circulating strains.”
For the analyses, sera were drawn before
(baseline) and one month after administration of a 30-µg booster
dose (fourth dose) of the companies’ Omicron BA.4/BA.5-adapted
bivalent vaccine. A subset of individuals, evenly stratified
between those who had evidence of prior SARS-CoV-2 infection and
those who did not, was selected for ages 18 to 55 years (n=38) and
older than 55 years and older (n=36). A comparator group of
participants older than 55 years of age (n=40), who received a
30-µg booster dose (fourth dose) of the companies’ original
COVID-19 vaccine as part of a prior study was randomly selected,
while ensuring the same equal stratification. Participants
receiving the bivalent vaccine had their prior booster dose
approximately 10-11 months earlier, whereas those who received the
original vaccine had their prior booster dose approximately 7
months earlier. Despite this difference, pre-booster antibody
titers were similar for both.
Among the overall study population who received
the Omicron BA.4/BA.5-adapted bivalent vaccine, there was a
substantially higher increase in Omicron BA.4/BA.5-neutralizing
antibody titers compared to pre-booster levels. For individuals 18
to 55 years of age, the geometric mean titer (GMT) against Omicron
BA.4/BA.5 was 606, representing a 9.5-fold rise (95% CI: 6.7, 13.6)
from pre-booster levels. For individuals older than 55 years, the
GMT was 896, representing a 13.2-fold rise (95% CI: 8.0, 21.6) from
pre-booster levels. By contrast, participants over 55 years of age
who received a 30-µg booster dose of the companies’ original
COVID-19 vaccine had a lower neutralizing antibody response against
Omicron BA.4/BA.5 measured one month post booster. For these
participants, the GMT was 236, representing a 2.9-fold rise (95%
CI: 2.1, 3.9). Therefore, the Omicron BA.4/BA.5 neutralizing
antibody titers were approximately 4-fold higher for the bivalent
vaccine compared to the companies’ original COVID-19 vaccine in
individuals over 55 years of age.
Further, when examining those with or without
evidence of prior SARS-CoV-2 infection who received a booster dose
of the bivalent vaccine, there was a substantial[SV1]
increase in neutralizing antibodies against Omicron BA.4/BA.5 in
both groups, which was greater in those without prior infection.
These data highlight the potential benefit of the bivalent vaccine
for all populations regardless of previous SARS-CoV-2 infection.
The safety and tolerability profile remains favorable for the
bivalent vaccine, similar to the companies’ original COVID-19
vaccine.
Pfizer and BioNTech have shared these data with
the U.S. Food and Drug Administration (FDA) and plan to share with
the European Medicines Agency (EMA) and other global health
authorities as soon as possible. A booster dose of the
BA.4/BA.5-adapted bivalent vaccine has been authorized for
emergency use by the FDA for ages 5 years and older and has also
been granted marketing authorization in the EU by the European
Commission following a positive opinion from the EMA for ages 12
years and older. An application for marketing authorization of the
BA.4/BA.5 booster has been submitted to the EMA for children ages 5
through 11.
Separately, Pfizer and BioNTech are continuing
to monitor immunogenicity of the BA.4/BA.5 bivalent booster against
emerging Omicron subvariants. The companies also initiated a Phase
1/2/3 trial in September 2022, to evaluate the safety, tolerability
and immunogenicity of different doses and dosing regimens of the
companies’ Omicron BA.4/BA.5-adapted bivalent vaccine among
children 6 months through 11 years of age.
The Pfizer-BioNTech COVID-19 Vaccines
(COMIRNATY®), which are based on BioNTech’s proprietary mRNA
technology, were developed by both BioNTech and Pfizer. BioNTech is
the Marketing Authorization Holder for BNT162b2 Wild Type and
BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 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.
About the Phase 2/3 StudyThis
arm of the multicenter, randomized, controlled Phase 2/3 trial
(NCT05472038) has enrolled about 900 healthy volunteers 12 years of
age and older in the U.S. who have received at least three doses of
an authorized COVID-19 vaccine. During the trial, participants aged
18 years and older received either a 30-µg or 60-µg booster dose
(fourth booster) of Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted
COVID-19 vaccine and participants aged 12 through 17 years received
a 30-µg booster (fourth booster) of the same vaccine. Comparisons
to support potential full licensure and registrations globally will
be made with a control group who previously received a fourth dose
with the original vaccine.
U.S. INDICATION & AUTHORIZED
USE
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)
AUTHORIZED USEPfizer-BioNTech
COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is
FDA-authorized under Emergency Use Authorization (EUA) for use in
individuals 5 years of age and older as a single booster dose
administered at least 2 months after either:
- completion of primary vaccination with any authorized or
approved monovalent* COVID-19 vaccine; or
- receipt of the most recent booster dose with any authorized or
approved monovalent COVID-19 vaccine.
*Monovalent refers to any authorized and
approved COVID-19 vaccine that contains or encodes the spike
protein of only the Original SARS-CoV-2 virus
COMIRNATY® (COVID-19 Vaccine,
mRNA)INDICATIONCOMIRNATY®
(COVID-19 Vaccine, mRNA) is a vaccine approved for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused
by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in
individuals 12 years of age and older.
AUTHORIZED
USECOMIRNATY® (COVID-19 Vaccine, mRNA) is
FDA-authorized under Emergency Use Authorization (EUA) to
provide:
Primary Series
- a third primary series dose to individuals 12 years of age and
older who have certain kinds of immunocompromise
Pfizer-BioNTech COVID-19
Vaccine
AUTHORIZED USESPfizer-BioNTech
COVID-19 Vaccine is FDA authorized under Emergency Use
Authorization (EUA) for use in individuals 6 months and older 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
EMERGENCY USE
AUTHORIZATIONEmergency uses of the vaccines 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 aged 6 months and older for the
Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.
IMPORTANT SAFETY
INFORMATION
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY® (COVID-19
Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine
Tell your vaccination provider about all
of your medical conditions, including if you:
- 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
- You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the
Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19
Vaccine, Bivalent if you have had a severe allergic reaction after
a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19
Vaccine or any ingredient in these vaccines
- There is a remote chance that these vaccines 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 you received the vaccine for monitoring
after vaccination. If you experience a severe allergic reaction,
call 9-1-1 or go to the nearest hospital
- Seek medical attention right away if you have 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 COMIRNATY® (COVID-19 vaccine, mRNA)
or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher
among adolescent males and adult males under 40 years of age than
among females and older males, and the observed risk is highest in
males 12 through 17 years of age. In most of these people, symptoms
began within a few days following receipt of the second dose of
vaccine. The chance of having this occur is very low
Side effects that have been reported with these
vaccines 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
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Unusual and persistent cool, pale skin
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.Individuals should always ask their 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. In addition, individuals can
report side effects to Pfizer Inc. at www.pfizersafetyreporting.com
or by calling 1-800-438-1985.
COMIRNATY® Full Prescribing Information
and EUA Fact Sheets for Vaccination Providers and Recipients and
Caregivers Fact Sheets:
EUA Fact Sheet for Vaccination Providers (12
Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT
DILUTE, Gray CapEUA Fact Sheet for Vaccination Providers (5 through
11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT
DILUTE, Orange CapCOMIRNATY® Full Prescribing Information (12 years
of age and older), DO NOT DILUTE, Gray CapEUA Fact Sheet for
Vaccination Providers (12 years of age and older), DO NOT DILUTE,
Gray CapEUA Fact Sheet for Vaccination Providers (6 months through
4 years of age), DILUTE BEFORE USE, Maroon CapEUA Fact Sheet for
Vaccination Providers (5 through 11 years of age), DILUTE BEFORE
USE, Orange CapEUA Fact Sheet for Recipients and Caregivers (12
years of age and older)EUA Fact Sheet for Recipients and Caregivers
(5 through 11 years of age)EUA Fact Sheet for Recipients and
Caregivers (6 months through 4 years of age)
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 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 November 4, 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 the Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5) and updated data from an
ongoing Phase 2/3 clinical trial, potential full licensure, a Phase
1/2/3 study in children aged 6 months through 11 years of age,
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,
bivalent or variant-adapted vaccine candidates or any other vaccine
candidate in the BNT162 program in any of our studies in
pediatrics, adolescents, or adults or real world evidence,
including the possibility of unfavorable new preclinical, clinical
or safety data and further analyses of existing preclinical,
clinical or safety data, including the risk that additional data
from the Phase 2/3 trial could differ from the data discussed in
this release; 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,
bivalent or variant-adapted vaccine candidates or any future
vaccine to prevent COVID-19 caused by emerging virus variants; the
risk that more widespread use of the vaccine will lead to new
information about efficacy, safety, or other developments,
including the risk of additional adverse reactions, some of which
may be serious; the risk that preclinical and clinical trial data
are subject to differing interpretations and assessments, including
during the peer review/publication process, in the scientific
community generally, and by regulatory authorities; whether and
when additional data from the BNT162 mRNA vaccine program will be
published in scientific journal publications and, if so, when and
with what modifications and interpretations; whether regulatory
authorities will be satisfied with the design of and results from
these and any future preclinical and clinical studies; whether and
when submissions to request emergency use or conditional marketing
authorizations for 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-vaccinations), 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 (including the submission pending with
the EMA for the BA.4/BA.5 booster for children ages 5 through 11
and any other potential submissions for the Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine), or other vaccines
that may result from the BNT162 program may be approved by
particular regulatory authorities, which will depend on myriad
factors, including making a determination as to whether the
vaccine’s benefits outweigh its known risks and determination of
the vaccine’s efficacy and, if approved, whether it will be
commercially successful; decisions by regulatory authorities
impacting labeling or marketing, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of a vaccine, including development of
products or therapies by other companies; disruptions in the
relationships between us and our collaboration partners, clinical
trial sites or third-party suppliers; the risk that demand for any
products may be reduced or no longer exist which may lead to
reduced revenues or excess inventory; risks related to the
availability of raw materials to manufacture a vaccine; challenges
related to our vaccine’s formulation, dosing schedule and attendant
storage, distribution and administration requirements, including
risks related to storage and handling after delivery by Pfizer; the
risk that we may not be able to successfully develop other vaccine
formulations, booster doses or potential future annual boosters or
re-vaccinations or new variant-based or next generation vaccines;
the risk that we may not be able to maintain or scale up
manufacturing capacity on a timely basis or maintain access to
logistics or supply channels commensurate with global demand for
our vaccines, which would negatively impact our ability to supply
the estimated numbers of doses of our vaccines within the projected
time periods; 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 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, bispecific
immune checkpoint modulators, targeted cancer antibodies and small
molecules. Based on its deep expertise in mRNA vaccine development
and in-house manufacturing capabilities, BioNTech and its
collaborators are developing multiple mRNA vaccine candidates for a
range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global pharmaceutical collaborators, including
Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
BioNTech Forward-looking
StatementsThis press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, statements
concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer including the program to
develop a COVID-19 vaccine and COMIRNATY® (COVID-19 vaccine, mRNA)
(BNT162b2) (including the Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine and updated data from an ongoing phase 2/3
clinical trial, a Phase 1/2/3 study in children aged 6 months
through 11 years of age, laboratory studies to evaluate
immunogenicity of the BA.4/BA.5 bivalent booster against emerging
Omicron subvariants, 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, real world data studies, and/or
in commercial use based on data observations to date; preclinical
and clinical data (including Phase 1/2/3 or Phase 4 data),
including the descriptive data discussed in this release, for
BNT162b2 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, including the risk that final
or formal results from the clinical trial could differ from the
topline data; the ability of BNT162b2 or a future vaccine to
prevent COVID-19 caused by emerging virus variants; the expected
time point for additional readouts on efficacy data of BNT162b2 and
its adapted vaccine variations in our clinical trials; the nature
of the clinical data, which is subject to ongoing peer review,
regulatory review and market interpretation; widespread use of
BNT162b2 and its adapted vaccine variations 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 timing for submission of data for BNT162, or
any future vaccine, in additional populations, (including in
children 6 months to less than 5 years of age, potential future
annual boosters or re-vaccinations), or receipt of, any marketing
approval or emergency use authorization or equivalent, including or
amendments or variations to such authorizations, 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; the
development of other vaccine formulations, booster doses or
potential future annual boosters or re-vaccinations or new variant
based vaccines; 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 and its
adapted vaccine variations to support clinical development and
market demand, including our production estimates for 2022;
challenges related to public vaccine confidence or awareness;
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; the availability of raw material to manufacture BNT162
or other vaccine formulation; 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; 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 Quarterly Report as Form 6-K for the
quarter ended June 30, 2022, filed with the SEC on August 8, 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) 733-1226
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
[SV1]I don´t think the sentinel group was powered for
superiority
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