- 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
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.
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“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 goal 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 significant 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 profile
remains favorable for the bivalent vaccine and consistent with the
original 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, 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 Study
This 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 USE
Pfizer-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)
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 12 years of age and older.
AUTHORIZED USE
COMIRNATY® (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 USES
Pfizer-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 AUTHORIZATION
Emergency 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
Cap
EUA Fact Sheet for Vaccination Providers (5 through 11
Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE,
Orange Cap
COMIRNATY® Full Prescribing Information (12 years of age and
older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 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 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’
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 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 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, 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 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 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.
Category: Vaccines
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221103006400/en/
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
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