- Sera collected from participants 7 days after administration of
a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine showed a substantial increase in the Omicron
BA.4/BA.5 neutralizing antibody response above pre-booster
levels
- Data suggest Omicron BA.4/BA.5-adapted bivalent booster is
anticipated to provide better protection against Omicron BA.4/BA.5
sublineages than original vaccine across younger and older
adults
- Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated
with early data showing a safety profile similar to that of the
original vaccine
- Additional data measuring responses at 1-month
post-administration of the Omicron BA.4/BA.5-adapted bivalent
vaccine booster are expected in the coming weeks
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced early data from a Phase 2/3 clinical trial (NCT05472038)
evaluating the safety, tolerability, and immunogenicity 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)).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221010005742/en/
A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent
vaccine demonstrated a substantial increase in the Omicron
BA.4/BA.5 neutralizing antibody response above pre-booster levels
based on sera taken 7 days after administration, with similar
responses seen across individuals aged 18 to 55 years of age and
those older than 55 years of age (40 participants in each age
group). When comparing responses in individuals older than 55 years
of age who received either the bivalent vaccine, or the original
vaccine, a 30-µg booster dose of the Original Pfizer-BioNTech
COVID-19 Vaccine (also referred to as BNT162b2 Wild Type) elicited
more limited increases in the neutralizing antibody response
against the Omicron BA.4/BA.5 variants. COVID-19 vaccine responses
to date have reliably shown consistent trends across age groups and
are further supported by these early data on the bivalent vaccine.
Together, these data suggest a 30-µg booster dose of the Omicron
BA.4/BA.5-adapted bivalent vaccine is anticipated to provide better
protection against the Omicron BA.4/BA.5 variants than the original
vaccine for younger and older adults. The Omicron BA.4/BA.5-adapted
bivalent vaccine was well tolerated with early data indicating a
favorable safety profile, similar to that of the original
vaccine.
“Since the earliest days of the pandemic, we have strived to
transparently share data regarding our COVID-19 vaccines in the
interest of public health,” said Albert Bourla, Chairman and Chief
Executive Officer, Pfizer. “While we expect more mature immune
response data from the clinical trial of our Omicron
BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are
pleased to see encouraging responses just one week after
vaccination in younger and older adults. These early data suggest
that our bivalent vaccine is anticipated to provide better
protection against currently circulating variants than the original
vaccine and potentially help to curb future surges in cases this
winter.”
“These preliminary findings are consistent with our preclinical
data showing a substantial increase in the neutralizing antibody
response against the Omicron sublineages BA.4 and BA.5,” said Prof.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The current
dominance of BA.4/BA.5 and related sublineages, underscores the
importance of our data and science-based approach to develop a
vaccine which is adapted to these prevalent strains of the virus
and make it available in a timely manner.”
Immunogenicity was evaluated using a SARS-CoV-2 live virus
fluorescent focus reduction neutralization test (FFRNT) assay. Sera
were collected 7 days post second booster dose from participants
aged older than 55 (40 participants in each age group) and compared
to 7-day post sera from 40 participants older than 55 years of age
that had received three prior doses of BNT162b2 encoding the
wild-type spike-protein of SARS-CoV-2 and a second booster with
BNT162b2 Wild-Type. Sera were also collected at 7 days post second
booster dose from participants 18 to 55 years of age who received
the Omicron BA.4/BA.5-adapted bivalent booster (n=40) to compare
bivalent vaccine responses in younger and older adults. The time
between third and fourth doses for the bivalent vaccine recipients
was approximately 11 months compared to approximately 6 months for
the original vaccine. Despite this difference, baseline
neutralizing antibody response was generally similar across groups.
Among the participants, samples were equally stratified at baseline
in each group between those who had a prior or current history of
SARS-CoV-2 and those with no prior or current history of
SARS-CoV-2.
Additional data measuring responses at one-month
post-administration of the Omicron BA.4/BA.5 bivalent vaccine
booster are expected in the coming weeks. These data will be used
to support potential full licensure and global registration of the
companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Additionally, the companies have initiated a similar Phase 1/2/3
trial (NCT05543616) investigating the Omicron BA.4/BA.5-adapted
bivalent vaccine among children 6 months through 11 years of
age.
A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent
vaccine has been authorized for emergency use by the U.S. Food and
Drug Administration (FDA) for ages 12 years and older and has also
been granted marketing authorization in the EU by the European
Medicines Agency (EMA) for the same age group.
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 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 and older received either a 30-µg or 60-µg booster dose 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
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 12 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
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 through 11 years
of age
- a third primary series dose to individuals 5 years through 11
years of age with certain kinds of immunocompromise
- a single booster dose to individuals 5 through 11 years of age
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine
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 12 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
Click for Fact Sheets and Prescribing Information for the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron
BA.4/BA.5): EUA Fact Sheet for Recipients and Caregivers (12 years
of age and older) EUA Fact Sheet for Vaccination Providers (12
Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT
DILUTE, Gray Cap
Click for Fact Sheets and Prescribing Information for
individuals 6 months of age and older: Recipients and Caregivers
Fact Sheet (6 months through 4 years of age) Recipients and
Caregivers Fact Sheet (5 through 11 years of age) Recipients and
Caregivers Fact Sheet (12 years of age and older) COMIRNATY® Full
Prescribing Information (12 years of age and older), DILUTE BEFORE
USE, Purple Cap COMIRNATY® Full Prescribing Information (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 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 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 13,
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
Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and early 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 will differ from the
early 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-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 (including any potential submissions for an
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 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, 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 early data
regarding an Omicron-adapted COVID-19 bivalent vaccine based on the
BA.4/BA.5 subvariant and its potential in adults 12 years of age
and older and planned regulatory submissions, qualitative
assessments of available data, potential benefits, expectations for
clinical trials, the anticipated timing of regulatory submissions,
regulatory approvals or authorizations and anticipated
manufacturing, distribution and supply); our expectations regarding
the potential characteristics of BNT162b2, any monovalent or
bivalent vaccine candidates or any future vaccine, in our clinical
trials and/or in commercial use based on data observations to date;
the ability of BNT162b2, any monovalent or bivalent vaccine
candidates or any future vaccine, to prevent COVID-19 caused by
emerging virus variants; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as risks associated with preclinical
and clinical data (including Phase 1/2/3 or Phase 4 data),
including the data 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, any monovalent or bivalent vaccine candidates or
any future vaccine, 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 2022; 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; the ability to successfully
develop other vaccine formulations, booster doses or potential
future annual boosters or re-vaccinations or new variant-based
vaccines; the ability to maintain or scale up manufacturing
capacity on a timely basis or maintain access to logistics or
supply channels commensurate with global demand for our vaccine,
which would negatively impact our ability to supply the estimated
numbers of doses of our vaccine within the projected time periods
as previously indicated; whether and when additional supply
agreements will be reached; 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221010005742/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
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2023 to Apr 2024