- Lead formulations evaluated in the Phase 1/2 study demonstrated
robust immune responses to influenza A, influenza B, and SARS-CoV-2
strains
- Safety profile of the mRNA-based combination vaccine candidates
consistent with the companies’ COVID-19 vaccine
- The companies plan to start a pivotal Phase 3 trial in the
coming months
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced positive topline results from a Phase 1/2 study
(NCT05596734) evaluating the safety, tolerability and
immunogenicity of mRNA-based combination vaccine candidates for
influenza and COVID-19 among healthy adults 18 to 64 years of age.
In the clinical trial, the vaccine candidates were compared to a
licensed influenza vaccine and the companies’ Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same
visit. The data from the trial showed that the companies' lead
formulations demonstrated robust immune responses to influenza A,
influenza B, and SARS-CoV-2 strains.
“We are encouraged by these early results in our Phase 1/2 study
of our combination vaccine candidates against influenza and
COVID-19. This vaccine has the potential to lessen the impact of
two respiratory diseases with a single injection and may simplify
immunization practices for providers, patients, and healthcare
systems all over the world,” said Annaliesa Anderson, PhD, FAAM,
Senior Vice President and Head, Vaccine Research and Development at
Pfizer. “mRNA-based vaccines have demonstrated their ability to
induce robust antibody and T-cell responses, and we look forward to
starting Phase 3 clinical development. Today’s results are an
important achievement towards our ambition of providing a broad
portfolio of respiratory combination vaccines.”
“Studies of confirmed viral infections suggest that COVID-19
adopts a seasonal pattern with peaks in fall and winter, similar to
other respiratory diseases. Co-infections as well as consecutive
respiratory infection during this period can further increase the
risk of severe illness,” said Prof. Ugur Sahin, MD, CEO and
Co-founder of BioNTech. “Combination vaccines have the potential to
become a mainstay of routine vaccination against respiratory
diseases, especially for the vaccination of populations who have a
higher risk of severe illness.”
The topline results of the ongoing trial demonstrated that the
combination formulations evaluated had a safety profile consistent
with the safety profile of the companies’ COVID-19 vaccine.
Immunogenicity results induced by lead formulations in the
companies’ Phase 1/2 trial showed point estimates for Geometric
Mean Titer (GMT) ratios that were consistent with the criteria
applied to regulatory approved vaccines against the respective
influenza and SARS-CoV-2 strains. Point estimates for GMT ratios
for all matched influenza vaccine strains with lead formulations
were >1 relative to a licensed Quadrivalent Influenza Vaccine
(QIV) given concomitantly with the Pfizer-BioNTech COVID-19
vaccine. A pivotal Phase 3 trial evaluating these lead formulations
is expected to be initiated in the coming months. Data from the
Phase 1/2 trial will be published in a peer-reviewed journal.
Pfizer and BioNTech previously announced that their mRNA-based
combination vaccine candidate for influenza and COVID-19 received
Fast Track Designation from the U.S. Food and Drug Administration
(FDA).
About Respiratory Diseases SARS-CoV-2 led to a global
pandemic with more than 6.5 million deathsi and a severe
socio-economic burden worldwide.ii While vaccinations can help
address the disease, COVID-19 is expected to remain a circulating,
severe respiratory disease, requiring adjustments of vaccines to
variants of concern. This is reminiscent of influenza, another
respiratory disease that requires repeated vaccinations due to its
genomic instability resulting in modifications of the surface
protein hemagglutinin. Each year, influenza results in up to one
billion infections, five million hospitalizations, and 650,000
deaths worldwide.iii
INDICATION, AUTHORIZED USE AND
IMPORTANT SAFETY INFORMATION INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people
12 years of age and older to protect against coronavirus disease
2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
- You should NOT receive
COMIRNATY® (COVID-19 Vaccine, mRNA) if you have had a severe
allergic reaction to any ingredient of COMIRNATY or a previous dose
of a Pfizer-BioNTech COVID-19 vaccine* or to any ingredient in
these vaccines *COMIRNATY (2023-2024 Formula) is made the same way
as Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and
Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the
spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5
(Omicron XBB.1.5).
- There is a remote chance that COMIRNATY could cause a severe
allergic reaction. A severe allergic reaction would usually occur
within a few minutes to 1 hour after getting a dose. For this
reason, your vaccination provider may ask you to stay at the place
where you received the vaccine for monitoring after vaccination.
Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of the face and throat
- A fast heartbeat
- A bad rash all over the body
- Dizziness and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received mRNA COVID-19 vaccines, including
COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and
pericarditis following COMIRNATY have occurred most commonly in
adolescent males 12 through 17 years of age. In most of these
individuals, symptoms began within a few days following
vaccination. The chance of having this occur is very low. You
should seek medical attention right away if you or your child have
any of the following symptoms after receiving the vaccine,
particularly during the 2 weeks after receiving a dose of the
vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding
heart
- Fainting can happen after getting injectable vaccines including
COMIRNATY. Your vaccination provider may ask you to sit or lie down
for 15 minutes after receiving the vaccine
- People with weakened immune systems may have a reduced immune
response to COMIRNATY
- COMIRNATY may not protect all vaccine recipients
- Before getting COMIRNATY, tell your vaccination provider
about all of your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose
of any COVID-19 vaccine
- 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
- Additional side effects that have been reported with COMIRNATY
or Pfizer-BioNTech COVID-19 vaccines include:
- Non-severe allergic reactions such as rash, itching, hives, or
swelling of the face
- Injection Site reactions: pain, swelling, redness, arm
pain
- General side effects: tiredness, headache, muscle pain, chills,
joint pain, fever, nausea, feeling unwell, lymph nodes
(lymphadenopathy), decreased appetite, diarrhea, vomiting,
dizziness.
These may not be all the possible side effects of COMIRNATY. Ask
your healthcare provider about any side effects that concern
you.
You may report vaccine side effects to the FDA/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.
Please click here for full Prescribing Information for
COMIRNATY.
AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine
(2023-2024 Formula)* is FDA authorized under Emergency Use
Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) in individuals 6 months through 11 years of age.
*Hereafter referred to as Pfizer-BioNTech
COVID-19 Vaccine
EMERGENCY USE AUTHORIZATION Pfizer-BioNTech COVID-19
Vaccine has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent
Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6
months through 11 years of age. The emergency use of this product
is 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
- A person should NOT get
Pfizer-BioNTech COVID-19 Vaccine if they had a severe allergic
reaction after a previous dose of any Pfizer-BioNTech COVID-19
vaccine or to any ingredients in these vaccines.
- There is a remote chance that the vaccine could cause a severe
allergic reaction. A severe allergic reaction would usually occur
within a few minutes to one hour after getting a dose of the
vaccine. For this reason, the vaccination provider may ask you to
stay at the place where you received the vaccine for monitoring
after vaccination. If your child experiences a severe allergic
reaction, call 9-1-1, or go to the nearest hospital. Signs of a
severe allergic reaction can include:
- difficulty breathing, swelling of the face and throat, a fast
heartbeat, a bad rash all over the body, or 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 mRNA COVID-19 vaccines. Myocarditis
and pericarditis following Pfizer-BioNTech COVID-19 vaccines have
occurred most commonly in adolescent males 12 through 17 years of
age. In most of these individuals, symptoms began within a few days
following vaccination. The chance of having this occur is very low.
Seek medical attention right away if your child has any of the
following symptoms after receiving the vaccine, particularly during
the 2 weeks after receiving a dose of the vaccine:
- Chest pain
- Shortness of breath or difficulty breathing
- Feelings of having a fast-beating, fluttering, or pounding
heart
Additional symptoms, particularly in children, may include:
- 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 skin
- Fainting can happen after getting injectable vaccines,
including Pfizer-BioNTech COVID-19 Vaccine. For this reason, your
vaccination provider may ask you to stay at the place where you
received the vaccine for monitoring after vaccination
- People with weakened immune systems may have a reduced immune
response to Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect
everyone
- Tell your vaccination provider about all of your medical
conditions, including if you:
- have 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 or is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
- Side effects that have been reported with Pfizer-BioNTech
COVID-19 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/tenderness
- 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
- Dizziness
- Irritability
These may not be all the possible side effects. Serious and
unexpected side effects may occur. Call the vaccination provider or
healthcare provider about bothersome side effects or side effects
that do not go away.
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. Please include “Pfizer-BioNTech
COVID-19 Vaccine(2023-2024 Formula) EUA” in the first line of box
#18 of the report form.
In addition, individuals can report side effects to Pfizer Inc.
at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for Pfizer-BioNTech COVID-19 Vaccine
Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver
EUA Fact Sheet.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice The information contained in
this release is as of October 26, 2023. 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
and BioNTech’s mRNA-based combination vaccine candidate for
influenza and COVID-19 among healthy adults 18 to 64 years of age,
including its potential benefits, plans to initiate a pivotal Phase
3 trial, Pfizer’s ambition of providing a broad portfolio of
respiratory combination vaccines, Pfizer’s efforts to combat
COVID-19, the collaboration between BioNTech and Pfizer to develop
a COVID-19 vaccine, the BNT162 mRNA vaccine program, and Pfizer and
BioNTech's COVID-19 vaccines, defined collectively herein as
COMIRNATY (including 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 pre-clinical and clinical data (including
Phase 1/2/3 or Phase 4 or pre-clinical data for Pfizer’s and
BioNTech’s mRNA-based combination vaccine candidate for influenza
and COVID-19, COMIRNATY or any of Pfizer’s other respiratory
vaccine candidates, including the data discussed in this release)
in any of our studies in pediatrics, adolescents, or adults or real
world evidence, including the possibility of unfavorable new
pre-clinical, clinical or safety data and further analyses of
existing pre-clinical, clinical or safety data or further
information regarding the quality of pre-clinical, clinical or
safety data, including the risk that additional data against newer
Omicron sublineages could differ from previously reported data; the
ability to produce comparable clinical or other results for
Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate
for influenza and COVID-19, COMIRNATY or any of Pfizer’s other
respiratory vaccine candidates, including the rate of vaccine
effectiveness and safety and tolerability profile observed to date
and additional studies, in real world data studies or in larger,
more diverse populations following commercialization; the ability
of Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate
for influenza and COVID-19, COMIRNATY or any of Pfizer’s other
respiratory vaccine candidates to prevent COVID-19 caused by
emerging virus variants; the risk that 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 pre-clinical 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 or other
COVID-19 programs 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 existing or future pre-clinical
and clinical studies; whether and when submissions to request
emergency use or conditional marketing authorizations for Pfizer’s
and BioNTech’s mRNA-based combination vaccine candidate for
influenza and COVID-19, COMIRNATY or any of Pfizer’s other
respiratory vaccine candidates in additional populations, for a
potential booster dose for COMIRNATY, any vaccine candidate 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 Pfizer’s
and BioNTech’s mRNA-based combination vaccine candidate for
influenza and COVID-19, COMIRNATY or any of Pfizer’s other
respiratory vaccine candidates, and if obtained, whether or when
such emergency use authorizations or licenses, or existing
emergency use authorizations, will expire or terminate; whether and
when any applications that may be pending or filed for Pfizer’s and
BioNTech’s mRNA-based combination vaccine candidate for influenza
and COVID-19, COMIRNATY or any of Pfizer’s other respiratory
vaccine candidates (including any requested amendments to the
emergency use or conditional marketing authorizations) 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 the authorization or
approval of products or therapies developed by other companies;
intellectual property and other litigation; disruptions in the
relationships between us and our collaboration partners, clinical
trial sites or third-party suppliers, including our relationship
with BioNTech; the risk that demand for any products may be
reduced, no longer exist or not meet expectations, which may lead
to reduced revenues, excess inventory on-hand and/or in the channel
which, for COMIRNATY, has resulted in inventory write-offs and
other charges and could continue to result in inventory write-offs
or other unanticipated changes; challenges related to and
uncertainties regarding the timing of a transition to the
commercial market for any of our products; uncertainties related to
the public’s adherence to vaccines and boosters; risks related to
our ability to achieve our revenue forecasts for Pfizer’s and
BioNTech’s mRNA-based combination vaccine candidate for influenza
and COVID-19, COMIRNATY or any of Pfizer’s other respiratory
vaccine candidates; the risk that other companies may produce
superior or competitive products; risks related to the availability
of raw materials to manufacture or test 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 or
potential combination respiratory vaccines; the risk that we may
not be able to maintain manufacturing capacity or access to
logistics or supply channels commensurate with global demand for
our vaccines, which would negatively impact our ability to supply
our vaccines within the projected time periods; whether and when
additional supply or purchase agreements will be reached or
existing agreements will be completed or renegotiated;
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; pricing and access challenges; challenges
related to public confidence in, or awareness of Pfizer’s and
BioNTech’s mRNA-based combination vaccine candidate for influenza
and COVID-19, COMIRNATY or any of Pfizer’s other respiratory
vaccine candidates; uncertainties around future changes to
applicable healthcare policies and guidelines issued by the U.S.
federal government in connection with the declared termination of
the federal government’s COVID-19 public health emergency as of May
11, 2023; trade restrictions; potential third party royalties or
other claims; the uncertainties inherent in business and financial
planning, including, without limitation, risks related to Pfizer’s
business and prospects, adverse developments in Pfizer’s markets,
or adverse developments in the U.S. or global capital markets,
credit markets, regulatory environment or economies generally;
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, 2022 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
(BioNTech) 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 Duality Biologics,
Fosun Pharma, Genentech, a member of the Roche Group, Genevant,
Genmab, OncoC4, Regeneron, Sanofi and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, but not limited to, statements concerning: the
initiation, timing, progress and results of BioNTech’s research and
development programs in infectious diseases, including the
collaboration between BioNTech and Pfizer; current and future
clinical trials of BioNTech and Pfizer’s mRNA-based combination
vaccine candidates for influenza and COVID-19, including statements
regarding the timing of initiation and completion of studies or
trials, including the planned initiation of a pivotal Phase 3
trial, related preparatory work and the availability of results;
timing for any data readouts; the potential safety and efficacy of
BioNTech’s product candidates; BioNTech’s anticipated market
opportunity and size for its product candidates; qualitative
assessments of available data and expectations of potential
benefits, including top-line results from a Phase 1/2 trial
evaluating the safety, tolerability and immunogenicity of BioNTech
and Pfizer’s mRNA-based combination vaccine candidates for
influenza and COVID-19 among healthy adults 18 to 64 years of age;
regulatory submissions and regulatory approvals or authorizations
and expectations regarding manufacturing, distribution and supply;
expectations regarding anticipated changes in COVID-19 vaccine
demand, including changes to the ordering environment; and expected
regulatory recommendations to adapt vaccines to address new
variants or sublineages. In some cases, forward-looking statements
can be identified by terminology such as “will,” “may,” “should,”
“expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue,” or the negative
of these terms or other comparable terminology, although not all
forward-looking statements contain these words. The forward-looking
statements in this press release are neither promises nor
guarantees, and you should not place undue reliance on these
forward-looking statements because they involve known and unknown
risks, uncertainties, and other factors, many of which are beyond
BioNTech’s control and which could cause actual results to differ
materially from those expressed or implied by these forward-looking
statements. These risks and uncertainties include, but are not
limited to: the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as risks associated with preclinical and
clinical data, including the data discussed in this release, and
including the possibility of unfavorable new preclinical, clinical
or safety data and further analyses of existing preclinical,
clinical or safety data; the nature of the clinical data, which is
subject to ongoing peer review, regulatory review and market
interpretation; future commercial demand and medical need;
the availability of raw materials to manufacture a vaccine; the
formulation, dosing schedule and attendant storage, distribution
and administration requirements of BioNTech’s vaccines, including
risks related to storage and handling after delivery; competition
from other products and product candidates, including those with
different mechanisms of action and different manufacturing and
distribution constraints, on the basis of, among other things,
efficacy, cost, convenience of storage and distribution, breadth of
approved use, side-effect profile and durability of immune
response; 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; the timing of and BioNTech's ability to
obtain and maintain regulatory approval for BioNTech's product
candidates; the ability of BioNTech’s COVID-19 vaccines, including
Pfizer’s and BioNTech’s mRNA-based combination vaccine candidates
for influenza and COVID-19, to prevent COVID-19 and/or influenza
caused by emerging virus variants; BioNTech's and its
counterparties’ ability to manage and source necessary energy
resources; BioNTech's ability to identify research opportunities
and discover and develop investigational medicines; the ability and
willingness of BioNTech's third-party collaborators to continue
research and development activities relating to BioNTech's
development candidates and investigational medicines; the impact of
the COVID-19 pandemic on BioNTech's development programs, supply
chain, collaborators and financial performance; unforeseen safety
issues and potential claims that are alleged to arise from the use
of BioNTech's COVID-19 vaccine and other products and product
candidates developed or manufactured by BioNTech, including
Pfizer’s and BioNTech’s mRNA-based combination vaccine candidates
for influenza and COVID-19; BioNTech's and its collaborators’
ability to commercialize and market BioNTech's COVID-19 vaccine
and, if approved, its product candidates, including Pfizer’s and
BioNTech’s mRNA-based combination vaccine candidates for influenza
and COVID-19; BioNTech's ability to manage its development and
expansion; regulatory developments in the United States and other
countries; BioNTech's ability to effectively scale BioNTech's
production capabilities and manufacture BioNTech's products,
including BioNTech's target COVID-19 vaccine production levels, and
BioNTech's product candidates; risks relating to the global
financial system and markets; and other factors not known to
BioNTech at this time.
You should review the risks and uncertainties described under
the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the
period ended June 30, 2023 and in subsequent filings made by
BioNTech with the U.S. Securities and Exchange Commission (“SEC”),
which are available on the SEC’s website at www.sec.gov. Except as
required by law, BioNTech disclaims any intention or responsibility
for updating or revising any forward-looking statements contained
in this press release in the event of new information, future
developments or otherwise. These forward-looking statements are
based on BioNTech’s current expectations and speak only as of the
date hereof.
i World Health Organization Coronavirus (COVID-19) Dashboard.
Available at https://covid19.who.int/ ii Delardas O, Kechagias KS,
Pontikos PN, Giannos P. Socio-Economic Impacts and Challenges of
the Coronavirus Pandemic (COVID-19): An Updated Review.
Sustainability. 2022; 14(15):9699.
https://doi.org/10.3390/su14159699 iii Influenza (Seasonal). World
Health Organization. Available at
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).
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Pfizer: Media Relations +1 (212) 733-1226
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Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49 (0)6131
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