- In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine
candidate against influenza and COVID-19 met one of its two primary
immunogenicity objectives
- The trial did not meet one of its primary immunogenicity
objectives of non-inferiority against the influenza B strain
despite obtaining higher influenza A responses and comparable
COVID-19 responses versus the comparator vaccines
- The companies are evaluating adjustments to the candidate and
will discuss next steps with health authorities
- Pfizer also provides update on its separate Phase 2
second-generation trivalent influenza mRNA vaccine trial which
showed encouraging data demonstrating robust immunogenicity against
all strains compared to a standard of care influenza vaccine
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX,
“BioNTech”) today announced top-line results from their Phase 3
clinical trial to evaluate the companies’ combined mRNA vaccine
candidate against influenza and COVID-19 in healthy individuals
18-64 years of age. The combination candidate consists of Pfizer’s
mRNA-based influenza vaccine candidate with the companies’ licensed
COVID-19 vaccine. The Phase 3 trial measured two primary
immunogenicity objectives (immunogenicity against SARS-CoV-2 as
well as immunogenicity against influenza A and B), of which one was
met. In a separate Phase 2 trial, Pfizer evaluated trivalent
(“tIRV”) influenza mRNA standalone vaccine candidates which
demonstrated robust immunogenicity in individuals 18-64 years of
age. The companies are evaluating adjustments to the combination
vaccine candidate aimed at improving immune responses against
influenza B and will discuss next steps with health
authorities.
Update on Phase 3 Pfizer and BioNTech
Combination Vaccine Trial
The Phase 3 randomized, observer-blinded study (NCT06178991)
enrolled more than 8,000 adults 18 through 64 years of age to
evaluate the safety, tolerability, and immunogenicity of a single
dose combination vaccine candidate against influenza and COVID-19.
In this clinical trial, the vaccine candidate was compared to a
licensed influenza vaccine and the companies’ licensed COVID-19
vaccine given at the same visit. The primary immunogenicity
objectives were to demonstrate that the antibody responses to
influenza (hemagglutination inhibition, “HAI”) and to SARS-CoV-2
(neutralizing titer, “NT”) elicited by the combination vaccine
candidate were non-inferior (“NI”) to standard of care (“SOC”).
Compared to a licensed influenza vaccine, the tIRV formulation was
noteworthy for eliciting robust influenza A responses, including a
continued trend of higher influenza A responses versus a licensed
influenza vaccine, while it showed lower geometric mean titers
(“GMT”) and seroconversion against the influenza B strain. In
addition, the formulation demonstrated comparable responses against
SARS-CoV-2 versus the companies’ licensed COVID-19 vaccine. No
safety signals with the combination vaccine have been identified in
an ongoing safety data review. Participants who received a licensed
influenza and COVID-19 vaccine with co-administration continued to
elicit robust immune responses against both influenza and COVID-19
with no safety signals identified to date.
“We are encouraged by the robust immunogenicity we saw with our
combination vaccine against influenza A, which was similar to what
we had seen for our initial quadrivalent influenza vaccine where we
saw superior relative vaccine efficacy against a comparator flu
vaccine,” said Annaliesa Anderson, PhD, Senior Vice President and
Head, Vaccine Research and Development at Pfizer. “We are committed
to developing vaccines that will reduce the burden of respiratory
diseases and believe that combination vaccines are the most
efficient way to do this. Today’s results provide insight and
direction towards achieving this goal, and we remain optimistic
about our combination COVID-19 and influenza program, for which we
are evaluating the next steps.”
“We are dedicated to developing combination vaccines which
provide broader protection against multiple respiratory diseases,”
said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The
insights gained from this combination vaccine trial are highly
valuable and will play a crucial role in guiding the further
development of Pfizer’s and our combination vaccine program against
influenza and COVID-19. We are committed to drawing on our
experience in developing mRNA-based vaccine candidates against
multiple antigens and believe we can successfully accomplish this
task in collaboration with our partner Pfizer.”
Update on Pfizer's Phase 2 Second
Generation Influenza Vaccine Trial
Pfizer’s Phase 2 trial (NCT06436703) to evaluate
second-generation candidates against influenza was initiated
earlier this year and enrolled 450 participants 18-64 years of age,
who were randomized to receive investigational mRNA-based influenza
vaccines or influenza vaccines approved by the U.S. Food and Drug
Administration (“FDA”). As previously stated, Pfizer announced
positive top-line Phase 3 results from its first-generation
quadrivalent (“qIRV”) vaccine candidate which achieved the first
and only demonstration of efficacy for an mRNA vaccine in a group
of study participants 18-64 years of age. The primary endpoints for
this qIRV first-generation candidate were not met in adults aged 65
and older, as statistical non-inferior relative vaccine efficacy
(“rVE”) compared to a licensed influenza vaccine was not met based
on the number of cases accrued. Pfizer developed second-generation
candidates with the goal of improving immunogenicity and
potentially breadth of protection, including new tIRV formulations
that matched updated recommendations by the World Health
Organization (“WHO”) and the FDA’s Vaccines and Related Biological
Products Advisory Committee (“VRBPAC”). The tIRV formulations
elicited robust influenza A responses and B responses, including
continued trend of higher influenza A responses versus a licensed
influenza vaccine. There were no safety signals reported. Data from
this Phase 2 trial for adults 65 years of age and older will become
available at a later date.
Pfizer will also continue to evaluate its influenza vaccine
program and discuss next steps with health authorities.
About Influenza Influenza causes an estimated 140,000 to
710,000 hospitalizations, 12,000 to 52,000 deaths1 and about $25
billion in economic loss2 in the U.S. each year. People 65 and
older are at increased risk of serious complications from
influenza, including hospitalization and death.3 Even when a
vaccine matches circulating strains well, current influenza
vaccines typically confer 40% to 60% protection each year, with
even lower protection in years with poor matching of strains.4 The
impact of influenza on racial and ethnic minority groups in the
U.S. is even larger. Black Americans are nearly two times more
likely than their white counterparts to be hospitalized for
influenza while Latino and Indigenous Americans are 1.2 and 1.3
times more likely, respectively.5
With circulating influenza strains continually changing,
predicting the best match for the next season’s vaccine is
difficult for global health experts as those strains are chosen
more than six months before the start of the flu season that they
target. The flexibility of mRNA technology and its rapid
manufacturing could potentially allow better strain matches in
future years, and in a pandemic influenza situation, mRNA
technology could enable rapid, large-scale manufacturing of
vaccines.
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 had a severe allergic
reaction to a previous dose of COMIRNATY or any 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 your 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 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. In addition, you can report
side effects to Pfizer Inc. at 1-800-438-1985 or
www.pfizersafetyreporting.com
Please click here for full Prescribing Information and Patient
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
- Pfizer-BioNTech COVID-19 Vaccine may not protect everyone
- Tell your vaccination provider about all of your child’s
medical conditions, including if your child:
- has any allergies
- has had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or is on a blood thinner
- is immunocompromised or is 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
- Arm pain
- Fainting in association with injection of the vaccine
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- 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
175 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 and follow us on X 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 August 15, 2024. 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
investigational modified RNA (modRNA) influenza vaccine candidates,
potential next-generation mRNA flu and combination vaccine
formulations, Pfizer’s and BioNTech’s mRNA-based combination
vaccine candidate for influenza and COVID-19, the flu and COVID/flu
combination programs, Pfizer’s respiratory vaccines portfolio and
mRNA technology, including their potential benefits, that involves
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 our clinical trials, regulatory
submission dates, regulatory approval dates and/or launch dates, as
well as the possibility of unfavorable new clinical data and
further analyses of existing clinical data, including uncertainties
regarding the outcome of the ongoing Phase 2 trial of Pfizer’s
second-generation influenza vaccine candidates in adults 65 years
of age and older; uncertainties regarding the future development of
Pfizer’s mRNA influenza vaccine candidates, potential
next-generation mRNA flu and combination vaccine formulations and
Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate
for influenza and COVID-19, including whether or when any such
candidates will advance to future studies or phases of development;
the risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when biologic
license applications may be filed in any jurisdictions for Pfizer’s
mRNA influenza vaccine candidates, potential next-generation mRNA
flu or combination vaccine formulations or Pfizer’s and BioNTech’s
mRNA-based combination vaccine candidate for influenza and COVID-19
for any potential indications or for any other potential vaccine or
product candidates; whether and when any such applications may be
approved by regulatory authorities, which will depend on myriad
factors, including making a determination as to whether the
product's benefits outweigh its known risks and determination of
the product's efficacy and, if approved, whether Pfizer’s mRNA
influenza vaccine candidates, potential next-generation mRNA flu or
combination vaccine formulations, Pfizer’s and BioNTech’s
mRNA-based combination vaccine candidate for influenza and COVID-19
or any such other potential vaccine or product candidates will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of Pfizer’s mRNA influenza vaccine candidates, potential
next-generation mRNA flu or combination vaccine formulations,
Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate
for influenza and COVID-19 or any such other potential vaccine or
product candidates, including development of products or therapies
by other companies; uncertainties regarding the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities regarding Pfizer’s mRNA influenza
vaccine candidates, potential next-generation mRNA flu or
combination vaccine formulations, Pfizer’s and BioNTech’s
mRNA-based combination vaccine candidate for influenza and COVID-19
or any such other potential vaccine or product candidates and
uncertainties regarding the commercial impact of any such
recommendations; 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
we may not be able to successfully develop other vaccine
formulations or combination vaccines; 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, 2023 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 global next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
BioNTech 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 and specialized pharmaceutical collaborators, including
Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the
Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and
Regeneron. 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 be limited to, statements concerning: the
collaboration between BioNTech and Pfizer, including Pfizer’s
investigational modified RNA (modRNA) influenza vaccine candidates,
potential next-generation mRNA flu and combination vaccine
formulations, and Pfizer’s and BioNTech’s mRNA-based combination
vaccine candidate for influenza and COVID-19, and mRNA technology;;
qualitative assessments of available data and expectations of
potential benefits, ; regulatory submissions and regulatory
approvals or authorizations and expectations regarding
manufacturing, distribution and supply; expectations regarding
anticipated changes in vaccine demand, including changes to the
ordering environment; and expected regulatory recommendations to
adapt vaccines to address new strains, 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; uncertainties
regarding potential next-generation mRNA flu and combination
vaccine formulations and Pfizer’s and BioNTech’s mRNA-based
combination vaccine candidate for influenza and COVID-19, including
whether or when any such candidates will advance to future studies
or phases of development; the future commercial demand and medical
need for an mRNA-based combination vaccine candidate for influenza
and COVID-19; the availability of raw materials to manufacture a
vaccine; vaccine formulation, dosing schedule and attendant
storage, distribution and administration requirements, including
risks related to storage and handling after delivery; competition
from other vaccines or related to BioNTech’s other 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 to prevent COVID-19 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;
unforeseen safety issues and potential claims that are alleged to
arise from the use of products and product candidates developed or
manufactured by BioNTech and/or its collaborators; BioNTech’s and
its collaborators’ ability to commercialize and market products
and, if approved, product candidates; BioNTech’s ability to manage
its development and expansion; regulatory developments in the
United States and other countries; BioNTech’s ability to
effectively scale production capabilities; 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, 2024, and in subsequent filings made by
BioNTech with the SEC, which are available on the SEC’s website at
www.sec.gov. These forward-looking statements speak only as of the
date hereof. 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.
1 Disease Burden of Flu. Centers for Disease Control &
Prevention. Available at
https://www.cdc.gov/flu/about/burden/index.html
2 Putri et al, Vaccine. 2018 Jun 22;36(27):3960-3966. doi:
10.1016/j.vaccine.2018.05.057
3 Flu & People 65 Years and Older. Centers for Disease
Control and Prevention. Available at: Flu & People 65 Years and
Older | CDC
4 Vaccine Effectiveness: How Well do the Flu Vaccines Work?
Centers for Disease Control & Prevention. Available at
https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm.
5 Flu Disparities Among Racial and Ethnic Minority Groups CDC.
Available at
https://www.cdc.gov/flu/highrisk/disparities-racial-ethnic-minority-groups.html.
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