- This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5
sublineage and indicated as a single dose for most individuals 5
years of age and older
- Pre-clinical data show that the updated COVID-19 vaccine
generates improved neutralizing antibody responses against multiple
circulating Omicron-related sublineages including XBB.1.5, BA.2.86
(Pirola), and EG.5.1 (Eris), which currently accounts for the
largest portion of U.S. cases1
- The companies are working closely with pharmacies, hospitals,
and clinics across the country to ensure rapid access to this
season’s vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced that the U.S. Food and Drug Administration (FDA) approved
the supplemental Biologics License Application (COMIRNATY 2023-2024
Formulation) for individuals 12 years and older and granted
emergency use authorization for individuals 6 months through 11
years of age for the companies’ Omicron XBB.1.5-adapted monovalent
COVID-19 vaccine. This season’s vaccine is indicated as a single
dose for most individuals 5 years of age and older. Children under
the age of 5 may be eligible to receive additional doses of this
season’s vaccine if they have not already completed a three-dose
series with previous formulations of a COVID-19 vaccine.
This decision follows guidance from the FDA’s Vaccines and
Related Biological Products Advisory Committee (VRBPAC), which
recommended an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
for the 2023-2024 fall and winter season. Although Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some
protection against a range of outcomes from XBB-related
COVID-19,2,3 evidence suggests that vaccines better matched to
currently circulating strains can offer improved protection against
symptomatic and severe disease.4 Pfizer and BioNTech have been
manufacturing the 2023-2024 COVID-19 vaccine at risk to ensure
supply readiness ahead of the fall and winter season, when demand
for COVID-19 vaccination is expected to increase in line with the
seasonality period also seen with other respiratory viruses.5
“This decision comes at a time when COVID-19 cases are once
again climbing. Now, most people 6 months or older in the U.S. are
eligible to receive this season’s COVID-19 vaccine, even if they
have never been vaccinated against COVID-19 before,” said Albert
Bourla, Chairman and Chief Executive Officer at Pfizer. “We expect
this season’s vaccine to be available in the coming days, pending
recommendation from public health authorities, so people can ask
their doctor about receiving their COVID-19 vaccine during the same
appointment as their annual flu shot, saving time now and helping
to prevent severe disease later when respiratory viruses are at
their peak.”
“With today's decision, an updated vaccine will shortly become
available that helps address multiple Omicron XBB-related
sublineages, which currently account for the vast majority of
COVID-19 cases globally,” said Prof. Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. “Studies about confirmed viral infections
suggest that COVID-19 adopts a seasonal pattern with peaks in fall
and winter, similar to other respiratory viruses. Our goal is to
provide people worldwide with COVID-19 vaccines that are adapted to
circulating virus variants or sublineages.”
The approval of this season’s COVID-19 vaccine is based on the
full body of previous clinical, non-clinical, and real-world
evidence supporting the safety and efficacy of the COVID-19
vaccines by Pfizer and BioNTech. Further, the application included
pre-clinical data showing this season’s vaccine substantially
improved responses against multiple Omicron XBB-related
sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to
the Omicron BA.4/BA.5-adapted bivalent vaccine. Additionally,
pre-clinical data demonstrate that serum antibodies induced by
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, when compared
to the Omicron BA.4/BA.5-adapted bivalent vaccine, effectively
neutralize the recently emerged Omicron BA.2.86 (Pirola) and the
globally dominant Omicron-related EG.5.1 (Eris) subvariant.6
This season’s COVID-19 vaccine will be available in pharmacies,
hospitals, and clinics across the U.S. following a recommendation
by the Centers for Disease Control and Prevention (CDC). The
2023-2024 formulation for individuals 12 years of age and older can
be ordered as either a pre-filled syringe or a single-dose vial.
The vaccine remains at no out-of-pocket cost to most Americans. For
more information, visit www.vaccines.gov.
In the European Union, the Omicron XBB.1.5-adapted monovalent
COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) has also received
marketing authorization by the European Commission for individuals
6 months of age and older on August 31, 2023. Pfizer and BioNTech
have submitted data for their Omicron XBB.1.5-adapted monovalent
COVID-19 vaccine to other regulatory authorities around the
world.
The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are
based on BioNTech’s proprietary mRNA technology and were developed
by both companies. BioNTech is the Marketing Authorization Holder
for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron
BA.1; COMIRNATY Original/Omicron BA.4/BA.5; COMIRNATY Omicron
XBB.1.5) in the United States, the European Union, the United
Kingdom and other countries, and the holder of emergency use
authorizations or equivalents in the United States (jointly with
Pfizer) and other countries.
INDICATION, AUTHORIZED USE AND
IMPORTANT SAFETY INFORMATION
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.
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
Pfizer-BioNTech COVID-19 vaccine
- 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 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 or your pre-teen or teenager experience 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, dizziness and
weakness
- Authorized or approved mRNA COVID-19 vaccines show increased
risks of myocarditis (inflammation of the heart muscle) and
pericarditis (inflammation of the lining outside the heart),
particularly within the first week following vaccination. For
COMIRNATY, the observed risk is highest in males 12 through 17
years of age. Seek medical attention right away if you 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 Additional symptoms, particularly in children, may include:
- Fainting
- 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
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
- 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 most commonly reported adverse reactions (≥10%)
after a dose of COMIRNATY were pain at the injection site (up to
90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up
to 49.2%), muscle pain (up to 45.5%), fever (up to 24.3%), joint
pain (up to 27.5%), injection site swelling (up to 11.8%), and
injection site redness (up to 10.4%). 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. You should always ask your 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. 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
Please see accompanying 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
- 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
Please see accompanying 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 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 September 11,
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
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, including
COMIRNATY® 2023-2024 Formula, defined collectively herein as
COMIRNATY (including an approval in the U.S. for COMIRNATY
2023-2024 Formula, data submitted for an Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine to other regulatory authorities,
qualitative assessments of available data, potential benefits,
expectations regarding demand for COVID-19 vaccination,
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 COMIRNATY or any vaccine
candidate in the BNT162 program, 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 COMIRNATY, any vaccine candidate or any other vaccines that may
result from the BNT162 program or any other COVID-19 program,
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 COMIRNATY, any vaccine candidate
or any future vaccine 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 COMIRNATY
or any future vaccines 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
COMIRNATY, any vaccine candidates or any other potential vaccines
that may arise from the BNT162 program, 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 COMIRNATY
(including any requested amendments to the emergency use or
conditional marketing authorizations), any vaccine candidates or
other vaccines that may result from the BNT162 program or any other
COVID-19 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 the authorization or approval of products or therapies
developed by other companies; 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 excess inventory
on-hand and/or in the channel or reduced revenues; 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
COMIRNATY or any potential future COVID-19 vaccines; 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 COMIRNATY; 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
DualityBio, 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 be limited to, statements
concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer; the rate and degree of
market acceptance of BioNTech’s COVID-19 vaccine, including the
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine; 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 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; BioNTech's pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors after BioNTech's initial sales to
national governments; the future commercial demand and medical need
for initial or booster doses of a COVID-19 vaccine; 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; competition from
other COVID-19 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;
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; BioNTech's and its collaborators’ ability to
commercialize and market BioNTech's COVID-19 vaccine and, if
approved, its 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
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.
___________________________________
1 Centers for Disease Control and Prevention. COVID Data
Tracker. Atlanta, GA: US Department of Health and Human Services,
CDC. Available at:
https://covid.cdc.gov/covid-data-tracker/#variant-proportions
2 Link-Gelles R, Ciesla AA, Roper LE, et al. Early estimates of
bivalent mRNA booster dose vaccine effectiveness in preventing
symptomatic SARS-CoV-2 infection attributable to Omicron BA.5– and
XBB/XBB.1.5–related sublineages among immunocompetent adults —
Increasing community access to testing program, United States,
December 2022–January 2023. MMWR Morb Mortal Wkly Rep
2023;72:119–124. doi: http://dx.doi.org/10.15585/mmwr.mm7205e1
3 Link-Gelles R, Weber ZA, Reese SE, et al. Estimates of
bivalent mRNA vaccine durability in preventing COVID-19–associated
hospitalization and critical illness among adults with and without
immunocompromising conditions — VISION Network, September
2022–April 2023. MMWR Morb Mortal Wkly Rep 2023;72:579–588. DOI:
http://dx.doi.org/10.15585/mmwr.mm7221a3
4 Khoury DS, Docken SS, Subbarao K, Kent SJ, Davenport MP,
Cromer D. Predicting the efficacy of variant-modified COVID-19
vaccine boosters. Nature Medicine. 2023 Mar;29(3):574-8.
5 Wiemken TL, Khan F, Nguyen JL, Jodar L, McLaughlin JM. Is
COVID-19 seasonal? A time series modeling approach. medRxiv.
2022:2022.06.17.22276570.
6 World Health Organization. EG.5 Initial Risk Evaluation, 9
August 2023. Available at:
https://www.who.int/docs/default-source/coronaviruse/09082023eg.5_ire_final.pdf?sfvrsn=2aa2daee_1
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230907854671/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 Victoria Meissner, M.D. +1 617 528 8293
Investors@biontech.de
BioNTech (NASDAQ:BNTX)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
BioNTech (NASDAQ:BNTX)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024