- One month after a 30-µg booster dose of the Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine, neutralizing antibody
titers against emerging Omicron sublineages increased 3.2- to
4.8-fold compared to the companies’ original COVID-19 vaccine
- Neutralizing antibody titers against Omicron sublineages
BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 increased 4.8- to 11.1-fold
from pre-booster levels, following a 30-µg booster dose of the
bivalent vaccine
- Omicron BA.5 continues to be the most prevalent sublineage in
the United States (nearly 30% of cases) at the time of publication
of the data, while the emerging BQ.1.1 sublineage accounts for
nearly 25% of cases and is increasing globally
NEW YORK and MAINZ, GERMANY, NOVEMBER
18, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced results from an analysis examining
the immune response induced by their Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine [Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)] against newer Omicron
sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1. These
data, posted on the preprint server bioRxiv, indicate that the
companies’ bivalent vaccine elicits a greater increase in
neutralizing antibody titers than the companies’ original COVID-19
vaccine against these emerging Omicron sublineages. Based on these
findings, the Omicron BA.4/BA.5-adapted bivalent booster may help
to provide improved protection against COVID-19 due to Omicron BA.4
and BA.5 sublineages as well as new sublineages that continue to
increase in prevalence.
Neutralization data were generated using a
nonvalidated fluorescent focus reduction neutralization test
(FFRNT) one month after administration of a 30-µg booster (fourth)
dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine or the original COVID-19 vaccine in adults aged 55 and
older (approximately 40/vaccine group). Sera were equally
stratified by prior SARS-CoV-2 infection. Results showed the
bivalent vaccine booster elicited a greater rise in neutralizing
antibody titers for all tested Omicron sublineages compared to the
original vaccine, regardless of prior SARS-CoV-2 infection
status.
Following a booster dose of the Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine, neutralizing
antibodies against BA.4.6 increased 11.1-fold (95% CI: 7.1, 17.3),
while neutralizing antibodies against BA.2.75.2, BQ.1.1, and XBB.1
increased by 6.7-fold (95% CI: 4.4,10.2), 8.7-fold (95% CI: 5.7,
13.3), and 4.8-fold (95% CI: 3.3, 6.9), respectively. By
comparison, the neutralizing antibody titers against BA.4.6,
BA.2.75.2, BQ.1.1, and XBB.1 following a booster dose of the
companies’ original COVID-19 vaccine increased 2.3-fold (95% CI:
1.9, 2.8), 2.1-fold (95% CI: 1.7, 2.5), 1.8-fold, (95% CI: 1.6,
2.2), and 1.5-fold (95% CI: 1.3, 1.8), respectively. Overall, the
bivalent booster generated a greater increase in neutralizing
antibodies against emerging Omicron sublineages than the original
Pfizer-BioNTech COVID-19 vaccine.
These results are similar to recent clinical
data showing the Omicron BA.4/BA.5-adapted bivalent booster evokes
a 13-fold increase in BA.4/BA.5 neutralizing titers from
pre-booster levels in individuals 55 years and older, resulting in
a 4-fold higher BA.4/BA.5 response than the companies’ original
COVID-19 vaccine.
A booster dose of the Omicron BA.4/BA.5-adapted
bivalent COVID-19 vaccine has been authorized for emergency use by
the U.S. Food and Drug Administration (FDA) for ages 5 years and
older and has been granted marketing authorization in the EU by the
European Commission for ages 5 years and older.
The Pfizer-BioNTech COVID-19 Vaccines
(COMIRNATY®) are based on BioNTech’s proprietary mRNA technology
and were developed by both BioNTech and Pfizer. BioNTech is the
Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2
Bivalent (Original/Omicron BA.4/BA.5) in the United States, the
European Union, the United Kingdom, Canada and other countries, and
the holder of emergency use authorizations or equivalents in the
United States (jointly with Pfizer) and other countries.
U.S. INDICATION & AUTHORIZED
USE
Pfizer-BioNTech Covid-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)
AUTHORIZED USEPfizer-BioNTech
COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is
FDA-authorized under Emergency Use Authorization (EUA) for use in
individuals 5 years of age and older as a single booster dose
administered at least 2 months after either:
- completion of primary vaccination with any authorized or
approved monovalent* COVID-19 vaccine; or
- receipt of the most recent booster dose with any authorized or
approved monovalent COVID-19 vaccine.
*Monovalent refers to any authorized and
approved COVID-19 vaccine that contains or encodes the spike
protein of only the Original SARS-CoV-2 virus
COMIRNATY® (COVID-19 Vaccine,
mRNA)
INDICATIONCOMIRNATY® (COVID-19
Vaccine, mRNA) is a vaccine approved for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12
years of age and older.
AUTHORIZED
USECOMIRNATY® (COVID-19 Vaccine, mRNA) is
FDA-authorized under Emergency Use Authorization (EUA) to
provide:
Primary Series
- a third primary series dose to individuals 12 years of age and
older who have certain kinds of immunocompromise
Pfizer-BioNTech Covid-19
Vaccine
AUTHORIZED USESPfizer-BioNTech
COVID-19 Vaccine is FDA authorized under Emergency Use
Authorization (EUA) for use in individuals 6 months and older to
provide:
Primary Series
- a 3-dose primary series to individuals 6 months through 4 years
of age
- a 2-dose primary series to individuals 5 years of age and
older
- a third primary series dose to individuals 5 years of age and
older with certain kinds of immunocompromise
EMERGENCY USE
AUTHORIZATIONEmergency uses of the vaccines have not been
approved or licensed by FDA but have been authorized by FDA under
an Emergency Use Authorization (EUA) to prevent Coronavirus Disease
2019 (COVID-19) in individuals aged 6 months and older for the
Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the
Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are
only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of the medical product under Section 564(b)(1) of the FD&C Act
unless the declaration is terminated or authorization revoked
sooner.
IMPORTANT SAFETY
INFORMATION
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY® (COVID-19
Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine
Tell your vaccination provider about all
of your medical conditions, including if you:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the
immune system
- are pregnant, plan to become pregnant, or are
breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- The vaccine may not protect everyone
- You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the
Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19
Vaccine, Bivalent if you have had a severe allergic reaction after
a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19
Vaccine or any ingredient in these vaccines
- There is a remote chance that these vaccines could cause a
severe allergic reaction. A severe allergic reaction would usually
occur within a few minutes to 1 hour after getting a dose of the
vaccine. For this reason, your vaccination provider may ask you to
stay at the place where you received the vaccine for monitoring
after vaccination. If you experience a severe allergic reaction,
call 9-1-1 or go to the nearest hospital
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or
swelling of the face
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the
heart)
- Injection site pain
- Tiredness
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Arm pain
- Fainting in association with injection of the vaccine
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Unusual and persistent cool, pale skin
- Seek medical attention right away if you have any of the
following symptoms: difficulty breathing, swelling of the face and
throat, a fast heartbeat, a bad rash all over the body, dizziness,
and weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received COMIRNATY® (COVID-19 vaccine, mRNA)
or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher
among adolescent males and adult males under 40 years of age than
among females and older males, and the observed risk is highest in
males 12 through 17 years of age. In most of these people, symptoms
began within a few days following receipt of the second dose of
vaccine. The chance of having this occur is very low
Side effects that have been reported with these
vaccines include:
These may not be all the possible side effects
of the vaccine. Call the vaccination provider or healthcare
provider about bothersome side effects or side effects that do not
go away.Individuals should always ask their healthcare providers
for medical advice about adverse events.
Report vaccine side effects to the US Food and
Drug Administration (FDA) and the Centers for Disease Control and
Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).
The VAERS toll-free number is 1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html. In addition, individuals can
report side effects to Pfizer Inc. at www.pfizersafetyreporting.com
or by calling 1-800-438-1985.
COMIRNATY® Full Prescribing Information
and EUA Fact Sheets for Vaccination Providers and Recipients and
Caregivers Fact Sheets:
EUA Fact Sheet for Vaccination Providers
(12 Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO
NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers
(5 through 11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO
NOT DILUTE, Orange Cap
COMIRNATY® Full Prescribing Information
(12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers
(12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers
(6 months through 4 years of age), DILUTE BEFORE USE, Maroon
Cap
EUA Fact Sheet for Vaccination Providers
(5 through 11 years of age), DILUTE BEFORE USE, Orange
Cap
EUA Fact Sheet for Recipients and
Caregivers (12 years of age and older)
EUA Fact Sheet for Recipients and
Caregivers (5 through 11 years of age)
EUA Fact Sheet for Recipients and
Caregivers (6 months through 4 years of age)
About Pfizer: Breakthroughs That Change
Patients’ LivesAt Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development and
manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 170 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice The
information contained in this release is as of November 18, 2022.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking
information about Pfizer’s efforts to combat COVID-19, the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech
COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA)
(BNT162b2) (including the Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5) and neutralization data
against newer Omicron sublineages, qualitative assessments of
available data, potential benefits, expectations for clinical
trials, potential regulatory submissions, the anticipated timing of
data readouts, regulatory submissions, regulatory approvals or
authorizations and anticipated manufacturing, distribution and
supply) involving substantial risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. Risks and uncertainties include,
among other things, the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as risks associated with preclinical
and clinical data (including Phase 1/2/3 or Phase 4 data),
including the data discussed in this release for BNT162b2, any
monovalent, bivalent or variant-adapted vaccine candidates or any
other vaccine candidate in the BNT162 program in any of our studies
in pediatrics, adolescents, or adults or real world evidence,
including the possibility of unfavorable new preclinical, clinical
or safety data and further analyses of existing preclinical,
clinical or safety data, including the risk that additional data
against newer Omicron sublineages could differ from the data
discussed in this release; the ability to produce comparable
clinical or other results, including the rate of vaccine
effectiveness and safety and tolerability profile observed to date,
in additional analyses of the Phase 3 trial and additional studies,
in real world data studies or in larger, more diverse populations
following commercialization; the ability of BNT162b2, any
monovalent, bivalent or variant-adapted vaccine candidates or any
future vaccine to prevent COVID-19 caused by emerging virus
variants; the risk that more widespread use of the vaccine will
lead to new information about efficacy, safety, or other
developments, including the risk of additional adverse reactions,
some of which may be serious; the risk that preclinical and
clinical trial data are subject to differing interpretations and
assessments, including during the peer review/publication process,
in the scientific community generally, and by regulatory
authorities; whether and when additional data from the BNT162 mRNA
vaccine program will be published in scientific journal
publications and, if so, when and with what modifications and
interpretations; whether regulatory authorities will be satisfied
with the design of and results from these and any future
preclinical and clinical studies; whether and when submissions to
request emergency use or conditional marketing authorizations for
BNT162b2 in additional populations, for a potential booster dose
for BNT162b2, any monovalent or bivalent vaccine candidates or any
potential future vaccines (including potential future annual
boosters or re-vaccinations), and/or other biologics license and/or
emergency use authorization applications or amendments to any such
applications may be filed in particular jurisdictions for BNT162b2,
any monovalent or bivalent vaccine candidates or any other
potential vaccines that may arise from the BNT162 program,
including a potential variant-based, higher dose, or bivalent
vaccine, and if obtained, whether or when such emergency use
authorizations or licenses will expire or terminate; whether and
when any applications that may be pending or filed for BNT162b2
(including any requested amendments to the emergency use or
conditional marketing authorizations), any monovalent or bivalent
vaccine candidates (including any other potential submissions for
the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine), or other
vaccines that may result from the BNT162 program may be approved by
particular regulatory authorities, which will depend on myriad
factors, including making a determination as to whether the
vaccine’s benefits outweigh its known risks and determination of
the vaccine’s efficacy and, if approved, whether it will be
commercially successful; decisions by regulatory authorities
impacting labeling or marketing, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of a vaccine, including development of
products or therapies by other companies; disruptions in the
relationships between us and our collaboration partners, clinical
trial sites or third-party suppliers; the risk that demand for any
products may be reduced or no longer exist which may lead to
reduced revenues or excess inventory; risks related to the
availability of raw materials to manufacture a vaccine; challenges
related to our vaccine’s formulation, dosing schedule and attendant
storage, distribution and administration requirements, including
risks related to storage and handling after delivery by Pfizer; the
risk that we may not be able to successfully develop other vaccine
formulations, booster doses or potential future annual boosters or
re-vaccinations or new variant-based or next generation vaccines;
the risk that we may not be able to maintain or scale up
manufacturing capacity on a timely basis or maintain access to
logistics or supply channels commensurate with global demand for
our vaccines, which would negatively impact our ability to supply
the estimated numbers of doses of our vaccines within the projected
time periods; whether and when additional supply agreements will be
reached; uncertainties regarding the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; challenges related
to public vaccine confidence or awareness; uncertainties regarding
the impact of COVID-19 on Pfizer’s business, operations and
financial results; and competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2021 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About BioNTechBiopharmaceutical
New Technologies is a next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
The Company exploits a wide array of computational discovery and
therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells, bispecific
immune checkpoint modulators, targeted cancer antibodies and small
molecules. Based on its deep expertise in mRNA vaccine development
and in-house manufacturing capabilities, BioNTech and its
collaborators are developing multiple mRNA vaccine candidates for a
range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global pharmaceutical collaborators, including
Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
BioNTech Forward-looking
StatementsThis press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, statements
concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer including the program to
develop a COVID-19 vaccine and COMIRNATY® (COVID-19 vaccine, mRNA)
(BNT162b2) (including the Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine and updated data from an ongoing phase 2/3
clinical trial, a Phase 1/2/3 study in children aged 6 months
through 11 years of age, laboratory studies to evaluate
immunogenicity of the BA.4/BA.5 bivalent booster against emerging
Omicron subvariants, qualitative assessments of available data,
potential benefits, expectations for clinical trials, the
anticipated timing of regulatory submissions, regulatory approvals
or authorizations and anticipated manufacturing, distribution and
supply); our expectations regarding the potential characteristics
of BNT162b2 in our clinical trials, real world data studies, and/or
in commercial use based on data observations to date; preclinical
and clinical data (including Phase 1/2/3 or Phase 4 data),
including the descriptive data discussed in this release, for
BNT162b2 or any other vaccine candidate in the BNT162 program in
any of our studies in pediatrics, adolescents or adults or real
world evidence, including the possibility of unfavorable new
preclinical, clinical or safety data, including the risk that final
or formal results from the clinical trial could differ from the
topline data; the ability of BNT162b2 or a future vaccine to
prevent COVID-19 caused by emerging virus variants; the expected
time point for additional readouts on efficacy data of BNT162b2 and
its adapted vaccine variations in our clinical trials; the nature
of the clinical data, which is subject to ongoing peer review,
regulatory review and market interpretation; widespread use of
BNT162b2 and its adapted vaccine variations will lead to new
information about efficacy, safety, or other developments,
including the risk of additional adverse reactions, some of which
may be serious; the timing for submission of data for BNT162, or
any future vaccine, in additional populations (including in
children 6 months to less than 5 years of age, potential future
annual boosters or re-vaccinations), or receipt of, any marketing
approval or emergency use authorization or equivalent, including or
amendments or variations to such authorizations, including making a
determination as to whether the vaccine’s benefits outweigh its
known risks and determination of the vaccine’s efficacy and, if
approved, whether it will be commercially successful; the
development of other vaccine formulations, booster doses or
potential future annual boosters or re-vaccinations or new variant
based vaccines; our contemplated shipping and storage plan,
including our estimated product shelf life at various temperatures;
the ability of BioNTech to supply the quantities of BNT162 and its
adapted vaccine variations to support clinical development and
market demand, including our production estimates for 2022;
challenges related to public vaccine confidence or awareness;
decisions by regulatory authorities impacting labeling or
marketing, manufacturing processes, safety and/or other matters
that could affect the availability or commercial potential of a
vaccine, including development of products or therapies by other
companies; disruptions in the relationships between us and our
collaboration partners, clinical trial sites or third-party
suppliers; the risk that demand for any products may be reduced or
no longer exist which may lead to reduced revenues or excess
inventory; the availability of raw material to manufacture BNT162
or other vaccine formulation; challenges related to our vaccine’s
formulation, dosing schedule and attendant storage, distribution
and administration requirements, including risks related to storage
and handling after delivery; and uncertainties regarding the impact
of COVID-19 on BioNTech’s trials, business and general operations.
Any forward-looking statements in this press release are based on
BioNTech current expectations and beliefs of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to: the ability to
meet the pre-defined endpoints in clinical trials; competition to
create a vaccine for COVID-19; the ability to produce comparable
clinical or other results, including our stated rate of vaccine
effectiveness and safety and tolerability profile observed to date,
in the remainder of the trial or in larger, more diverse
populations upon commercialization; the ability to effectively
scale our productions capabilities; and other potential
difficulties.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report as Form 6-K for the
quarter ended September 30, 2022, filed with the SEC on November 7,
2022, which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
CONTACTS
Pfizer: Media Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49
(0)6131 9084 1513 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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