- Phase 3 trial demonstrates that the investigational pentavalent
meningococcal vaccine (MenABCWY) was well-tolerated with an
acceptable safety profile and immunogenicity non-inferior to
Trumenba® + Menveo® for all serogroups
- Based on these findings, Pfizer plans to submit an application
for approval to the U.S. Food and Drug Administration in the fourth
quarter of 2022
- If approved, MenABCWY could help simplify the meningococcal
vaccination schedule and provide the broadest serogroup coverage of
any meningococcal vaccine
Pfizer Inc. (NYSE:PFE) today announced positive top-line results
from the pivotal Phase 3 trial (NCT04440163) assessing the safety,
tolerability, and immunogenicity of its investigational pentavalent
meningococcal vaccine (MenABCWY) in healthy individuals 10 through
25 years of age. The trial met all primary and secondary endpoints,
with the investigational vaccine demonstrating non-inferiority to
licensed vaccines for the five meningococcal serogroups that cause
the majority of invasive meningococcal disease: serogroups A, B, C,
W and Y.1 Currently, MenACWY and MenB vaccines are licensed
separately, and no single vaccine is available to help protect
against the five serogroups.
Participants in the trial were randomly assigned to receive
either two doses of MenABCWY or licensed vaccines (two doses of
Trumenba® + one dose of Menveo®). Non-inferiority was demonstrated
for all five serogroups following two doses of MenABCWY compared to
two doses of Trumenba® and one dose of Menveo®.
Additionally, a single dose of MenABCWY met the non-inferiority
criteria for serogroups A, C, W and Y compared to one dose of
Menveo®. Furthermore, in individuals who had not previously
received a meningococcal vaccine, the proportion of subjects with
≥4-fold increases in immune responses was observed to be higher
following either one or two doses of MenABCWY for serogroups A, C,
W and Y compared to one dose of Menveo®. Finally, the proportion of
subjects with ≥4-fold increases in immune responses was also
observed to be higher against all four serogroup B strains
following two doses of MenABCWY compared to two doses of Trumenba®.
The pentavalent vaccine candidate was well-tolerated, with a safety
profile consistent with licensed vaccines.
“We are very pleased with these positive Phase 3 data, which are
the first for a MenABCWY vaccine candidate,” said Annaliesa
Anderson, Ph.D., Senior Vice President and Chief Scientific
Officer, Vaccine Research and Development, Pfizer. “A pentavalent
vaccine has the potential to help simplify what is currently a
complex meningococcal vaccination schedule in the U.S. and improve
vaccine coverage. Our goal is to help ensure as many adolescents
and young adults as possible are protected against this devastating
disease.”
Based on these Phase 3 results, which meet pre-determined
criteria for licensure, Pfizer intends to submit a Biologics
License Application to the U.S. Food and Drug Administration in the
fourth quarter of this year. Submissions to additional regulatory
authorities outside the U.S. are also planned.
“The potential recommendation of a pentavalent vaccine in the
U.S. as an alternative to the existing MenACWY vaccines across both
the 11- to 12-year-old and 16-year-old vaccination platforms
provides a significant opportunity for Pfizer to enter the U.S.
MenACWY vaccine market and help protect more young people across
the country. Today, we estimate there are approximately 52 million
adolescents and young adults who are in the age range for
meningococcal vaccination according to CDC guidance,” said Angela
Hwang, President, Global Biopharma Business, Pfizer. “We look
forward to the public health impact a pentavalent vaccine may
provide, and to strengthening our position as a global leader in
the prevention of meningococcal disease.”
Potential Public Health Impact of a MenABCWY Vaccine
Meningococcal disease is an uncommon but serious illness that
can lead to death within 24 hours, and for survivors can result in
life-altering, significant long-term disabilities.2 Together, five
serogroups (A, B, C, W and Y) account for 96 percent of all
invasive meningococcal disease cases worldwide, with serogroup B
accounting for the majority of disease in adolescents and young
adults in the U.S. and Europe.3
In the U.S., the current vaccination recommendations for
adolescents and young adults include a MenACWY vaccine and a
separate MenB vaccine (total four doses) to help achieve the
broadest protection available against meningococcal disease.
However, less than a third of U.S. adolescents receive even one
dose of a MenB vaccine, and fewer complete the two-dose series,
resulting in many adolescents being unprotected against
meningococcal disease caused by serogroups A, B, C, W, and Y.4,5 If
approved and recommended, Pfizer’s pentavalent vaccine candidate
could help simplify the meningococcal vaccination schedule by
potentially reducing the total number of doses needed for
individuals to be fully vaccinated against the five serogroups.6
Routine use of a MenABCWY vaccine could help improve meningococcal
vaccination rates and coverage, thereby reducing cases of invasive
meningococcal disease and associated mortality, the rate of
long-term sequelae in survivors, and costs associated with
controlling outbreaks.7
About the Phase 3 Trial
The randomized, active-controlled and observer-blinded Phase 3
trial of Pfizer’s pentavalent meningococcal vaccine candidate
(NCT04440163) was initiated in June 2020 and enrolled 2,431 healthy
adolescents and young adults (10 through 25 years of age) from the
U.S. and Europe. The study was designed to compare immune responses
in individuals after MenABCWY administration to responses in
control groups receiving licensed vaccines Trumenba® (meningococcal
group B vaccine) and Menveo® (meningococcal group A, C, W-135, and
Y conjugate vaccine), as well as to describe the safety profile of
the MenABCWY vaccine. Immune responses were assessed by human serum
bactericidal assay (hSBA). The study enrolled both individuals who
had previously received a MenACWY vaccine and those who had not.
All participants had not received any meningococcal group B vaccine
prior to enrollment.
Additional information about the trial can be found at
www.clinicaltrials.gov. Pfizer plans to present the detailed
results from this trial at a future medical congress and submit the
results for peer review in a scientific journal.
Pfizer’s pentavalent meningococcal vaccine candidate combines
its two licensed meningococcal vaccines, Trumenba® and Nimenrix®
(meningococcal group A, C, W-135, and Y conjugate vaccine).
Approvals of Nimenrix® and Trumenba® vary by country.
INDICATIONS FOR TRUMENBA® IN THE U.S.
- Trumenba® is a vaccine indicated for individuals 10 through 25
years of age for active immunization to prevent invasive disease
caused by Neisseria meningitidis group B
IMPORTANT SAFETY INFORMATION
- Trumenba® should not be given to anyone with a history of a
severe allergic reaction to any component of Trumenba®
- Some individuals with weakened immune systems may have a
reduced immune response
- Persons with certain complement deficiencies and persons
receiving treatments such as Soliris® (eculizumab), are at
increased risk for invasive disease caused by Neisseria
meningitidis group B even with receipt of vaccination with
Trumenba®
- Vaccination with Trumenba® may not protect all vaccine
recipients against N meningitidis group B infections
- Fainting can occur in association with administration of
injectable vaccines, including Trumenba®
- The most common adverse reactions in adolescents and young
adults were pain at injection site, fatigue, headache, and muscle
pain
- Data are not available on the safety and effectiveness of using
Trumenba® and other meningococcal group B vaccines interchangeably
to complete the vaccination series
- Tell your health care provider if you are pregnant, or plan to
become pregnant
- Ask your health care provider about the risks and benefits of
Trumenba®. Only a health care provider can decide if Trumenba® is
right for you or your child
INDICATION FOR NIMENRIX® IN THE E.U.
- Nimenrix® is a vaccine indicated for individuals six weeks of
age and older for active immunization to prevent invasive disease
caused by Neisseria meningitidis groups A, C, W-135 and Y
IMPORTANT SAFETY INFORMATION
- Nimenrix® should not be given to anyone with a history of a
severe allergic reaction after a previous dose of Nimenrix®
- Some individuals with weakened immune systems may have a
reduced immune response
- Persons with certain complement deficiencies and persons
receiving treatments such as Soliris® (eculizumab), are at
increased risk for invasive disease caused by Neisseria
meningitidis groups A, C, W, and Y, even with receipt of
vaccination with Nimenrix®
- As with any vaccine, vaccination with Nimenrix® may not protect
all vaccine recipients against N. meningitidis groups A, C, W and
Y
- Fainting can occur shortly before or after injecting vaccines,
including Nimenrix®
- The most common adverse reactions were loss of appetite,
irritability, drowsiness, headache, fatigue, fever, and pain,
redness, and swelling at the injection site
- Tell your healthcare provider if you are pregnant, or plan to
become pregnant
- Ask your healthcare provider about the risks and benefits of
Nimenrix®. Only a healthcare provider can decide if Nimenrix® is
right for you or your child
Menveo® and Nimenrix® are trademarks of GlaxoSmithKline
Biologicals S.A.
Soliris® is a trademark of Alexion Pharmaceuticals, Inc.
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.
Disclosure Notice: The information contained in this
release is as of September 15, 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
MenABCWY vaccine candidate, including its potential benefits, its
potential recommendation and planned regulatory submissions, 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; 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 any biologic
license applications may be filed in any jurisdictions for Pfizer’s
MenABCWY vaccine candidate; whether and when any such applications
may be approved by regulatory authorities, which will depend on a
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 such product
candidate 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 MenABCWY vaccine candidate;
uncertainties regarding the ability to obtain recommendations from
vaccine advisory or technical committees and other public health
authorities for Pfizer’s MenABCWY vaccine candidate and
uncertainties regarding the commercial impact of any such
recommendations; 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.
______________________________
1 National Library of Medicine. Global estimate of Neisseria
meningitidis serogroups proportion in invasive meningococcal
disease: A systematic review and meta-analysis. September 2019.
Available at: https://doi.org/10.1016/j.micpath.2019.103571.
Accessed June 2, 2022.
2 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of
Meningococcal disease in adolescence: prospective, matched-cohort
study. Pediatrics. 2009;123:e502-e509.
3 Purmohamad A, Abasi E, Azimi T, Hosseini S, Hossein S, Nasiri
M, Fooladi A. Global estimate of Neisseria meningitidis serogroups
proportion in invasive meningococcal disease: A systematic review
and meta-analysis. Microbial Pathogensis. 2019
4 Pingali C, Yankey D, Elam-Evans LD, et al. National
Vaccination Coverage Among Adolescents Aged 13–17 Years — National
Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal
Wkly Rep 2022;71:1101–1108. DOI:
http://dx.doi.org/10.15585/mmwr.mm7135a1.
5 La EM, Garbinsky D, Hunter S, Poston S, Novy P, Ghaswalla P.
Meningococcal B vaccination coverage among older adolescents in the
United States. Vaccine. 2021;39(19):2660-2667.
6 National Library of Medicine. Rationale for the Development of
a Pentavalent Meningococcal Vaccine: A US-Focused Review. 2022.
Available at: https://pubmed.ncbi.nlm.nih.gov/35357651/
7 National Library of Medicine. Potential Public Health Impact
of a Neisseria Meningitidis A, B, C, W, and Y Pentavalent Vaccine
in the Unites States. 2022. Available at:
https://pubmed.ncbi.nlm.nih.gov/33615973/
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から 12 2022 まで 12 2023
