If approved, the vaccine could help simplify
the meningococcal vaccination schedule and provide the broadest
serogroup coverage of any meningococcal vaccine
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and
Drug Administration (FDA) accepted for review a Biologics License
Application (BLA) for its investigational pentavalent meningococcal
vaccine candidate (MenABCWY). Pfizer submitted MenABCWY for the
prevention of meningococcal disease caused by the most common
serogroups in individuals 10 through 25 years of age.
The Prescription Drug User Fee Act (PDUFA) goal date for a
decision by the FDA on the pentavalent meningococcal vaccine
application is in October 2023.
Pfizer’s MenABCWY vaccine candidate combines the components of
two vaccines into one, helping protect against the meningococcal
serogroups that cause the majority of invasive meningococcal
disease (IMD) globally.1 In the U.S., approximately 55 million
adolescents and young adults are in the age range for meningococcal
vaccination (11-23 years old), according to ACIP
recommendations.2
“The FDA’s acceptance of our application for the pentavalent
meningococcal vaccine candidate is an essential step toward helping
protect individuals and communities against the most common types
of meningococcal disease,” said Annaliesa Anderson, Ph.D., Senior
Vice President and Chief Scientific Officer, Vaccine Research and
Development, Pfizer. “We believe our investigational MenABCWY
vaccine, if approved and recommended, could help simplify the
meningococcal vaccination schedule for adolescents and young
adults, and in turn improve vaccination rates, and provide the
broadest serogroup coverage of any meningococcal vaccine. The
pentavalent vaccine candidate was well-tolerated in clinical
trials, with a safety profile consistent with currently licensed
meningococcal vaccines.”
The regulatory submission is supported by previously announced
positive results from a randomized, active-controlled and
observer-blinded Phase 3 trial assessing the safety, tolerability,
and immunogenicity of the pentavalent vaccine candidate compared to
currently licensed meningococcal vaccines, with the goal of
determining immunologic noninferiority. The Phase 3 trial
(NCT04440163) evaluated more than 2,400 patients from the U.S. and
Europe.
Potential U.S. 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.3 Together, the
five most common meningococcal serogroups account for 95 percent of
all IMD cases worldwide, with serogroup B accounting for the
majority of disease in adolescents and young adults in the U.S. and
Europe.1
In the U.S., the current meningococcal vaccination platform for
adolescents and young adults includes a routine recommendation for
MenACWY vaccines (two doses) and a separate, shared clinical
decision recommendation for MenB-specific vaccines (two doses) in
order to achieve the broadest serogroup 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 series.4,5 If approved and recommended, Pfizer’s
pentavalent vaccine candidate could be another option for the
current routine recommendations in place for MenACWY vaccines.
Pfizer’s pentavalent vaccine candidate could potentially reduce the
total number of doses needed for individuals to be fully vaccinated
against the five serogroups, thereby simplifying meningococcal
vaccination and increasing the number of adolescents and young
adults vaccinated.6 Routine use of a MenABCWY vaccine could reduce
IMD cases and associated mortality, the rate of long-term sequelae
in survivors, and costs associated with controlling outbreaks.7
About the Pentavalent Meningococcal Vaccine Candidate
(MenABCWY)
Pfizer’s pentavalent meningococcal vaccine candidate combines
the components from its two licensed meningococcal vaccines,
Trumenba® (meningococcal group B vaccine) and Nimenrix®
(meningococcal groups A, C, W-135, and Y conjugate vaccine);
approvals of Nimenrix® and Trumenba® vary by country. Together, the
5 serogroups included in MenABCWY are responsible for the majority
of currently circulating meningococcal disease globally.1 Top line
results from a randomized, active-controlled and observer-blinded
Phase 3 trial of Pfizer’s pentavalent meningococcal vaccine
candidate (NCT04440163) were previously announced in September
2022. Additional information about the trial and results can be
found at www.clinicaltrials.gov.
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 December 28,
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, a BLA
pending with the FDA and its potential recommendation, 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 particular jurisdictions for
Pfizer’s MenABCWY vaccine candidate; whether and when the BLA
pending with the FDA or any such other 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 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 Centers for Disease Control and
Prevention. Meningococcal vaccination: Recommendations of the
Advisory Committee on Immunization Practices, United States, 2020.
September 2020. Available at:
https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htm. Accessed
December 19, 2022. 3 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. Available at:
https://pubmed.ncbi.nlm.nih.gov/19254985/. Accessed December 19,
2022. 4 Pingali C et al. National Vaccination Coverage Among
Adolescents Aged 13–17 Years — National Immunization Survey-Teen,
United States, 2021. Available at:
https://www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7135a1-H.pdf.
Accessed November 17, 2022. 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.Available at:
https://pubmed.ncbi.nlm.nih.gov/33849722/. Accessed December 19,
2022. 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/. Accessed
December 19, 2022. 7 National Library of Medicine. Potential Public
Health Impact of a Neisseria Meningitidis A, B, C, W, and Y
Pentavalent Vaccine in the United States. 2022. Available at:
https://pubmed.ncbi.nlm.nih.gov/33615973/. Accessed December 19,
2022. https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htmhttps://pubmed.ncbi.nlm.nih.gov/19254985/
Category: Vaccines
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