If approved, the vaccine would provide the
broadest serotype coverage of any pneumococcal conjugate vaccine in
infants and children, and have the potential to help protect
against more of the clinically significant remaining burden of
disease
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and
Drug Administration (FDA) accepted for priority review a
supplemental Biologics License Application (sBLA) for its 20-valent
pneumococcal conjugate vaccine candidate (20vPnC) for the
prevention of invasive pneumococcal disease (IPD) caused by the 20
Streptococcus pneumoniae (pneumococcus) serotypes contained in the
vaccine in infants and children 6 weeks through 17 years of age,
and for the prevention of otitis media caused by seven of the 20
Streptococcus pneumoniae serotypes contained in the vaccine.
Priority Review designation by the FDA reduces the standard sBLA
review period by four months. The Prescription Drug User Fee Act
(PDUFA) goal date for a decision by the FDA on the 20vPnC vaccine
application is anticipated in April 2023. The FDA previously
granted Pfizer’s 20vPnC Fast Track Designation in May 2017 and
Breakthrough Therapy Designation in August 2020 for the pediatric
indication for IPD.
“Today’s regulatory milestone further advances Pfizer’s
commitment to the more than 20-year legacy of helping protect
infants and children from invasive pneumococcal disease through
conjugate vaccination,” said Annaliesa Anderson, Ph.D., Senior Vice
President and Chief Scientific Officer, Vaccine Research and
Development, Pfizer. “By offering the broadest serotype coverage by
a pneumococcal conjugate vaccine against important serotypes
causing pneumococcal disease in U.S. infants and children, 20vPnc,
if approved, can help expand the protection for this vulnerable
pediatric population.”
The regulatory submission is supported by results from the Phase
3 and Phase 2 clinical trial programs for the pediatric indication
for 20vPnC. Three core Phase 3 pediatric studies contributed to
data on the safety, tolerability, and immunogenicity of 20vPnC,
including previously announced positive, top-line results of the
pivotal U.S. Phase 3 study (NCT04382326). These studies
collectively enrolled approximately 3,500 infants and 800 children
of all ages. Further data from a Proof-of-Concept Phase 2 study
(NCT03512288) in 460 U.S. infants that assessed the safety and
immunogenicity of 20vPnC, with previously announced positive
results, also supported the regulatory submission.
About 20vPnC Pfizer’s 20vPnC pediatric vaccine candidate
includes the 13 serotypes already included in Prevnar 13® – 1, 3,
4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new
serotypes included in 20vPnC are global causes of IPD.1,2,3,4,5 and
are associated with high case-fatality rates6,7,8,9 antibiotic
resistance10,11 and or meningitis.12,13 Together, the 20 serotypes
included in 20vPnC are responsible for the majority of currently
circulating pneumococcal disease in the U.S. and
globally.14,15,16,17,18,19,20
The supplemental Biologics License Application (sBLA) for 20vPnC
includes for review indications in the following pediatric
populations:
- The prevention of invasive disease caused by Streptococcus
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F,
14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in infants and children 6
weeks through 17 years of age.
- The prevention of otitis media caused by Streptococcus
pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in infants
and children 6 weeks through 5 years of age.
In September 2022, Pfizer announced positive top-line results
from its pivotal Phase 3 study (NCT04546425) in infants in the
European Union, and in November 2022, submitted the 20vPnC
pediatric indication to the European Medicines Agency (EMA).
The FDA previously approved PREVNAR 20® (Pneumococcal 20-valent
Conjugate Vaccine) on June 8, 2021, for the prevention of invasive
disease and pneumonia caused by the 20 pneumococcus serotypes in
the vaccine in adults ages 18 years and older.
INDICATIONS FOR PREVNAR 13®
- Prevnar 13® is approved for children 6 weeks through 17 years
of age (prior to the 18th birthday) for the prevention of invasive
disease caused by the 13 strains of S. pneumoniae in the vaccine,
and for children 6 weeks through 5 years (prior to the 6th
birthday) for the prevention of ear infections caused by 7 of the
13 strains in the vaccine
- Prevnar 13® is not 100% effective and will only help protect
against the 13 strains in the vaccine
IMPORTANT SAFETY INFORMATION
- Prevnar 13® should not be given to anyone with a history of
severe allergic reaction to any component of Prevnar 13® or any
diphtheria toxoid–containing vaccine
- Children and adults with weakened immune systems (e.g., HIV
infection, leukemia) may have a reduced immune response
- In adults, the most common side effects were pain, redness, and
swelling at the injection site, limitation of arm movement,
fatigue, headache, muscle pain, joint pain, decreased appetite,
vomiting, fever, chills, and rash
- A temporary pause of breathing following vaccination has been
observed in some infants born prematurely
- The most commonly reported serious adverse events in infants
and toddlers were bronchiolitis (an infection of the lungs) (0.9%),
gastroenteritis (inflammation of the stomach and small intestine)
(0.9%), and pneumonia (0.9%)
- In children 6 weeks through 17 years, the most common side
effects were tenderness, redness, or swelling at the injection
site, irritability, decreased appetite, decreased or increased
sleep, and fever
- Ask your healthcare provider about the risks and benefits of
Prevnar 13®. Only a healthcare provider can decide if Prevnar 13®
is right for you or your child
INDICATIONS FOR PREVNAR 20®
- PREVNAR 20® is a vaccine indicated for active immunization for
the prevention of pneumonia and invasive disease caused by
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V,
10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults
18 years of age and older
- The indication for preventing pneumonia caused by S. pneumoniae
serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on
immune responses. Continued approval may depend on a supportive
study.
IMPORTANT SAFETY INFORMATION
- PREVNAR 20® should not be given to anyone with a history of
severe allergic reaction to any component of PREVNAR 20® or to
diphtheria toxoid
- Adults with weakened immune systems may have a lower response
to PREVNAR 20®. Safety data are not available for these groups.
Your healthcare provider can tell you if PREVNAR 20® is right for
you
- In adults 18 years of age and older, the most common side
effects were pain at the injection site, muscle pain, fatigue,
headache, and joint pain. Additionally, injection site swelling was
also common in adults 18 through 59 years of age
- Ask your healthcare provider about the risks and benefits of
PREVNAR 20®. Only a healthcare provider can decide if PREVNAR 20®
is right for you
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 January 6, 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
20vPnC vaccine candidate, including its potential benefits, an sBLA
pending with the FDA and an application submitted to the EMA for a
pediatric indication, 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 20vPnC for any potential indications; whether and
when the sBLA pending with FDA, the application submitted to the
EMA and any such other 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 20vPnC; uncertainties regarding the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities regarding 20vPnC 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.
___________________________________________________
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Streptococcus pneumoniae causing invasive disease in children in
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of an ecological experiment – Conjugate Vaccination against the
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Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial Meningitis
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