- Pivotal top-line data demonstrate a four-dose series of
20-valent pneumococcal conjugate vaccine candidate (20vPnC), if
approved, would provide the broadest serotype coverage of any
pneumococcal conjugate vaccine in infants
- 20vPnC elicited robust immune responses to all 20 serotypes
meeting the statistical non-inferiority criteria for the co-primary
objective after Dose 4
- 20vPnC demonstrated a favorable safety and tolerability profile
similar to Prevnar 13®
- Pfizer plans to submit an sBLA by the end of this year, subject
to discussions with U.S. FDA
Pfizer Inc. (NYSE:PFE) today announced positive top-line results
from its pivotal U.S. Phase 3 study (NCT04382326) in infants
evaluating 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 for the pediatric population.
The study had two co-primary objectives, associated with
immunogenicity responses one month after the third and fourth doses
of the four-dose vaccination series, respectively: non-inferiority
(NI) of the percentage of participants with predefined
serotype-specific immunoglobin G (IgG) concentrations after Dose 3
and NI of IgG geometric mean concentrations (GMCs) after Dose 4.
All 20 serotypes met the co-primary objective of NI of IgG GMCs
after Dose 4. Fourteen of the 20 serotypes met the co-primary
objective of NI of the percentage of participants with predefined
IgG levels after Dose 3 (two serotypes missed by a wider margin
while four narrowly missed), and all serotypes met noninferiority
for the key secondary objective of IgG GMCs after Dose 3. All 20
serotypes elicited robust functional responses (OPA) and increases
in antibody responses after Dose 4, with the totality of data
supporting the potential benefit of all serotypes in this 20-valent
vaccine candidate.
“We are encouraged by today’s data which show that if approved
for a pediatric indication, 20vPnC would have the potential to
cover more of the clinically significant remaining burden of infant
pneumococcal disease than any other available pneumococcal
conjugate vaccine,” said Annaliesa Anderson, Ph.D., Senior Vice
President and Chief Scientific Officer, Vaccine Research and
Development, Pfizer. “We are grateful to everyone who made this
study possible, including the study investigators and in particular
the trial participants and their parents/guardians for their
contribution to this important research.”
Overall, the safety profile of the 20vPnC candidate was
consistent with Prevnar 13 given in the same schedule. A similar
percentage of infants receiving either vaccine experienced local
reactions (pain at the injection site, redness, and swelling),
fever, and other systemic events (decreased appetite, drowsiness,
and irritability). The study also met non-inferiority objectives
for responses to co-administered routinely used pediatric
vaccines.
Based on the totality of positive safety and immunogenicity
data, Pfizer plans to submit a supplemental Biologics License
Application (sBLA) by the end of this year, subject to discussions
with the U.S. Food and Drug Administration. Pfizer will seek to
present and publish outcomes from this clinical trial at a future
date once safety and immunogenicity data have been fully analyzed.
Additional top-line results from other pediatric 20vPnC clinical
trials are expected to read out in the second half of 2022, with
discussions with other regulatory bodies planned once those pivotal
data become available.
About the 20vPnC Phase 3 Pediatric Program
In 2020, Pfizer initiated the Phase 3 clinical trial program for
the pediatric indication for 20vPnC. Four core Phase 3 pediatric
studies will help expand the data on the safety, tolerability, and
immunogenicity of 20vPnC. These studies collectively enrolled
approximately 4,700 infants and 800 toddlers and children of all
ages including:
- A Phase 3 study describing the tolerability and safety and
comparing immunogenicity of 20vPnC to Prevnar 13® in infants
vaccinated at 2, 4, 6, and 12-15 months of age in the U.S.
(NCT04382326)
- A Phase 3 study describing the tolerability and safety of
20vPnC, with Prevnar 13® serving as the control in infants
vaccinated at 2, 4, 6, and 12-15 months of age in multiple
countries. (NCT04379713)
- A Phase 3 study describing the tolerability and safety and
comparing immunogenicity of 20vPnC to Prevnar 13® in infant
vaccination at approximately 2, 4, and 11-12 months of age in
Europe and Australia (NCT04546425)
- A Phase 3 study in children 15 months through <18 years of
age receiving a single dose of 20vPnC in the U.S.
(NCT04642079).
About 20vPnC
Pfizer’s 20vPnC pediatric vaccine candidate includes 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 invasive pneumococcal disease (IPD),
and are associated with high case-fatality rates, antibiotic
resistance, and/or meningitis. Together, the 20 serotypes included
in 20vPnC are responsible for the majority of currently circulating
pneumococcal disease in the U.S. and globally.
On August 14, 2020, Pfizer’s 20vPnC received the FDA’s
Breakthrough Therapy Designation for the prevention of disease
caused by Streptococcus pneumoniae serotypes in the vaccine in
infants, children, and adolescents.
The FDA previously granted Fast Track Designation for 20vPnC in
May 2017 for the pediatric indication.
On June 8, 2021, the FDA approved PREVNAR 20® for the prevention
of invasive disease and pneumonia caused by the 20 Streptococcus
pneumoniae (pneumococcus) serotypes in the vaccine in adults ages
18 years and older.
INDICATIONS FOR PREVNAR 13®
- Prevnar 13® is a vaccine approved for adults 18 years and older
for the prevention of pneumococcal pneumonia and invasive disease
caused by Streptococcus. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B,
7F, 9V, 14, 18C, 19A, 19F, and 23F
- Prevnar 13® is also 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 August 12,
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
20vPnC vaccine candidate, including its potential benefits, results
from the Phase 3 study (NCT04382326) in infants and anticipated
clinical trial readouts and 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
particular jurisdictions for 20vPnC for any potential indications;
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 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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