- Positive pivotal top-line data demonstrates 20-valent
pneumococcal conjugate vaccine candidate (20vPnC), if approved, can
likely help protect against all 20 vaccine serotypes in three-dose
series and potentially offer the broadest serotype coverage of any
available pneumococcal conjugate vaccine (PCV)
- The safety profile of 20vPnC was favorable and similar to
Prevenar 13® (or Prevnar 13® in the U.S.) in this schedule, and
concomitant use with common pediatric vaccines was supported and
well tolerated
- 20vPnC also showed robust functional antibody responses to the
vaccine serotypes post Dose 2 and 3 similar to Prevenar® and
Prevenar 13®
- The company intends to file for regulatory approval in the EU
in the next few months
Pfizer today announced positive top-line results from its
pivotal E.U. Phase 3 study in infants (NCT04546425) evaluating its
20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the
prevention of invasive pneumococcal disease (IPD), pneumonia, and
acute otitis media caused by the 20 Streptococcus pneumoniae
(pneumococcus) serotypes contained in the vaccine for the pediatric
population.
The study had three coprimary outcomes, associated with
immunogenicity responses one month after the second and third doses
of a three-dose vaccination series given at approximately 2, 4, and
11-12 months of age of 20vPnC compared to Prevenar 13®. For the
non-inferiority (NI) co-primary objective of immunoglobulin G (IgG)
geometric mean concentrations (GMCs) one month after Dose 3 at
11-12 months of age, 19 of the 20 serotypes met the NI criteria
with only one serotype narrowly missing. For the NI co-primary
objective of IgG GMCs one month after Dose 2, 16 of the 20
serotypes met NI. Finally, for the third NI co-primary objective of
the percentage of participants with predefined serotype-specific
IgG concentrations one month after Dose 2, nine of the 20 serotypes
met the NI criteria. All 20 serotypes showed increased booster
responses from post dose 2 to post dose 3 which are indicative of
immunological memory and long-term protection. All 20 vaccine
serotypes also showed strong functional antibody responses as
measured by the opsonophagocytic assay (OPA) post-dose 2 and post
dose 3 similar to Prevenar® and Prevenar 13®. The totality of data
is therefore directionally consistent with prior clinical
experience with Prevenar® and Prevenar 13® after 2 and 3 infant
doses, both of which have demonstrated effectiveness in a
three-dose schedule against the serotypes contained in the vaccine
in post-licensure studies.
In summary, the totality of these positive 20vPnC data, combined
with the experience with Prevenar 13® in this schedule,
demonstrates that the 20vPnC candidate, if approved, is likely to
help protect against all 20 vaccine serotypes in a three-dose
vaccine series.
“Today marks another important milestone in the 20vPnC pediatric
program, with these data demonstrating 20vPnC’s potential to
provide the most comprehensive pneumococcal serotype coverage of
any available pneumococcal conjugate vaccine,” said Annaliesa
Anderson, Ph.D., Senior Vice President and Chief Scientific
Officer, Vaccine Research and Development, Pfizer. “Based on the
totality of immunogenicity and safety data, we feel confident that
20vPnC is likely to be protective against all vaccine serotypes in
a three-dose series. We are thankful to everyone who worked on or
participated in this study, and we look forward to hopefully being
able to provide infants with more robust and meaningful protection
against more pneumococcal disease-causing serotypes in the near
future.”
The safety profile of 20vPnC was similar to Prevenar 13® in this
schedule, and concomitant use with common pediatric vaccines were
supported.
Pfizer plans to file these data by the end of this year with the
European Medicines Agency (EMA). These positive data mark the
conclusion of pivotal topline readouts for the 20vPnC pediatric
program. Pfizer will also seek to present and publish outcomes from
this clinical trial at a future date once safety and immunogenicity
data have been fully analyzed.
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 Prevenar 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 Prevenar 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 Prevenar 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 Prevenar 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 EU and
globally.
On Feb 14, 2022, the European Commission Decision was adopted
for APEXXNAR ® (20vPnC) 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 PREVENAR 13®
- Active immunisation for the prevention of invasive disease,
pneumonia and acute otitis media caused by Streptococcus pneumoniae
in infants, children and adolescents from 6 weeks to 17 years of
age.
- Active immunisation for the prevention of invasive disease and
pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of
age and the elderly.
- The use of Prevenar 13 should be determined on the basis of
official recommendations taking into consideration the risk of
invasive disease and pneumonia in different age groups, underlying
comorbidities as well as the variability of serotype epidemiology
in different geographical areas.
IMPORTANT SAFETY INFORMATION
- Prevenar 13® should not be given to anyone with a history of
severe allergic reaction to any component of Prevenar 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
Prevenar 13®. Only a healthcare provider can decide if Prevenar 13®
is right for you or your child
INDICATIONS FOR APEXXNAR®
- Active immunisation for the prevention of invasive disease and
pneumonia caused by Streptococcus pneumoniae in individuals 18
years of age and older. APEXXNAR ® should be used in accordance
with official recommendations.
IMPORTANT SAFETY INFORMATION
- APEXXNAR should not be given to anyone with a history of severe
allergic reaction to any component of APEXXNAR or to diphtheria
toxoid
- Adults with weakened immune systems may have a lower response
to APEXXNAR ®. Safety data are not available for these groups. Your
healthcare provider can tell you if APEXXNAR ® 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 49 years of age
- Ask your healthcare provider about the risks and benefits of
APEXXNAR ®. Only a healthcare provider can decide if APEXXNAR ® 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 September 19,
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 (NCT04546425) in infants and anticipated
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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