The U.S. FDA awarded Breakthrough Therapy Designation for this
potential indication based on these Phase 2 data
– – –
The Biologics License Application is expected to be submitted to the
U.S. FDA by the end of 2020, subject to the successful completion of
Phase 3 studies
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a
Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC)
candidate, PF-06482077, being investigated for the prevention of
invasive disease and pneumonia caused by Streptococcus pneumoniae
serotypes contained in the vaccine in adults aged 18 years and older.
The presentation was delivered at the 29th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) in Amsterdam, Netherlands.
Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar
13 plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
“The safety and immunogenicity results from this study suggest that our
20vPnC candidate, which initiated Phase 3 development in adults last
year, could potentially offer comprehensive coverage of additional
serotypes causing pneumococcal disease globally and in the U.S. as
substantiated by the receipt of FDA’s Breakthrough Therapy Designation,”
said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine
Research & Development, Pfizer. “We believe the full extent of Prevenar
13 protection of adults has yet to be fulfilled. At the same time, there
continues to be a global health need to protect against the potential
effects of invasive pneumococcal disease and pneumonia caused by
additional serotypes not yet covered by existing conjugate vaccines.”
The Phase 2 study was a randomized, active-controlled, double-blinded
trial that enrolled 444 adult subjects age 60 to 64. Subjects received a
single injection of 20vPnC or Prevnar 13 (Vaccination 1). One month
later subjects receiving 20vPnC were given an injection of saline
placebo, and subjects receiving Prevnar 13 were given 23-valent
polysaccharide vaccine (Vaccination 2). Local reactions and systemic
events were recorded for 10 and 7 days respectively after Vaccination 1
and data on adverse events (AEs) were collected for one month following
each vaccination. Immunogenicity was assessed by measuring antibody
associated with serotype-specific bacterial killing (opsonophagocytic
activity [OPA]) prior to vaccination and one month after each
vaccination. The study was designed to describe safety and
immunogenicity data with 20vPnC in a population of older adults. Given
the stage of the study there was no hypothesis testing and data were
summarized.
Of the 444 subjects enrolled, 443 received Vaccination 1 and 427
received Vaccination 2. Robust OPA responses were observed for all 20
vaccine serotypes in the 20vPnC group. The OPA geometric mean fold-rises
from baseline ranged from 6.1 to 68.6 for the serotypes in common with
Prevnar 13, and 9 to 112.2 for the seven additional serotypes not
included in Prevnar 13.
Injection site reactions (redness, swelling or pain) and systemic event
rates were similar after vaccination with 20vPnC or Prevnar 13, with
severe injection site reactions or systemic events reported in less than
one percent of 20vPnC recipients. No deaths or serious AEs considered
related to vaccine were reported in the study. The overall safety
profile of 20vPnC in this study was consistent with historical
experience with Prevnar 13.
The safety and immunogenicity findings from this Phase 2 study supported
progression to Phase 3 clinical development for the adult indication
which started in December 2018.
The seven new serotypes included in 20vPnC are global causes of invasive
pneumococcal disease,1,2,3,4,5 and are associated with high
case-fatality rates,6,7,8,9 antibiotic resistance5,10,11
and/or meningitis.12,13 Together, the 20 serotypes included
in 20vPnC are responsible for the majority of currently circulating
pneumococcal disease in adults in the U.S. and globally.14,15,16,17,18,19,20
About the 20vPnC Phase 3 Program
Pfizer has begun enrollment in three Phase 3 trials (NCT03828617,
NCT03835975 and NCT03760146) evaluating 20vPnC in adults. Combined,
these three trials will enroll more than 6,000 adult subjects, including
populations of vaccine-naïve adults and adults with prior pneumococcal
vaccination.
Pfizer’s Phase 3 pivotal development program for 20vPnC includes three
clinical trials in populations of vaccine-naïve adults and adults with
prior pneumococcal vaccination.
The pivotal Phase 3 trial is enrolling an estimated 3,880 adults and is
designed to compare immune responses after 20vPnC administration to
responses in control subjects ≥60 years old receiving 13-valent
pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide
vaccine; evaluate the immunogenicity of 20vPnC in adults 18-59 years of
age; and describe the 20vPnC safety profile in adults ≥18 years old.
More on the study can be found on www.clinicaltrials.gov
under the identifier NCT03760146.
Another Phase 3 trial was initiated on February 12, 2019 and is planned
to enroll an estimated 875 adults. It is designed to describe the safety
and immunogenicity of 20vPnC in adults 65 years of age or older with
prior pneumococcal vaccination. More on the study can be found on www.clinicaltrials.gov
under the identifier NCT03835975.
A third Phase 3 trial was initiated on February 14, 2019, and is planned
to enroll an estimated 1,610 adults. The study is designed to provide
additional safety data and evaluate three different lots of 20vPnC in
adults 18 through 49 years of age. More on the study can be found on www.clinicaltrials.gov
under the identifier NCT03828617.
About 20vPnC
On September 20, 2018, Pfizer announced the U.S. Food and Drug
Administration (FDA) granted Breakthrough Therapy Designation for 20vPnC
for the prevention of invasive disease and pneumonia in adults age 18
years and older. Breakthrough Therapy Designation is designed to
expedite the development and review of drugs and vaccines that are
intended to treat or prevent serious conditions and preliminary clinical
evidence indicates that the drug or vaccine may demonstrate substantial
improvement over available therapy on a clinically significant
endpoint(s).21 Drugs and vaccines that receive Breakthrough
Therapy Designation are eligible for all features of the FDA’s Fast
Track designation, which may include more frequent communication with
the FDA about the drug’s development plan and eligibility for
Accelerated Approval and Priority Review, if relevant criteria are met.22
The FDA previously granted Fast Track designation for 20vPnC in
September 2017 for use in adults aged 18 years and older.23
The FDA’s Fast Track approach is a process designed to facilitate the
development and expedite the review of new drugs and vaccines intended
to treat or prevent serious conditions and address an unmet medical need.22
Additionally, in May 2017 the FDA granted Fast Track status for a
pediatric indication for 20vPnC and clinical development is in progress.
Pfizer Inc: Working together for a healthier world™
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. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best‐known consumer health care products. 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 150 years, we have worked to make a difference for all who
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In addition, to learn more, please visit us on www.pfizer.com
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DISCLOSURE NOTICE: The information contained in this release is as of
April 13, 2019. 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
20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate,
PF-06482077, including potential regulatory submission, timing and its
potential benefits, 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 biologics license applications may be filed in any
jurisdictions for 20vPnC for any indications; whether and when any such
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 20vPnC 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 technical
committees and other public health authorities regarding 20vPnC and
uncertainties regarding the commercial impact of any such
recommendations; 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, 2018 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.
References:
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2Hausdorff W & Hanage W. Interim
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3Cohen R, Cohen J, Chalumeau M, et
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M, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent
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13Thigpen MC, Whitney CG,
Messonnier NE, et al. Bacterial Meningitis in the United States,
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14Centers for
Disease Control and Prevention. Active Bacterial Core (ABCs)
surveillance. National Center for Immunization and Respiratory Diseases.
Atlanta, GA.
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Rapid increase in non-vaccine serotypes causing invasive pneumococcal
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observational cohort study. Lancet Infect Dis. 2018;18(4):441-451.
16
Menéndez R, España PP, Pérez-Trallero E, et al. The burden of PCV13
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2017;35(39):5264-5270.
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F, et al. Pneumococcal serotype distribution in adults with invasive
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protection of adults through infants’ vaccination? Hum Vaccin
Immunother. 2016;12(2):344-350.
18Pivlishi T. Impact of
PCV13 on invasive pneumococcal disease (IPD) burden and the serotype
distribution in the U.S. Centers for Disease Control and Prevention.
Advisory Committee on Immunization Practices. October 24th,
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19European Centre for Disease Prevention and
Control. Invasive pneumococcal disease. In: ECDC. Annual epidemiological
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20Beall B,
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21U.S. Food and
Drug Administration. Breakthrough Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
22
U.S. Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
23
Data on file. Pfizer Inc., New York, NY
Contacts
Media:
Jessica Smith (U.S.)
(212) 733-6213
jessica.m.smith@pfizer.com
Dervila Keane (EU)
(353) 86 211 0834
Dervila.M.Keane@pfizer.com
Investors:
Ryan Crowe
(212) 733-8160
ryan.crowe@pfizer.com