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
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 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 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:
1Baisells E, Guillot L, Nair H, et al. Serotype distribution of
Streptococcus pneumoniae causing invasive disease in children in
the post-PCV era: A systematic review and meta-analysis. PlosOne.
2017;12(5): e0177113.2Hausdorff W & Hanage W. Interim results
of an ecological experiment – Conjugate Vaccination against the
pneumococcus and serotype replacement. Hum Vaccin Immunother.
2016;12(2):358-374.3Cohen R, Cohen J, Chalumeau M, et al. Impact of
pneumococcal conjugate vaccines for children in high- and non-high
income countries. Expert Rev Vaccines. 2017;16(6):625-640.4Moore M,
Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent
pneumococcal conjugate vaccine in children on invasive pneumococcal
disease in children and adults in the USA: analysis of multisite,
population-based surveillance. Lancet Infect Dis.
2015;15(3):301-309.5Metcalf B, Gertz RE, Gladstone RA, et al.
Strain features and distributions in pneumococci from children with
invasive disease before and after 13-valent conjugate vaccine
implementation in the USA. Clin Microbiol Infect. 2016;22(1):60.
e9-60. e29.6Oligbu G, Collins S, Sheppard CL, et al. Childhood
Deaths Attributable to Invasive Pneumococcal Disease in England and
Wales, 2006–2014. Clin Infect Dis. 2017;65(2):308-314.7van Hoek,
Andrews N, Waight PA, et al. Effect of Serotype on Focus and
Mortality of Invasive Pneumococcal Disease: Coverage of Different
Vaccines and Insight into Non-Vaccine Serotypes. PlosOne.
2012;7(7): e39150.8Stanek R, Norton N, Mufson M. A 32-Years Study
of the Impact of Pneumococcal Vaccines on Invasive Streptococcus
pneumoniae Disease. Am J Med Sci. 2016;352(6):563-573.9Harboe ZB,
Thomsen RW, Riis A, et al. Pneumococcal Serotypes and Mortality
following Invasive Pneumococcal Disease: A Population-Based Cohort
Study. PlosOne. 2009;6(5): e 1000081.10Tomczyk S, Lynfield R,
Schaffner W, et al. Prevention of Antibiotic-Nonsusceptible
Invasive Pneumococcal Disease With the 13-Valent Pneumococcal
Conjugate Vaccine. Clin Infect Dis. 2016;62(9):1119-1125.11Mendes
RE, Hollingsworth RC, Costello A, et al. Noninvasive Streptococcus
pneumoniae Serotypes Recovered from Hospitalized Adult Patients in
the United States in 2009 to 2012. Antimicrob Agents Chemother.
2015;59(9):5595-5601.12Olarte L, Barson WJ, Lin PL, et al. Impact
of the 13-valent pneumococcal conjugate vaccine on pneumococcal
meningitis in US children. Clin Infect Dis.
2015;61(5):767-775.13Thigpen MC, Whitney CG, Messonnier NE, et al.
Bacterial Meningitis in the United States, 1998–2007. NEJM.
2011;364(21):2016-2025.14Centers for Disease Control and
Prevention. Active Bacterial Core (ABCs) surveillance. National
Center for Immunization and Respiratory Diseases. Atlanta,
GA.15Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in
non-vaccine serotypes causing invasive pneumococcal disease in
England and Wales, 2000–17: a prospective national 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 serotypes in hospitalized pneumococcal pneumonia in Spain
using a novel urinary antigen detection test. CAPA study. Vaccine.
2017;35(39):5264-5270.17Azzari C, Cortimiglia M, Nieddu F, et al.
Pneumococcal serotype distribution in adults with invasive disease
and in carrier children in Italy: Should we expect herd 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, 2018.19European
Centre for Disease Prevention and Control. Invasive pneumococcal
disease. In: ECDC. Annual epidemiological report for 2016.
Stockholm: ECDC; 2018.20Beall B, Chochua S, Gertz RE Jr, et al. A
population-based descriptive atlas of invasive pneumococcal strains
recovered within the U.S. during 2016-2016. Front Microbiol.
2018;19(9).21U.S. Food and Drug Administration. Breakthrough
Therapy
https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm22 U.S.
Food and Drug Administration. Fast Track
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm23 Data
on file. Pfizer Inc., New York, NY
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190413005002/en/
Media:Jessica Smith (U.S.)(212)
733-6213jessica.m.smith@pfizer.com
Dervila Keane (EU)(353) 86 211
0834Dervila.M.Keane@pfizer.com
Investors:Ryan Crowe(212) 733-8160ryan.crowe@pfizer.com
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