Additionally, Pfizer Has Completed
Enrollment of its Phase 3 Studies (NCT03828617, NCT03835975 and
NCT03760146) for its 20-Valent Pneumococcal Conjugate Vaccine
Candidate Being Investigated for the Prevention of Invasive Disease
and Pneumonia in Adults Aged 18 Years and Older
Pfizer Inc. (NYSE: PFE) announced today positive preliminary
results following administration of three doses in a four-dose
series for a Proof-of-Concept Phase 2 study (B7471003) to assess
safety and immunogenicity of its 20-valent pneumococcal conjugate
vaccine (20vPnC) candidate, PF-06482077, being investigated for the
prevention of invasive disease and otitis media caused by
Streptococcus pneumoniae serotypes contained in the vaccine in
healthy infants. Pfizer’s 20vPnC candidate includes the 13
serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate
Vaccine [Diphtheria CRM197 Protein]) plus seven additional
serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
“The initial three doses of 20vPnC in this Phase 2 trial provide
preliminary evidence that the vaccine candidate in infants has an
overall safety profile that is similar to Prevnar 13. 20vPNC
induced immune responses for all 20 serotypes in infants. These
findings are encouraging and should support the program’s
advancement to Phase 3,” said Kathrin U. Jansen, Ph.D., Senior Vice
President and Head of Vaccine Research & Development, Pfizer.
“Once data with the fourth dose are available, we will discuss
Phase 3 plans with regulators. If successful in Phase 3 and
approved, 20vPnC may help protect infants against seven additional
Streptococcus pneumoniae serotypes, which represent prevalent
circulating global disease strains today, in addition to those
contained within Prevnar 13.”
B7471003 is a randomized, double-blind Phase 2 proof-of concept
study to assess the safety and immunogenicity of 20vPnC in
approximately 460 healthy infants. Subjects were randomized equally
to receive a 4-dose series of either 20vPnC or Prevnar 13 at 2, 4,
6, and 12 months of age. Local reactions and systemic events were
collected for 7 days after each vaccination. Adverse events were
collected in a similar fashion to the Prevnar 13 infant program.
More details on the study can be found on www.clinicaltrials.gov.
(NCT03512288)
Pfizer will seek to present and publish outcomes from this
clinical trial at a future date once safety and immunogenicity data
has been analyzed following the completion of the four-dose
regimen.
20vPnC Phase 3 Adult Program Completes Enrollment
Pfizer has completed enrollment in its three Phase 3 pivotal
clinical trials (NCT03828617, NCT03835975 and NCT03760146)
evaluating 20vPnC for the prevention of invasive disease and
pneumonia in adults 18 years and older. Combined, these three
trials have enrolled more than 6,000 adult subjects, including
populations of vaccine-naïve adults and adults with prior
pneumococcal vaccination. Pfizer remains on track to submit the
Biologics License Application for the adult 20vPnC indications to
the U.S. FDA by the end of 2020, subject to the successful
completion of these Phase 3 studies.
About 20vPnC
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 rates6,7,8,9, 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 the U.S. and
globally.14,15,16,17,18,19,20
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.
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 S. 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 Streptococcus
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 (eg, 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
Pfizer Inc.: 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 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 September 9, 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,
potential advancement to Phase 3 trials for a potential pediatric
indication 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 2015-2016. Front Microbiol. 2018;19(9).
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190909005325/en/
Media: Jessica Smith (212) 733-6213 jessica.m.smith@pfizer.com
Investor: Ryan Crowe (212) 733-8160 ryan.crowe@pfizer.com
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