20-valent pneumococcal conjugate vaccine
elicits consistent immune response across three different
lots
Pfizer Inc. (NYSE:PFE) today announced top-line results from a
second Phase 3 study (NCT03828617), which described the safety and
evaluated the consistency of immune responses elicited across three
different lots of its 20-valent pneumococcal polysaccharide
conjugate vaccine (20vPnC) candidate in adults 18 through 49 years
of age not previously vaccinated against pneumococcal disease.
Responses elicited by 20vPnC for all 20 serotypes were equivalent
across all three lots, meeting the primary immunogenicity objective
of the study. In this study the 20vPnC safety profile was similar
to the Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine
[Diphtheria CRM197 Protein]) control group. This clinical lot
consistency study is expected to satisfy licensure requirements for
manufacturing consistency by the U.S. Food and Drug Administration,
and other countries’ regulatory agencies.
“We are excited by the progress of our adult development program
for 20vPnC as this is the second phase 3 trial for this
investigational vaccine for which we have positive topline data,”
said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of
Vaccine Research & Development, Pfizer. “These new data
highlight Pfizer’s strong heritage, expertise and success in
manufacturing highly-complex biological products such as
pneumococcal conjugate vaccines. Demonstration of lot consistency
is critical to help ensure that vaccine recipients receive the same
level of protection irrespective of the manufactured lot used.”
Pfizer’s 20vPnC vaccine candidate includes 13 serotypes already
included in Prevnar 13. The seven new serotypes included in 20vPnC
are global causes of invasive pneumococcal disease (IPD),1,2,3,4,5
and are associated with high case-fatality rates,6,7,8,9 antibiotic
resistance,5,10,11 and/or meningitis.12,13 Globally, pneumococcal
pneumonia is estimated to cause about 500,000 deaths and 30 million
episodes in adults 70 years and older annually. 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
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.
20vPnC Phase 3 Adult Program
Pfizer’s Phase 3 adult clinical program for 20vPnC includes
three clinical trials (NCT03760146, NCT03828617, and NCT03835975)
evaluating the vaccine candidate for the prevention of invasive
disease and pneumococcal pneumonia in adults 18 years or 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.21,22 All three trials have
been completed and the data for one remaining study will be reading
out over the next few months.
- This press release refers to NCT03828617: Phase 3
randomized, double-blind trial enrolled 1,700 adults aged 18
through 49 years with no history of pneumococcal vaccination. The
study was designed to describe the safety and evaluate consistency
of immune response elicited across three different lots of 20vPnC.
The 20vPnC lots were three unique drug product lots. A 13vPnC arm
was included in the study as a control group for safety
assessments. More on the study can be found on
www.clinicaltrials.gov under the identifier NCT03828617.
Additional trials include:
- NCT03760146: Phase 3 randomized, double-blind trial
comparing immune responses in patients ≥60 years old after 20vPnC
administration to responses in a control group receiving 13vPnC or
PPSV23. The study also evaluated immune responses of 20vPnC in
adults 18 to 59 years (secondary endpoints) and described the
safety profile of 20vPnC in all adults ≥18 years old (primary
endpoint). Additional information about the study can be found at
www.clinicaltrials.gov under the identifier NCT03760146. Pfizer
announced topline findings from this trial in March 2020.
- NCT03835975: Phase 3 randomized, open-label trial,
designed to describe the safety and immune response of 20vPnC in an
estimated 875 adults aged 65 years or older with prior pneumococcal
vaccination. More on the study can be found on
www.clinicaltrials.gov under the identifier NCT03835975.
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 or 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).23 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.24
The FDA previously granted Fast Track designation for 20vPnC in
September 2017 for use in adults aged 18 years or older.25 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.25
Additionally, in May 2017 the FDA granted Fast Track status for
a pediatric indication for 20vPnC.26
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 May 14, 2020.
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,
including expected licensure criteria 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; the impact of
COVID-19 on our 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, 2019 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.
1 Baisells 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. 2 Hausdorff 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. 3 Cohen 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.
4 Moore 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. 5 Metcalf 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. 6 Oligbu 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. 7 van 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. 8 Stanek 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. 9 Harboe 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. 10 Tomczyk 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. 11 Mendes
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. 12 Olarte 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. 13
Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial Meningitis
in the United States, 1998–2007. NEJM. 2011;364(21):2016-2025. 14
Centers for Disease Control and Prevention. Active Bacterial Core
(ABCs) surveillance. National Center for Immunization and
Respiratory Diseases. Atlanta, GA. 15 Ladhani, 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. 17 Azzari 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. 18 Pivlishi
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. 19 European Centre for Disease
Prevention and Control. Invasive pneumococcal disease. In: ECDC.
Annual epidemiological report for 2016. Stockholm: ECDC; 2018. 20
Beall 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). 21 Pfizer
Inc. NCT03828617 Study Design. Available at www.clinicaltrials.gov
under the identifier NCT03828617. 22 Pfizer Inc. NCT03835975 Study
Design. Available at www.clinicaltrials.gov under the identifier
NCT03835975. 23 U.S. Food and Drug Administration. Breakthrough
Therapy
https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm 24
U.S. Food and Drug Administration. Fast Track
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm 25
Data on file. Pfizer Inc., New York, NY 26 Data on file. Pfizer
Inc., New York, NY
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Pfizer Media Contact: Jessica Smith (212) 733-6213
jessica.m.smith@pfizer.com Pfizer Investor Contact: Ryan Crowe
(212) 733-8160 Ryan.Crowe@pfizer.com
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