If approved, the vaccine would help protect
adults against 20 serotypes responsible for the majority of
invasive pneumococcal disease and pneumonia
Pfizer Inc. (NYSE:PFE) today announced that the European
Medicines Agency (EMA) accepted for review the Marketing
Authorization Application (MAA) for its 20-valent pneumococcal
conjugate vaccine (20vPnC) candidate, as submitted for the
prevention of invasive disease and pneumonia caused by
Streptococcus pneumoniae serotypes in the vaccine in adults ages 18
years and older. With the MAA acceptance, the formal review process
by the EMA’s Committee for Medicinal Products for Human Use (CHMP)
begins.
“The epidemiology of pneumococcal serotypes causing disease has
been changing due to the success of pneumococcal conjugate vaccines
targeting pediatric and adult populations. In many countries across
Europe and around the world, more than half of all cases of
invasive pneumococcal disease in older adults are due to the 20
serotypes covered in 20vPnC, including seven serotypes (8, 10A,
11A, 12F, 15B, 22F, and 33F) that are not included in any currently
licensed pneumococcal conjugate vaccine,” said Kathrin U. Jansen,
Ph.D., Senior Vice President and Head of Vaccine Research and
Development, Pfizer. “20vPnC builds on the legacy of Prevenar and
Prevnar 13 and our more than two decades of experience and
innovation in developing pneumococcal conjugate vaccines. Today’s
acceptance of the 20vPnC application in the European Union is a
significant step forward in our continuing efforts to potentially
provide adults with robust and meaningful protection against more
pneumococcal disease-causing serotypes.”
The 20vPnC MAA submission encompasses data from Pfizer’s
clinical program in adults, which includes Phase 1 and 2 trials and
three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975)
describing the safety and evaluating the immunogenicity of the
vaccine candidate to support licensure for an indication to prevent
invasive pneumococcal disease and pneumococcal pneumonia caused by
Streptococcus pneumoniae serotypes in the vaccine in adults 18
years or older. The three Phase 3 trials have enrolled more than
6,000 adult subjects, 18 years and older, including adults 65 years
of age and above, vaccine-naïve adults, and adults with prior
pneumococcal vaccination.i,ii
ABOUT 20vPnC
Pfizer’s 20vPnC vaccine candidate includes capsular
polysaccharide conjugates for the 13 serotypes in Prevenar 13®1
(pneumococcal polysaccharide conjugate vaccine [13 – valent,
adsorbed]). The vaccine also contains capsular polysaccharide
conjugates for seven additional serotypes that cause invasive
pneumococcal disease (IPD),iii,iv,v,vi,vii and have been associated
with high case-fatality rates,viii,ix,x,xi antibiotic
resistance,5,xii,xiii and/or meningitis.xiv,xv Together, the 20
serotypes included in 20vPnC are responsible for the majority of
currently circulating pneumococcal disease
globally.xvi,xvii,xviii,xix,xx,xxi,xxii
The U.S. FDA has accepted for priority review the biologics
license application of 20vPnC in adults 18 years of age and older
with a Prescription Drug User Fee Act goal date in June 2021. In
June 2020 Pfizer announced initiation of two Phase three trials for
20vPnC evaluating the safety and efficacy of the investigational
vaccine in infants.
INDICATIONS FOR PREVNAR 13® (Pneumococcal 13-valent Conjugate
Vaccine [Diphtheria CRM197 Protein])
- 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
U.S. 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
For the full prescribing information for Prevnar 13®, please
visit http://labeling.pfizer.com/showlabeling.aspx?id=501
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 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 February 26,
2021. 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 a MAA filed in the European Union for the prevention of
invasive disease and pneumonia in adults age 18 years or older,
expected licensure criteria, 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 other
jurisdictions for 20vPnC for the prevention of invasive disease and
pneumonia in adults age 18 years or older and in any jurisdictions
for any other potential indications; whether and when the MAA
pending in the EU and the biologics license application pending in
the U.S. may be approved and whether and when any such other
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, 2020, 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 Trademark. Prevnar 13 is the trade name in the United States,
Canada, and Taiwan.
i Pfizer Inc. NCT03828617 Study Design. Available at
www.clinicaltrials.gov under the identifier NCT03828617.
ii Pfizer Inc. NCT03835975 Study Design. Available at
www.clinicaltrials.gov under the identifier NCT03835975.
iii 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.
iv 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.
v 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.
vi 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.
vii 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.
viii 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.
ix 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.
x 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.
xi 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.
xii 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.
xiii 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.
xiv 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.
xv Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial
Meningitis in the United States, 1998–2007. NEJM.
2011;364(21):2016-2025.
xvi Centers for Disease Control and Prevention. Active Bacterial
Core (ABCs) surveillance. National Center for Immunization and
Respiratory Diseases. Atlanta, GA.
xvii 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.
xviii 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.
xix 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.
xx Pilishvili 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.
xxi European Centre for Disease Prevention and Control. Invasive
pneumococcal disease. In: ECDC. Annual epidemiological report for
2016. Stockholm: ECDC; 2018.
xxii 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).
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Media: Steve Danehy +1 (978) 273-3946 Steve.Danehy@pfizer.com Investor: Bryan Dunn +1 (212) 733-8917 Bryan.Dunn@pfizer.com
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