Study Finds Prevnar 13 was Associated With Reduced Risk of
Hospitalization From Vaccine-Type Community-Acquired Pneumonia in Older
Adults
1
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE) announced today that results from a study
analyzing real-world effectiveness data found that Prevnar 13®
(pneumococcal 13-valent conjugate vaccine [diphtheria CRM197
Protein]) reduced the risk of hospitalization from vaccine-type
pneumococcal community-acquired pneumonia (CAP) by 73% (95% CI:
12.8−91.5%) in adults aged 65 and older.1 Importantly,
Prevnar 13 (PCV13) worked under real-world conditions where people
received pneumococcal vaccination as advised by their health care
providers, and many had underlying medical conditions that increase the
risk for pneumococcal pneumonia.1 The results were published
in Clinical
Infectious Diseases.
The study, conducted jointly between the University of Louisville School
of Medicine and Pfizer, was designed as a test-negative case-control
study and provides evidence supporting the findings of the landmark
randomized, controlled Community-Acquired Pneumonia Immunization Trial
in Adults (CAPiTA).1 CAPiTA was one of the largest vaccine
efficacy trials ever conducted in older adults and demonstrated a
significant reduction by 45.6% (95.2% CI: 21.8-62.5; p<0.001) in
vaccine-type pneumococcal CAP in adults vaccinated with PCV13.2
The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA)
excluded people with high-risk medical conditions.2 The
safety profile of PCV13 in CAPiTA was consistent with studies previously
conducted in adults.2
“The new effectiveness data further demonstrate that vaccinating adults
aged 65 and older against pneumococcal pneumonia with PCV13 could help
prevent hospitalization and save lives,”1 said Dr. Julio A.
Ramirez, Chief, Division of Infectious Diseases, University of
Louisville School of Medicine, and one of the study authors.
“Specifically, based on a 73% vaccine effectiveness observed in this
study, we estimate that PCV13 vaccination in adults 65+ might prevent
thousands of CAP-related hospitalizations.”1
Streptococcus pneumoniae, also known as pneumococcus, is the most
common bacterial cause of CAP.3,4 Pneumococcal pneumonia can
be classified as non-invasive, when bacteria cause infection in the
lungs but are not detected in the blood, or invasive, when bacteria also
enter the bloodstream (bacteremic pneumonia) or another normally sterile
site in the body.5 For every one case of invasive
pneumococcal pneumonia in adults, it is estimated that at least three
cases of non-invasive pneumococcal pneumonia occur.6 While
non-invasive forms of pneumococcal disease are typically more common,
the invasive types of disease are generally more severe.7
“These results complement the Community-Acquired Pneumonia Immunization
Trial in Adults study, suggesting that PCV13 is effective under the
real-world circumstances of an immunization program, including a
percentage of individuals with high-risk conditions that were excluded
from the Community-Acquired Pneumonia Immunization Trial in Adults
analysis,”1 said Dr. Luis Jodar, Chief Medical and Scientific
Affairs Officer, Vaccines Medical Development, Scientific and Clinical
Affairs, Pfizer Inc. “These findings, as well as the continuous
circulation of the 13 serotypes included in PCV13 among adults, confirm
the importance of direct vaccination in this age group.”
About the Test-Negative Design Study in Older Adults
The study was nested within a population-based surveillance study of
adults in Louisville, Kentucky, United States, who were hospitalized
with CAP. The population-based surveillance study prospectively enrolled
adults in Louisville, Kentucky who were hospitalized with CAP in one of
nine adult acute-care hospitals between October 7, 2013 and September
30, 2016. The nested case-control sub-study analyzed a subset of CAP
patients enrolled between April 1, 2015 and April 30, 2016. The study
used an established measure of vaccine effectiveness known as a
test-negative design. In this study, patients hospitalized with CAP had
routine cultures performed as well as a urine antigen detection test to
determine if they had infections with pneumococcal serotypes included in
the vaccine, PCV13. Patients with pneumonias caused by pneumococcal
serotypes included in PCV13 were considered “cases,” and “control”
subjects were patients with CAP who tested negative for PCV13 serotypes.1
Considerations for Using Real-World Data: Clinical studies analyzing
real-world data have the potential to supplement randomized trials by
providing additional information about how a medicine performs in
routine medical practice. Clinical studies analyzing real-world data
have several limitations. For example, the source and type of data used
may limit the generalizability of the results and of the endpoints. Due
to these limitations, real-world data analyses are not generally used as
stand-alone evidence to validate the efficacy and/or safety of a
treatment.
In the study period, there were a total of 2,034 CAP hospitalizations
with a median age of 76 years. Researchers identified PCV13 serotypes in
68 (3.3%) of patients who served as the case subjects. Cases were less
likely to have received PCV13 vs. controls (4.4% vs. 14.5%, P=0.02).
This indicated that PCV13 use in adults aged 65 and older can prevent
73% of CAP caused by PCV13 serotypes.1
Additional information on the study population included:
-
88% had at least one underlying risk factor for pneumococcal
pneumonia, including chronic obstructive pulmonary disease (53%),
coronary artery disease (35%), congestive heart failure (32%), and
diabetes (32%)1
-
46% were immunocompromised, with chronic kidney disease (23%) and
cancer (19%) being the most common conditions1
-
21% had previously received another pneumococcal vaccine, PPSV23 in
the past 5 years; the effectiveness of PCV13 was not affected by prior
use of PPSV23.1 As noted in the United States Prescribing
Information, prior receipt of PPSV23 within 1-year results in
diminished immune responses to PCV13 compared to PPSV23-naïve
individuals8
-
The median hospital stay for CAP was 6 days1
-
6.5% of patients with CAP died during the initial hospital stay and
12.7% died within 30 days1
In 2014, the U.S. Centers for Disease Control and Prevention’s Advisory
Committee on Immunizations Practices (ACIP) recommended routine
immunization with PCV13 for adults 65 years and older based on the data
from the Community-Acquired Pneumonia Immunization Trial in Adults
(CAPiTA).9 This follows the ACIP 2012 recommendation for
routine vaccination with PCV13 for adults 19 years of age and older with
immunocompromising conditions (eg, HIV, chronic renal failure, cancer),
functional or anatomic asplenia (eg, sickle cell disease), cerebral
spinal fluid leak, and Cochlear implants.10
About Prevnar 13
®
Prevnar 13® (pneumococcal 13-valent conjugate vaccine
[diphtheria CRM197 Protein]) was approved in the U.S. in
February 2010 for use in infants and young children.
The vaccine is indicated in children 6 weeks through 17 years (prior to
the 18th birthday) for active immunization for the prevention of
invasive disease caused by Streptococcus pneumoniae (S. pneumoniae)
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and
for children 6 weeks through 5 years of age (prior to the 6th birthday)
for the prevention of otitis media caused by 7 of the 13 serotypes only
(4, 6B, 9V, 14, 18C, 19F, and 23F).
In adults 18 years of age and older, Prevnar 13® is indicated
for active immunization for the prevention of pneumonia and invasive
disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V,
14, 18C, 19A, 19F, and 23F.
Limitations of Use and Effectiveness
-
Prevnar 13® does not protect against disease caused by S.
pneumoniae serotypes that are not in the vaccine
Prevnar 13® is the trade name in the United States, Canada,
and Taiwan. Outside these countries, it is marketed as Prevenar 13®
(pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]).
It is approved in the EU and other countries for use in infants, older
children and adolescents aged 6 to 17 years. In addition, Prevenar 13 is
approved for use in adults 50 years of age and older in more than 100
countries. Prevenar 13 is approved in the EU and more than 40 other
countries for use in adults 18 to 49 years of age.
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
click here http://labeling.pfizer.com/ShowLabeling.aspx?id=501.
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
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DISCLOSURE NOTICE: The information contained in this release is as of
May 22, 2018. 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 Prevnar
13/Prevenar 13, including 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, uncertainties
regarding commercial impact; the uncertainties inherent in research and
development, including, without limitation, the possibility of
unfavorable clinical trial results, including unfavorable new clinical
data and additional analyses of existing clinical data; uncertainties
regarding the ability to obtain or maintain recommendations from vaccine
technical committees, recommending bodies and other public health
authorities regarding Prevnar 13 and uncertainties regarding the
commercial impact of any such recommendations; decisions by regulatory
authorities regarding labeling and other matters that could affect the
availability or commercial potential of Prevnar 13/Prevenar 13; 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, 2017 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 McLaughlin J, Jiang Q, Isturiz
RE, et al. Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine
Against Hospitalization for Community-Acquired Pneumonia in Older US
Adults: A Test-Negative Design. Clinical Infectious Diseases.
doi: 10.1093/cid/ciy312. https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/ciy312.
Accessed May 22, 2018.
2 Bonten MJM, Huijts SM,
Bolkenbaas M, et al. Polysaccharide Conjugate Vaccine against
Pneumococcal Pneumonia in Adults. N Engl J Med.
2015;372(12):1114-1125. doi:10.1056/NEJMoa1408544.
3
World Health Organization. International travel and health. Pneumococcal
disease. http://www.who.int/ith/diseases/pneumococcal/en/.
Accessed May 22, 2018.
4 Welte T, Torres A, Nathwani D.
Clinical and economic burden of community-acquired pneumonia among
adults in Europe. Thorax. 2012;67(1):71-79.
5
Centers for Disease Control and Prevention. MMWR Recommendations and
Reports. Prevention of pneumococcal disease: Recommendations of the
Advisory Committee on Immunization Practices (ACIP). 1997;46(RR-8):1-24.
6
Said MA, Johnson HL, Nonyane BAS, et al. Estimating the burden of
pneumococcal disease among adults: a systematic review and meta-analysis
of diagnostic techniques. PLoS ONE. 2013;8(4):e60273.
7
World Health Organization. Immunization, vaccines and biologicals.
Pneumococcal vaccines. Available at: http://archives.who.int/vaccines/en/pneumococcus.shtml.
Accessed May 22, 2018.
8 PREVNAR 13- pneumococcal
13-valent conjugate vaccine injection, suspension. Wyeth Pharmaceutical
Division of Wyeth Holdings LLC, a subsidiary of Pfizer Inc. Full
prescribing information. 8/2017.
9 Tomczyk S, Bennett
NM, Stoecker C, et al. Use of 13-valent pneumococcal conjugate vaccine
and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65
years: recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822-825.
10
Centers for Disease Control and Prevention. Morbidity and Mortality
Weekly Report. Use of 13-valent pneumococcal conjugate vaccine and
23-valent pneumococcal polysaccharide vaccine for adults with
immunocompromising conditions. http://stacks.cdc.gov/view/cdc/29139.
October 12, 2012. Accessed May 22, 2018.
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Source: Pfizer Inc.