A new study published in The Journal of
Infectious Diseases showed high rates of GBS infection among the
elderly, African Americans, and people with chronic
conditions
Pfizer Inc. (NYSE:PFE) today announced detailed results of the
first study to show the burden of both invasive and non-invasive
Group B Streptococcus infections (GBS) among hospitalized adults in
the United States. The study, published in The Journal of
Infectious Diseases, estimated that 188,570 GBS-related
hospitalizations (95% confidence interval [CI]: 175,290–202,710)
and 5,660 deaths (95% CI: 5,260–6,080) occur each year among US
adults ages 18 or older when including both invasive and
non-invasive GBS infections. Previous studies describing the burden
of GBS infection in adults have primarily focused on invasive
disease because existing surveillance systems rely on blood culture
collection. In the new study, however, non-invasive disease was 3–4
times more common than invasive disease, suggesting that adult GBS
burden is considerably greater than previously recognized.
The most prevalent sites of GBS infection were the skin and soft
tissue (39%), urinary tract (23%), and bone and joint (16%).
Overall, 79% of infections were non-invasive and most infections
(60%) identified GBS as the only pathogen.
Rates of GBS-associated hospitalization were significantly
higher in adults 65 years and older, African Americans, and people
with underlying chronic medical conditions such as obesity,
diabetes, chronic renal disease, and coronary artery disease. The
finding that obesity and diabetes put patients at increased risk
for GBS-associated hospitalization is especially noteworthy given
that recent Centers for Disease Control and Prevention (CDC)
reports have highlighted that the prevalence of obesity among U.S.
adults is 42%1, and that as many as 34 million American adults
(roughly 13% of all U.S. adults) have diabetes, with another 88
million having pre-diabetes (roughly 35% of all U.S. adults), a
condition that if not treated often leads to type 2 diabetes within
five years.2
The study was conducted as a collaboration between Pfizer and
the University of Louisville Division of Infectious Diseases. The
University of Louisville was recently designated as the first
Center of Excellence for epidemiological research of
vaccine-preventable diseases by Pfizer Vaccines. This collaboration
between the university and Pfizer is aimed at determining the human
health burden of important infectious diseases and potential
vaccine effectiveness.
“These new data suggest that the burden of GBS infection is
considerably greater than previously recognized in earlier
surveillance studies that only focused on invasive disease,” said
Julio Ramirez, M.D., Chief of the Division of Infectious Diseases
at the University of Louisville. “Importantly, we found that the
rates of GBS infection in this study are comparable to that of
other adult infections for which vaccines are routinely
recommended, which underscores the need for developing approaches
for preventing this infectious disease among an aging adult
population.”
Additional findings from the study included the following:
- 73 in every 100,000 adults were hospitalized with GBS infection
each year (95% CI: 68–78), and this annual incidence reached 100
per 100,000 in adults ages 65 or older (95% CI: 85–117)
- 3% of adults hospitalized with GBS infection died
- For every invasive GBS infection, 3.7 non-invasive infections
occurred
- Annual rates of GBS infection in African American adults were
2.6 (95% CI: 2.2–3.1) times higher than in white adults– 157 per
100,000 vs. 60 per 100,000
- Compared with the general population, annual GBS infection
rates were 2 to 6 times higher among adults with underlying chronic
medical conditions, including:
- Chronic renal disease – 421 per 100,000
- Diabetes mellitus – 409 per 100,000
- Coronary artery disease – 259 per 100,000
- History of stroke – 171 per 100,000
- Obesity – 129 per 100,000
- Chronic obstructive pulmonary disorder (COPD) – 98 per
100,000
- Current smokers – 98 per 100,000
“This type of study, evaluating both invasive and non-invasive
GBS infections, is essential for understanding the full spectrum of
GBS disease burden among adults,” said John M. McLaughlin, PhD,
Global Epidemiology and Scientific Affairs Lead, Pipeline Vaccines,
Pfizer Inc., and the lead study author. “These data should aid
healthcare providers with clinical decision-making. Our
population-based study gives the first estimates of total annual
GBS burden in the United States, emphasizing the importance of
preventive efforts in the growing population of adults who are
older or have chronic medical conditions, and will inform future
vaccination strategies.”
In January 2020, Pfizer launched its Vaccines Division’s Centers
of Excellence Network, a global program of collaborations with
academic institutions to conduct real-world epidemiologic research
to accurately identify and measure the burden of specific
vaccine-preventable diseases and potentially evaluate vaccine
effectiveness in adults. This collaborative study between the
University of Louisville and Pfizer was completed prior to the
university being named as Pfizer Vaccine’s first Center of
Excellence site.
About the Study
Study investigators identified GBS infections among adults ≥18
years of age by retrospectively reviewing laboratory and medical
records from six hospitals in Louisville, Kentucky between January
1, 2014 and December 31, 2016. Data describing demographic and
clinical characteristics (e.g., chronic medical conditions) were
collected for each patient. At the time of the study, Louisville’s
population was generally similar to the United States in terms of
demographics and prevalence of underlying chronic medical
conditions based on data from the Behavioral Risk Factor
Surveillance System (BRFSS), an annual survey conducted by the CDC
that provides United States specific and Louisville Metropolitan
Statistical Area specific estimates.
Among the 1,076 adults with GBS infection, the median age was 52
years, 51% were male, 73% were white, 24% were black, and 89% had
≥1 chronic medical condition. Patients had to have GBS isolated
from culture obtained during hospitalization with (1) clinical or
laboratory evidence of local signs and symptoms of infection or (2)
systemic inflammatory response. Instances where GBS was isolated
from culture without local or systemic evidence of infection were
categorized as colonization (only) and were excluded. Pregnant
women meeting criteria for GBS infection were included (except
positive screening cultures from asymptomatic pregnant women).
Annual rates of GBS infection were estimated by dividing the
number of GBS cases occurring among permanent residents of the
catchment area (most-serious site only) identified across the five
hospitals used for calculating incidence by US Census population
estimates for the catchment area. For calculation of
risk-group-specific incidence rates, the prevalence of chronic
medical conditions in the catchment area were obtained from the
Louisville Metropolitan Statistical Area-specific BRFSS.
About Group B Streptococcus
Bacteria called Group B Streptococcus or Streptococcus
agalactiae (Group B strep, GBS) commonly live in people’s
gastrointestinal and genital tracts. The gastrointestinal tract is
the part of the body that digests food and includes the stomach and
intestines. The genital tract is the part of the body involved in
reproduction. Most of the time the bacteria are not harmful and do
not make people feel sick or have any symptoms. Sometimes the
bacteria invade the body and cause certain infections, which are
known as GBS disease.
GBS bacteria can cause many types of infections: bacteremia
(bloodstream infection) and sepsis (the body’s extreme response to
an infection); meningitis (infection of the tissue covering the
brain and spinal cord); pneumonia (lung infection); bone and joint
and skin and soft-tissue infections.
Unfortunately, experts have not identified effective ways to
prevent GBS disease in people older than one week old. How people
get these bacteria or spread them to others is generally unknown,
as the bacteria do not spread through food, water, or anything with
which people may come into contact.
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
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DISCLOSURE NOTICE:
The information contained in this release is as of May 4, 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
results of a study to show the burden of both invasive and
non-invasive GBS among hospitalized adults in the United States
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; risks
associated with interim 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 drug applications may be filed in any jurisdictions for any
potential indications for Pfizer’s vaccine candidate against GBS;
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 they 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 Pfizer’s vaccine candidate against GBS; 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 Hales CM, Carroll MD, Fryar CD, Ogden
CL. Prevalence of obesity and severe obesity among adults: United
States, 2017–2018. NCHS Data Brief, no 360. Hyattsville, MD:
National Center for Health Statistics. 2020. Available at:
https://www.cdc.gov/nchs/data/databriefs/db360-h.pdf. Accessed on
April 20, 2020. 2 Centers for Disease Control and Prevention.
National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for
Disease Control and Prevention, U.S. Dept of Health and Human
Services; 2020. Available at:
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
Accessed on April 20, 2020.
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Media: Jessica Smith 646-899-3178 Steven.Danehy@pfizer.com
Investors: Ryan Crowe 212-733-8160 Ryan.Crowe@pfizer.com
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