- Grant from the Bill & Melinda Gates
Foundation will help advance potential new vaccine that could
provide protection from debilitating infections before and shortly
after birth
- About 1 out of every 4 pregnant women
carries group B Streptococcus bacteriai which could be passed from
mother to baby during labor and birth
- A severe, aggressive and potentially
deadly infection, group B Streptococcus is a leading cause of
life-threatening neonatal sepsis and meningitisii
Pfizer Inc. (NYSE:PFE) today announced an award of a grant from
the Bill & Melinda Gates Foundation to conduct a Phase 1/2
clinical trial of Pfizer’s vaccine candidate against group B
Streptococcus (group B strep or GBS) infection, a leading cause of
neonatal sepsis, a serious life-threatening blood infection.iii The
investigational vaccine is designed to protect newborns via
maternal immunization.
There is an urgent global health need for a vaccine that could
protect pregnant women and their infants against GBS, particularly
in developing countries where prophylactic administration of
antibiotics is not routine. A pregnant woman has the ability to
transfer protective antibodies to her unborn child through the
placenta; if successful, the vaccine could help augment this
protective effect for the newborn baby.
"The first few days and weeks of a baby's life are the most
dangerous by far,” said Keith Klugman, Director for Pneumonia at
the Bill & Melinda Gates Foundation. “The clinical development
of a group B streptococcal vaccine would be an important landmark
in the story of vaccine development to protect newborns from this
disease through the immunization of their mothers."
Neonatal GBS infection is a debilitating and often fatal disease
with mortality rates of around 6% to 14% of those infected in
industrialized countriesiv and approximately 14% to 38% of those
infected in parts of the developing world.v The estimated incidence
of invasive GBS disease is among the highest in South Africa, with
2.38 cases per 1,000 live births.vi
“The health benefits of maternal immunization to protect
pregnant mothers and their babies against flu, tetanus and
pertussis are well-documented,” said Kathrin U. Jansen, Ph.D.,
Senior Vice President and Head of Vaccine Research &
Development, Pfizer. “We are looking to determine whether our
investigational vaccine could generate levels of protective
antibodies in the mother that, when passed to her unborn baby, will
protect the baby against deadly GBS infection during a time when
the infant is most vulnerable to infection.”
GBS bacteria have the potential to cause severe disease,
particularly in newborn infants who have an immature immune system
that is still adapting to the environment outside the womb. Some of
the most common complications caused by GBS impact the blood,
lungs, lining of the brain, and spinal cord in the form of sepsis,
pneumonia or meningitis. It is estimated that more than 40% of
survivors remain impaired during childhood.vii Current preventative
care in the developed world consists of prophylactic treatment with
intravenous antibiotics before delivery of the baby, which is an
uncommon practice in the developing world as it presents multiple
challenges to implementation in countries lacking a robust health
care infrastructure.
Research has shown that a potential conjugate vaccine that
incorporates at least five serotypes of GBS could prevent
approximately 95% of group B streptococcal disease in infants
younger than three months.viii
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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
products. 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, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us
at www.pfizer.com. In addition, to learn more, follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, and like us on
Facebook at Facebook.com/Pfizer.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of October 19,
2016. 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 an award
of a grant from Bill & Melinda Gates Foundation to Pfizer and
Pfizer’s vaccine candidate against group B Streptococcus (group B
strep or GBS), including their 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 study commencement and
completion dates as well as the possibility of unfavorable study
results, including unfavorable new clinical data and additional
analyses of existing data; risks associated with preliminary data;
the risk that clinical trial data are subject to differing
interpretations, and, even when we view data as sufficient to
support the safety and/or effectiveness of a product candidate,
regulatory authorities may not share our views and may require
additional data or may deny approval altogether; 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 the assessment by such
regulatory authorities of the benefit-risk profile suggested by the
totality of the efficacy and safety information submitted;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of Pfizer’s vaccine candidate against GBS; 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, 2015 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.
_________________________
i Centers for Disease Control and
Prevention, “Group B Strep (GBS): Fast Facts.” Accessed 8 June
2016. Available at
http://www.cdc.gov/groupbstrep/about/fast-facts.html
ii Thigpen, MC, et al. Bacterial Meningitis in the United States,
1998–2007. N Engl J Med. 2011; 364:2016-2025. iii Thigpen MC, et
al. Bacterial Meningitis in the United States, 1998–2007. N Engl J
Med. 2011: 364:2016-2025.
iv Edwards MS, Gonik B, “Preventing the
broad spectrum of perinatal morbidity and mortality through group B
streptococcal vaccination.” Accessed 24 June 2016. Available at
http://www.ncbi.nlm.nih.gov/pubmed/23200934
v Johri AK, Lata H, et al., “Epidemiology
of Group B Streptococcus in developing countries.” Accessed 24 June
2016. Available at http://www.ncbi.nlm.nih.gov/pubmed/23973346
vi Dangor Z, Lala SG, et al., “Burden of
Invasive Group B Streptococcus Disease and Early Neurological
Sequelae in South African Infants.” Accessed 13 October 2016.
Available at
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123014#sec014
vii Libster R, Edwards KM, et al.,
“Long-term outcomes of group B streptococcal meningitis.” Accessed
24 June 2016. Available at
http://www.ncbi.nlm.nih.gov/pubmed/22689869
viii Le Doare K, Heath PT, “An overview of
global GBS epidemiology.” Vaccine. 2013; D7– D12. Accessed October
10 2016. Available at
http://www.sciencedirect.com/science/article/pii/S0264410X13000285
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Pfizer Inc.MediaSally Beatty,
347-330-7867sally.beatty@pfizer.comorInvestorsRyan Crowe,
212-733-8160ryan.crowe@pfizer.com
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