Pfizer Awarded Grant to Evaluate Vaccine to Protect Newborns Against Group B Streptococcus Infection

  • 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
    bacteria1 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 meningitis2

NEW YORK–(BUSINESS WIRE)–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. 3 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
countries4 and approximately 14% to 38% of those infected in
parts of the developing world.5 The estimated incidence of
invasive GBS disease is among the highest in South Africa, with 2.38
cases per 1,000 live births. 6

“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.7 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.8

Pfizer Inc.: Working together for a healthier
world®

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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.

__________________

1 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

2 Thigpen, MC, et al. Bacterial Meningitis in the United
States, 1998–2007. N Engl J Med. 2011; 364:2016-2025.
3 Thigpen MC, et al. Bacterial Meningitis in the United
States, 1998–2007. N Engl J Med. 2011: 364:2016-2025.

4 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

5 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

6 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

7 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

8 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

Contacts

Pfizer Inc.
Media:
Sally Beatty, 347-330-7867
sally.beatty@pfizer.com
or
Investors:
Ryan
Crowe, 212-733-8160
ryan.crowe@pfizer.com