Pfizer Begins Phase 1 Clinical Trial to Evaluate Investigational Group B Streptococcus Vaccine

An estimated 10 to 30 percent of pregnant women carry the GBS
bacteria;
1 the vaccine candidate is being studied to
help protect newborns from infection via maternal immunization

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1
trial in healthy volunteers of PF-06760805, an investigational vaccine
designed to help protect against Group B Streptococcus (GBS)
infection. In newborns, GBS manifests as sepsis, pneumonia, and
meningitis,2 with potentially fatal outcomes for some, and
long-lasting neurological damage in 46 to 50 percent of those infected.3

“Because their immune systems are still immature, GBS can have
potentially devastating effects on newborns,” said Carol J. Baker, M.D.,
Professor of Pediatrics-Infectious Disease at the Baylor College of
Medicine in Houston, Texas. “The global health community would welcome a
vaccine that could help reduce the impact of GBS everywhere,
particularly in areas where the routine administration of antibiotics is
not common practice.”

Women who are carriers of the GBS bacteria may pass it on to their
newborns during labor and birth. The U.S. and certain developed
countries have established recommendations for women to be screened for
GBS during their third trimester of pregnancy, and administered
prophylactic antibiotics during labor to prevent transmission to their
newborns at delivery.4,5 However, this requires a
robust health delivery infrastructure that is not widely available
globally.

“Pfizer is proud to take this important first step to support our
efforts to ultimately develop a GBS vaccine with the potential to
immunize a mother to help protect her infant against a devastating
disease,” said Kathrin Jansen, Ph.D., senior vice president and head of
Vaccine Research and Development for Pfizer Inc.

The risk of developing GBS is highest in the first three months of a
newborn’s life.6 While there is variation in the incidence of
GBS infant disease among regions of the world, the disease is
potentially devastating. A successfully developed, efficacious vaccine
could be an important strategy for global disease prevention.

Clinical Development Program

The trial is designed as a Phase 1/2 randomized, placebo-controlled,
observer-blinded study in healthy adults 18 to 49 years of age with no
history of a GBS infection, and will be conducted in the United States.

Because of the urgent need to help protect newborns in low- and
middle-income countries from this devastating condition, and the intent
to make a successfully developed vaccine available globally as quickly
as possible, Pfizer is pursuing a clinical development strategy in
high-, middle- and low-income countries.

In 2016, Pfizer received a grant from the Bill & Melinda Gates
Foundation to conduct a Phase 1/2 clinical trial of Pfizer’s vaccine
candidate against GBS infection in South Africa, which has one of the
highest invasive GBS disease incidences of 2.38 cases per 1,000 live
births.7

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
best-known consumer health care 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
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DISCLOSURE NOTICE: The information contained in this release
is as of June 19, 2017. 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
vaccine candidate against Group B Streptococcus (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, 2016 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 (CDC) “2010 Guidelines for the Prevention
of Perinatal Group B Streptococcal Disease”. Accessed June 5, 2017.
Available at https://www.cdc.gov/groupbstrep/guidelines/guidelines.html
2
Kwatra G, et al. “Prevalence of maternal colonization with group b
streptococcus: a systematic review and meta-analysis. Lancet Infectious
Disease 2016; 16:1076-84. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/27236858
3
Kwatra G, et al. “Prevalence of maternal colonization with group b
streptococcus: a systematic review and meta-analysis. Lancet Infectious
Disease 2016; 16:1076-84. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/27236858
4
Centers for Disease Control and Prevention (CDC) “2010 Guidelines for
the Prevention of Perinatal Group B Streptococcal Disease”. Accessed
June 5, 2017. Available at https://www.cdc.gov/groupbstrep/guidelines/guidelines.html
5
Di Renzo G.C, et al. “Intrapartum GBS screening and antibiotic
prophylaxis: a European consensus conference.” The Journal of
Maternal-Fetal & Neonatal Medicine 2014.28(7): 766-82. Accessed on June
8, 2017. Available at http://www.tandfonline.com/doi/full/10.3109/14767058.2014.934804
6
Edmond KM, Kortsalioudaki C, Scott S, et al.: “Group B streptococcal
disease in infants aged younger than 3 months: systematic review and
meta-analysis.” Lancet. 2012;379(9815):547–556.
10.1016/S0140-6736(11)61651-6. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/22226047
7
Dangor Z, Lala SG, et al., “Burden of Invasive Group B Streptococcus
Disease and Early Neurological Sequelae in South African Infants.”
Accessed May 25, 2017. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123014#sec014

Contacts

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