BUSINESS WIRE: Study Shows Prevenar 13* Is Immunog...

BUSINESS WIRE: Study Shows Prevenar 13* Is Immunogenic In Young Children
Previously Vaccinated

With Prevenar*



MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS
BERICHTENDE UNTERNEHMEN VERANTWORTLICH.
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Other Data Support the Inclusion of Pneumococcal Serotypes 6A and 19A in
Prevenar 13

NEW YORK --(BUSINESS WIRE)--17.03.2010--

According to results from a Phase III safety and immunogenicity study
presented today, Prevenar 13* (Pneumococcal polysaccharide conjugate
vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally
well tolerated in healthy young children who had received at least three
prior doses of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine,
Adsorbed). These data were presented today at the 7th International
Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv,
Israel.

Prevenar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F)
in Prevenar plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A).
Together, these 13 serotypes represent the most prevalent invasive
disease-causing strains in young children worldwide.

“Prevenar has significantly reduced the incidence of invasive pneumococcal
disease in young children in areas where it is routinely used. The data
from this Phase III study showed that children up to 5 years of age
previously vaccinated with Prevenar had an increased immune response
against all 13 serotypes included in Prevenar 13,” says Robert W. Frenck,
Jr., M.D., the study’s coordinating investigator and professor of
pediatrics, Cincinnati Children's Hospital Medical Center.

Also presented at this meeting were data comparing immunogenicity and
functional antibody responses in young children who were administered
Prevenar and Prevenar 13. It has been suggested that pneumococcal conjugate
vaccines that include serotypes 6B and 19F may provide some cross
protection against invasive disease caused by 6A and 19A. The data
presented suggest that the immunogenicity and functional antibody responses
induced by Prevenar 13 for serotypes 6A and 19A were greater than the
responses elicited by Prevenar. These results are believed to be
attributable to the inclusion of these two serotypes in Prevenar 13.

“These data further suggest the importance of providing direct coverage
against the 13 most common pneumococcal disease-causing serotypes
worldwide,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine
Research, Pfizer Inc. “Notably, serotypes 6A and 19A, which are included in
Prevenar 13, are prevalent in many regions of the world.”

About the Studies

Abstract #153: Immunogenicity and Safety of 13-valent Pneumococcal
Conjugate Vaccine in Children Previously Immunized with 7-valent
Pneumococcal Conjugate Vaccine

This abstract pertained to an open-label Phase III study that was conducted
to evaluate the immune response of 307 children between the ages of 15
months and 5 years who received at least three prior doses of Prevenar (the
evaluable immunogenicity population). The study measured immunoglobulin G
(IgG) and response was assessed as greater than or equal to 0.35 mcg/mL for
each of the Prevenar 13 serotypes measured one month after the last
scheduled vaccination (the study’s primary endpoint).

The study showed that children aged >15 months to