Pfizer Inc. PFE announced today that the U.S. Food and Drug
Administration (FDA) has granted approval for the expansion of the company's
pneumococcal conjugate vaccine, Prevnar 13^®* (Pneumococcal 13-valent
Conjugate Vaccine [Diphtheria CRM[197] Protein]), for use in older children
and adolescents aged 6 years through 17 years for active immunization for the
prevention of invasive disease caused by the 13 Streptococcus pneumoniae
serotypes contained in the vaccine. For this age group, Prevnar 13 is
administered as a one-time dose to patients who have never received Prevnar
13.^1
“As a global leader in pneumococcal disease prevention, extending the impact
of Prevnar 13 to older children and adolescents aged 6 through 17 years is a
reflection of our dedication to improving public health worldwide,” said Susan
Silbermann, president, vaccines, Pfizer. “We continue to work tirelessly to
make this vaccine available to people at risk for invasive pneumococcal
disease.”
The FDA approval followed submission and review of a Phase 3, open-label trial
of Prevnar 13 in 592 older children and adolescents, including those with
asthma.^2 The study met all endpoints, demonstrating immunogenicity and
establishing a safety profile in children aged 6 years through 17 years
consistent with the safety profile established in previous trials in infants
and young children.^2
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