FDA Extends Pneumococcal Vaccine Use to Older Children

Karyn Hede

January 29, 2013

The US Food and Drug Administration (FDA) has approved Pfizer Inc's pneumococcal vaccine Prevnar 13 for use in children and adolescents between 6 and 17 years of age for the prevention of invasive pneumococcal disease. The approval fills an age gap in the vaccine's recommended use.

The vaccine has been used in infants and young children since 2010, when it replaced an earlier version targeting 7 common serotypes. It has been approved for older adults (aged 50 years or older) to prevent pneumonia and invasive pneumococcal disease since December 2011.

The FDA approval comes 2 weeks after the European Union approved the vaccine for the same age group. Infants, young children, and people of any age with certain underlying chronic conditions, such as asthma, are at greatest risk for infection. The incidence of invasive pneumococcal disease, including pneumococcal meningitis, has been dramatically reduced among young children since routine vaccination began in 2000, according to the Centers for Disease Control and Prevention. The company recommends that children in the older age group who have not previously been vaccinated receive the vaccine in a single dose.

The approval was based on a phase 3, open-label trial of the vaccine in 592 older children and adolescents, including those with underlying chronic illness such as asthma. The study met all endpoints, according to the manufacturer, demonstrating immunogenicity and providing a safety profile for older children in line with earlier safety profiles established in infants and young children. The vaccine has been distributed as part of international immunization programs in more than 60 countries and is approved for use in more than 120 countries worldwide.