FDA clears expanded use of Pfizer's Prevnar 13 for older children, adolescents

Pfizer announced that US regulators broadened the approval for Prevnar 13 (pneumococcal 13-valent conjugate vaccine) to prevent infections caused by the pneumococcal bacteria in children and adolescents aged 6 years to 17 years. The company said that for this age group, Prevnar 13 is administered as a one-time dose to patients who have never received the vaccine.

The decision follows a review of a Phase III trial of the vaccine in 592 older children and adolescents, including those with asthma. Results showed 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, the company said.

Earlier this month, EU regulators expanded the use of Prevenar 13 to prevent invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae in children and adolescents aged 6 to 17 years. The vaccine, which has annual sales of about $3.5 billion, is also indicated to prevent infections in infants and young children in both the US and EU, as well as in adults who are at least 50 years of age.

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