Pfizer received approval from the FDA for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), a 13-valent pneumococcal conjugate vaccine. Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years for the prevention of invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Prevnar 13 is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F.

Invasive pneumococcal disease includes bloodstream infections, meningitis (inflammation of the coverings of the brain and spinal cord), bacteremic pneumonia, and empyema (accumulation of pus in the cavity surrounding the lungs).

The approval is based Phase III studies involving more than 7,000 infants and young children that support the safety and efficacy of Prevnar 13 for the prevention of invasive pneumococcal disease. Clinical trial data indicate that Prevnar 13 can be administered with all routine pediatric vaccines studied.

“The approval of Prevnar 13 means that infants and young children in the United States will have access to a pneumococcal conjugate vaccine that provides coverage against 13 serotypes that could potentially result in life-threatening illnesses,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer. “Together, these 13 serotypes are responsible for the majority of invasive pneumococcal disease in the United States. Notably, serotype 19A is now the most common invasive disease-causing serotype in young children.”