FDA Approves Pfizer’s 13-Valent Pneumococcal Conjugate Vaccine

Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age 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.

The drug is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) – the first pneumococcal conjugate vaccine introduced in 2000 – plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A).

Pfizer said that in connection with the approval by the FDA, it has agreed to certain post-marketing commitments involving conducting a study to further evaluate the safety profile of Prevnar 13, a study to evaluate the prevention of overall invasive pneumococcal disease and various studies to evaluate reduction in otitis media.

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

Pfizer is expected to discuss Prevnar 13 at the upcoming meeting of the Advisory Committee on Immunization Practices (ACIP) and the it expects the vaccine to be introduced commercially in the US in the first quarter of this year. Further regulatory filings for Prevnar 13 for pediatric use are in advanced stages of review in various countries. Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later this year.

Emilio Emini, chief scientific officer of vaccine research at Pfizer, said: “The approval of Prevnar 13 means that infants and young children in the US will have access to a pneumococcal conjugate vaccine that provides coverage against 13 serotypes that could potentially result in life-threatening illnesses. Together, these 13 serotypes are responsible for the majority of invasive pneumococcal disease in the US.”

Geno Germano, president and general manager of specialty care business unit at Pfizer, said: “This approval is a significant milestone for Pfizer and yet another expression of our mission to improve health and well-being at every stage of life. Prevnar 13 is an important priority for the entire Pfizer organisation as we continue to expand our presence in the vaccine category.”