FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine

Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has granted approval for Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]), the Company’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. Prevnar 13 is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.

“Prevnar 13 is an important priority for the entire Pfizer organization as we continue to expand our presence in the vaccine category.”

Invasive pneumococcal disease includes sepsis and bacteremia (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 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 Inc. “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.”

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).

“While the incidence of invasive pneumococcal disease caused by the serotypes in Prevnar has been substantially reduced since the introduction of the vaccine in 2000, invasive pneumococcal disease remains a serious health threat to infants and young children,” adds Dr. Emini.

In connection with the approval by the FDA, the Company 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. 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.

Prevnar 13 is recommended to be administered as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Children who have received one or more doses of Prevnar may complete the 4-dose immunization series with Prevnar 13. Children 15 months through 5 years of age who have received four doses of Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. The immune responses induced by this Prevnar 13 transition schedule may result in lower antibody concentrations for the six additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following four doses of Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known.

“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,” says Geno Germano, president and general manager, Specialty Care Business Unit, Pfizer Inc. “Prevnar 13 is an important priority for the entire Pfizer organization as we continue to expand our presence in the vaccine category.”

Prevnar 13 will be discussed today at the upcoming meeting of the Advisory Committee on Immunization Practices (ACIP) and the Company expects the vaccine to be introduced commercially in the United States in the first quarter of this year. In addition to its approval in the United States, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), as it is known in most countries outside the United States, has been approved for use in infants and young children in 38 other countries. 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.