Pfizer's Prevenar 13 granted European marketing authorization

Dec 11 2009

The European Commission has granted Pfizer Inc. (NYSE: PFE) a European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.

Prevenar 13, built on the scientific foundation of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), provides the broadest serotype coverage of any pneumococcal conjugate vaccine. It includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar – the standard in pneumococcal disease prevention in infants and young children – plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A), which together represent the most prevalent invasive disease-causing strains in young children worldwide. Prevenar 13 is the only pneumococcal conjugate vaccine to include serotypes 3, 6A, and 19A. Both Prevenar and Prevenar 13 use CRM – a carrier protein which has been used in various approved pediatric conjugate vaccines for more than 20 years. Available in Europe since 2001, Prevenar is currently available in more than 100 countries and more than 300 million doses have been distributed worldwide.

“Although the incidence of pneumococcal disease has been significantly reduced in European countries and elsewhere where Prevenar is routinely used, pneumococcal disease remains a serious threat to children in Europe as strains such as serotypes 19A and 6A are increasing in prevalence and frequently resistant to antibiotics,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. “By providing the broadest serotype coverage of any pneumococcal conjugate vaccine, Prevenar 13 is poised to help reduce the serious public health risk and economic burden associated with pneumococcal disease.”

The European Commission’s authorization of Prevenar 13 was based on a clinical trial program of 13 core Phase III studies involving more than 7,000 children. Data from the Phase III trials support the safety and efficacy of Prevenar 13 for the prevention of pneumococcal disease in infants and young children. Clinical trial data indicate Prevenar 13 has a safety profile similar to that of Prevenar, and can be administered with all routine pediatric vaccines studied.

In the European marketing authorization, the schedule recommended for Prevenar 13 consists of four doses, three primary doses, followed by a booster dose between 11 and 15 months of age. Alternatively, when Prevenar 13 is given as part of a routine infant immunization program, Prevenar 13 may be administered as a three dose series, two primary doses followed by a booster dose. Infants and children who have begun immunization with Prevenar may switch to Prevenar 13 at any point in their dosing schedule. It is also recommended that children up to 5 years of age who have completed vaccination with Prevenar should be offered coverage against the six additional serotypes included in Prevenar 13. The number of doses of Prevenar 13 required to complete immunization should follow official recommendations in each member state. It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.

“Prevenar 13, with serotype coverage unmatched by any other pneumococcal conjugate vaccine, is an excellent example of Pfizer’s innovative vaccine technology at work,” says Geno Germano, president and general manager, Specialty Care Business Unit, Pfizer Inc. “We are committed to vaccines as a key part of our growth strategy, which is an expression of our mission to improve health and well-being at every stage of life.”

To date, Prevenar 13 has been approved for use in infants and young children in 3 countries. On November 18, 2009, the United States Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented from the Biologic License Application (BLA) for Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]), as the vaccine is known in the United States, support its safety and efficacy for the prevention of invasive pneumococcal disease in infants and young children. The FDA will consider the Advisory Committee’s votes and discussion in its review of the Prevnar 13 BLA, which has an action date of December 30, 2009. Other pediatric regulatory filings for Prevnar 13 are in advanced stages of review in various countries spanning six continents. Prevenar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected in 2010.