Pfizer Inc announced that the US Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the company’s candidate 13-valent pneumococcal conjugate vaccine. As a result, the review will continue beyond the prescription drug user fee (PDUFA) action date of December 30, 2009.

“We remain confident that the data in the BLA support the approval of Prevnar 13,” said Emilio Emini, chief scientific officer, Vaccine Research, Pfizer Inc. “We will continue to work closely with the US FDA to help expedite the completion of its review of our BLA.”

In May 2009, Prevnar 13 was designated for priority review, which is given to products that, if approved by the Center for Biologics Evaluation & Research (CBER), would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. In August 2009, the US FDA extended its review by 90 days from the original action date of September 30, 2009, to December 30, 2009, based on the submission of additional manufacturing data requested by the US FDA. Pfizer is seeking an indication for Prevnar 13 for active immunization of infants and toddlers for the prevention of invasive disease and otitis media caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine.

On November 18, 2009, the US FDA’s Vaccines and Related Biological Products Advisory Committee voted 10 to one that the data presented from the BLA for Prevnar 13 support its safety and efficacy for the prevention of invasive pneumococcal disease in infants and young children. On December 11, 2009, the European Commission granted marketing authorization for Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) - as it is known outside the United States – for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 S. pneumoniae serotypes in infants and children from six weeks to five years of age.

To date, Prevnar 13 has been approved for use in infants and young children in 34 countries. Further paediatric regulatory filings for Prevnar 13 are in advanced stages of review in various countries spanning six continents. Prevnar 13 is also being studied in global phase-3 clinical trials in adults, with regulatory submissions expected in 2010.

Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these 13 serotypes are responsible for the majority of remaining invasive pneumococcal disease in infants and young children in the United States. Serotype 19A is now the most common serotype in the United States.

The review of Prevnar 13 is based on data from 13 core phase-3 studies involving more than 7,000 children.

Prevnar is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine.