Pfizer Provides Regulatory Update On Prevnar 13 Vaccine

The FDA has not yet completed its review of Pfizer’s 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.

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

In August 2009, the FDA has 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 FDA.

The company 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.

Reportedly, on November 18, 2009, the FDA’s Vaccines and Related Biological Products Advisory Committee said 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.

Additionally, on December 11, 2009, the European Commission has granted marketing authorisation for Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) – as it is known outside the US, 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 pediatric 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 US.

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