FDA advisory committee votes to extend use of pneumococcal vaccine to adults

December 2, 2011

FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement.

FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement. The vote of the 15-member panel was 14 in favor and 1 against.

If approved by FDA, Prevnar 13, which is now approved only for use in children, will become the first and only pneumococcal conjugate vaccine approved for adults in the United States. Currently, Pfizer’s supplemental biologics license application (sBLA) is under FDA review, with agency action expected in January.

FDA will consider the committee’s favorable recommendation, although not binding, in its final review of the sBLA for the vaccine. If approved, FDA will determine final prescribing information.

FDA granted Pfizer an “accelerated approval designation” for its sBLA, a decision that reflects the high rate of life-threatening pneumococcal pneumonia in adults aged 50 years and older, and it is based on the potential of Prevnar 13 to provide clinical benefit over the currently available nonconjugated pneumococcal polysaccharide vaccine.

The advisory committee’s votes in support of Prevnar 13 were based on a review of immunogenicity data from Phase 3 clinical studies involving more than 6,000 adults aged 50 years and older.