Prevnar 13: FDA Approval in Adults

The US Food and Drug Administration (FDA) approved Pfizer’s pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults on December 31, 2011. This expands Prevnar 13’s indications too include adults aged 50 years and older for active immunization to prevent pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This is the first pneumococal vaccine available to adults at age 50 and in one shot. Prevnar 13 had already been approved children, aged 6 weeks through 5 years.

“As adults grow older they become more susceptible to infectious diseases, such as pneumococcal pneumonia, due to their aging immune systems,” said Thomas M. File, Jr, MD, MS, president-elect, National Foundation for Infectious Diseases. “As a conjugate vaccine, Prevnar 13 offers an important new option for adults 50 years and older to include as part of their preventive strategy for healthy aging.”

In Phase 3 safety and immunogenicity trials involving approximately 6000 older adults, Prevnar 13 vaccination induced a functional antibody response to the 13 serotypes contained in the vaccine, including individuals previously vaccinated with the conventional pneumococcal polysaccharide vaccine (PPSV) and those naive to pneumococcal vaccines. Prevnar 13’s effectiveness when administered less than 5 years after PPSV is unknown.

Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) is currently ongoing to fulfill requirements under the accelerated approval pathway. CAPiTA has been designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia (CAP) caused by the 13 pneumococcal serotypes contained in the vaccine. It will enroll approximately 84,000 subjects.

In addition, Pfizer has agreed, as a post-marketing commitment in connection with the approval by the FDA, to conduct a study evaluating concomitant use of Prevnar 13 and TIV (annual trivalent inactivated influenza vaccine) in adults 50 years of age and older who have been previously immunized with PPSV.

Prevnar 13 will not protect against disease caused by Streptococcus pneumoniae serotypes that are not in the vaccine.