Pneumococcal 13-valent conjugate vaccine (Prevnar 13): A pneumococcal polysaccharide conjugated to carrier protein diphtheria CRM197 for the prevention of pneumonia and invasive pneumococcal disease in adults aged 50+ years

March 1, 2012

New indication: Pneumococcal 13-valent conjugate vaccine (Prevnar 13) was granted accelerated FDA marketing approval for the prevention of pneumonia and invasive disease (infection of blood or spinal fluid) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults age 50 years and older.

On December 30, 2011, pneumococcal 13-valent conjugate vaccine (Prevnar 13) was granted accelerated FDA marketing approval for the prevention of pneumonia and invasive disease (infection of blood or spinal fluid) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults age 50 years and older. Prevnar 13 was previously approved for use in children aged 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of S. pneumoniae and for the prevention of otitis media caused by 7 of the serotypes of the bacterium.

Efficacy. Prevnar 13's efficacy was established in five phase 3, noninferiority, clinical trials conducted in the United States and Europe, evaluating the immunogenicity of Prevnar 13 in individuals who were either previously vaccinated or unvaccinated with Pneumovax 23. In all 5 studies, antibody levels elicited by Prevnar 13 were similar or higher to those elicited by the comparator for the 12 serotypes common to both vaccines. Antibody responses to Prevnar 13 were lower in subjects >65 years of age compared to antibody responses in subjects between ages 50 and 59 years. Of note, there have been no controlled trials in adults demonstrating a decrease in pneumonia or invasive disease after vaccination with Prevnar 13. Moreover, the effectiveness of Prevnar 13 when administered <5 years after Pneumovax 23 is not currently known.

Safety. The safety of Prevnar 13 was evaluated in 6 controlled studies conducted in the United States and Europe (n=6,198) in patients aged 50 to 95 years. In these studies, the most commonly reported adverse reactions were pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, injection-site redness, injection-site swelling, limitation of arm movement, chills, and rash.