The Food and Drug Administration (FDA) has approved Prevnar 13™, a pneumococcal 13-valent conjugate vaccine, for infants and young children ages 6 weeks through 5 years.

Prevnar 13 is the successor to Prevnar®, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease-causing bacteria.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of Streptococcus pneumoniae. It also is approved for the prevention of otitis media caused by the seven serotypes shared with Prevnar. The bacterium can cause infections of the blood, middle ear, and the covering of the brain and spinal cord, as well as pneumonia.

Vaccine effectiveness was assessed in a randomized U.S. multicenter immunogenicity study. Prevnar 13 postvaccination antibody response comparisons with Prevnar were evaluated by several immunological measures. An evaluation of all of these measures found that Prevnar 13 induced antibodies comparable with those shown to be protective in Prevnar.

Safety was evaluated in 5084 infants and young children who received Prevnar 13, compared with 2760 that received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 included pain, redness and swelling at the injection site, irritability, decreased appetite, and fever. These reactions were similar to what has been observed with Prevnar, which has a good safety record in the United States.

Postmarketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety. The vaccine is administered in a four-dose schedule given at 2, 4, 6 and 12 to 15 months of age. The vaccine is available in single-dose, prefilled syringes.

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, PA, which is a wholly owned subsidiary of Pfizer Inc.

1. Food and Drug Administration (FDA) [website]. News & Events. FDA News Release. February 24, 2010. FDA Approves Pneumococcal Disease Vaccine with Broader Protection. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm. Accessed March 3, 2010.

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This entry was posted on Wednesday, March 3rd, 2010 at 12:00 pm.