FDA approves Wyeth Pharmaceuticals' Prevnar 13 pneumococcal disease vaccine

Successor to Prevnar is intended for infants, young children

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be 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 the bacterium 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.

"Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research. "The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes."

The seven Streptococcus pneumoniae serotypes against which Prevnar is directed accounted for about 80 percent of IPD in young children in North America at the time that the vaccine was licensed. With the use of Prevnar, by 2007 the overall rate of IPD caused by these seven serotypes in children less than 5 years old was reduced by 99 percent. However, at that time, it was also shown that of the remaining invasive pneumococcal disease in this age group, 62 percent are caused by the six additional serotypes that will be included in Prevnar 13.

Safety was evaluated in 5,084 infants and young children who received Prevnar 13, compared with 2,760 who received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 were 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.

Vaccine effectiveness was assessed in a randomized U.S. multi-center immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were evaluated by several immunological measures. An evaluation of all these measures showed that Prevnar 13 induced antibodies that were comparable to those shown to be protective in Prevnar.

Post marketing 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 12-15 months of age. The vaccine is available in single-dose, pre-filled syringes.

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