The U.S. Food and Drug Administration 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.

Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research, said, “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. The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

The FDA said that 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. Post marketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm