FDA Approves Pfizer's Prevnar 13 for the Prevention of Invasive Pneumococcal Disease

February 24, 2010

The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages six weeks through five years, manufactured by Wyeth Pharmaceuticals, Inc. (Collegeville, PA), a wholly owned subsidiary of Pfizer, Inc.

The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages six weeks through five years, manufactured by Wyeth Pharmaceuticals, Inc. (Collegeville, PA), a wholly owned subsidiary of Pfizer, Inc. 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, the covering of the brain and spinal cord, and pneumonia.

The seven S. pneumoniae serotypes against which Prevnar is directed accounted for about 80% 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 five years old was reduced by 99%. However, at that time, it was also shown that of the remaining IPD in this age group, 62% are caused by the six additional serotypes that will be included in Prevnar 13.

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, prefilled syringes.