The US Food and Drug Administration (FDA) has approved Wyeth’s Prevnar 13, a new broadened version of the company’s original drug Prevnar to prevent invasive pneumococcal disease (IPD).
The new vaccine extends the protection to six additional types of the disease-causing bacteria Streptococcus pneumoniae and is also 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.
FDA Centre for Biologics Evaluation and Research’s Karen Midthun said that although rates of invasive pneumococcal disease have declined dramatically, there are still children suffering in the US.
“The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes,” Midthun said.
The seven Streptococcus 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.
After the introduction of Prevnar in 2007 the overall rate of IPD caused by these seven serotypes in children under five years old was reduced by 99%. It was also shown, however, that of the remaining cases 62% are caused by the six additional serotypes that will be included in Prevnar 13.