BioCentury
ARTICLE | Clinical News

Prevnar 13 regulatory update

February 4, 2013 8:00 AM UTC

FDA approved expanding the label of Prevnar 13 from Pfizer to include prevention of invasive disease caused by the 13 serotypes of Streptococcus pneumoniae contained within the vaccine in subjects ages 6-17 years. The pneumococcal vaccine is already approved in the U.S. in children ages 6 weeks to 5 years. The vaccine is approved as Prevenar 13 in the EU to prevent invasive disease, pneumonia and acute otitis media caused by S. pneumoniae in subjects ages 6 weeks to 17 years and in the U.S. and EU to prevent invasive disease caused by S. pneumoniae in adults >=50 years. ...