Pfizer announces approval of Prevnar-13 for older kids, teens
Prevnar-13 was previously approved to prevent infection of Streptococcus pneumoniae bacteria in infants and children up to five years of age. The pneumococcal vaccine was also approved in adults 50 and older, MedPage Today reports.
Pfizer said that the FDA approval of the vaccine was based primarily on an open-label Phase III trial that involved 592 children and teens. Adverse reactions and immunogenicity were similar to the results seen in trials with younger children.
Prevnar-13 is also approved for infants and children up to five years of age for the prevention of otitis media caused by seven of the 13 strains that are covered in the multivalent vaccine.
Pfizer said that contraindications of the vaccine include a history of severe allergic reaction to any component of Prevnar-13 or any vaccines that contain diphtheria toxoid. The vaccine is less likely to be effective in children and adults who are immunocompromised. Some infants born prematurely may briefly stop breathing after they receive the vaccine.
Serious adverse events, all with incidences of less than one percent, include pneumonia, gastroenteritis and bronchiolitis. Milder adverse effects that have been reported more frequently include fever, sleep abnormalities, decreased appetite, irritability, and injection-site swelling, redness and pain, MedPage Today reports.