World Health Organization Indication for Prevenar 13*
Earlier this year, the World Health Organization (WHO) prequalified Prevenar 13 for active immunization of infants and children from 6 weeks through five years of age against invasive disease, pneumonia and otitis media caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine. WHO prequalification allows for the procurement of Prevenar 13 by United Nations agencies. The prequalification is for global use of the vaccine in a single-dose vial.
Important Safety Information for Prevnar 13® in the United States
Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), or any diphtheria toxoid–containing vaccine.
Prevnar 13 may not protect all individuals receiving the vaccine.
Protection against ear infections is expected to be less than that for invasive disease.
Children with weakened immune systems may have a reduced immune response to Prevnar 13.
A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13 and Prevnar, respectively.
The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability,
|SOURCE Pfizer Inc.|
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