The ACIP's recommendations include the routine use of Prevnar 13 for infants and toddlers, as well as a supplemental dose for children through 59 months of age who have completed the 4-dose immunization series with Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). In addition, the ACIP recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar - available in the United States since 2000 - plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these 13 serotypes are responsible for the majority of remaining invasive pneumococcal disease in infants and young children in the United States. In particular, serotype 19A is now the most common cause of invasive pneumococcal disease among children younger than 5 years of age in the United States.
"We are pleased that the Advisory Committee has recommended the use of Prevnar 13, with coverage for 13 important invasive disease-causing serotypes, in infants and young children in the United States," says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. "The incidence of disease caused by serotypes not included in Prevnar has been increasing in children younger than 5 years of age in the United States, including 19A , the most common serotype."
The ACIP's recommendations for Prevnar 13 vaccination of healthy unimmunized children 2 months through 59 months of age are identical to those previously recommended by ACIP for Prevnar, with Prevnar 13 replacing Prevnar for all doses.
Highlights of the ACIP recommendations included the following:
- Prevnar 13 is administered as a 4-dose series at 2, 4, 6 and 12 through 15 months of age.
- Children who have begun their vaccination series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.
- A single supplemental dose of Prevnar 13 is recommended for children through 59 months of age who have completed the 4-dose immunization series with Prevnar.
Earlier today, the United States Food and Drug Administration (FDA) approved Prevnar 13 for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
In the United States, the Prevnar 13 product label recommends a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Children who have received one or more doses of Prevnar may complete the 4-dose immunization series with Prevnar 13. Additionally, children 15 months through 5 years of age who have received four doses of Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. The immune responses induced by this Prevnar 13 transition schedule may result in lower antibody concentrations for the six additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following four doses of Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known.
Pfizer expects Prevnar 13 to be introduced commercially in the United States in the first quarter of 2010. In addition to the approval of Prevnar 13 in the United States, Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), as it is known in most countries outside the United States, has been approved for use in infants and young children in 38 other countries. Further regulatory filings for Prevnar 13 for pediatric use are in advanced stages of review in various countries spanning six continents. Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later this year.
According to a World Health Organization (WHO) 2002 estimate, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years. Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium S. pneumoniae. It affects infants and young children and includes invasive infections such as bacteremia/ sepsis and meningitis, as well as non-invasive disease including acute otitis media.
Indication for Prevnar 13
Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).
Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.
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