Brand Name Drug: Prevnar
Active Ingredient Drug: pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)
Indication: Prevention of invasive pneumococcal disease in infants and toddlers
Company Name: American Home Products Corporation (Wyeth Lederle Vaccines division)
Availability: Approved by the FDA on February 17, 2000
Introduction
It is estimated that each year in the US, there are about 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis among children under age 5. Children under the age of 2 are at highest risk for infection. In up to half the cases of meningitis, brain damage and hearing loss occurs, and about 10% die. Now a new vaccine is available to prevent invasive pneumococcal disease in infants and toddlers: Prevnar (pneumococcal 7-valent conjugate vaccine [diphtheria CRM197 protein]). The vaccine is manufactured by American Home Products Corporation by their Wyeth Lederle Vaccines division.
Prevnar is the first multivalent conjugate pneumococcal vaccine for children under the age of 2. Infants can receive the vaccine as a series of four inoculations administered at 2, 4, 6, and 12-15 months of age. The dose is 0.5 ml given intramuscularly. For children who cannot receive the vaccine starting at age 2 months, including previously unvaccinated older infants and children, the alternate dosing schedule is as follows: children 7-11 months old at first dose should receive three 0.5 ml doses, those 12-23 months at first dose should receive two doses, and those 24 months through 9 years should receive one dose (refer to package insert for recommended time between doses).
On February 16, the Advisory Committee on Immunization Practices voted to recommend the use of Prevnar for all infants up to age 23 months, and in certain children ages 24 to 59 months who are immunocompromised; those who are African-American, native American, or Alaskan natives; those with certain chronic diseases; children in day care; socioeconomically disadvantaged children; and those with recurrent or frequent otitis media.
How It Works
Prevnar targets the most common seven strains of pneumococcus (Streptococcus pneumoniae) that account for approximately 80% of invasive disease in infants. It is manufactured by attaching the polysaccharides (purified surface components of the different strains) to a genetically modified nontoxic form of the diphtheria toxin protein called CRM197.
Prevnar: Clinical Study Results
Clinical trials included a large multicenter safety and efficacy study conducted at Northern California Kaiser Permanente in Oakland, California. The controlled, double- blind trial enrolled approximately 38,000 children, about half of whom received Prevnar. The vaccine was given at 2, 4, 6, and 12-15 months of age along with routinely recommended vaccines. In this trial, the vaccine was 100% effective in preventing invasive pneumococcal disease caused by the seven strains of pneumococcus in the vaccine. The vaccine was approximately 90% effective in preventing invasive disease for illnesses caused by all pneumococcal subtypes.
What the Patient Should Know
Side effects reported in the clinical trials were generally mild and included local injection site reactions, irritability, drowsiness, restless sleep, and decreased appetite. Approximately 21% of the children had fevers over 100.3 degrees F, compared to about 14% in the control group not receiving Prevnar.
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