Menactra, produced by Pennsylvania-based Sanofi Pasteur, was first approved in 2005 for people 11 to 55. In 2007, the FDA gave its OK for the drug to be used in children as young as age 2.
Rates of meningococcal disease are low in the U.S., but infants and toddlers are particularly susceptible to getting the disease, the FDA says.
“The highest rate of meningococcal disease occurs in children under one year of age,” Karen Midthun, MD, of the FDA, says in a news release.
The FDA says Menactra was studied in four studies that involved more than 3,700 infants and toddlers.
In the studies, the most common adverse events were injection-site tenderness and irritability, the FDA says. The occurrence of fever was comparable to other vaccines that are routinely used for young children, the FDA’s statement says.
Menactra is given as a two-dose series, three months apart, starting at age 9 months. The research results showed the vaccine produces antibodies in the blood that are protective against the disease.
Protecting the Young From Meningitis
Stephen I. Pelton, MD, of the Boston University School of Medicine, says in a statement released by Sanofi Pasteur that approval of Menactra for infants and toddlers provides “the opportunity to help protect” these children “when the likelihood of exposure supports a need for early protection.”
Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur, says in the company’s statement that approval of Menactra “is a significant advancement toward potentially eliminating the threat of this serious disease” in most vulnerable populations.
According to Sanofi Pasteur, meningoccal disease, including meningitis, strikes between 1,000 and 2,600 Americans annually.