FDA OKs Meningitis Vaccine for Infants

April 26, 2011 -- The FDA has approved the use of Menactra, a vaccine that prevents a life-threatening form of meningitis, in children as young as 9 months.

Menactra is already approved for use in people ages 2 through 55. It helps prevent invasive meningococcal disease caused by a bacterium called Neisseria meningitidis.

The FDA says as many as 15% of people who get meningococcal disease die from the infection. About 20% suffer severe complications, including brain damage, loss of limbs, or loss of hearing.

Early symptoms of meningitis are often confused with flu, but the infection can kill within hours of onset, the FDA says.

Who Gets Menactra?

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.