The FDA has approved the use of Menactra in children as
young as 9 months for the prevention of invasive meningococcal disease caused
by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is
approved for use in people ages 2 through 55 years.
Meningococcal disease is a life-threatening illness caused
by bacteria that infect the bloodstream (sepsis) and the lining that surrounds
the brain and spinal cord (meningitis). Neisseria meningitidis is a leading
cause of meningitis in young children. Even with appropriate antibiotics and
intensive care, between 10 percent and 15 percent of people who develop
meningococcal disease die from the infection. Another 10 percent to 20 percent
suffer complications such as brain damage or loss of limb or hearing.
Although the rates of meningococcal disease are low in the United States,
infants and toddlers are more susceptible to getting this serious illness.
Meningococcal disease is particularly dangerous because it progresses rapidly
and can cause death within hours. Early symptoms are often difficult to
distinguish from influenza and other common illnesses.
“The highest rate of meningococcal disease occurs in
children under one year of age. With today’s approval, Menactra can now be used
in children as young as 9 months of age to help prevent this potentially
life-threatening disease,” said Karen Midthun, M.D., director of FDA’s
Center for Biologics Evaluation and Research.
The safety of Menactra in children as young as 9 months was
evaluated in four clinical studies in which over 3,700 participants received
the vaccine. The most common adverse events reported in children who received
Menactra at 9 months and 12 months of age were injection-site tenderness and
irritability. Occurrence of fever was comparable to other vaccines routinely
recommended for young children.
Menactra is given as a two-dose series beginning at
9-months, three months apart; and the study results showed the vaccine produces
antibodies in the blood that are protective against the disease.
Menactra was originally approved on Jan. 14, 2005, for use
in individuals ages 11 years through 55 years and was approved in October 2007
for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur
Inc. of Swiftwater, Pa.
