Although Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years in 2004, and in October 2007 for children as young as 2 years, the FDA has now deemed it safe for children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.
“The highest rate of meningococcal disease occurs in children under one year of age. With last week’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.
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%-15% of people who develop meningococcal disease die from the infection. Another 10%-20% 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. While early onset can be difficult to distinguish from influenza and other common illnesses symptoms of the disease in infants and young children often include having high fever along with cold hands and feet, arching of the back and retracting neck, fussiness when being held, whimpering and/or high-pitched crying, difficulty waking and being very lethargic when awake, staring blankly, appearing pale or blotchy, refusing to eat and vomiting.
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. The most common adverse side affects reported in children who received the vaccine 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.”
The Connecticut Department of Health currently recommends that all children be given the meningitis vaccine at their routine preadolescent check-up at 11-12 years of age. “For those who never got a dose previously, a dose is recommended at high school entry or at about age 15 years.” In addition
Connecticut Public Act No. 0193 states that all college students living in on-campus housing be vaccinated against meningitis. The law applies to all public and private colleges and universities.
Proof of immunization includes the following: Students must show proof of immunization with a meningococcal vaccine within the last five (5) years or
- Present a certificate from a physician stating that, in the opinion of the physician, vaccination with meningococcal vaccine is contraindicated because of the physical condition of the student, or
- Present a statement that vaccination would be contrary to the religious beliefs of the student.
To learn more contact the Connecticut Department of Public Health Immunization Program, 410 Capitol Ave., P.O. Box 340308, Hartford, CT 06134-0308 (860 509-7929