Menactra, a vaccine for the prevention of invasive meningococcal disease for children from 9 months of age has been approved by the FDA (Food and Drug Administration). The vaccine, which is already on the market for patients aged between 2 and 55 years, protects against Neisseria meningitides serogroups A, C, Y and W-135.

Meningococcal disease refers to infection caused by Neisseria meningitides, a type of bacterium. If left untreated the mortality rate is high. Although meningococcal disease is better known to cause meningitis, the more dangerous and life-threatening complication comes from sepsis (widespread blood infection). Neisseria meningitides is a major cause of death in young children. Even with the right treatment it is estimated that from 10% to 15% of infected patients die from complications, while a further 10% to 20% suffer brain damage, deafness, and loss of limb.

Meningococcal disease, with its rapid progression, is potentially very dangerous, particularly among infants and toddlers – patients can develop complications fast and die within hours.

Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research, said:

“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.”

The FDA granted approval after examining one Phase II and three Phase III modified single-blind, controlled, multicenter trials involving more than 3,700 patients that included safety data for children as young as nine months. Among babies aged from 9 to 12 months, the most commonly reported adverse events included irritability and tenderness at the injection site. The likelihood of fever was similar to that found among other pediatric vaccines.

Menactra is administered when the child is nine months old, and then again three months later. The vaccine was approved for patients aged between 11 to 55 years of age in 2005 – in 2007 the minimum age was reduced to 2 years.

Menactra is made by Sanofi Pasteur Inc.

Infants and young children:

  • Elevated body temperature (fever)
  • Irritability
  • Aversion to being handled
  • Convulsions
  • Diarrhea
  • Drowsiness
  • Floppiness, extreme tiredness
  • Fretfulness
  • Moaning or grunting
  • Nausea, there may also be vomiting
  • Photophobia (aversion to light)
  • Red-purple pinprick spots or larger bruises on skin
  • Refusing to feed
  • Twitching

Older children and adults:

  • Headache
  • Fever
  • Loss of appetite
  • Stiff neck
  • Photophobia
  • Nausea, there may also be vomiting
  • Diarrhea
  • Sore and perhaps painful muscles
  • Walking difficulties
  • Swollen and/or painful joints
  • Generally feeling unwell (malaise)
  • Speech may be unintelligible
  • Confusion
  • Drowsiness
  • Collapse
  • Red-purple pinprick spots or larger bruises on skin

Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur, said:

“The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups. With this approval, it is now possible to help protect persons from 9 months through 55 years of age.”

In a communique, Sanofi Pasteur wrote:

Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons age 9 months through 55 years of age for active immunization against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y and W-135.

Written by Christian Nordqvist