The vaccine is called MenHibrix and is designed for children who are six weeks to 18 months old. It combines vaccines for Hib disease and meningococcal disease. Both diseases are common causes of meningitis infection.
MenHibrix was rejected by the FDA on two previous occasions over the last two years. However, Glaxo said the questions raised by the regulator had been resolved about the efficacy and potency of the vaccine.
Bacterial meningitis is an infection of the lining surrounding the brain and the spinal cord. The results can be severe damage to the brain, which in 50% of the cases; it is fatal if not treated.
In the U.S., there were close to 4,100 cases of the infection each year between 2003 and 2007, which is the most current information available. During that time, over 500 people died from the infection said the Centers for Disease Control. The group at the highest risk are infants.
Regulators said the infection spreads rapidly in youngsters who have not been vaccinated and causes long-term damage or death. Long-term effects can include mental retardation, blindness or the need for amputations. Early symptoms of the disease can be hard to distinguish from other common illnesses in children.
The meningococcal Y and C strains of bacteria and the Hib bacteria are targeted by the vaccine. Hib disease was previously the most common reason bacterial meningitis occurred in children 5 and younger, before vaccines became common for that strain.