FDA greenlights GSK vaccine for infants against bacteria linked to meningitis

6.14.12 | Stephanie Baum  The U.S. Food and Drug Administration has approved British drug developer GlaxoSmithKline's (NYSE: GSK) vaccine against two bacteria associated with meningitis for infants and toddlers. The MenhHibrix vaccine is the first of its kind that can be given to infants as young as six weeks old, according to Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.  The FDA had twice declined to approve the vaccine, requiring the drug maker to produce additional data.  MenHibrix will be used against Neisseria meningitidis or Meningococcal disease and Haemophilus influenzae, or Hib, type b bacterial diseases, which can cause life threatening complications like sepsis if they infect the bloodstream and meningitis if they infect the lining of the brain, according to a statement from the regulator. It will be administered as a four-dose series every other month from two to six months and sometime between 12-18 months of age.  European regulators approved a different vaccine against meningococcal bacteria from GSK earlier this year under the name Nimenrix. It is for 12 years olds and older.

ADVERTISEMENT  One of the dangers of these bacterial diseases is that the early symptoms mirror other common childhood illnesses, making them to tough to distinguish. Without vaccination, children younger than two years are susceptible to these serious illnesses. Meningococcal and Hib diseases are particularly dangerous because both diseases often progress rapidly and can cause death or have devastating consequences like blindness, mental retardation, or amputations.  The Centers for Disease Control and Prevention estimates that between 1,000 and 3,000 cases of meningococcal disease are reported each year in the United States. The vaccine is aimed at the age group which has the most cases of the bacterial disease.  The safety of the MenHibrix vaccine was evaluated in 7,500 infants and toddlers in the U.S., Mexico and Australia. Adverse reactions included pain, redness and swelling at the injection site, irritability and fever, according to the FDA statement.  The company, which has its U.S. headquarters in North Carolina, resubmitted the biologics license application for approval in December last year. It had received complete response letters in 2011 and 2010.