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 MenHibrix 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, and required the drugmaker 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 to 18 months of age.
The next step for the combination vaccine will come October 24-25 when the Centers for Disease Control’s advisory committee on immunization practices votes on whether to recommend the vaccine for routine use, said Dr. Leonard Friedland, vice president, clinical and medical affairs, North America, GlaxoSmithKline Vaccines, told MedCity News.
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.
One of the dangers of these bacterial diseases is that the early symptoms mimic other common childhood illnesses, which makes it too tough to distinguish. In some cases patients seen in a hospital are sent home, only to return much sicker because the disease spreads so fast, Friedland said
Without vaccination, children younger than 2 years old 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.
Between 1998 and 2007, an estimated 1,525 cases per year of meningococcal disease occurred in the United States across all age groups, according to data from GSK. However, rates of meningococcal disease are highest in infants and toddlers younger than 2 years old. An estimated 274 cases were reported annually in the United States in infants and toddlers younger than 2 years of age during this time period.
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.