FDA Approves New Meningitis Vaccine
The U.S. Food and Drug Administration announced yesterday that it has approved a new vaccine for bacterial meningitis in children.
MenHibrix is a combination vaccine for children aged 6 weeks to 18 months.
"With today's approval of MenHibrix, there is now a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children. It is the first meningococcal vaccine that can be given starting as young as six weeks of age," said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.
FDA said that Meningococcal and Hib result in serious complications like blindness, mental retardation or amputation. These diseases can even cause death. Symptoms of the two diseases are similar to more common diseases that affect children which makes it even harder to treat.
The vaccine was tested on some 7,500 children in the U.S., Mexico and Australia. Common side-effects included pain, irritation and fever.
MenHibrix vaccine is manufactured by GlaxoSmithKline PLC at facilities in Belgium.
The FDA had rejected MenHibrix twice before, once in 2010 and again in 2011, according to Reuter.
"All of us at GSK Vaccines look at today’s approval as a good day for infants, toddlers and healthcare providers. MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers," said Dr. Leonard Friedland, Vice President of Clinical and Medical Affairs, North America Vaccine Development, GSK Vaccines, in a press release.
"[Meningitis] is one of those diseases that although not common, when it occurs it's absolutely devastating and horrible. It presents to the doctor when a child just looks ill, and within 18 to 24 hours, they're on the deathbed in the hospital. ... To be able to have a vaccine to prevent meningitis is really a great day," Dr. Len Friedland told Reuters.