The Food and Drug Administration has approved a new vaccine against meningitis meant for children as young as six weeks old.
The FDA approved Menhibrix, a combination vaccine for infants and babies that prevents meningococcal disease and haemophilus influenza, according to the Associated Press.
“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,” Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Reuters reported that the FDA had rejected MenHibrix twice in the past, but GlaxoSmithKline, the makers of the vaccine, said it had resolved regulators' questions about the vaccine's potency and efficacy.
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According to the FDA website, meningitis can be life-threatening. Bacteria can infect the bloodstream causing sepsis, or attack the lining that surrounds the brain and spinal cord. The FDA warns that without vaccination, children younger than two are susceptible to these serious illnesses.
The symptoms of meningitis can be difficult to spot as they mimic those of the common cold. Symptoms include a fast heart rate, change in mental state and a stiff neck.
About 4,100 cases of bacterial meningitis occurred in the United States each year from 2003 to 2007 - the most recent data available - and 500 people died from the disease, according to the Centers for Disease Control and Prevention.
Dr. Len Friedland, vice president of clinical and medical affairs for Glaxo in North America, told Reuters that meningitis is one of those diseases that while rare, can still be devastating.
"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," he said.