FDA Approves Combo Vaccine That Protects Infants Against Two Dangerous Bacterial Infections

By: CBS Posted By: Stephanie Schultz
By: CBS Posted By: Stephanie Schultz

(CBS News) A new combination vaccine that protects infants from two deadly infections that can cause meningitis, meningococcal disease and Hib disease, was approved Thursday by the U.S. Food and Drug Administration.

The vaccine, called Menhibrix, has been approved for children ages 6 weeks through 18 months old. It's given as a four-dose series at 2, 4, 6 and 12 through 15 months of age, and the first dose may be given as early as 6 weeks of age. It is manufactured by GlaxoSmithKline.

Meningococcal disease is caused by the bacteria Neisseria meningitides, and is most commonly diagnosed among infants, adolescents and young adults. A common outcome of the infection is meningitis, a life-threatening infection of the covering that surrounds the brain and spinal cord. About 1,000 causes of meningococcal disease occur each year.

The bacteria spreads through respiratory and throat secretions like spit, but aren't as contagious as the common cold or flu. Infants with meningococcal meningitis may appear to be slow or inactive, irritable, vomiting or feeding poorly, according to the Centers for Disease Control and Prevention.

Hib disease is caused by the Haemophilus influenzae type b bacteria and spreads through mucus or secretions from the nose or throat, typically from coughing and sneezing. It can affect different parts of the body: the most common type of Hib disease is meningitis, but it can also cause life-threatening infections that make it difficult to breathe, including epiglottitis (infection in the throat) and pneumonia (infection in the lungs). Other forms of Hib disease include blood, bone, or joint infections. About 12,000 children get the disease each year.

According to the FDA, both Neisseria meningitides and Hib bacteria can infect an infant's bloodstream causing potentially lethal sepsis.

Without vaccination, children younger than two years are susceptible to these serious illnesses, the FDA said. Meningococcal and Hib diseases are particularly dangerous because both diseases often progress rapidly and can cause death or serious, long-lasting health consequences such as blindness, intellectual disability or amputations. Early symptoms for both diseases often are difficult to distinguish from other common childhood illnesses.

"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," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a news release.

The vaccine's effectiveness was studied by the FDA in "several hundred U.S. infants and toddlers" and found it to be as effective as other FDA-approved Hib vaccines. Menhibrix's safety was tested among 7,500 infants and toddlers in the U.S., Mexico and Australia, with common side effects of pain, redness and swelling at the injection site, irritability and fever.


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