FDA OKs new meningitis vaccine for babies
  • Fri, 06/15/2012 - 3:16pm

The U.S. Food and Drug Association approved a new vaccine for infants as young as six weeks and as old as 18 months that prevents two major causes of bacterial meningitis – a sometimes life-threatening disease.
Infants can now receive GlaxoSmithKline PLC’s new combination vaccine MenHibrix to protect against bacterial meningitis. According to the FDA, the vaccine works against two bacterial diseases that often cause bacterial meningitis, meningococcal disease (Neisseria meningitidis C and Y) and Hib disease (Haemophilus influenzae type b) and is delivered in a series of four doses.
Children younger than two who have not been vaccinated against these diseases are at a greater risk of getting bacterial meningitis because the symptoms of meningitis are often indistinguishable from common childhood illnesses, says the FDA. The disease is serious, acts fast and can cause death or long-term health problems like blindness, mental retardation, and the need for amputation.
The FDA reported that MenHibrix’s effectiveness in preventing meningococcal disease was determined by the levels of antibodies it produced in study participants’ blood, which were considered to be adequate levels to protect against the disease. Antibodies, according to MedicineNet, are specialized immune proteins produced by white blood cells if there is a foreign substance in the body that the immune system sees as harmful.
The vaccine’s ability to protect against Hib disease was measured by comparing the immune responses of several hundred infants and toddlers taking MenHibrix in the U.S. to those infants and toddlers taking an already FDA-approved vaccine. According to the FDA, around 7,500 infants and toddlers in the U.S., Mexico and Australia were examined to determine the safety of MenHibrix, and common side effects included pain, redness and swelling at the injection site, irritability and fever.
According to WebMD, bacterial meningitis occurs when the thin layers of tissue that surround the brain and spinal cord, called membranes, become inflamed due to the invasion of bacterial infection. Common symptoms include:

  • Fever
  • Intense and consistent headache
  • Stiff, painful neck
  • Vomiting
  • Confusion and a decreased level of consciousness
  • Seizures

Sometimes infants and young children may not have the common signs of meningitis. While younger children may simply appear to have the flu and a cough or trouble breathing, babies can have symptoms like:

  • irritability that is hard to calm
  • decreased appetite
  • rash
  • vomiting
  • a stiff body
  • a shrill cry

Depending on the type and severity of the meningitis, treatment can range from antibiotics received through intravenously to prescription medications to reduce fever or seizures. Oxygen may be given to assist breathing.
Anyone can get meningitis, so other vaccines have been developed for people of different ages, like meningoccocal conjugate vaccine (MCV4), which is used for people from 9 months to 55 years of age, and meningococcal polysaccharide vaccine (MPSV4), which is used in people over the age of 55. According to the Centers for Disease Control and Prevention, both vaccines can prevent against two of the three types of meningococcal disease most commonly found in the U.S.
If you have any questions about meningitis vaccines or you think you or someone you know may have meningitis, please contact a health care professional as soon as possible.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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