FDA approves new vaccine for babies to prevent deadly bacterial diseases
A new vaccine to protect infants as young as 6 weeks against two potentially deadly bacterial infections has been approved by the Food and Drug Administration (FDA). MenHibrix, made by GlaxoSmithKline (GSK), is a combination vaccine that prevents meningococcal disease and haemophilus influenza (Hib disease), two serious illnesses that can lead to blindness, mental retardation and amputation. The diseases are difficult to diagnose because their symptoms are similar to the common cold.
MenHibrix is approved for use in children aged 6 weeks through 18 months. The vaccination schedule is a four-dose series given at 2, 4, 6 and 12 through 15 months of age. The first dose can be given as early as 6 weeks of age and the last as late as 18 months of age.
The vaccine was developed to align with the Centers for Disease Control and Prevention’s (CDC) recommended infant immunization schedule for Hib vaccination to allow for vaccination against meningococcal groups C & Y without adding additional shots.
Meningococcal disease is rare but deadly disease that most often occurs in infants and toddlers. It is unpredictable and can rapidly worsen within 24 to 48 hours after the onset of symptoms. Hib disease most commonly presents as meningitis and is the leading cause of bacterial meningitis in the United States among children younger than 5 years of age before the introduction of effective Hib vaccines.
The disease has been virtually eliminated through routine infant vaccination. In the United States, most cases of Hib disease occur in under-immunized children and infants who are too young to have completed the primary immunization series.
Side effects from the vaccine include severe allergic reaction, fainting, apnea, and injection site pain and swelling. GSK says it will provide additional details on when MenHibrix will be available in the near future.