FDA approves first combination vaccine to help prevent meningococcal serogroups C and Y and Hib disease

FDA has approved the first combination vaccination for use in children aged 6 weeks through 18 months for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenza type b (Hib), according to an FDA statement.

GlaxoSmithKline will provide additional details on when the vaccine MenHibrix (meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine) will be available in the near future, the company said.

The vaccination schedule for MenHibrix is a 4-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. MenHibrix was developed to align with the Centers for Disease Control and Prevention’s recommended infant immunization schedule for Hib vaccination and to allow for vaccination against meningococcal groups C and Y without adding additional shots.

“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 Leonard Friedland, MD, vice president, head, clinical and medical affairs, North America Vaccine Development, GSK Vaccines, in a press release.

The basis for FDA approval of MenHibrix included data GSK submitted from clinical trials conducted in the United States, Mexico, Australia, Belgium, and Germany over 7 years in which 7,521 infants and toddlers received at least 1 dose of MenHibrix. Of these participants, 3,349 were located in the United States. Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness, and loss of appetite.

Meningococcal disease is a rare but serious bacterial infection caused by the bacterium N. meningitidis. The highest incidence of meningococcal disease, across all serogroups, occurs in infants and toddlers

While serogroup distribution may vary from year to year, serogroups B, C, and Y cause most cases of meningococcal disease in the United States. The most common vaccine-preventable serogroups are C and Y. No vaccine is currently available in the United States to protect against serogroup B.

Hib most commonly presents as meningitis, and it was 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.

Common adverse reactions reported after administration of MenHibrix were pain, redness and swelling at the injection site, irritability, and fever.