Family physicians now have a new weapon in their immunization armamentarium, thanks to the FDA's recent approval(www.fda.gov) of GlaxoSmithKline Biologicals' application to market its meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine, MenHibrix, in the United States. The vaccine is indicated for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib) and is approved for use in children ages 6 weeks through 18 months.
This photomicrograph shows Neisseria meningitidis, which causes between 2,500 and 3,500 cases of meningococcal infection each year in the United States.
According to Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, approval of the new product "means 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."
"It is the first meningococcal vaccine that can be given starting as young as 6 weeks of age," she said in a June 14 FDA news release(www.fda.gov).
The vaccine's package insert(www.fda.gov) calls for MenHibrix to be given as a four-dose series at ages 2, 4, 6 and 12 through 15 months. The first dose may be given as early as age 6 weeks, and the fourth dose may be given as late as age 18 months.
In its approval letter, the FDA directs vaccine manufacturer GlaxoSmithKline to conduct a Phase III controlled, multicenter study to evaluate concomitant administration of MenHibrix with rotavirus, 13-valent pneumococcal conjugate and hepatitis A vaccines administered according to the CDC-recommended vaccine schedule. The study is to begin no later than Oct. 31, 2013, with a final study report to be submitted by Dec. 15, 2016.