Haemophilus influenzae type B-Neisseria meningitidis serogroups C (MenC) and Y (MenY)-tetanus toxoid (Hib-MenCY-TT, MenHibrix) vaccine has been approved by the Food and Drug Administration for an infant indication to be administered according to the standard 2-, 4-, 6-, and 12 months vaccine schedule in the United States as endorsed by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the Centers for Disease Control and Prevention (CDC).
According to the presentation given at the CDC meeting Oct. 14, 2011, by Dr. Ismael Ortega-Sanchez, giving the vaccine could prevent 130 of the projected 377 (34.5%) cases of meningococcal infection in the 4-million-child birth cohort of the United States cumulatively to age 10 years. Also infant vaccination would prevent one death per 642,000 infants (seven deaths/year). The vaccine could be given along with a DTaP/inactivated polio vaccine/hepatitis b vaccine (DTaP/IPV/HepB, Pediarix) and the 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar13) without increasing the total number of shots in a visit. The vaccine has been proven safe and effective.
Yet at the October meeting of the CDC Advisory Committee on Immunization Practices (ACIP), Hib-MenCY-TT (MenHibrix) vaccine was not recommended for universal use. Instead, it was recommended for high risk children as previously defined as complement deficient and asplenic. Why the restricted recommendation?*
• It isn’t the right time. When the ACIP/AAP/AAFP endorsed meningococcal vaccination for 11- to 12-year-olds 7 years ago, the annual incidence of meningococcal disease was fivefold higher than it is now. The drop in incidence cannot be fully attributed to the initiation of our national vaccination campaign. It was known before the meningococcal conjugate vaccine was recommended that meningococcal disease had a cyclical pattern with high and low years of incidence. But, had the incidence been as low as it is now, then one might speculate that the vote to recommend universal vaccination might have been different. The passionate pleas of concerned parents and the desire by all of us in health care to protect every single adolescent against the devastation of meningococcal infections carried the day, even though the cost for prevention of those cases and deaths was the highest ever seen up to that time. So, if the incidence of meningococcal infections is now at an all time low, the calculations of cost to prevent cases and deaths would be a multiple of what it was 7 years ago.
• The vaccine doesn’t include all the serotypes. Hib-MenCY-TT has meningococcal serotypes C and Y. The vaccine does not include serotype A or serotype W-135 (because these serotypes are virtually absent and uncommon, respectively, in the United States and other developed countries. So, a concern could be that serotype replacement might occur over time as we have seen with Prevnar7, now replaced in the United States with Prevnar13 because of serotype replacement. But more importantly is the absence of serotype B in the vaccine. Serotype B meningococci cause 60%-65% of meningococcal disease in the United States in infants. That is why the number of cases projected to be prevented with Hib-MenCY-TT is about one-third of all cases among infants.