Two meningococcal vaccines, MenACWY-D and Hib-MenCY-TT, were licensed for use in infants in April 2011 and June 2012, respectively. Evidence of benefits, harms, values and preferences, and cost-effectiveness were reviewed in accordance with GRADE methods[1]. The primary policy question was “Should meningococcal vaccines be administered routinely to all infants for prevention of meningococcal disease?”.

The evidence for these two meningococcal vaccines were evaluated to answer these specific questions:

“Should the meningococcal vaccine MenACWY-D be administered to all infants at 9 and 12 months of age for prevention of meningococcal disease?” and “Should the meningococcal vaccine Hib-MenCY-TT be administered routinely to all infants at 2, 4, 6, and 12 months of age for prevention of meningococcal disease?”. The benefits outcomes considered for each vaccine included short-term vaccine efficacy (1 month after vaccination) and long-term efficacy (1, 3 and 5 years after vaccination, if data available). The harms outcomes considered for each vaccine included occurrence of serious adverse events (SAE) after vaccination and interference with other co-administered vaccines. Data from four unpublished observational studies (Obs) and 1 unpublished RCT were reviewed for MenACWY-D; data from nine randomized controlled trials (RCT) were reviewed for Hib-MenCY-TT[2-10]. The evidence type for each outcome was derived through a review of study design, risk of bias, inconsistency, indirectness, imprecision, and other considerations (Tables 1 and 2).

Evidence Type 1:

Randomized controlled trials, or overwhelming evidence from observational studies.

Evidence Type 2:

Randomized controlled trials with important limitations, or exceptionally strong evidence from observational studies.

Evidence Type 3:

Observational studies.

Evidence Type 4:

Clinical experience and observations, observational studies, or randomized controlled trials with notable limitations.[1].