What do policy makers need to know? Lessons from the decision to add pneumococcal conjugate and rotavirus vaccines to the US immunization program

Abstract

The decisions to introduce pneumococcal conjugate and otavirus vaccines into the US immunization programs were good nes. The vaccines have performed even better than expected, arkedly reducing disease not only among young children who eceived them but also among unvaccinated persons in the comunity [1,2]. But when the US Centers for Disease Control and revention (CDC) first considered whether to recommend routine se of these vaccines, several pieces of information – such as data on isease burden and vaccine efficacy, safety, and cost-effectiveness – ad to be gathered before the decision to use these vaccines became lear. First, policy makers had to determine the need. Do pneumococci nd rotavirus cause enough hospitalizations and deaths in the US o warrant vaccinating every child? In the US, as in most parts of he world that use Haemophilus influenzae type b vaccine, pneuococcus was the most common cause of severe pneumonia and acterial meningitis in young children [3]. Likewise, rotavirus was he most common cause of diarrhea requiring hospitalization [4]. hile sub-populations at greater risk of both severe pneumococal and rotavirus disease were identified (e.g., premature infants), argeting vaccination to these groups would miss the vast majority f cases and thus universal vaccination was the best option. Next, policy makers had to determine that the vaccines were oth safe and effective, turning to evidence from randomized conrolled clinical trials. For rotavirus vaccines, data were carefully eviewed to assess risk of intussusception, an adverse event that ed to the withdrawal of a previous rotavirus vaccine from the US arket in 1999, and age restrictions were put in place to keep the heoretical risk as low as possible [4]. The pneumococcal conjugate