Case-control Study of the Effectiveness of Vaccination With Pentavalent Rotavirus Vaccine in Nicaragua

Abstract

The Merck-Nicaragua Rotavirus Vaccine Partnership promoted rapid and widespread uptake of a novel vaccine in a developing country. Vaccine effectiveness was greatest for children younger than 12 months of age who were at the highest risk for severe rotavirus disease.

Effectiveness of vaccination with the pentavalent rotavirus vaccine in Nicaragua as determined using the screening method

“…15 In 2008, 37 children had severe RGE (Vesikari score ≥ 11), were age-eligible to have received 3 doses of RV5, and had a valid vaccination record. Of those 37 children, 23 had documentation of having received 3 doses of RV5 [proportion of cases vaccinated (PCV) = 62%] and were included in the calculation of VE.…”

“…14, 15 The primary objective of this case-control study was to determine the VE of RV5 in reducing the risk for severe (Vesikari score ≥ 11), wildtype RGE resulting in hospitalizations and ED visits among subjects administered 3 doses of vaccine. 15 In addition to evaluating the effectiveness of RV5 in reducing the risk of hospitalizations or ED visits, the study also had several exploratory objectives.…”

Evaluating the health impact of a public-private partnership

“…The three main objectives of the partnership were to demonstrate that a new rotavirus vaccine could (1) be introduced rapidly in a developing country, (2) be successfully integrated into the existing vaccine delivery infrastructure and (3) have a significant and measurable public health impact at the end of the 3-y program. 5 Although clinical trial data supporting the efficacy of rotavirus vaccines in developed countries were widely available at the time of product licensure, there were no data demonstrating the effectiveness or efficacy of any rotavirus vaccine in a real world, low income, developing country setting. Such data were critical to the Strategic Advisory Group of Experts (SAGE) of the World Health Organization (WHO) in determining whether global recommendations for the vaccine should be made.…”

Post-licensure experience with rotavirus vaccination in high and middle income countries; 2006 to 2011

“…In the upper-middle income Latin American countries of Mexico and Brazil, effectiveness estimates have ranged from 79 to 94%, and in the lower middle income country of El Salvador effectiveness was estimated at 76% [16][17][18][19]. Notably, the lowest effectiveness of 46% was observed in Nicaragua, which is the most impoverished setting where vaccine performance in routine use has been evaluated to date [20,21].…”