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

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Rotavirus causes one-third to one-half of severe diarrheal disease in children under the age of five years worldwide. In 2006 two rotavirus vaccines became available and, in the intervening years, approximately thirty countries have introduced them into their immunization programs, primarily in high-income and middle-income settings. Major reductions in rotavirus hospitalizations have been observed in a number of these locations, and in select countries, there have been impacts on gastroenteritis mortality associated with rotavirus vaccine introduction. In addition to these direct health benefits, reduced gastroenteritis risk has been documented in unvaccinated groups, including older children and adults, suggesting indirect benefits (i.e. herd immunity). In this paper, we summarize what has been learned from programs studying post-licensure vaccine effectiveness, impact on health-care utilization and death, safety issues (namely, intussception and the detection of adventitious viruses) and the potential selective pressure of vaccination on the diversity of rotavirus genotypes.

Highlights

► Since 2006 approximately thirty countries have introduced rotavirus vaccines into their immunization programs. ► Major reductions in rotavirus hospitalizations have occurred. ► In select countries there have been impacts on gastroenteritis mortality associated with rotavirus vaccine introduction. ► Indirect benefits (i.e. herd immunity) have been conferred to unvaccinated children as well as older age groups.

Section snippets

Vaccine effectiveness and impact

A number of assessments of vaccine effectiveness against severe rotavirus disease have been undertaken using observational methods (e.g. case-control and cohort studies), and these studies have confirmed good vaccine performance in routine use (for a thorough review, see [8, 9, 10, 11]). In high income countries such as the United States [12], Australia [13••], Austria [14] and Israel [15], vaccine effectiveness was on par with estimates from the clinical trials (>85%) and was sustained through

Strain-specific vaccine effectiveness and potential evolutionary pressure of vaccination

Based on the pre-licensure clinical trial data, there was some controversy as to whether RV1 provided a high level of protection against the completely heterotypic G2P[4] genotype. In the Latin American trials, VE against G2P[4] was estimated at 41% (95% CI −79% to 82%) [38]; although the number of cases from this strain was small and the trial was not powered to measure VE against G2P[4]. In Europe, VE was measured to >85% against severe rotavirus gastroenteritis caused all G types through the

Intussusception

While pre-licensure trials of RV5 and RV1 did not show a risk of intussusception (in a 42 or 31 day window after vaccination, respectively), they were only able to evaluate a level of risk similar to that observed with the Rotashield vaccine (1 in 10 000 vaccinees) [43, 48]; thus, on-going monitoring is important to assess the possibility of a smaller risk or risk in small time-windows. Indeed, post-licensure evaluations in Mexico (RV1) and in Australia (RV5 and RV1) have both detected a lower

Future directions

Below we outline a number of the key remaining issues for middle and high income settings and highlight where these overlap with challenges in low-income settings. [Developing country-specific challenges will be discussed in detail by Babji and Kang, in this issue [61].

  • (1)

    While both vaccines have provided good protection against a broad range of circulating homotypic and heterotypic rotavirus strains, the question of whether vaccination will exert a selective pressure and promote the emergence of

References and recommended reading

Papers of particular interest, published within the period of review, have been highlighted as:

  • • of special interest

  • •• of outstanding interest

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    Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.

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