special edition of the rotavirus bulletin...for the strategic review, analysis focused on sites that...

Globa l Rotav i rus Sur ve i l l ance Bul l e t in : Spe c ia l Edi t ion on the St ra t eg i c Rev iew

Ministryof Health

VOLUME 8: NOV. 2013 • GLOBAL ROTAVIRUS INFORMATION & SURVEILLANCE BULLETIN

SPECIAL EDITION OF THE ROTAVIRUS BULLETIN

Independent Strategic Review of the Global Rotavirus Surveillance Network

The World Health Organization (WHO) produces this Global Rotavirus Information and Surveillance Bulletin twice a year to share activities and data from the WHO-coordinated global senti-

nel hospital surveillance network with partners. This special edition summarizes the conclusions and recommendations of a strategic re-view of the surveillance network that was conducted during 2013.

New format for global rotavirus information and surveillance bulletinIn collaboration with the International Vaccine Access Center at Johns Hopkins University, WHO has been working to improve this global bulletin and the WHO surveillance website. This edition of the bulletin introduces a new format; additional changes will be made in 2014.

• Strategic Review of the WHO-Coordinated Global Rotavirus Surveillance Network ...............2

• Purpose of the review ............................................2• Key findings ...............................................................2• Key conclusions and recommendations from the 2013 Strategic Review .........................5

• Surveillance Data Reporting Calendar ............... 6

• Acknowledgements ................................................. 6

• WHO Rotavirus Surveillance Websites ............... 6

Independent Strategic Review Meeting, Geneva, Switzerland, September 2013 (above). Dr. Okwo-Bele, WHO; Dr. Broome iTAG, Chair; and Dr. Kang iTAG, Co-Chair lead discussion at the strategic review meeting, Geneva, Switzerland, September 2013 (right).

TABLE OF CONTENTS


Strategic Review of the WHO-Coordinated Global Rotavirus Surveillance Network

Purpose of the reviewIn 2008 existing local and regional surveillance networks estab-lished primarily in low and middle income countries were brought together into a WHO coordinated global sentinel hospital rotavirus (RV) surveillance network. The objectives of this global network were to document presence of disease, describe disease epidemiol-ogy, provide data for inclusion in disease burden estimation in the pre-vaccine introduction period, as well as to assess disease trends over time and to monitor vaccination programme impact during the post-vaccine introduction period. In February 2013, WHO under the oversight of an informal Technical Advisory Group for new vaccines surveillance (iTAG), initiated a strategic review of the surveillance network to determine whether the original objectives were met, determine what measures were needed to fill gaps and enhance performance, and to consider how the network could be

made more fit-for-purpose for evolving surveillance needs. Since many countries have introduced RV vaccines, the focus is shift-ing from having data for vaccine introduction decisions to docu-menting impact. The review consisted of surveillance data analyses; questionnaires to obtain national perspectives on the value and per-formance of the surveillance system; independent reviews of the laboratory activities and the data management; review of the pub-lished literature and GAVI applications to evaluate whether national surveillance data had been used in vaccine introduction decision making; internal review of WHO activities and resource availability to support activities.

Key findingsDuring 2008-2012, 265 sites in 67 countries reported any data to WHO (Figure 1.) For the strategic review, analysis focused on sites that reported during 2011 and 2012, and reported > 10 months of data as well as enrolled > 100 cases during each of these years. Seventy-nine sites (80% GAVI-eligible) in 37 countries (86% GA-VI-eligible) met these inclusion criteria. Most sites included in the analysis met targets for the 6 surveillance performance indicators1

Figure 1. WHO Member States that reported to the global rotavirus sentinel surveillance network, 2008-2012

1 http://www.who.int/immunization/monitoring_surveillance/resources/NUVI/en/index.html

2


Table: Age distribution of rotavirus deaths* reported by sites included in the strategic review, 2011-2012 (n-65 sites)

Figure 2. Percentage of acute gastroenteritis hospitalizations due rotavirus at sites included in the strategic review, by WHO Region, 2011-2012

Among these sites, the mean RV detection of the 75,353 tested chil-dren was 36%, with the largest percentage positive (42%) in the 6-11 month age group. Sixty-five deaths among RV positive cases were

reported, with the case fatality ratio ranging from 0% to 5.9% of cases by site (Table below). RV seasonality differed by region with seasonal peaks seen more obviously in AMR, EUR, and WPR. (Figure 2).

* Data from the WHO-coordinated Global Rotavirus Surveillance Network as of September, 2013

Data from the WHO-coordinated Global Rotavirus Surveillance Network as of November, 2013

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AFR (N=15 SITES)

AMR (N=22 SITES)

EMR (N=12 SITES)

EUR (N=9 SITES)

SEAR (N=5 SITES)

WPR (N=15 SITES)

No. Rotavirus NegativeNo. Rotavirus Positive Average % Rotavirus Positive

Age Group Number of Deaths % Total Rotavirus Deaths

0-11 months 45 69

12-23 months 16 25

24-59 4 6

Total 65 100


Figure 3. Global rotavirus genotype distribution by year, global rotavirus sentinel surveillance network, 2009-2012.

Figure 3 portrays the annual distribution of rotavirus genotypes from a convenience sample of specimens. From 2009–2011, the global dis-tribution of genotypes varied from year to year with G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8] the most globally prevalent; G12P[8] also emerged as globally prevalent in 2012. In some Regions, the

year-to-year variation was even more remarkable2. Changes in geno-type distribution occur without vaccine use, hence extreme caution should be exercised in attributing genotype distribution changes to RV vaccination alone. Available data from the literature show that current RV vaccine provide broad crossgenotypic protection.

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Data from the WHO-coordinated Global Rotavirus Surveillance Network as of September 2013

2 Building rotavirus laboratory capacity to support the Global Rotavirus Surveillance Network: http://www.who.int/wer/2013/wer8821/en/index.html; MMWR/May 24,2013/ Vol.62 /N°.20


Figure 4. Rotavirus vaccine introduction or planned introduction among WHO Member States, 2013

Key conclusions and recommendations from the

2013 Strategic ReviewThe RV network met the original 2008 objectives for docu-menting presence of disease, describing disease epidemiology, using surveillance as a platform for special studies in some coun-tries, and using the data for policy decisions. The RV surveil-lance network was overall generating quality data useful for de-cision makers. At least 37 (55%) of 67 participating countries had collected at least 2 years of pre-vaccine introduction data that met the inclusion criteria for quality as defined via the strategic

review. However, further targeted enhancements to the network would provide more standardized information to national, re-gional, and global policy makers. In particular, all sentinel sites must meet the standard definition for a site so that calculations of RV positivity are based on hospitalized children, rather than children seen at peripheral clinics. Additionally, case-based data should be reported through the system with linking of clini-cal, vaccination and laboratory data and standardized protocols should be developed for specimen selection for genotyping.

Globally, 47 countries had introduced rotavirus vaccine and 27 countries planned to introduce vaccine as of August 2013 (Figure 4).

The strategic review found that countries used surveillance data when making vaccine introduction decisions.

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RECOMMENDATIONS FOR THE OVERALL RV SURVEILLANCE SYSTEM• Network participation requires meeting minimum data qual-

ity standards regarding consistent reporting, enrolment of cases, laboratory, and surveillance performance indicators. In prin-ciple, all (GAVI and non-GAVI eligible) countries should be encouraged to participate in the network; however, network size may need to be limited as WHO support to countries is subject to financial and human resource constraints;

• The current surveillance performance indicators should be examined for usefulness; and• Further networking should be encouraged including laboratory collaboration with measles, polio, IBVPD surveil-

lance and sharing of resources.

RECOMMENDATIONS FOR SENTINEL SITES• All sites should meet the defined performance criteria so that

surveillance objectives can be met;• Eligibility criteria should be revised for inclusion in data analy-

ses to include 12 months reporting and >100 specimens at a single site (no satellite sites)

• Zero reporting should be initiated to enable differentiation be-tween no cases enrolled or no report submitted to WHO; and

• Strategies are needed to improve performances at all laborato-ries. (GAVI and non-GAVI). Strategies may be based on find-ings from monitoring and evaluation of the surveillance system.

RECOMMENDATIONS FOR DATA MANAGEMENT AND DISSEMINATION• Countries should be encouraged to report case-based data to all

regional offices and HQ;• The RV data reported through the network should be further

standardized;


Surveillance Data Reporting Calendar

Following the recommendations from the strategic review, data report-ing to WHO headquarters (HQ) will increase from twice annually to

quarterly during 2014. The new reporting calendar for the WHO coordinated global sentinel hospital surveillance networks is below:

Acknowledgements

WHO gratefully acknowledges the dedicated efforts of the numerous individuals and organizations involved with compiling this surveillance information, including Ministries of Health, sentinel hospitals, as well as the network of global, regional and national reference laboratories. WHO also gratefully acknowledges the financial support from GAVI that is provided to GAVI-eligible countries to conduct this surveillance.

WHO Rotavirus Surveillance Websites

http://www.who.int/immunization/diseases/rotavirus/en/index.html;

http://www.who.int/immunization/monitoring_surveillance/burden/laboratory/Rotavirus/en/index.html;

http://www.who.int/immunization/monitoring_surveillance/en/

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• RRLs should report genotype data to ROs twice yearly, as fea-sible within current resource constraints; and

• Global Bulletins should be modified to show all reporting countries on a map, but limit analysis to subset of reporting sites that report every month and enrol > 100 cases annually.

RECOMMENDATIONS FOR THE RV LABORATORY NETWORK• Sample selection for genotyping should be standardized;• Sentinel site case-based data should be linked to genotype data;

• Country-level genotype distribution should be examined in addition to distribution at regional and global levels;

• Additional technical capacity should be built at the national laboratory (NL) level, if possible; and

• Funding permitting, all laboratories. including those in non-GAVI countries should be included in the EQA programme.

In January 2014, WHO will develop a Performance Management Framework for the implementation of these recommendations from the strategic review.

Please email comments to Dr. Mary Agócs ([email protected]).

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