Update on Vaccines not Included in this Tender: Rotavirus Vaccines

Pre Tender MeetingUNICEF Supply Division, 10-11th December 2008Ann Ottosen

WHO strongly recommends the inclusion of rotavirus vaccination into the national immunization programmes of regions and countries where vaccine efficacy data suggest a significant public health impact and where appropriate infrastructure and financing mechanisms are available to sustain vaccine utilization.

To date, the clinical efficacy of rotavirus vaccines has been demonstrated mainly in the USA, Europe and Latin America. Experience with several other oral vaccines has demonstrated that in terms of vaccine safety and efficacy, considerable regional differences may exist. Until the full potential of the current rotavirus vaccines has been confirmed in all regions of the world, WHO is not prepared to recommend global inclusion of rotavirus vaccines into national immunization programmes.

WER 2007; 10 August

Rotavirus is the most common cause of severe, dehydrating diarrhea among children worldwide

Each year it causes:

•About 111M cases of disease requiring home care only

•25M clinic visits

•2M hospitalisations

About 500,000 deaths in children under 5 years of age attributable to Rotavirus Infection, 2004

Tony Burton, WHO 2007

Rotavirus Vaccines can reduce childhood deaths by nearly 120,000 per year by 2015 (RotaADIP IC)

Total Infants Vaccinated: 716 million Lives Saved1: 2.4 million Hospital and Outpatient Visits Avoided2: 93M

1 Adapted from Rheingans et al. 2005 (unpublished) 3.4 lives saved per 1000 infants vaccinated (range: 2.5 to 5 lives saved per 1000; = 1.8 to 3.6 million lives saved)2Adapted from Rheingans et al. 2005 (unpublished) and Parashar 2003: 100 hospitalizations avoided per 1000 infants vaccinated

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Approved for intro

GAVI Board decision November 2006 to approve the strategy for accelerating introduction of rotavirus vaccines between 2007 and 2015 and an envelope of $13-49M for procurement of rotavirus vaccines as well as additional funds for supportive activities between 2007 and 2010 - 4 countries approved to introduce rotavirus vaccines with GAVI support in the PAHO region, all expressed interest in response to GAVI request- 6 GAVI eligible countries with procurement through UNICEF have indicated interest, of which 5 are located in regions where clinical data on safety and efficacy are currently being established - birth cohort approximately 5.7M

Interest in vaccine introduction

Next steps to assure access to vaccines in GAVI eligible countries

1. Safety and efficacy data to be established outside of EURO/TACRO• Expected end of 2008 from studies in Africa (South Africa, Malawi, Ghana,

Mali, and Kenya)• Expected by Q3 2009 from studies in Asia (Bangladesh and Vietnam)

2. Review of data and updated recommendation from the Strategic Advisory Group of Experts to WHO

• Provided that data are available, that trial results document vaccine safety and efficacy in each region, SAGE could come up with a positive recommendation for use of vaccine in Africa by April 2009 and in Asia by November 2009

3. First possible receipt of GAVI applications from regions outside of EURO/TACRO based on a SAGE recommendation

• May 2009 • Earliest possible in-country introductions early or mid 2010

UNICEF to issue tender following the outcome of the GAVI applications review in June 2009 in support of country vaccine introduction plans

Thank you