Can we achieve rotavirus vaccine immunization worldwide by 202X? Global Vaccines 202X: Access, Equity, Ethics May 3, 2011 Topics Burden of illness Current use of rotavirus vaccines (public sector) Impact of rotavirus vaccines Intussusception Current pricing GAVI shortfall New rotavirus vaccines Challenges - new vaccine development Solutions? 2 Global burden of rotavirus Source: WHO. WER. 2009;84(51/52). 3 Status of rotavirus vaccine use (public sector) Source: WHO NUVI 24 countries have introduced vaccine to-date Birth cohort = 14 million 4 Nicaragua: effectiveness by severity (full course of vaccine) SeverityCommunity Controls Hospital Controls Mild to moderate (0-10) [33%] 23% (-74, 66)4% (-120, 38) Severe (>=11) [67%] 52% (18, 72)63% (34, 80) Very severe (>=15) [19%] 73% (18, 91)86% (46, 96) Patel, et al. JAMA. 2009; 309(21). Slide courtesy of K. Neuzil, PATH 5 Mexico: Impact on total diarrhea deaths after vaccine introduction Richardson et al. NEJM. 2010; 362(4). Diarrhea deaths among children $20 per 2-dose course PAHO Revolving Fund 2009 contracts (birth cohort = 8 million) GSK: $15.00 for 2-dose course Merck: $16.50 for 3-dose course GAVI Prices: Same price as PAHO 10 GAVIs country commitment To satisfy country demand and introduce new vaccines to tackle rotavirus and pneumococcal disease, the GAVI Alliance needs to raise US$ 4.3 billion between now and The need for new vaccines Two safe and effective commercial rotavirus vaccines exist, however Not yet widely available or affordable for low- income communities. Reduced efficacy in low-income settings. Slight elevation in intussusception risk. New rotavirus vaccines are needed to Create a sustainable market. Increase global supply. Reduce prices in order to ultimately satisfy global needs. 12 Advancing rotavirus vaccine development Goal: to accelerate the development and introduction of new safe, affordable, and effective rotavirus vaccines into the developing world through technical and financial support to emerging-country manufacturers. 13 Shared technology platform Several emerging-country manufacturers have licensed the bovine-human reassortant rotavirus vaccine (BRV) from the US National Institutes for Health. PATH created a shared technology platforma toolbox of technologies, training, and common technical support to speed development and global accessfor all companies actively developing the BRV. 14 Vaccine development partnerships 15 Pipeline RV vaccines ResearchPhase 1 Phase 2 Phase 3Licensure3 Market B BI L ( E) LIBP BMC POLYVAC 16 Challenges in developing new rotavirus vaccines Need low cost vaccine Price highly dependent on volume for individual manufacturer Clinical development of new rotavirus vaccines Intussusception/post licensure surveillance Vaccine presentation and cold chain requirements/capacity 17 Can we achieve rotavirus vaccine immunization worldwide by 202X? Near term aspirations Optimize current vaccines for developing world Obtained lower prices Long term aspirations Develop new rotavirus vaccines Manufacture at high volume, low price, and optimal presentation 18 John Boslego, MD Director Vaccine Development Global Program