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Can we achieve rotavirus vaccine immunization worldwide by 202X?
Global Vaccines 202X: Access, Equity, Ethics
May 3, 2011
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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?
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Global burden of rotavirus
Source: WHO. WER. 2009;84(51/52).
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Status of rotavirus vaccine use (public sector)
Source: WHO NUVI
24 countries have introduced vaccine to-date
Birth cohort = 14 million
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Nicaragua: effectiveness by severity (full course of vaccine)
Severity Community 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
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Mexico: Impact on total diarrhea deaths after vaccine introduction
Richardson et al. NEJM. 2010; 362(4).
Diarrhea deaths among children <5, July 2002-May 2009
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If we get vaccines where they are needed most…
• Global impact: 2.4 million lives saved (2007-2025)1
• Greatest impact in countries with highest burden
• Potential herd immunity: In El Salvador, ~41-68% decline in rotavirus hospitalization among children too old to be vaccinated.2
1 Atherly, et al. JID. 20098; 200(S1)2 Yen, et al. PIDJ. 2011;30(S1)7
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Efficacy estimates of current rotavirus vaccines generally correlate with mortality quartiles
WHO mortality
strata
Under-5 child mortality Vaccine efficacy Countries
HIGH Highest (top 25%) 50-64% Ghana, Kenya, Malawi,
Mali
INTER-MEDIATE
LOW
High mid (next 25%)
46-72% Bangladesh, South Africa
Low mid (next 25%) 72 - 85% Vietnam, Region of the
Americas
Least (lowest 25%) 85 – 100% Region of the Americas,
Europe, Western Pacific
http://www.who.int/whosis/en/ WHO. WER. 2009. 84(51/52). Slide courtesy of K. Neuzil, PATH
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Intussusception• Rotashield: 1998, first rotavirus vaccine in the US.
Voluntarily withdrawn from the market in October 1999, estimated to cause intussusception in 1 infant out of every 10,000.
• Rotarix/RotaTeq: 2006, large pre-approval studies evaluated risk of intussusception. FDA review found both to be safe and effective with no increased risk of intussusception.
• Rotarix: 2010, post-marketing data in Mexico showed slight elevation in intussusception rate, but benefits of vaccination outweigh risk. FDA and CDC continue to recommend Rotarix and RotaTeq.
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Current vaccine pricesGSK and Merck vaccines in industrialized
countries • US$120-$200 per course
South Africa public sector (birth cohort = 1 million)• GSK: >$20 per 2-dose course
PAHO Revolving Fund 2009 contracts (birth cohort = 8 million)• GSK: $15.00 for 2-dose course• Merck: $16.50 for 3-dose course
GAVI Prices:• Same price as PAHO
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GAVI’s country commitment
To satisfy country demand and introduce new vaccines to tackle rotavirus and pneumococcal disease, the GAVI Alliance needs to raise US$ 4.3 billion between now and 2015.
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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
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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.
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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 platform”—a toolbox of technologies, training, and common technical support to speed development and global access—for all companies actively developing the BRV.
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Vaccine development partnerships
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Pipeline RV vaccines - 2010
Research Phase 1 Phase 2 Phase 3 Licensure3 Market
BBIL
( 116
E) LIBP
LIBP
BMC
POLYVAC16
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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
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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
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