Can we achieve rotavirus vaccine immunization worldwide by 202X?

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?

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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

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Voluntarily withdrawn from the market in October 1999, estimated to cause intussusception in 1 infant out of every 10,000.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

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

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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John Boslego, MDDirectorVaccine Development Global [email protected]

www.path.org