“ Challenges in Healthcare: Access & Affordability ” Davinder Gill, PhD Chief Executive Officer

1. “Challenges in Healthcare: Access & Affordability” Davinder Gill, PhD Chief Executive Officer

2. Gross National Income < Rs. 200 a day

3. The Devastation • One death every 20 seconds. Because, each year, 23 million children in developing countries do not receive life-saving vaccines. • Countries eligible for GAVI support require a Gross National Income per capita below or equal to ~ INR200/day • By 2011, all of the 57 countries eligible for GAVI support would have applied for at least one new or underused Vaccines

4. WHO recommendations & vaccine introduction 1974: WHO initiates EPI: TB, Polio, Measles, and DTP 2004: WHO reiterates recommendation for universal vaccination against Hep B 2006: WHO recommends universal vaccination against HiB 2010: First GAVI-eligible country receives pneumococcal conjugate vaccine under the Advance Market Commitment (WHO recommended vaccination with PCV in 2007) 2011: First GAVI-eligible country in Africa receives rotavirus vaccine (WHO recommended vaccination with rotavirus vaccine in 2009) 2011: WHO recommends universal immunization with rubella vaccine and GAVI Board endorses decision to open a rubella vaccine The Right Shot: Extending the reach of affordable and adapted vaccines, Medicins Sans Frontieres, 2012

5. Estimated cost to purchase a full course of vaccines The Right Shot: Extending the reach of affordable and adapted vaccines, Medicins Sans Frontieres, 2012

6. 2011 UNICEF price per dose of DTP-HepB-Hib vaccines by supplier The Right Shot: Extending the reach of affordable and adapted vaccines, Medicins Sans Frontieres, 2012

7. Special considerations for Developing World vaccines 2nd Vaccine Global Congress: Procedia in Vaccinology 1 (2009) 183–188

8. MSD Wellcome Trust Hilleman Laboratories The Purpose Apply world-class vaccine development technologies and know-how to develop safe and effective vaccines Focus on novel vaccines in areas of high unmet medical need and existing vaccines that can be optimized to better meet the needs of developing countries Build partnerships that enable the widest possible access to these products 8

9. Global estimates of mortality from Rotavirus • Rotavirus is the single most important cause of severe dehydrating diarrhea worldwide. • More than 6,00,000 children die every year from rotavirus, 80% of whom are in developing countries. • These represent about 5% of all deaths in children younger than 5 years. • It causes nearly 2 million hospitalizations each year. • In Asia, up to 45% of the children hospitalized for diarrhea are infected with rotavirus. • Mortality is greatest in South Asia & sub-Saharan Africa, with more than 1,00,000 deaths every year occurring in India alone. • About 1 in 200 children born in these regions will die of rotavirus. Figure 2: Map of the world with estimated mortality from rotavirus diarrhea. Shading represents risk of death per child by 5 years of age. Source: www.lancent.com, Vol 368 July 22, 2006 9

10. The Need for Optimization of Current Rotavirus Vaccine • Stability: • Both vaccines require cold chain • Footprint: • Both vaccines require substantial additional space for transport and storage in the cold chain • Cost: • > $50/dose (both) • Rs.900 /dose RotaTeq • Rs 999/dose Rotarix Countries Using Rotavirus Vaccine in National Immunization Schedule Global Rotavirus Mortality Distribution 10

11. Currently Available Vaccines: 1) Rotarix (GSK) Lyophilized vaccine in glass vial • Footprint: 120 cm3/dose • Lyophilized, stored at 2-8oC • 2 dose; 1 mL each dose • Shelf life: 2 years • Price: Rs. 999 / dose (2 dose course) Package Contents Steps in administration

12. Currently Available Vaccines: 2) RotaTeq (Merck) Reconstituted vaccine in squeeze tube • Footprint: 60 cm3/dose • Liquid, stored at 2-8oC • 3 dose; 2 mL each dose • Shelf life: 2 years • Price : Rs. 900/dose (3 dose course) Package Contents Steps in administration

13. HL Proposed TPP-1 Vaccine in Pouch Package Contents 10 dose vaccine granules 10 dose Liquid Buffer + Antacid 10 disposable , single-use Droppers Steps in administration Step 1: Reconstitute by Pouring the pouch content in buffer in vial (Supplied) Step 2: Close the vial and mix by inverting 3-4 times Step 3: Draw a 2ml aliquot with the help of marked disposable dropper Step 5: Administer the complete dose and dispose the dropper in approved waste container Step 4: Cap the vial and store the remaining dose as recommended

14. HL Proposed TPP-2 Vaccine in Blister Package Contents 10 disposable, single-use Droppers 10 dose blister pack containing lyophilized vaccine 10 dose Liquid Buffer + Antacid Steps in administration Step 1: Peel the blister and reconstitute by pouring the contents in buffer in vial (Supplied) Step 2: Close the vial and mix by inverting 3-4 times Step 3: Draw a 2ml aliquot with the help of marked disposable dropper Step 5: Administer the complete dose and dispose the dropper in approved waste container Step 4: Cap the vial and store the remaining dose as recommended

15. “A dose of vaccine for the cost of an egg”http://www.hillemanlabs.org/

16. Thank you