CURRENTLY AVAILABLE VACCINES AND INTRODUCTION STATUS

Journalist Workshop

Concorde Hotel, Singapore

Megan Carey

April 26, 2017

© 2014 Bill & Melinda Gates Foundation

OUR GOAL (EDD Team)

To end diarrheal disease deaths

in children under age 5 in low

and lower-middle income

countries and to significantly

reduce the burden of ill health

and impaired nutrition due to

enteric infections in populations

of low and lower-middle income

countries

ENTERIC & DIARRHEAL DISEASE TEAM ROTAVIRUS GOALS

• Adequate supply secured

and acceptable

presentations of

prequalified rotavirus

vaccines for delivery in

Gavi-eligible countries and

Lower-Middle Income

Countries

• Rotavirus vaccine is

introduced in at least 50

Gavi-eligible countries and

LMICs

© Bill & Melinda Gates Foundation | 5

GLOBAL ROTAVIRUS VACCINE INTRODUCTION

Image and numbers courtesy of VIEW-hub website: http://rotacouncil.org/resources/RVIntroductionStatusMap.pdf

• 85 national introductions into

routine immunization systems,

including 43 Gavi countries and 6

non-Gavi LMICs

• 39 of these have introduced

Rotarix® and 8 of these have

introduced RotaTeq®

• India has introduced

ROTAVAC™

• Planned introductions of note:

• Uganda (2017, 1.7M)

• Nigeria (2018, 7.2M)

• Bangladesh (2018, 3.1M)

• DRC (2018, 3.2M)

WHO PREQUALIFIED VACCINES

• Attenuated human G1P[8] strain

• Prequalified in 2007

• Introduced in 77 national and sub-

national programs, including 39

Gavi countries

• Clinical efficacy in low-income

countries: 51.7% (44.0, 73.2)1

© Bill & Melinda Gates Foundation | 7

WHO PREQUALIFIED VACCINES - ROTARIX® (GSK)

Doses/Course 2

Price/Dose €1.88

Volume/Course 34 cm3

VVM 14

1. Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants.

N Engl J Med. 2010;362(4):289-98. Price and product presentation characteristics from UNICEF Supply Division website

• Human-bovine reassortant with G1,

G2, G3, G4, and P8 human surface

proteins

• Prequalified in 2008

• Introduced in 28 national and sub-

national programs and 8 Gavi

countries

• Clinical efficacy in low-income

countries: 51.0 – 64.2%1,2

© Bill & Melinda Gates Foundation | 8

WHO PREQUALIFIED VACCINES - ROTATEQ® (MERCK)

Doses/Course 3

Price/Dose $3.50

Volume/Course 139 cm3

VVM None

1. Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, et al. Lancet. 2010;376(9741):615-23

2. Armah GE, Sow S, Breiman RF et al. Lancet 2010; 376: 606-614. Price and product characteristics from UNICEF Supply Division website.

NATIONALLY LICENSED VACCINES

• Naturally occurring neonatal strain G9P[11]

• Licensed in India in 2014

• 56.4% efficacy first year of life, 48.9% 2nd year of life1

• Safety cohort of 11,000 in clinical studies; post-marketing surveillance ongoing

• Supplying Government of India Universal Immunization Program Bridging studies to liquid

product (ROTAVAC 5C) ongoing

ROTAVAC -20C

Formulation Frozen (-20°C)

Dose volume 0.5 ml (5 drops)

Volume/Course ~ 9.0 cm3 / course

Shelf life -20°C for 60 mo.

(2-80 C for 6 mo.)

VVM 21. N. Bhandari, T. Rongsen-Chandola, A. Bavdekar, J. John, K. Antony, S. Taneja, et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind,

placebo-controlled trial. Lancet, 383 (2014), pp. 2136–2143. Presentation characteristics: http://www.bharatbiotech.com/products/vaccines/rotavac/

• Human-Bovine Reassortant, Pentavalent (G1-G4, G9)

• Lyophilized product

• Phase III study in India completed (PATH), analysis

ongoing and data expected to be published soon

• Phase III study conducted by MSF in Niger

• 66.7% efficacy (10 months of data) in ITT protocol1

• Liquid product

• Clinical evaluation of 2nd generation liquid underway,

Phase I in adults completed

© Bill & Melinda Gates Foundation | 11

ROTASIIL (BRV-PV)

Formulation lyophilized

Dose volume 2 ml

Volume/Course 105.5 cm3 with

diluent (single-dose)

Shelf life 3 years at 25 °C and

18 months at 40 °C

VVM 30

1. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1609462

© Bill & Melinda Gates Foundation | 12

OTHER NATIONALLY LICENSED VACCINES

Candidate Producer Strain Characteristics Route Recent Findings

Lanzhou

Lamb

rotavirus

Lanzhou Institute of

Biological Products,

China

Lamb strain

G10P[12]

First generation: Liquid

Second generation:

multivalent

Oral Licensed in China

Effectiveness study of

35%

ROTAVIN

-M1

POLYVAC, Vietnam Human

G1P[8]

First generation: frozen

Second generation:

liquid

2-dose course

Oral Licensed in Vietnam

on immunogenicity

Effectiveness study

commencing soon

SUMMARY

© Bill & Melinda Gates Foundation |13

▪ New suppliers have implications for lower weighted average price

▪ Increasing country uptake, particularly in Africa and South Asia

▪ Still room for improvement in Southeast Asia

▪ Increasing vaccine impact data showing value of vaccines

▪ Reduction in hospitalizations and mortality (RV-specific and all-cause)

▪ Price of vaccines, particularly in increasingly “crowded” vaccine space and

impending Gavi graduations, remain challenging

▪ Increasing need for cost-effectiveness analyses incorporating cost of illness to

make the case for vaccine intros, particularly as mortality decreases

▪ Importance of considering pooled procurement and other financing tools

© Bill & Melinda Gates Foundation | 14

MAJOR OPPORTUNITIES FOR ROTAVIRUS VACCINES