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Keynote Address: The Challenge of Achieving Universal Access to

WIPO & AMF Seth Berkley M.D, CEO 8 November 2017

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WIPO 8 November 2017 The world before vaccines Examples of major disease outbreaks

Polio Cholera New York pandemic 1916 Europe 6,000 deaths 1829-1851 >200,000 deaths Yellow fever Philadelphia Smallpox 1793 epidemic >5,000 India deaths 1974 15,000 deaths

Flu pandemic 1918-1920 > 50-100 million deaths worldwide

WIPO 8 November 2017 History of vaccine development

Source: Delaney et.al. 2014

WIPO 8 November 2017 Cumulative number of vaccines developed licensed 50+ vaccines

Lyme OspA, protein (1998) Tuberculosis (Bacille Calmette-Guérin) Pneumococcal conjugate, heptavalent* (2000) 1927 Typhus Varicella (1995) Meningococcal quadrivalent conjugates* (2005) Japanese encephalitis (Vera-cell) (2009) 1938 Cholera (recombinant B) # (1993) Cholera (WC only) (2009) toxoid Cholera (WC-rBC) (1991) Human papillomavirus recombinant bivalent (2009) Influenza H. influenzaeconjugate* (1987) Quadrivalent influenza vaccines (2012) Typhoid Cholera Pertussis 1936 Meningococcal C and Y and 1886 1896 1926 H. influenza type B polysaccharide (1985) Haemophilusinfluenza type b (2012) Adenovirus (1980) Meningococcal B (2013) Smallpox Yellow Rabies, cell culture (1980) (baculovirus) (2013) 1798 toxoid Fever Typhoid (2013) Rabies Plague Meningococcal polysaccharides (1974) 1923 1935 Human papillomavirus, 9-valent (2014) 1885 Rubella, live (1969) 1897 vaccines of number Cumulative Enterovirus(2015) Polio (oral live) (1963) Dengue (2015) Measles, live (1963) RTS,S (2015)

2017

13 valent pneumococcal conjugates (2010) Zoster, live (2006) Polio (injected inactivated) Rotavirus (attenuated and new reassortants (2006) (1955) Mumps, live Human papillomavirus recombinant quadrivalent(2006) (1967) Cold-Adapted Influenza (2003) Anthrax, secreted proteins (1970) Rotavirus reassortants(1999) Pneumococcus polysaccharides (1977) Meningococcal conjugate* (group C) (1999) Hepatitis B (plasma derived) (1981) Acellar pertussis, various (1996) Tick-borne encephalitis (1981) Hepatitis A, inactivated (1996) Sources: timeline as of the end of 2010: Plotkin SA, Plotkin SL. The development of vaccines: how the Hepatitis B surface antigen recombinant (1986) Cholera, live attenuated (1994) past led to the future. Nature Reviews Microbiology, AOP, 2011, 1–5. 2011-2015: US Food and Drug Typhoid (salmonella ), Live (1989) Typhoid (Vi) polysaccharide (1994) Administration (FDA) Japanese encephalitis, inactivated (1992) WIPO 8 November 2017 Growing market

Vaccine market value in $bn Compound annual growth $49 rate of $32 7.5%

$6

2000 2016 2022

Source: PATH (March 2016), Markets & Markets (2017)

WIPO 8 November 2017 Vaccine industry dynamics

Highly consolidated

Four companies: ~80% global vaccine revenues

Diverse business models Pipelines Portfolios Revenues and number of doses sold globally

WIPO 8 November 2017 Vaccine suppliers to Gavi (volume)

700 15 16 13 13 14 600 12 12 500 10 306 323 10 400 331 361 8 300 6 200 178 4 268 301 100 191 123 153 2 suppliers Gavi of Number

Doses supplied to Gavi (million) Gavi to supplied Doses 0 12 6 13 11 13 0 2012 2013 2014 2015 2016 Other suppliers IFPMA suppliers DCVMN suppliers # Suppliers

* Non-member suppliers: FSUE of Chumakov IPV and Institut Pasteur de Dakar WIPO 8 November 2017 Innovation needed to address challenges across the value chain

R&D Supply Delivery

• Basic research • Manufacturing • Supply chain

• Translational • Pricing • Data research • Product quality • Health systems • Clinical development

WIPO 8 November 2017 Product development partnership (PDP) model critical to drive innovation and fill gaps

Example: IAVI is an integrated organization that links its …

Industry-style Academic, Network of Advocacy and labs and diverse government and outreach from research private-sector centers in Africa community to portfolio partnerships and India international level

WIPO 8 November 2017 Acceleration in number of PDPs

BY YEAR STARTED

Gates MRI

1977

1986 ’87 ’88 1989’89 1990 ’91 ’92 ’93 ’94 ’95 1996’96 ’97 1998’98 1999’99 2000 2001’01 2002’02 2003’03 ’04 2005’05 ’06 ’07 ’08 ’09 ’10 ’11 ’12 ’13 ’14 ’15 ’16 ’17

Selected other public-private partnerships Working on health issues WIPO 8 November 2017 Gavi’s mission, model and 2 achievements to date

WIPO 8 November 2017 Gavi’s mission

Saving by increasing and protecting in lower-income children’s equitable use of people’s health countries lives vaccines

WIPO 8 November 2017 About Gavi

Vaccine Alliance partners

IMPLEMENTING COUNTRY DONOR COUNTRY GOVERNMENTS GOVERNMENTS

CIVIL SOCIETY RESEARCH ORGANISATIONS AGENCIES

VACCINE PRIVATE MANUFACTURERS SECTOR PARTNERS The Gavi business model: reinventing aid

Pooling demand of Long-term Accelerating Shaping Strengthening vaccine Sustaining poorest countries funding access to vaccines markets delivery platforms immunisation

Market shaping Transition Country out of Country support Donor base Supply Demand Country Country

Country Co-financing Continued support Country As economies grow, countries transition out of Gavi support

Initial self- Preparatory Accelerated Fully self- financing transition transition financing 100%

Access to vaccine price commitments % of $0.20 per dose Co-financing for 5 or more years vaccine accelerates to cost As the country’s national reach 100% income grows, payments Country enters Gavi increase by 15% a year support, co-financing its vaccines

years Variable duration Variable duration 5 years 5 years

Low-income Eligibility End of Gavi country threshold threshold financing < US$ 1,025 per capita gross > US$ 1,580 per capita GNI national income (GNI) Note: the eligibility threshold is adjusted annually for inflation. Source: Gavi, the Vaccine Alliance, 2016 WIPO 8 November 2017 One third of initial 73 Gavi countries in or completed transition

Initially 73 Gavi-supported countries 17 in accelerated transition 9 fully self-financing all vaccines

Note: Gavi’s support to the Ukraine WIPO Map reflects 2017 eligibility ended before the co-financing and 8 November 2017 Source: Gavi, the Vaccine Alliance, 2017 transition policies were implemented. Immunisation coverage: closing the gap Launch of Gavi 100 96% High-income countries 86% 80 80% Post-Gavi 21% increase 60 points 2000-2016 Global average Lowest-income countries Gavi-supported countries 40

20 Immunisation coverage rate (%) rate coverage Immunisation

0 1980 1985 1990 1995 2000 2005 2010 2016

Expanded Programme Stall in immunisation Gavi support to world’s on takes off coverage poorest countries

. Note: Includes DTP-containing vaccines, such as . WIPO Source: WHO/UNICEF Estimates of National Immunization Coverage, 2016 8 November 2017 Achieving impact: India

Launch of Intensified Mission Under-immunised children (million) Indradhanush 9.3

7.7 6.6 5.3 Gavi HSS 1 Gavi HSS 2 4.5 4.4 4.2 3.7 3.2 2.9

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Under-immunised child: not received 3rd dose of DTP containing vaccine WIPO Source: WUENIC 2016 (July 2017 Release) 8 November 2017 Currently 7 of 10 countries with most under- immunised children receive Gavi support

Top 10 countries, under-immunised, DTP3 3.44M 2.91M

1.43M 1.02M 0.72M 0.65M 0.44M 0.41M 0.41M 0.39M

Nigeria India Pakistan Indonesia Ethiopia DRC Iraq Angola Brazil South Africa Other Transitioned Gavi

WIPO 8 November 2017 Equitable access to life-saving vaccines

Prior to Gavi support Now High-income countries Low-income countries High-income countries Low-income countries 100% 100% 100% 91% 86% 86% 77% 72% Hepatitis B 67% Hib Pneumococcal

% of countries introduced vaccines nationally

3% 6% 6% 2000 2009 2000 2009 2016

Note: Only countries with universal national introduction are included. World Bank 2016 country classification has been applied to the whole time series. WIPO Source: The International Vaccine Access Center (IVAC) VIMS database. Data as of 31 December 2016. 8 November 2017 Gavi vaccine introductions and campaigns

Year of first introduction/use of stockpile Introductions by September 2017

2001 PENTAVALENT HEPATITIS B YELLOW FEVER Pentavalent* 73

2002 HIB Pneumococcal 58

2007 MEASLES 2ND DOSE Rotavirus 41

2008 ROTAVIRUS Inactivated polio 54

2009 PNEUMOCOCCAL Meningitis A 6 25 >370 intros 2010 MENINGITIS A Yellow fever 17 14 in total

2013 MEASLES-RUBELLA HPV (CERVICAL CANCER) HPV 4 25

routine introduction 2014 ORAL CHOLERA INACTIVATED POLIO Measles 19 10 campaign or demonstration project 2015 JAPANESE ENCEPHALITIS Measles-rubella 5 24

2017 EBOLA Japanese encephalitis 1 3

* 5 of the 73 countries introduced pentavalent WIPO vaccine independently of Gavi support. ** Measles routine = measles 2nd dose 8 November 2017 As of 20 September 2017 Increased breadth of protection* delivered through routine immunisation

70% 60% 62% 50% 40% 37%

30% Breadth of of Breadth

protection (%) protection 30% 23% 20% 20% 2013 2014 2015 2016 2017 2018 2019 2020 Year *Average coverage across all Gavi-supported vaccines in Gavi-supported countries

WIPO 8 November 2017 Coverage rates for new vaccines

Source: WHO/ UNICEF 2016

WIPO 8 November 2017 Innovative finance key to Gavi’s funding model

International Advance Market Advance Purchase The Gavi Matching Finance Facility for Commitment (AMC) Commitment (APC) Fund Immunisation for pneumococcal for (IFFIm) vaccine

> US$ 5 billion US$1.5 billion

WIPO 8 November 2017 Gavi started at a time of limited supply

2001: 5 suppliers from 5 countries of production

Belgium 1 France 1 Switzerland 1 Republic of Korea 1

Senegal 1

2001

Source: UNICEF Supply Division WIPO 8 November 2017 Gavi has helped create a viable market with more secure supply

2016: 17 manufacturers from 11 countries of production

Netherlands 1 Russian Belgium 1 Federation 1 France 1 Republic United States 2* of Korea 13 China 1 Senegal 1 India 4

Brazil 1 * One US manufacturer Indonesia 1 also produces in the Netherlands. Note: Country of production represents country of national regulatory agency responsible for vaccine lot release. 2016 WIPO Source: UNICEF Supply Division (March 2017) and WHO list of pre-qualified vaccines (2016) 8 November 2017 Affordable and sustainable vaccine prices

Cost to immunise a child with full course of:

HEPATITIS B

PENTAVALENT DTP Approx. USA price: HIB US$ 35 ROTAVIRUS US$ 950

PNEUMOCOCCAL

INACTIVATED POLIO

MEASLES

RUBELLA

HPV (CERVICAL CANCER)

WIPO 8 November 2017 Immunisation: a platform for universal health coverage

TERTIARY Towards universal SECONDARY health coverage PRIMARY HEALTH CARE Build out system to reach the ~98% remaining of children touched by immunisation 14% IMMUNISATION PLATFORM 86% of children reached through routine WIPO 8 November 2017 immunisation worldwide Improving health and immunisation systems

Integrated Demand service promotion & delivery community engagement

Health Management service & workforce coordination

Vaccine supply chain – Cold Health Chain Equipment information Platform systems WIPO 8 November 2017 Emerging challenges and 3 opportunities

WIPO 8 November 2017 Emerging disease priorities – addressing the gaps

WIPO 8 November 2017 Epidemic preparedness: launch of CEPI

Richard Hatchett CEO, Coalition for Epidemic Preparedness Innovations (CEPI)

WIPO 8 November 2017 Gavi’s growing role in outbreak preparedness and response

Yellow fever vaccine Measles outbreak Meningitis vaccine stockpile response stockpiles

Oral Ebola vaccine stockpile stockpile WIPO 8 November 2017 Routine immunisation key to global health security Strong routine immunisation systems help build the capacity for communities and countries to • Countries are more detect, prevent and respond to outbreaks connected than ever • Diseases spread faster and further • 70% of countries are not prepared* • Threat to health security • Threat to economic stability

WIPO * Source: CDC, Decoding GHSA: Global Health Security Agenda 8 November 2017 Vaccine candidates will be evaluated and prioritised to enable potential investment decisions in 2018

Health impact Economic impact Vaccine Analyses Ranking Equity and social protection Funding decisions criteria impact Global health security impact Value for money • Likely strategy Gavi comparative advantage E.g. • Uptake in countries Broader health systems benefits • Financing vaccines for • Target population Secondary routine immunisation Implementation feasibility • Coverage criteria • Catalytic (operational) Availability of alternate • Efficacy support for introduction interventions • Impact • Stockpile Vaccine procurement cost • Price • Learning agenda • Etc. Cost In-country operational cost Additional implementation costs Vaccine analyses during Oct 2017 – Feb 2018

WIPO 8 November 2017 Looking ahead: Gavi’s future vaccine investments to be decided in 2018

Candidate Vaccines Incremental investments New or pipeline vaccines

Planned Diphtheria Hepatitis B Dengue Hepatitis E Hepatitis A Preventative Tetanus Oral cholera vaccine RSV Rabies Rabies Ig/mAb Immunisation for Endemic Pertussis Meningitis C, Y, W, X RSV mAb Group B streptococcus Diseases Influenza – Routine Malaria (RTS,S) PCV Maternal Immunisation ? Public Health Risk Ebola Zika virus Reduction

IPV IPV post-eradication

Flu Influenza – Pandemic Response

AMR WIPO * Further analyses and information might shift this list over the course of the next few months 8 November 2017 Increasing volumes, growing number of suppliers, reducing prices: Penta example

Further 50% price reduction expected over 2017-2019

# Gavi Suppliers 1 1 1 1 1 2 2 4 4 5 4 4 5 6 6 6

Source: UNICEF Supply Annual Report, 2014 and UNICEF Vaccine Price Data, 2017 WIPO 8 November 2017 : example of an increasingly healthy market

Start of YF Between 2013 and 2017, Gavi and Gavi support partners identified opportunities to improve supply security for YFV:

Encouraging manufacturers to invest in securing and increasing supply

Providing technical and financial support to manufacturers

Strengthening National Regulatory Agencies responsible for ensuring vaccine quality and safety

WIPO 8 November 2017 Oral cholera vaccine: impact of investment

Gavi support for 16 operational costs 14 Euvichol 12 prequalified 10 Creation of 8 stockpile/Gavi investment 6 Euvichol 4 Shanchol Dukoral prequalified 2 Shanchol

Number of doses used globally (millions)usedglobally of dosesNumber - 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 (to WIPO date) 8 November 2017 Aligning vaccine supply with demand: unmet needs

Current supply status (against demand) for WHO recommended antigens and gaps

Manufacturers with pre-qualified vaccines at end of 2016 Total Supply vs. Demand (2017)

Pentavalent 8 Supply exceeds demand Yellow fever 4 Needs planning Rotavirus 2 Limited supply PCV 2 Needs planning Men. A conj. 1 Supply exceeds demand Measles 3 Needs planning MR 1 Needs planning HPV 2 Limited supply IPV 4 Limited supply

JE 3 Needs planning

Cholera 3 Limited supply

Source: WHO 2016, UNICEF 2017 WIPO Note: The antigens listed are those funded by Gavi. The manufacturers listed represent all prequalified vaccines for each antigen but not necessarily suppliers to Gavi 8 November 2017 Intellectual property regime – impact on innovation Example: Prevnar

Australia • patent granted in 2013

Europe • patent granted in 2015 • grant of patent opposed • final decision pending

India • patent granted in 2017

WIPO 8 November 2017 Stagnating global immunisation coverage rates

Children immunised with DTP3 containing vaccine (Gavi68) DTP3 containing vaccine (Gavi68) MCV1 (Gavi68)

78% 80%80% 80% 78% 78% 78% 78% 68% 68% 60% 63.9M 60% 63.1M 62.4M 60.4M 60.3M 60.6M

59.5M

2010 2011 2012 2013 2014 2015 2016

2001 2005 2010 2014 2015 2016

2005 2001 2010 2014 2015 2016

WIPO 8 November 2017 Low polio3 coverage a risk to achieving and sustaining eradication

60%

72%

49%

WPV type 1 cVDPV type 2 Endemic country Onset of paralysis 6 March 2017 – 5 September 2017 Data source: DTP3 WUENIC 2016 WIPO 8 November 2017 Low polio3 coverage a risk to achieving & sustaining eradication

Syria: 42% 65%

72%

Chad: 46% Niger: 67% Yemen: 71% Ethiopia: 77% 49% Somalia: 47% CAR: 47% South Sudan: 31%

DR Congo: 79%

Madagascar: 77% WPV type 1 cVDPV type 2 Endemic country Onset of paralysis 6 March 2017 – 5 September 2017 Data source: DTP3 WUENIC 2016 WIPO 8 November 2017 Persisting challenge of measles outbreaks

Number of reported measles cases (over a 6 month period) Based on data received 2017-10 Surveillance data 2017-3 to 2017-8 * Countries with highest cases for the period (Source: WHO 2017) WIPO 8 November 2017 Supporting product innovation and new partnerships

Accelerating product innovation to better meet country programmatic needs and improve coverage and equity Innovation

Align product innovation priorities Delivery options and definitions across market- • Transdermal micro-array patch shaping partners • Needle free jet injectors • Blow-filled seal technology • Solar Direct Drive refrigerators Weigh benefits of long-term product innovations to support Product Presentations investment decisions

2013Shape cold chain equipment markets

WIPO 8 November 2017 Zipline – reaching the last mile in Rwanda

WIPO 8 November 2017 Reaching the fifth child 1 in 5 in Gavi countries do not get a full course ~140 Rest of world India of the most basic million 19.5 vaccines Other Gavi children born million Nigeria every year Indonesia are not fully Pakistan protected with only 1 in 14 the most 80% are fully immunised basic in Gavi-supported with all vaccines countries recommended vaccines WIPO Number of children globally not receiving the third dose of DTP-containing vaccine, 2016. Source: WHO/UNICEF Estimates of National Immunization Coverage, 2016 8 November 2017 Thank you

WIPO www.gavi.org 8 November 2017