Vaccine Preventable Diseases:Pneumococcal Vaccine

An Opening Wedge for New Vaccine Introduction and Development

Presented by:Christopher W. Woods

Slides Prepared by Orin LevineExecutive Director, International Vaccine Access Center

Professor, International HealthJohns Hopkins Bloomberg School of Public Health

Other Remedies of the Time

Vaccine History

• 1794-Dr. Edward Jenner• 1952-Polio vaccine• 1963-Measles vaccine• 1974-Expanded Program on Immunization

– Measles, Polio, DPT

• 1980-Smallpox Eradication• 20??-Polio Eradication

Expanded Program on Immunization

Why is new vaccine introduction important?

• Child mortality rates remain unacceptably high in many countries– Injustice– Expensive– Destabilizing

Why is new vaccine introduction important?

A Global Forecasting Model of Political Instability

by Goldstone et al.

“lower-income countries showed a higher risk of instability. This is one of the best-established results in the conflict literature, of course, so we sought to improve on it. …

Yet no model, no matter how complex, performed significantly better than models that simply used infant

mortality (logged and normalized) as a single indicator of standard of living.”

Why is new vaccine introduction important?

AIDS

Diarrhea

Pertussis

Measles

Meningitis

Malaria

Pneumonia

1.58M pneumonia deathsamong children < 5 years

Causes of 8.8M child deaths, 2008 (Black et al. Lancet 2010)

Annual deaths & deaths averted by vaccines

9

2.5m

il de

aths

ave

rted

Source: W. Orenstein, Gates Foundation; WHO, Burden of Disease 2004, released 2008

Why is new vaccine introduction important?

• Vaccines can contribute to improving child survival, economic development, & national security– Vaccines available vs leading killers of children– New vaccines available shortly– Substantial existing delivery program

Consider Hib conjugate vaccine

• Hib – a leading cause of childhood meningitis and pneumonia worldwide

• Safe, effective vaccine used since 1990 in USA and other rich countries

If you build it, they will come…

It worked in the movie but does it work for new vaccine introduction?

Global Hib Vaccine Uptake High and Low Income Countries

Vicious Cycle That Delayed Hib Vaccines

Limited supply

Higher price

Uncertain demand

3) Higher prices keep developing countries uncertain about demand and donors uncertain about financing needs

1) Uncertainty about demand in developing countries leads industry to limit investments in capacity

2) Limited vaccine supply keeps prices relatively high

Saving lives requires finding “solution space”

15

Solution space where

lives are saved

Industry willing to supply

Donors & countries willing to pay

Countries willing & able to introduce

Pneumococcal conjugate vaccine• Licensed in 2000• Leading cause of childhood pneumonia &

meningitis deaths• Proven safe, effective

7 deaths preventedper 1000 vaccinatedin African trial of 9v vaccineCutts F et al Lancet 2005

Mission: To improve child health and reduce mortality by accelerating the evaluation of and access to new, life-saving pneumococcal vaccines for the world’s children.

Global Alliance for Vaccines and Immunisation (GAVI): PneumoADIP

PneumoADIP strategic goals

• Strategic Goal 1: Provide information that enables national decision-makers, the GAVI board and its partners to make an evidence-based decision regarding the use of vaccine.

• Strategic Goal 2: Accelerate the availability of affordable, new vaccines appropriate for use in developing countries.

“Solution space” status: 2003

• No financing for vaccine purchase• “Too expensive to manufacture/Never affordable”

Industry Willing to

Supply

Supply limited; just enough for rich countries

Vaccines $60/dose; doesn’t include vial sizes countries want

CountriesWilling toIntroduce

No WHO recommendation

No WHO disease burden estimates by country

Donors/CountriesWilling toFinance

Surveillance documents disease patterns

Epidemiology, effectiveness, & economics

WHO Disease Burden Estimates by Country

Serotype Distribution by Region

?How much pneumococcal disease do we have in children?

?How well with the vaccine match our serotypes?

Epidemiology, effectiveness, & economics

Cost-Effectiveness & Health Impact Estimates by Country?How cost-effective will the vaccine be in our country?

On-line web tool for national estimates using local data

Global Vaccine Policy at WHO

malaria

TB

HIV/AIDS

pneumonia (observed)

pneumonia (predicted)

0

100

200

300

400

500

600

700

800

900

0 0.5 1 1.5 2 2.5 3 3.5 4

Deaths (in millions)

Go

og

le h

its

(in

mil

lio

ns)

Pneumonia attention does not equate with disease burden

World Pneumonia Day Coalition

http://worldpneumoniaday.org/

Illustrative

Illustrative

Investment case

Major PneumoADIP accomplishments“GAVI’s efforts have truly accelerated the demand for

pneumococcal vaccines.”– GAVI Phase 2 Independent Evaluation

“Solution space” status: 2008

• GAVI Board endorsed Investment Case for Pneumococcal Vaccines

• $1.5 billion for an Advance Market Commitment for pneumococcal vaccines

Industry Willing to

Supply

Multinational & emerging manufacturers now committed to supply GAVI countries

Vaccines will have high serotype coverage, affordable price, and good vial size

CountriesWilling toIntroduce

WHO recommends pneumococcal vaccine in routine immunization programs

8 approvals, 3 conditional approvals & 34 expressions of interest

Donors/CountriesWilling toFinance

GAVI Pneumo: actual, recommended and forecasted introductions (Sept. 2010)

BurundiBenin

CAR

Cameroon

DR Congo

Ethiopia

Gambia

GuyanaHonduras

Kenya

Madagascar

Mali

Malawi

Nicaragua

Pakistan

Rwanda

Sierra Leone

Yemen

Forecast

ActualRecommended

Number of

Countries per year

Slide courtesy Lauren Franzel, PATH

Pneumococcal Vaccine Access Accelerated, Compared to Hib

The value of accelerated vaccine introduction

Source: GAVI website

COI Results - Health Impact of Vaccine Scale-up

6.4 million Deaths Averted 426 million Cases Averted

63,000 Disabilities AvertedDue to meningitis prevention

72 GAVI Countries; 2011-2020 (inclusive)Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.

Immediate Economic BenefitsPreventing illness could save $6.2 billion ($4.8-9.1 b) in treatment

costs and $1.2 billion ($0.7-1.4 b) in lost output of caretakers

Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.

Long-term Economic BenefitsFuture economic output increased by $144 billion ($120-168B) -

Totaling $151 billion ($131-176B) in immediate & long-term benefits

Immediate Benefits = Treatment costs + Caretaker ProductivityLong-term Benefits = Morbidity Productivity + Mortality Productivity Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.

Main takeaways

1. Dedicated team1. Team that “sweats the details” every day

2. Use evidence to set consensus & policies1. Need “push” to move into implementation

3. Strategic demand forecast1. Lays out “what will it take” for each stakeholder

Evidence to policy to implementation

Levine OS et al. Curr Op Infect Dis 2010

Moving from policy to implementation

Can feel like it’s a lot to handlehttp://www.youtube.com/watch?v=8NPzLBSBzPI

Opportunities & Challenges

Opportunities• Impact on child health &

economies• Success breeds success• Improved equity

Challenges• Biggest ever coordination

needed• Maintaining focus in face of

competing priorities• Economic setbacks

Thank you!

For more information, please visit

www.jhsph.edu/ivac

www.preventpneumo.org

www.sabin.org/PACE

Global Pneumococcal Vaccine Uptake High & Low Income Countries

Historical Hib Introduction by Income Group

Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).

Global PCV Introduction Status

Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).

GAVI Countries PCV Introduction Status

Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).

Pneumococcal is learning from Hib

Hibyrs since licensure Pneumo

yrs since licensure

Years accelerated

Licensure 1990 0 2000 0 0

Africa trial 1993 3 1998 -2 5

Asia trial 1998 8 2002 2 6

Financing 2000 10 2006 6 4

ADIP created 2005 15 2003 3 12

1st WHO rec 1998 8 2003 3 5

2nd WHO rec 2006 16 2007 7 9

Procurement 1998 8 2008 8 0

Significant acceleration of “evidence”, recommendations, advocacy and financing but little improvement in access to

supply and Unicef procurement

More than 40 countries by 2015

Following the May 2011 round, almost 70% of GAVI countries have sought support for PCV introduction. A total of 37 GAVI-eligible countries have been approved for GAVI support to introduce pneumococcal conjugate vaccine into

their national immunisation programmes.

With an additional 18 countries approved as of September 2011, pneumococcal vaccines will soon be administered in more than half of GAVI eligible countries.

This is an unprecedented rapid ramp up.

To date, 14 countries in the developing world have begun the introduction of pneumococcal vaccines. By rapidly scaling up the number of countries and the

number of children receiving the vaccines, GAVI and its partners can avert over 650,000 deaths by 2015 and up to seven million deaths by 2030.

Supplier perspective: Volumes / yr

Country/donor perspective: $ / yearIllustrative