developing country vaccine industry and global vaccine · pdf filedeveloping country vaccine...

Developing Country Vaccine

Industry and Global Vaccine Needs

ADVAC 2015

Dr. Suresh Jadhav Executive Director

Serum Institute of India Limited

Maharashtra, India, 411028

[email protected]

11 May 2015

mailto:[email protected]

Outline Immunization landscape

Vaccine Industry: DCVMN Overview

Role of DCVM

- UN Supplies

- Global Vaccination Coverage

-Vaccine Affordability

- Global Health Threats

Global unmet needs and The way forward

Global Vaccine Market

Source: Kaddar, WHO Presentation 2014

Global Vaccine supply

• Comprise 25 leading international companies.

• Majority of revenue stake owned by Big 5 Pharma.

• Represents research-based pharmaceutical and biotech companies.

• Generates 80-85 % of total revenue in global vaccine market.

• Contributes 12-15 % in volumes to global vaccine requirement.

Formed in Year 2000.

Year -2014. 39 members in 15 countries

representing Latin America, Middle East,

Africa, and the Asia-Pacific region.

WHO prequalified production facilities.

High volume low cost business models

In 2013, Emerging vaccine

manufacturers catered to 50 % of

procurement volumes and 50 % by value

of UNICEF shares.

Largely kept prices of traditional

vaccines affordable in-spite of declining

interest of Big Pharma in EPI vaccines.

Jadhav et al 2014, CMI.

Developing countries: Vaccine Industry

Supplies vaccines to 80 % of population: However shares less than

20% of global market in value

Increase in production capacities and potential to undertake or

partner for newer vaccines development

Business models based on access to emerging economies and

markets, UN market and Private sector in Low and Middle income

countries

Growth drivers: Large population, Unmet vaccination needs and low vaccination rates, Increasing governments focus on prevention/childhood rates

Future growth Expectations: Combination vaccines, -Influenza, -Traveller vaccines, Neglected Tropical diseases, pneumococcal and rotavirus, HPV vaccines

DCVMN

DCVMN: Formed in

Year 2000

Year 2014: 39

members in 15

countries. 12 members are

WHO prequalified.


COUNTRY VACCINE MANUFACTURER

ARGENTINA National Administration Of Laboratories And Institute Of

Health Anlis "Dr.Carlos G. Malbran

BANGLADESH Incepta Vaccine limited

BRAZIL Bio-Manguinhos / Fiocruz

Instituto Butantan

CHINA Beijing Minhai Biotechnology Co., Ltd.

Changchun BCHT Biotechnology Co.

China National Biotech Corporation

Hualan Bio

Liaoning ChengDa Biotechnology Co., Ltd,

Sinergium Biotech

Sinovac

TiantanBio

Walvax Biotechnology Co., Ltd

Xiamen Innovax Biotech Co.,Ltd

CUBA Finlay Institute

The Center for Genetic Engineering and

Biotechnology

EGYPT Vacsera


COUNTRY VACCINE MANUFACTURER

INDIA Bharat Biotech International Limited

Cadilla Pharmaceuticals

Biological E Ltd.

Haffkine Bio-Pharmaceutical Corporation Ltd.

Indian Immunologicals Ltd

Panacea Biotec Limited

Serum Institute of India Ltd.

INDONESIA Bio Farma

IRAN Razi Vaccine & Serum Research Institute

Pasteur Institute of Iran

KOREA Greencross Corporation

EuBiologics Co., Ltd.

LG Life Sciences

SK Chemicals

MEXICO Birmax

SOUTH AFRICA Biovac

TAIWAN The National Institute of Infectious Diseases and Vaccinology

THAILAND BioNet-Asia Co., Ltd.

Queen Saovabha Memorial Institute

The Government Pharmaceutical Organization,

VIETNAM Institute of Vaccines and Medical Biologicals,

Vabiotech

WHO Prequalified Vaccines & DCVMN Name of DCVMN Member WHO Prequalified Vaccines

1. Bio Farma / Indonesia TT, DT, Td, DTwP, Hep B, DTwP-Hep B,

Measles, mOPV, bOPV, tOPV

2. Biological-E / India TT, DTwP-Hep B-Hib, JE

3. Bio-Manguinhos / Fiocruz / Brazil YF, Men. A + C

4. The Center for Genetic Engineering and

Biotechnology / Cuba

Hep B, Hib

5. Chengdu Institute/ China JE

6. Green Cross Corpn. / Korea Seasonal and Influenza A (H1N1) - Pandemic

Influenza vaccines.

7. The Government Pharmaceutical

Organization / Thailand

Measles

8. Haffkine Institute/Mumbai mOPV, bOPV, tOPV

9. The Pasteur Institute, Dakar YF

10. Serum Institute of India TT, DT, Td, DTwP, Hep B, BCG, Hib,

Measles, Rubella, MR, MMR, Meningococal

conjugate vaccine against serotype A, H1N1

Pandemic Influ., bOPV, tOPV, DTwP-Hep B,

DTwP-Hib, DTwP-Hep B-Hib

11. LG Life Sciences/South Korea Hep-B, DTwP-Hep B-Hib

12 Panacea Biotech, India DTwP-Hep B-Hib

Global distribution of deaths among

children under five (2013)

6.6 million children died in 2013

More than half due to conditions that could be prevented or treated with access to simple, affordable interventions

Global Disease Burden of Vaccine-

Preventable Deaths (< 5 years)

Pertussis 13%

Hib* 13%

Measles 8%

Tetanus 4%

Pneumo diseases

* 32%

Rotavirus* 30%

Lancet, 2010 Jun 5; 375(9730): 1969-87.

Estimated 1.5 million

deaths in children

preventable through

routine vaccination

*WHO estimates

Global Vaccination Coverage-2013

Global Vaccine Action Plan

(GVAP)

Framework to prevent millions of deaths by 2020 through more equitable access to existing vaccines for people in all communities

Endorsed at 2012 World Health Assembly

Developed by Decade of Vaccines (DoV) Collaboration

Challenges in Meeting Global Needs

Limited resources

Competing health priorities

Poor management of health systems

Inadequate monitoring and supervision

Political instability

Priority needs to be given to strengthening routine vaccination globally.

Rapid growth in Emerging Economy

producers (DCVMs).

From Year 2008 to Year 2013: GAVI funded vaccines from DCVMN was above 50 %. Jadhav et al 2014, CMI.

Emergence of DCVMs

UNICEF publication, 2014

Vaccine Supplies to UNICEF

In Year 2012-14, the contributions of DC manufacturers to UNICEF supplies were

maintained around 54 %. Jadhav et al 2014, CMI.

DC Vaccine Industry Contributions

SAGE presentation 2014

In Year 2013: This coverage increased to 84 %.

Measles vaccine

Global coverage of children by their second birthday with one dose of measles

-containing vaccine in 2013: 84% SAGE presentation 2014

Hepatitis B Vaccine

Global coverage with three doses of hepatitis B vaccine is estimated at 79 % in year 2013. (WHO data; 2014)

Polio eradication

Year 2014: SEARO certified polio-free (27 March)

•No type 3 virus globally for 16 months

•Most countries on track to stop type 1



Hib Vaccine

Global coverage with three doses of Hib vaccine is estimated at 45 % in 2013

(WHO estimates, 2013)

Pentavalent vaccine and UNICEF

Supplies

Vaccine Pricing and Affordability

Year 1974: EPI program was launched.

Year 1999: Total cost of full course of EPI vaccine averaged USD

1.37

Year 2000: Adding two priority vaccines-Hepatitis B and Hib to EPI

vaccines increased the cost to USD10.

Year 2011: The expansion of EPI Program have raised the price of

purchasing the full course of vaccine in GAVI country to 38.80 USD.

(Price does not include programmatic or cost associated with vaccine

wastage).

Price of vaccine became a significant issue for immunization

stakeholders in Year 2011, when GAVI faced a US $ 3.7 billion

financial shortfall for its 2011-2015 programme implementation.

In Past 5 Years: WHO is recommending high unit cost products such

as pneumococcal conjugate vaccine and rotavirus vaccine for global

use in infants and HPV vaccines for adolescents.

The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012

Pricing and DCVMN

Crucell GSK DCVMN (SII/BE)

Presentation Single

dose

Two dose

lyophilized

Single

dose

-liquid

Two dose

lyo

Ten dose

liquid

Country of

manufacture

Republic

of Korea

Belgium India India India

2011 price

per dose

$2.80-

3.20

$2.95 $2.25-2.50 $2.25 $1.19-

2.11

DCVMN supplied Pentavalent vaccines, mainstay of GAVI Purchase at prices

almost 40 % less than Crucell, a European company.

GAVI’s support for pentavalent vaccine has averted 474,000 future deaths. source: WHO Department of Immunisation, Vaccines and Biologicals’ estimates and projections, November 2010

2011 Price Per dose of DTP-Hep-B-Hib (Pentavalent)


Poliomyelitis (Polio)

Launch of Global Polio Eradication Initiative has led to 99% drop in cases since 1988

3 countries remain polio-endemic: Afghanistan, Nigeria, Pakistan (vs 125 in 1988)

Polio Eradication and Endgame Strategic Plan 2013–2018 – aims to eradicate disease by 2018

One of major challenge in end game strategy will be vaccine supplies.

Supply of IPV and DCVM Existing price from developed country vaccine manufacturer (Big

Pharma): 4.50 Euros/dose.

EVM* Price: 2.50 Euros/dose till year 2013.

Year 2013 DCVM price: 1.25 Euro/dose in single dose container.

0.90 Euro/dose in multidose container for immediate use. Future

pricing may reduce to 0.60 Euros/dose in multidose vial.

Year 2014: 10 dose vial cost EUR 0.75 per dose from Big Pharma.

* Pricing from IPV producer in Europe acquired by Indian Vaccine Manufacturer

DCVMN and Global Pandemic threats

WHO Global Action Plan for Pandemic Influenza (GAP). -This represent an leading

example wherein pandemic

threats led to capacity building.

-New manufacturers have been

established in developing

countries, which brings hopes to

more adequate production

capacity and equitable access in

case of a future pandemic.

- By 2015, production capacity

of more than 1 billion doses is

expected by DC manufacturers.

DCVM and Global Health Threats Meningitis

Vaccine Project Successful example of Global Partnerships

MenAfric Vac: Impact

MVP and NIBSC presentation

DCVMN and Access to New Vaccines

Vaccine 2010, 28, 2115-21.

Vaccines DCVMN manufacturer Country Comments

Pneumococcal

Conjugate

BioManguinhos/GSK

Chengdu Institute/PATH SII, India/PATH Finlay Institute

Brazil

China India Cuba

Under development

Rotavirus Serum Institute of India

-Instituto Butantan -China National Biotech Group

-Biological Evans

India

Brazil China India

Phase-3

Phase-2 Under development Under development

Meningococcal

vaccines Includes

polysaccharide and

conjugate vaccines

Biological Evans

China National Biotech Group Finlay

Serum Institute of India Ltd

Panacea Biotech BioManguinhos

India

China Cuba India

India Brazil

Under development

Japanese

encephalitis vaccine

Vabiotech

Bharat Biotech Indian Immunologicals

Panacea Biotech

Vietnam

India India India

Under development

Phase 3 Under development Under development

Seasonal and

Pandemic Influenza

Vaccines

(also includes vaccines

with oil in water

adjuvants

-Vabiotech

-GPO - IVAC

- Butantan

- Chinese National Biotech Grp - Birmax

- BioManguinhos

Vietnam

Thailand Vietnam

Brazil

China Mexico

Brazil

Under development

Phase III Under development Phase I/II (new adjuvant)

Under development Under development

Under development

DCVMN and Access to New Vaccines

Vaccines DCVMN manufacturer Country Comments

Malaria vaccine Bharat Biotech India Under development

Typhoid Vaccine Finlay Institute Cuba Under development

Dengue Vaccine Biological Evans

Bio-anguinhos/Bionet

India

Brazil

Under development

Yellow fever ANLIS Argentina Phase III

Hepatitis A Bio-manguinhos Brazil Under development

Leishmaniases Bio-manguinhos Brazil Under development

Leptospirosis Bio-manguinhos Brazil Under development

HPV Vaccine Serum Institiute

CCGEB Innovax

Indian Immunologicals

India

Cuba China India

Under development

Chikungaya Indian immunologicals India Under development

Anthrax vaccine Panacea Biotech India Phase III

DCVMN and Pneumococcal Vaccines

Year 2000: PCV 7: CDC Purchase price was USD 44.25/dose.

Year 2009; PCV 13 CDC Purchase price was at 71.04 USD per dose.

Following deliberation in Year 2007, access to PCV 7 and 13 was supported by AMC with initial target price of USD 2.00 per dose. Finally the price was locked in with tail price of 3.50 USD/dose.

No competition from low cost producers as on date. However, some DCVMN members are expected to enter this segment of vaccines by Year 2016.


DCVMN and Rotavirus Vaccines

Year 2006: USD 15.00 for full course; PAHO supplies

Year 2011: Big Pharma manufacturers reduced the price in range of 5.00 to 10.00 USD per course following sales of 30 million doses.

Two DCVMN members are expected to have vaccine by Year 2015. One of member have announced its plan to launch this vaccine at USD 1.00 per dose.


Human papillomavirus (HPV)

Most common viral infection of the reproductive tract (> 100 types)

Can cause cervical cancer, other types of cancer, and genital warts

> 85% of cervical cancer deaths are in low- and middle-income countries

HPV vaccine introduced in 45 countries by end of 2012

HPV Vaccines and GAVI

36

Summary

DCVM have moved from dependency to self sufficiency and has finally emerged as global suppliers for affordable vaccines.

DCVM look forward to supplies and markets in developed world:

- Will have to overcome challenges and would need partnerships/collaborations with scientific community and Big Pharma to address issues of access, IP.

-Support from international agencies/foundations in terms of funding and advocacy.

The Facts

1 in 5 children do not have access to

life-saving immunizations

Vaccines

prevent

2 to 3

million deaths

annually

around

the world $20 can fully

vaccinate a

child against

pneumonia,

diarrhea, polio

and measles

Over 22 million infants remain

unimmunized in the world each

year

Thank You

We have to choose between a global market driven only by calculations of short-term profit,

Or

one which has a human face — Kofi Annan

We at DCVMN believe in second option

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