The Power of Protecting ’s future

Property of Bill & Melinda Gates Foundation 2

The Power of Vaccines Protecting India’s Future

Acknowledgements Contents Content support provided by Global Health Strategies (GHS) India and the International Access Center (IVAC) at 1 4 the Johns Hopkins Bloomberg School of , in collaboration with Dr. Jacqueline E. Tate, Centers for Disease Executive Summary 02 Diarrhoea and Control and Prevention, Dr. Chandrakant Lahariya, World Pneumonia in India 11 Health Organization (WHO), and Dr. Satish Gupta, UNICEF. 2 Rotavirus: Leading cause of severe diarrhoea Developed and published by Childhood deaths and Hib and pneumococcus: Leading causes of Immunization Technical Support Unit (ITSU) disease in India 05 severe pneumonia India’s share of global About ITSU Need for a comprehensive approach Leading causes of under-five child deaths ITSU was established by the Public Health Foundation of India (PHFI) in March 2012, under the auspices of the 5 Ministry of Health and Family Welfare (MoHFW) to support 3 Vaccines for diarrhoea the Universal Immunisation Programme (UIP). The overall and pneumonia 15 vision of ITSU is to catalyse national improvements in routine Value of Prevention 07 immunisation by providing the technical and management Vaccines: A public health “best buy” Global impact expertise required to design, create, implement, and More than just saving lives Status of introduction institutionalise a stronger immunisation programme fully “Herd immunity” and other indirect effects Potential impact led by the Immunisation division of MoHFW, Government of India, and supported by Bill & Melinda Gates Foundation. Role of vaccines in reducing death and 20 ITSU works through six different pillars to accomplish this, disease in India References including monitoring and evaluation (M&E); vaccine logistics Routine immunisation in India: A system and cold chain management; strategic communication; built to deliver AEFI management and vaccine quality and safety; strategic planning and system design; and evidence to policy. Case study: Success in eliminating smallpox ITSU serves to harmonise various initiatives being piloted Case study: Success in eliminating polio or implemented in different states by all immunisation partners and provide a single platform for discussions, development of strategies, and coordination with partners for scaling up successful models.

Design by Design Route © 2015 by ITSU

Vaccines and Immunization 2 3

Executive 1 Summary

Property of Bill & Melinda Gates Foundation

The unique role of vaccines nationwide coverage of the third dose of Vaccines – necessary part of an Recommended by national and Vaccines have played a pivotal role in the diphtheria-tetanus-pertussis (DTP) integrated strategy to address diarrhoea international experts improving child health and survival in vaccine increasing to an estimated 72% in and pneumonia The aforementioned diarrhoea and India and around the world. They are 2012 from 60% in 2000.[3] World Health Organization (WHO) and pneumonia vaccines are: considered one of the most cost-effective Several states have shown marked United Nations Children's Fund (UNICEF) • Recommended by the WHO for use in national solutions in the history of health and improvement in recent years. Bihar, for recommend an integrated approach immunisation programmes worldwide. development. Vaccines are unique in that example, has increased DTP3 coverage to protect against, prevent and treat • Recommended by the Indian Academy of they help people stay healthy by preventing from 54% in 2007-2008 (per District Level childhood diarrhoea and pneumonia in Pediatrics (IAP) for all Indian children. infection at the very outset, in turn avoiding Health Survey-3) to over 80% in 2012-2013 the “Integrated Global Action Plan for the • Listed as a necessary component of WHO and recurring sickness, death and unnecessary (per Annual Health Survey). Prevention and Control of Pneumonia and UNICEF’s GAPPD. social and economic costs to society. Diarrhoea” (GAPPD). They recommend • Key elements of the WHO Global Vaccine Childhood diseases in India Immunisation not only helps protect health the adoption of a comprehensive approach Action Plan, which is endorsed by 194 and provide medical savings, but also Despite making important progress in that includes vaccines as one of the most member states, including India. yields indirect economic benefits, including reducing the burden of vaccine preventable critical tools to prevent child deaths and improvements in cognitive development, diseases and achieving overall reductions suffering. Equal access for all educational attainment and labour in child mortality, serious challenges Delivering vaccines to children safely and Vaccines protect against the leading productivity. Many vaccines also provide remain. An estimated 1.3 million Indian effectively requires a strong immunisation causes of diarrhoea and pneumonia “herd immunity,” offering protection even children under five continue to die each system. In India, the Pulse Polio Program, to unimmunised individuals. year, with more child deaths in India than The leading cause of moderate-to- as well as the Japanese encephalitis and in any other country in the world. India severe diarrhoea – rotavirus – and measles catch-up campaigns, have amply Vaccines work in India alone accounts for roughly one-fifth of the the two leading causes of bacterial demonstrated the capacity of a well- India has made significant progress world’s total under-five deaths.[1, 4] pneumonia – Haemophilus influenzae developed immunisation system to deliver towards reducing child deaths as it aims type b (Hib) and Streptococcus oral and injectable vaccines to millions Diarrhoea and pneumonia – the leading to achieve multiple child health targets. pneumoniae (pneumococcus) – are all of children safely and effectively. Several causes of death and suffering in children The country’s child mortality rates have vaccine preventable in children. Vaccines children across India rely solely on the under five declined by over 58% since 1990.[1] This that protect against these causes are national public to access has been possible due to the many steps Diarrhoea and pneumonia together widely used around the world and have childhood vaccines. Given that pneumonia taken by the Government of India (GoI) to account for the largest share (23%) of proven to be very effective in preventing and diarrhoea are the leading causes of accelerate child survival in the country, total under-five deaths in India. In 2013, and reducing cases of diarrhoea and death for children under-five, vaccines that including strengthening the country’s diarrhoea claimed the lives of more than pneumonia. As of January 2015 the Hib protect against these diseases must be routine immunisation (RI) programme. 130,000 Indian children under five. In the vaccine has been introduced into India’s included in India’s routine immunisation same year, pneumonia caused nearly Universal Immunisation Programme Vaccines have successfully eliminated program. 175,000 deaths of Indian children under (UIP) in 15 states and union territories in smallpox and polio from India; brought five.[1, 4] Even in cases of survival, the the form of the pentavalent (DTP-HepB- Equitable access to these life-saving measles to an all-time low; and reduced severe burden of illness that diarrhoea and Hib) vaccine, with plans for a nation wide vaccines is an essential step in India’s tetanus by an estimated 95% over the pneumonia cause could adversely impact scale-up. India has also developed and effort to successfully accelerate past three decades, with at least 18 child growth and development. These licensed its first indigenous rotavirus progress towards achieving national and states since 2003 validated as having diseases also place a significant economic vaccine, manufactured by Bharat Biotech international child health and development eliminated maternal and neonatal burden on families, communities and the in collaboration with the Department of targets. tetanus as of December 2013.[2, 3] Over healthcare system. Biotechnology (DBT) and All India Institute the years, India has also seen progress of Medical Sciences (AIIMS). expanding immunisation coverage, with

EXECUTIVE SUMMARY EXECUTIVE SUMMARY 5

More children die each year in India than in any CHILDHOOD DEATHS other country 2 AND DISEASE IN INDIA

In 2013, there were an estimated 1.3 million deaths among Indian children under-five. Many of these deaths were from largely preventable causes.[4, 1] While the country has made significant progress in reducing child deaths, current efforts, especially for pneumonia and diarrhoea, must be enhanced and accelerated to achieve national and global goals. In the years to come, India will also need to continue its efforts towards reducing child deaths in line with the Post-2015 Development Agenda.[5]

INDIA’S SHARE OF GLOBAL However, more than 17,000 children CHILD MORTALITY continue to die globally each day. India witnesses more child deaths each year The incidence of global deaths among than any other country, accounting for 21% children under-five has reduced by more of global deaths among children under than half, from an estimated 12.6 million five.[1] deaths in 1990 to 6.3 million deaths in 2013.[1]

Figure 1 India’s Share of Global Child Mortality 2013 (figures in thousands)

Kenya Democratic Republic 106 (2%) of Congo 320 (5%) Bangladesh 129 (2%) Pakistan 394 (6%) Angola 153 (2%) Nigeria 827 (13%) Indonesia 136 (2%) India 1,340 (21%) Ethiopia 196 (3%) Other countries China 2,471 (40%) 236 (4%)

Reference: Committing to Child survival - a Promise renewed. Progress report 2014. UNICEF, 2014.

Property of Bill & Melinda Gates Foundation Childhood deaths and disease in India 6 7

After the first LEADING CAUSES OF (RBSK) or National Child Health Programme month of life, UNDER-FIVE CHILD DEATHS is one such initiative that was launched to provide services for the screening of childhood VALUE OF vaccine preventable Pneumonia, diarrhoea, and newborn diseases. Similarly, schemes like the Janani- diseases are the complications account for the majority Shishu Suraksha Karyakram (JSSK) have been biggest threats to of under-five deaths in India. Figure 2 introduced to provide financial and medical 3 PREVENTION children illustrates the leading causes of deaths in assistance to childbearing mothers and children under-five, while also highlighting newborns on a national scale. More recently, the diseases for which vaccines are under the National Health Mission (NHM), the available.* GoI has initiated the National Urban Health Mission (NUHM) to meet the healthcare • Newborns (0-27 days): More than half the needs of those living in urban centres. These total under-five deaths in India occur in the comprehensive and far-reaching schemes first 27 days of life, or the neonatal period.[4] are part of the GoI’s “cohesive approach” to These deaths are primarily due to prematurity reproductive, maternal, newborn, child, and and low birth weight, birth trauma, asphyxia, adolescent health (RMNCH+A), which seek to and infections.[1] While some newborn deaths address major causes of sickness and death can be prevented by vaccines, such as the among women and children, as well as the maternal tetanus vaccine, many require problems they face in accessing and utilising prevention through dedicated antenatal and Vaccines are considered to be one of the most effective healthcare services.[7] newborn care.[1] interventions among the many public health efforts and Despite these efforts, under-five deaths • 1-59 months: After the first month of life, development initiatives that have contributed to the laudable from several preventable causes remain vaccine-preventable diseases are the biggest reduction in global child deaths. high. This is, in large part, due to the high threats to child survival.[4, 6] Diarrhoea and incidence of illness caused by diarrhoea Vaccines prevent deaths and put a halt to the vicious cycle of pneumonia are the two leading causes of and pneumonia, which resulted in more death among children in this age group.[4] recurring illness, hospitalisations, and unnecessary social and than 300,000 deaths in 2013.[1] Even when economic costs to families and society. Today, more than 30 The GoI has taken many steps to reduce these not fatal, the severe burden of illness common infectious diseases are preventable with vaccines.[8] preventable child deaths, some of which have that diarrhoea and pneumonia cause can been carried out under the National Rural adversely impact a child's growth and Health Mission (NRHM), established in 2005 to development, while also economically VACCINES: A PUBLIC HEALTH “HERD IMMUNITY” AND *Not all vaccines are improve access to and affordability of quality burdening families, communities, the ‘BEST BUY’ OTHER INDIRECT EFFECTS available in India’s national health care for all rural populations. The government, and the healthcare system. immunisation programme. Vaccines are also considered to be one Many vaccines protect more than only NRHM’s Rashtriya Bal Swasthya Karyakram of the most cost-effective solutions in those who have been immunised. They Figure 2 the history of health and development. also protect unimmunised individuals by [9] In 2012, some of the world’s leading reducing disease transmission between Causes of Under-Five Child Deaths in India, 2013 health economists ranked childhood people – a phenomenon known as “herd immunisation among the top three most immunity” or “indirect protection.”[8, 12] cost-effective solutions to advance human This type of protection helps safeguard welfare.[10] Vaccines prevent illness and communities, including the most Malaria 1% death, while also offering long-term vulnerable members of society, such Measles Pneumococcus benefits for economic growth and national as persons whose immunity has been Hib, Measles, development.[11] compromised, the elderly, or infants who Pertussis Meningitis 2% are too young to receive immunisations. Measles 3% MORE THAN JUST For example, immunising children with SAVING LIVES pneumococcal conjugate vaccines is Injury 3% Vaccines prevent known to significantly reduce the Tetanus illness and death Vaccines don’t just save lives. They also number of elderly patients hospitalised for InjuryDiarrhoea 10% 4% and also offer long- prevent illness, hospitalisation, disability, pneumonia.[13] and unnecessary human suffering. They Others 14% term benefits for also provide indirect benefits to individuals economic growth and society, including improvements Pneumonia 11% and national in cognitive development, educational Rotavirus, Cholera Neonatal causes 56% development attainment, and labour productivity.

Vaccines available to help protect against forms of diseases are highlighted

Reference: Committing to Child survival - a Promise renewed. Progress report 2014. UNICEF, 2014.

Childhood deaths and disease in India Value of Prevention 8 9

ROLE OF VACCINES IN having not reported a single case of maternal The government ROUTINE IMMUNISATION IN DTP3 coverage from 54% in 2007-2008 to REDUCING DEATH AND and neonatal tetanus as of December 2013.[2] has taken INDIA: A SYSTEM BUILT TO 81.6% in 2012-13.[15,16] • Following the introduction of a second dose of The GoI has taken concrete steps to DISEASE IN INDIA the measles vaccine and intensive concrete steps to DELIVER strengthen RI in recent years, including • Smallpox elimination was achieved in India, campaigns, measles is at an all-time low.[3] strengthen routine Reductions of vaccine-preventable introducing a National Vaccine Policy in contributing to global eradication of the immunisation in diseases would not have been possible • Since 1980, diphtheria cases have declined by 2011 and declaring 2012 as the year of disease in 1980.[3] without the many steps taken by the 94%, with only around 2,500 cases reported in recent years "Intensification of Routine Immunisation," • India was declared polio free in 2014, after [3] GoI to accelerate child survival in the 2012. with concentrated efforts on improving no cases had been reported in India for three • Pertussis vaccination has helped reduce the country, including the strengthening of coverage in low-performing states.[17] consecutive years; a feat once widely regarded the country’s routine immunisation (RI) burden of disease by 86% between 1980 and During this time, special immunisation as impossible.[3] programme. 2012.[3] weeks were initiated to boost immunisation • Tetanus cases have reduced by over 95% over According to the 2009 UNICEF Coverage coverage. The GoI has also made vaccine- the past three decades, with at least 18 states Evaluation Survey All India Report, specific efforts, including introducing national coverage of three doses of the a second dose of the measles vaccine. Figure 3 DTP vaccine is an estimated 72%, Catch-up campaigns for a second dose of The Vaccine Story in India compared to, for example, 43% for oral the measles vaccine in low-coverage states Pentavalent vaccines are currently rehydration therapy among children with were completed by 2013.[3] In January being used in 15 states: Kerala, Tamil Nadu, Haryana, Jammu & diarrhoea, and 33% for breast feeding 2014, the GoI approved a Comprehensive Kashmir, Gujarat, Karnataka, Goa, within one hour of birth.[14] Multi-Year Strategic Plan for Universal DISEASE BEFORE VACCINES AFTER VACCINES % Puducherry, Delhi, Rajasthan, Immunisation Programme in India (2012- # OF CASES # OF CASES DECREASE Several states are showing strong Madhya Pradesh, Chhattisgarh, 2017).[18] Punjab, Bihar and West Bengal. progress. Bihar, for example, has increased

SMALLPOX 1975 1976 0 100% 23,546 eradicated Figure 4 Routine Immunisation Coverage Trend in India by Antigen: 1980-2011* 1985 2012 POLIO 0 100%

150,000 eradicated

100% TETANUS 1990 2013 NEONATAL 97% 90% 11,849 415

80% TOTAL 1980 2013 94% 45,948 2,814 70%

60% DIPTHERIA 1980 2013 92% Reference: 3,133 39,231 50% Rabindra Nath Basu, R.N.,Jezek, Z & Ward, N.A. “The Eradication of Smallpox from India.” World Health Organization, 40% South- East Asia Regional Office, 1979. 1980 2013 India Polio Learning Exchange. Polio 30% IndiaFact Sheet. UNICEF, 2012. http:// PERTUSSIS 90% www.iple.in/document/media-fact- 20% sheet-on-polio-in-india

Polio refers to all polio cases (indigenous 10% or imported), including polio cases 320,109 31,089 caused by vaccine derived polio viruses (VDPV) it does not include cases of 0% vaccine- associated paralytic polio (VAPP) and cases of non polio acute 1980 1990 2000 2007 2008 2009 2010 2011 flaccid paralysis (AFP) 1980 2013 MEASLES 88% reduced drastically Verma, Ramesh & Khanna, Pardeep. “Tetanus toxoid vaccine: Elimination 114,036 13,822 of neonatal tetanus in selected states of India.”Human Vaccines & Immunotherapeutics 8:10, 1439-1442; BCG OPV3 Hep B3 October 2012.

WHO VPD Monitoring System: Global Summary. Last Updated 15 July 2014. 10,000 reported cases Less than 10,000 reported cases DTP MCV1 http://apps.who.int/immunization_ monitoring/globalsummary/countries?co Reference: WHO-UNICEF coverage untrycriteria%5Bcountry%5D%5B%5D=I estimates Routine Immunisation Coverage ND&commit=OK Trend in India by Antigen 1980-2011

Value of Prevention Value of Prevention 10 11

Diarrhoea and Currently, India’s Universal Immunisation In July 2014, the Office of the Prime pneumonia take a Programme includes vaccines against the Minister of India announced that four following diseases: tuberculosis (BCG), new vaccines, an indigenously developed DIARRHOEA AND toll on children’s polio, diphtheria, pertussis, tetanus, rotavirus vaccine, the inactivated polio bodies, leaving them measles, and hepatitis B. Some states also vaccine, the rubella vaccine and the more vulnerable to 4 include Haemophilus influenzae type b vaccine against Japanese encephalitis, PNEUMONIA IN INDIA subsequent infections, (Hib, as pentavalent vaccine) and tetanus would be provided to all children in India. malnutrition, stunting, toxoid (TT) vaccines. In some endemic wasting, and poor areas, the Japanese encephalitis (JE) physical and cognitive vaccine is also used. development, ultimately leaving SUCCESS IN ELIMINATING SMALLPOX them more likely to die from other Smallpox, one of the deadliest diseases where more than two-thirds of the causes too in human history, was eradicated from cases had occurred. In 1975, India the globe more than 30 years ago. witnessed its last case of smallpox and Global eradication efforts came into by 1980 WHO declared that smallpox full force in 1966, with the launch of had been eradicated worldwide, a Figure 5 WHO’s Intensified Smallpox Eradication feat that would have been impossible Programme, which envisaged the goal without vaccines. of universal vaccination. In India, during 2013 One of five remaining smallpox- endemic countries at the time, India 134,000 children died from reported more than 60,000 smallpox less than five years Diarhhoea cases in the first few months of 1974.[19] The country acted quickly to address the most troublesome areas, namely 174,200 children died from delivering smallpox vaccines to remote less than five years pneumonia populations in Bihar and West Bengal, This One Fifth of all equals global diarrhoea and pneumonia deaths SUCCESS IN ELIMINATING POLIO

India marked three years without a On achieving three years as polio- case of polio on 13 January 2014, a free, India and WHO's South-East landmark achievement for global Asia Region were officially certified ROTAVIRUS: Leading Cause five. In the same year, the virus accounted public health and the worldwide effort as polio-free in March 2014. India’s of Severe Diarrhoea for more than 872,000 hospitalizations and to eradicate polio. India’s remarkable success with polio demonstrates that it over 3 million outpatient visits.[26] success proves that polio can be can successfully deliver critical life- Diarrhoea in children is caused by eliminated under the most challenging saving vaccines to all children, even in infections from a broad range of viruses, HIB AND PNEUMOCOCCUS: of circumstances. Once considered by the hardest to reach places. Today, the bacteria, or parasites, which infect the experts as the most technically difficult strategies and infrastructure built to intestinal tract and disrupt the normal Leading causes of severe place to end polio, India had at least tackle polio are being used to address functioning of the intestines. If left pneumonia A study found 150,000 cases of polio in 1985.[20] other vaccine preventable diseases, untreated, diarrhoea can lead to cases Most cases of pneumonia are caused by The country launched an intensive such as measles. that children with of severe dehydration that may require bacteria or viruses. The Hib and campaign to end polio, which was one episode of hospitalisation or even cause death. pneumococcus bacteria are two leading supported by numerous international moderate-to-severe causes of pneumonia in children in India Rotavirus is the leading cause of partners and technical experts. A and also cause meningitis, an infection of diarrhoea had an moderate-to-severe diarrhoea among surveillance network of more than the membranes surrounding the brain and 8.5-fold increased children in India, accounting for 33,000 reporting sites was established spinal cord. and more than 2.3 million vaccinators risk of dying two approximately 40% of all reported were deployed. Strategies to reach months later from diarrhoea cases according to numerous Pneumococcus and Hib are the leading every child ensured the delivery of any cause compared studies.[22, 23, 24] Recent studies have causes of severe bacterial pneumonia several million doses of oral polio to children who estimated that rotavirus led to more than in children, together accounting for approximately 60% of pneumonia deaths in vaccine each year.[21] did not have an 78,000 deaths in India in 2011 and over 11 million episodes among children under- children under the age of 5 years. In India, episode[25]

Value of Prevention Diarrhoea and Pneumonia in India *Unpublished estimates based it is estimated that in 2013 pneumococcus NEED FOR A on published disease-specific caused more than 60,000 pneumonia Integrated Global Action Plan for the estimates and updated COMPREHENSIVE APPROACH child mortality estimates deaths and Hib caused more than 35,000 for 2013.[1, 27, 28] pneumonia deaths.* In addition to this Diarrhoea and pneumonia are preventable Prevention and Control of Pneumonia and high mortality burden, these two bacteria and treatable diseases. WHO and UNICEF are responsible for millions of cases of recommend an integrated approach Diarrhoea (GAPPD) pneumonia and tens of thousands of cases to protect against, prevent and treat of debilitating meningitis in children each childhood diarrhoea and pneumonia in year.[1, 27, 28] the “Integrated Global Action Plan for the Reduce Pneumonia & Diarrhoea Morbidity and Mortality Prevention and Control of Pneumonia Even where treatment can save lives, cases and Diarrhoea”(GAPPD).[29] The GAPPD of meningitis caused by pneumococcus strategy emphasises a range of proven and Hib often have negative life-long health interventions, including breast feeding, effects, such as deafness, seizures, motor vitamin supplements, hand washing with impairment, and mental disabilities. soap, treatments such as oral rehydration Pneumococcal Similarly, even if children survive, each salts (ORS) and antibiotics, improved disease is the episode of diarrhoea and pneumonia sanitation, and immunisation, among number one vaccine- takes a toll on their bodies, leaving them many other strategies. A key element of more vulnerable to subsequent infections, the GAPPD strategy is the use of vaccines preventable cause malnutrition, stunting, wasting, and poor to prevent disease, as the leading causes of death in children physical and cognitive development, of diseases such as diarrhoea and under five, globally ultimately leaving them more likely to die pneumonia are vaccine preventable.[29] and in India.[4] from any cause.

Protect Prevent Treat Rotavirus is the leading cause Children by establishing Children from becoming Children who are ill from of moderate-to- good health practices ill from pneumonia and pneumonia and diarrhoea severe diarrhea in from birth diarrhoea with appropriate treatment India, accounting for approximately • Exclusive breast feeding for 6 • Vaccines: pertussis, measles, • Improved care seeking and months Hib, PCV and rotavirus referral 40% of all diarrhea cases requiring

• Adequate complementary • Handwashing with soap • Case management at the treatment.[22, 23, 24] feeding health facility and community level • Safe drinking water and • Vitamin A supplementation sanitation • Supplies: Low-osmolarity ORS, zinc, antibiotics and oxygen • Reduce household air pollution

• Continued feeding (including • HIV prevention breast feeding)

• Cotrimoxazole prophylaxis for HIV infected and exposed children

Reference: WHO and UNICEF The Integrated Global Action Plan for Pneumonia and Diarrhoea (GAPPD). 2013.

Property of Bill & Melinda Gates Foundation 15

Hib disease has been virtually eliminated VACCINES FOR from industrialised countries, where Hib 5 DIARRHOEA AND vaccines have been in widespread use for PNEUMONIA over 20 years.[30]

There are several safe and effective vaccines that protect against rotavirus, Hib, and pneumococcal disease. These vaccines are widely used all over the world: • Rotavirus can be prevented with the help of vaccines. In India, two effective rotavirus vaccines are currently available in the private market, and the country has developed and licensed its first indigenous vaccine. In July 2014, the Prime Minister's Office announced it would introduce rotavirus vaccines into the country's UIP. As of September 2014, rotavirus vaccines have been introduced in more than 70 countries.[30] • Hib disease can be prevented by Hib vaccines, such as the five-in-one pentavalent vaccine or the stand-alone Hib vaccine. Hib vaccines have been introduced in over 185 countries as of September 2014. The pentavalent (DTP-HepB-Hib) vaccine, which is used in over 100 countries, is part of India’s national immunisation programme in selective states.[30] • Pneumococcal disease can be prevented through vaccination with a pneumococcal conjugate vaccine (PCV). Two PCVs are currently available in India only in the private market, while an indigenous PCV candidate is in the early stages of development. As of September 2014, PCV has been introduced in over 110 countries.[30]

GLOBAL IMPACT Hospitalisations from pneumonia have also shown dramatic reductions, following the Hib disease has been virtually eliminated introduction of the vaccine.[37] from industrialised countries, where Hib vaccines have been in widespread use for Swift and significant declines in more than 20 years. In developing countries hospitalizations and deaths due to rotavirus that introduced Hib vaccines into their diarrhea and all-cause diarrhea have been national immunisation programmes, cases observed in many countries that have of Hib pneumonia and meningitis have introduced rotavirus vaccines, including been drastically reduced.[31] In countries low- to-middle-income countries, such that introduced pneumococcal vaccines, as Mexico (See Figure 6).[38, 39] Since the the disease has almost been eliminated, introduction of the rotavirus vaccine, one including reductions in affected cases of of the most interesting and unanticipated unvaccinated children and adults.[32, 33, 34, findings was its indirect 35, 36] Property of Bill & Melinda Gates Foundation Vaccines for diarrhoea and pneumonia 17

Figure 6 Figure 8 Reductions in Rotavirus Hospitalisations for Vaccinated and Unvaccinated Age Cohorts kenya: Decline in Cumulative Admissions of Children Under Five for Invasive Penumococcal Disease in Kilifi District Hospital

100% 40 VACCINATED AGE GROUP 92% 90% (DIRECT BENEFITS) 91% 35 83% 82% 83% 80% 80% 80% INTRODUCTION OF 78% 30 75% PNEUMOCOCCAL 74% 73% 70% 71% VACCINE: JANUARY 2011 25 63% 60% 60% 60% 61% 57% 20 50% 50%

42% 15 40% 41% 35% 10 30% UNVACCINATED AGE GROUP 24% 20% (INDIRECT BENEFITS) 5

10% 0 Cumulative Cases Cumulative

0% 0 5 10 15 20 25 30 35 40 45 50 Week US (24) US (26) US (21) US (30) US (43) US (64) Australia Australia Austria Brazil El (31) (39) (36) (40) Salvador (43) 2010 2011 2012 2013 Country (Reference)

Based on, Patel et al. lancet ID 2012;12:561-570 Reference: KEMRI-Wellcome Trust, ongoing data as of 16 September 2013

Figure 7 Figure 9 mexico: Decline in Diarrhoeal Deaths in Children Under 5 Following Rotavirus Vaccine Introduction BANGLADESH: Decline in Hib Meningitis After Hib Vaccine Introduction

70 35

250 INTRODUCTION INTRODUCTION 60 30 COUNTRYWIDE VACCINE 0-11 mo OF VACCINE OF VACCINE 200 INTRODUCTION IN MAY 2007 12-23 mo 50 25 24-59 mo 150 40 20

100 30 15

20 10 50

10 5

No.of Diarrhea Deaths 0

Incidence/100,000 0 No.of Cases 0

Jul-02Nov-02Mar-03Jul-03Nov-03Mar-04Jul-04Nov-04Mar-05Jul-05Nov-05Mar-06Jul-06Nov-06Mar-07Jul-07Nov-07Mar-08Jul-08Nov-08Mar-09Jul-09Nov-09Mar-10Jul-10Nov-10Mar-11Jul-11Nov-11 2008 2009 2010 2011 2012 2008 2009 2010 2011 2012

Population Surveillance around Sentinel Site: Sentinel Site surveillance :No. of Cases (N=119) 1. Reduction in deaths of more than 50% realized and 2. Reduction in deaths by 35% seen in just the first year.2 Incidence (<1Y) sustained (2009-2011) across all regions – even in less economically developed regions.1 Hib Vaccine Impact Assessment on Meningitis Using Sentinel Site and Defined Population in Bangladesh

Reference: 1. Gastañaduy, Pediatrics, 2013. 2. Richardson, NEJM, 2010 Reference: Unpublished data from Samir Saha Chile Health Research Foundation, Bangladesh

Vaccines for diarrhoea and pneumonia Vaccines for diarrhoea and pneumonia 18

effect of significantly reducing rotavirus POTENTIAL IMPACT disease among older children who were not vaccine-eligible. The data in Figure 6 is Rotavirus vaccine: According to one study, from multiple settings (the US, Australia, introduction of a rotavirus vaccine in the Austria, Brazil, and El Salvador) showing national immunization program would declines in hospitalisations not only in prevent over 25,000 deaths, nearly 300,000 vaccinated age groups (in blue) but also age hospitalisations, and more than 600,000 groups who were unvaccinated (in red)– the outpatient visits each year in India.[43] result of “herd immunity”. Pentavalent (Hib) vaccines: A study conducted in the Vellore district of Tamil STATUS OF INTRODUCTION Nadu found a significant reduction in Hib meningitis hospitalisations once Among these new vaccines, only the Hib the vaccine became available in the vaccine is included in India’s UIP in the private market, while hospitalisations form of the five-in-one pentavalent for other diseases remained stable.[44] vaccine.[31, 40] As of January 2015, As pentavalent vaccine is introduced in pentavalent vaccines have been introduced additional states, experts anticipate a more in 15 states and union territories. The substantial impact from the vaccine than National Technical Advisory Group on that found in the Vellore study. Immunisation (NTAGI) has recommended that the pentavalent vaccine be scaled Pneumococcal conjugate vaccines (PCV): up nationally so that all children in India In clinical trials conducted in several are protected. In July 2014, the Prime countries, PCV showed on average efficacy Minister's Office (PMO) announced the of 80% and prevented 36% of severe inclusion of rotavirus vaccines in India's pneumonia cases (caused by any pathogen) UIP. PCV is currently not included in India's in children.[45] Both the PCVs available in UIP. However, India's first indigenous India protect against more than 70% of the PCV vaccine is currently in early stages of disease-causing strains of pneumococcus development. in the country that could result in a significant reduction of the disease.[46] Since the affordability of vaccines impacts decisions regarding their inclusion in the national immunisation system, many manufacturers have decided to offer these vaccines at lower prices. For example, the manufacturer of the recently licensed domestic rotavirus vaccine has pledged to make the current formulation of the vaccine available at US$1 per dose for governments and UN procurement agencies.[41, 42] Making vaccines more widely available and accessible through the UIP would have a significant impact on reducing childhood deaths and disease in India. All three vaccines — Hib, PCV and rotavirus— are widely recommended and endorsed by numerous Indian and international stakeholders, including WHO and the IAP. They are listed as a necessary component of WHO and UNICEF’s GAPPD and are a key element of the WHO’s Global Vaccine Action Plan (GVAP), which is endorsed by 194 member states, including India.

Vaccines for diarrhoea and pneumonia Property of Bill & Melinda Gates Foundation 20

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