The Rising Incidence of Diarrhea in India

By: Hilleman Laboratories on December 30, 2016

Diarrhea is the second leading cause of child mortality, worldwide. As estimated by Health Ministry, over 1.2 lakh children aged less than five years, succumb to diarrhea every year. The mortality rate is of 5 per 1000 live births in the country, as stated in an annual report released by International Vaccine Access Center.  

The primary factors which contribute to Diarrheal attacks among children are:

•          contaminated water and food
•          malnutrition
•          inadequate sanitation and
•          lack of immunization

The diarrheal disease further compromises the health of the child by hindering development, cognitive impairment and poor immune response.

According to a new research published in The Lancet, the number of cases of children dying from Diarrhea was twice as high as estimated previously. The attributable pathogens – Viruses, parasites, bacteria and other infections has been substantially underestimated. The research consisted of analysis of over 1000 samples from Bangladesh, India, Pakistan, the Gambia, Kenya, Mali and Mozambique. Its findings included that shigella and rotavirus were the most common infections among children below the age of 5. The other infections were followed by adenovirus, enterotoxin-producing E coli (ETEC), Cryptosporidium, and Campylobacter. The study concluded that while there is an oral vaccine that exists for rotavirus, a need was highlighted for shigella and ETEC vaccines which should to be prioritized. Diarrhea can also be managed through supportive care with rehydration and zinc supplementation. The use of antibiotics is not usually recommended unless there are signs of dysentery or if cholera is suspected.

Progress in immunization coverage is now being made in India with the introduction of rotavirus vaccine in Haryana, Andhra Pradesh, Himachal Pradesh and Odisha in 2016. There is a further expansion plan in March 2017 where the vaccine will be introduced in in the state of Rajasthan.17.25 lakh children will benefit from this introduction. Along with Rajasthan Tripura, Assam, Madhya Pradesh and Tamil Nadu in second phase. There are also simple proven interventions that can prevent death, including vaccines, antibiotics, exclusive breastfeeding, and access to treatment and care.

"It may not be possible to stop incidence of diarrhea by intervention but prevent deaths from it," says CK Mishra, additional secretary to the Health Ministry.

In India, only 54.4% children suffering from diarrhea receive ORS, whereas 30% of children are malnourished and are therefore, at an increased risk of getting the infection. We urgently need to find approaches to escalate the deployment of solutions to ensure that there is continued positive progress in reducing preventable child deaths.

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Blog: Evolution of Universal Immunization Programme (UIP)

By: Hilleman Laboratories on December 15, 2016

Vaccines have been a proven tool for controlling and eliminating life-threatening infectious diseases. Vaccines empower the body’s own immune system to protect the person against subsequent diseases. As per World Health Organization(WHO), vaccinations have averted 2-3 million deaths annually. Till date, number of initiatives have been undertaken around the world to improve the immunization coverage and protect children and adults against infectious diseases.

First Immunization Programme in India called the ‘Expanded Programme of Immunization (EPI)’ was launched in 1978 with an objective to increase the Immunization coverage up to 80 per cent in infants. The vaccines included in the programme were DPT, OPV, BCG and typhoid vaccines. Unfortunately, the programme couldn’t cover the targeted population as planned and was only able to cover a part of the urban population. At such a point in time, the country needed a significant programme for immunization which could reduce mortality and morbidity of various infectious diseases.

Later in 1985, the Government of India renamed Expanded Programme of Immunization (EPI) to Universal Immunization Programme (UIP). The main objective of Universal Immunization Programme was to reduce mortality and morbidity.

It aimed to enhance indigenous vaccine production capacity in India and establish cold chains. It focused on phased implementation of vaccines with a goal to cover all districts by 1990. Implementation of monitoring and evaluation system was also included in the programme. As time progressed, following were the key improvements introduced in the Universal Immunization Programme: 

With several improvements and successful implementations, Universal Immunization Programme is amongst the largest public health intervention measures undertaken in India. It is also amongst the largest Immunization programmes in the world in terms of- quantity of vaccine used, number of beneficiaries reached out to, number of immunization sessions organized and the geographical spread and diversity of areas covered. It has changed how cold chain system used to work, helped establish a network of outreach immunization sites, identified alternative delivery model for the vaccines and also enhanced capacity building of health functionaries and medical officers.

Keeping in the mind the progression of vaccines and their massive reach in the world, the Universal Immunization Programme(UIP) has remained focused and has prioritized number of initiatives both at the national as well as the state levels. The government of India along with multiple development partners have initiated various measures to escalate and improve the functioning and service delivery of various vaccination programmes in the country.

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Immunization Catch Up Chart Schedule in India 2016

By: Hilleman Laboratories on November 30, 2016

The catch-up vaccination schedule makes sure that all the vaccines are administrated appropriately after taking the delayed/missed dose into account.

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Pneumonia Vaccine to be introduced under Universal Immunization Programme in 2017

By: Hilleman Laboratories on November 24, 2016

Pneumonia and diarrhoea are major reasons for death in the post-neonatal period. In 2015, India recorded an under-five death rate of around 48 deaths for each 1,000 live births. It is serious situation as around 1.26 million children aged below five years die in the country every year.

In a recent report released by International Vaccine Access Centre (IVAC) and Johns Hopkins Bloomberg School of Public Health, the top five countries with highest burden of child pneumonia & diarrhoea cases globally are India, Nigeria, Pakistan, Democratic Republic of Congo and Angola. The report also stated that 15 years after pneumococcal conjugate vaccines’ (PCV) first introduction globally in 2000, five of the highest pneumonia burden countries (India, Indonesia, Chad, China and Somalia) are still not using the vaccine in their routine immunisation programs.

Post the report launch, Ministry of Health and Family Welfare(MoHFW) announced that the pneumococcal conjugate vaccines(PCV) that combats pneumonia, will be rolled out as part of the Universal Immunisation Programme in a phased manner in the states of Himachal Pradesh, Uttar Pradesh, Bihar, Madhya Pradesh and Rajasthan. The introduction of the vaccine will start in 2017.

"Adding this life-saving vaccine such as PCV and Rotavirus to our immunization program will not only improve the health of our children but will also reduce hospitalisation and other conditions associated with diarrhoea and pneumonia such as malnutrition, delayed physical and mental development among children," said Union Health Minister Shri J P Nadda. 

There are still many conversations with the cost issues related to the newly introduced vaccine. In private sector, three doses of PCV will cost around Rs 15,000. Dr Pradeep Haldar, Deputy Commissioner (Immunization), Union Health Ministry has stated that the vaccine will be supported by Global Alliance for Vaccines and Immunization(GAVI) initially and later Ministry of Health will acquire vaccines under Government of India’s programme at subsidized costs.

The introduction of the PCV vaccine is a commendable move by the Ministry and would help in saving a lot of lives. The recently introduced PCV and Rotavirus vaccine will help in reducing hospitalisation rates in children prone to Pneumonia and Diahhroea, which will hence reduce the economic burden on the family and the health cost burden on the country.

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Cholera Vaccines: Need of the Hour in Haiti

By: Hilleman Laboratories on October 31, 2016

Haiti, the Caribbean nation has been frequently hit by natural disasters like hurricanes, floods and has also been struck by powerful earthquakes. In 1963, Hurricane Flora killed 6,000 people in Haiti and Cuba. During the hurricane season eight years ago, Haiti was hit by four storms- Fay, Gustav, Hannah and Ike, which killed more than 800 people and devastated nearly three fourth of its agricultural land. The country has also suffered dire flooding in 2002, 2003, 2006 and 2007. Devastating earthquake flattened parts of the capital, Port-au-Prince in 2010. It killed at least 90,000 people and displaced more than 1.5 million.

With so many natural calamities, Haiti had witnessed many Cholera outbreaks in the recent past. Cholera which causes severe diarrhea, is spread through contaminated water and has a short incubation period, which leads to rapid outbreaks. The major earthquake in 2010 claimed about 10,000 lives due to Cholera. 771 Cholera cases have been reported every week in 2016, with 28,559 cases in the last ten months.

Hurricane Matthew which hit the country on 4^th October has hit the country hard. More than 200,000 homes have been severely damaged and 175,000 people are still living in temporary shelters across the country. Since the storm, health workers have diagnosed more than 200 people with cholera, and 13 have died. As per WHO figures, 35 of 197 health facilities in Haiti, including hospitals, clinics and treatment centres have been affected by the floods and heavy winds following the hurricane.

International organizations like Gavi and WHO have announced that they will be sending doses of Cholera Vaccine in order to protect Haitians against the growing threat of cholera outbreak. According to Dominique Legros, cholera expert at the WHO, since Hurricane Matthew hit the island there has been a sharp increase in cholera cases, with more than 200 suspected cases reported since the storm hit. Public health officials have already indicated that there is a high risk of cholera transmission in the worst hit areas and the assessment will help in drawing an effective roadmap for the emergency vaccination programme in the country.

“Gavi will continue to work closely with the Government of Haiti and with our global health colleagues to stave off the potential threat of cholera outbreaks and enable the Haitian people to stay healthy and focused on repairing the damage caused by Hurricane Matthew.” said Dr. Seth Berkley, CEO of Gavi.

Though International organizations are working towards stopping another Cholera outbreak through vaccines, supplies are still low to reach the high number of people at risk. According to Justin Lessler, an associate professor of epidemiology at Johns Hopkins Bloomberg School of Public Health "the people who need cholera vaccine are generally the poorest people. People with money generally have the ability to get clean water, stay away from cholera"

Cholera is endemic in over 50 countries with estimated mortality of 100,000-120,000 deaths and a morbidity of 3.8-4.4 million annual cases attributed to this disease. There is an urgent need of highly effective and affordable Cholera vaccines both for outbreaks as well as mass vaccination campaigns.

The huge Cholera burden has led to a demand for an effective, low-cost Cholera vaccine for use in epidemic outbreaks as well as for mass vaccinations in endemic settings. A market also exists for travellers to endemic regions. Demand estimates for Cholera vaccines vary significantly across scenarios with an expected 30 million doses needed by 2016 rising to expected 200 million doses by 2025, assuming vaccination of all 1-14 year old patients in high risk populations. Global public health community has also expressed concern that current Cholera vaccine manufacturers may not be able to meet the projected increase in demand further strengthening the requirement for alternate, low-cost vaccine supply.

Hilleman Laboratories in collaboration with Gotovax AB (a University of Gothenburg spin-off biopharmaceutical company) aims to deliver a high impact Oral Cholera vaccine at a significantly more affordable price than the ones currently available in the market. Easy to administer, with cross protection against ETEC diarrhea and enhanced with a longer shelf life, this vaccine candidate will be most suited for geographies with the highest cholera burden like Africa and South Asia.

Hilleman Laboratories has also recently announced the signing of an MoU with ICDDR,B and Incepta Vaccine Ltd, both based in Bangladesh for further development and manufacturing of our vaccine.

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Securing Our Children’s Future

By: Hilleman Laboratories on October 25, 2016

"Early childhood development will not only benefit the children of today, but will have a direct impact on the stability and prosperity of nations in the future".

-Dr. Margaret Chan, Director-General, WHO

Malnutrition and infection account for a large proportion of the mortality and morbidity that prevails in developing countries, especially among vulnerable groups of infants and young children. Millions of lives are being lost every year from disease for which there are vaccines. Hence, meeting the basic needs of nutritional wellbeing and addressing malnutrition in its various forms among children is therefore an urgent global priority.

Hilleman Laboratories also understands and recognizes the importance of interplaying role of nutrition and immunity, along with vaccination in reducing childhood mortality and improving child health and development. With an objective of ‘Improving Infant and Child Health’, Hilleman Laboratories recently organized ‘Securing Our Children’s Future’ a workshop on nutrition and immunity for infant and child health. The workshop brought together research scientists, academicians, nutritionists, medical community and policy makers and provided a platform to discuss the latest development, practices and challenges in the field of nutrition and immunity.

The workshop took place in New Delhi, on the 21^st and 22^nd of September, 2016. With speakers and participants from diverse backgrounds, the workshop started with opening remarks by Dr. Davinder Gill, Chief Executive Officer (CEO), Hilleman Laboratories. The first speaker of the workshop was Professor Gagandeep Kang, Christian Medical College (Vellore), who was able to set in the context with her keynote presentation on ‘Malnutrition and Vaccine Response’. She explained how malnutrition is the most common immunodeficiency globally through case studies and statistics. Professor Kang shared insights and cases on three key areas-1) Immunology of malnutrition 2) Vaccination in the context of malnutrition and 3) Malnutrition in the context of vaccination.

Followed by the insightful keynote presentation, Dr. Prema Ramachandran, Director, Nutrition Foundation of India (New Delhi) began Session 1 on ‘Nutritional Epidemiology for Infant and Child health’ by giving an overview of health and nutritional status of Indian children. She spoke about the challenges, interventions and achievements in the area of infant and child nutrition. Dr. Ramachandran also discussed the current status of World Health Assembly targets on low birth weight rates, breast feeding rates, and also stunting and wasting rates. Dr. Shweta Khandelwal from Public Health Foundation of India (New Delhi) continued the session and spoke on ‘Importance of nutrition in chronic diseases’. She threw light on the impact of changing diet patterns, nutrients and food items on chronic diseases. The session was wrapped up by Dr. Uma Chandra Mouli Natchu from Translational Health Science and Technology Institute (Faridabad) who spoke on ‘Early life nutritional influences on immunity’. Dr. Natchu shared some interesting facts on how Vitamin D deficiency leads to higher risk of respiratory syncytial virus (RSV) infections, ultimately leading to Asthma. He also revealed how daily zinc supplementation in childhood reduces incidence of pneumonia & all-cause mortality.

Second session on ‘Nutrition for Children’ was initiated by Dr. Sumathi Swaminathan from St. John’s National Academy of Health Sciences (Bengaluru). Dr. Swaminathan spoke about ‘Nutritional requirements in infants & children’. She talked about changes in nutrition requirements during infancy and young childhood and also covered key aspects of feeding. She also highlighted that how the existence of breast milk banks is fruitful and how they have been successful in many parts of the country. Dr. Swaroop Kumar Sahu from Jawaharlal Institute of Postgraduate Medical Education and Research (Puducherry) proceeded further with the session with the discussion on the topic ‘Effects of malnutrition in children’ which highlighted on the spectrum of malnutrition and the growth charts to monitor the malnutrition. Furthermore, both the direct and indirect effects of malnutrition on children were discussed along with the interventions to address the problem of malnutrition among children. Dr. Nisha Wadhwani continued the session and spoke on behalf of Dr. Sadhana Joshi from Bharati Vidyapeeth University (Pune) on the topic of ‘Prenatal maternal Nutrition’ which focussed on the direct effect of maternal nutrition on fetal programming and also threw light on the role of the epigenetic modification in altering placental function and fetal development. The last presentation of the second session was made by Dr. Anju Pradhan Sinha from Indian Council of Medical Research (New Delhi) on the ‘Intestinal Microbiota and the role of probiotics in child health’ and it gave a glimpse on the importance of the gut flora and its role in human immune functions and showcased case studies of using different probiotics for prevention of neonatal infection.

Day 1 of the workshop ended with Dr. Anjali Ahuja from Nestle Nutrition (Gurgaon) speaking about ‘Complementary Feeding - Role of Critical micronutrients in Paediatric nutrition’. Dr. Ahuja showcased how micronutrient deficiencies are linked to poor growth, intellectual impairment & increased risk of morbidity & mortality. She spoke about fortified complementary feed and its impact on infant and child health. Dr. Ahuja also covered key initiatives by Nestle Nutrition and how the organization is committed to the well-being and overall health of children.

The second day of the workshop started with Ms. Ruchika Chugh Sachdeva from PATH speaking on ‘Role of nutrition in prevention of disease’. She started the fourth session by drawing audience attention to the relationship of nutrition with health and disease. She focused on the link between nutrition and immunity with respect to macronutrient & micronutrient deficiency, and over-nutrition. Ms. Sachdeva also spoke about food fortification and stated various facts related to the same. She ended her presentation with interesting quote by Thomas Edison-

“The doctor of the future will no longer treat the human frame with drugs, but rather will cure and prevent disease with nutrition”

The session proceeded with Dr. B S Ramakrishna from SRM Institute of Medical Science (Chennai), who spoke on ‘Environmental Enteropathy’. The key areas covered in his presentation were tropical enteropathy, and consequences of enteropathy and how it is measured. Dr. Ramakrishna also gave examples of cases highlighting relationship of stunting with diarrhoea. The fourth session was concluded by Dr. Ira Praharaj from Christian Medical College (Vellore) who addressed the audience on ‘Probiotics and the response to vaccines’ highlighting the immunomodulation by the gut microbiota and probiotics. Through her talk she emphasized on one of the key questions on the role of probiotics to improve/affect immune responses to vaccines by discussing various case studies.

Dr. Francis Odhiambo from UNICEF India (New Delhi) took the last session of the workshop, and delivered a presentation on the pertinent topic of ‘Integrated approaches to address underlying risks’. He spoke on Water, Sanitation and Hygiene Programme (WASH) and various interventions executed by UNICEF, related to water quality, sanitation, safe handling and storage, hand washing with soap. The final presentation was given by Dr. Vanisha S Nambiar from Maharaja Sayajirao University of Baroda (Vadodara). Dr. Nambiar spoke on Nutritional programming (nutritional education and counselling programs). She took the audience through the various stages of change, in case of nutritional programming. She explained how nutrition education as well as counselling has a high potential in bringing about a behavioural change.

Dr. Davinder Gill concluded the workshop by calling it “A truly successful endeavour, which saw participation from cross disciplinary set of speakers, attendees, stakeholders and other members of the community who came together and shared insightful details on key topics like advocacy, clinical trials and some recent scientific innovations that are happening around the country, which in totality is helping to build a strong case for the interplaying role of nutrition and immunity as the key factors along with vaccination in reducing childhood mortality and improving child health and development”. He also underlined the significance of such workshops in building new friendships and collaborations.

Through this workshop, Hilleman Laboratories was successfully able to provide a platform for meaningful discussions which could help resolve gaps related to public health issues on infant and child health and at the same time provided a great opportunity for the nutrition focal managers to be oriented on key technical updates on child nutrition and immunity. 

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Improving Efficiency of Vaccination Systems through Intelligent Vaccine Management

By: Hilleman Laboratories on September 30, 2016

The Ministry of Health and Family Welfare has been working towards reducing morbidity and mortality from vaccine-preventable diseases through its Universal Immunization Programme (UIP). The ministry has introduced numerous initiatives to improve the vaccine coverage in the country but there are still critical gaps in the vaccine logistics management system in the country with issues related to inadequate and poor infrastructure, weak monitoring and management information system, vaccine management and issues related to technical capacities of staff.

Districts around the country have been facing challenges related to vaccine coverage because of frequent equipment breakdowns, overstocking and stock-outs, inadequate monitoring and supervision, high rates of breakdown of equipment, overstocking and stock-outs, inadequate monitoring and supervision, and poor management. To overcome these challenges the Ministry of Health and Family Welfare (MoHFW) in partnership with United Nations Development Programme (UNDP) and GAVI are rolling out Electronic Vaccine Intelligence Network (eVIN) across 12 states in India.

eVIN helps in addressing three critical questions in vaccines logistics management - where vaccines are; whether they are in adequate quantities; and whether they are stored at recommended temperatures?

The eVin system uses a three prompt approach of people, processes and product. The Electronic Vaccine Intelligence Network (eVIN) is a technology system that digitizes vaccine stocks through a smartphone application. The technology uses mobile and web based dashboards to track locations, temperatures and stock levels of vaccines, making sure that the supply is safe and reliable. The system helps in providing real time data that can be viewed on a web and application-based dashboard by programme managers across districts, states and national levels. All the data is uploaded on a cloud based server by trained professionals through a smartphone application.

“Seeing health workers being able to show on their smartphones, real time data and having temperature monitoring that can be monitored externally is a really powerful thing” said Dr Seth Berkley, CEO of GAVI, the Vaccine Alliance.

With the eVIN system recently being rolled out in districts of Assam, Rajasthan, Bihar, Chhattisgarh, Gujarat, Himachal Pradesh, Jharkhand, Manipur, Nagaland and Odisha; policymakers will be able to make data-informed decisions in planning for vaccine distribution and improving supply chain. As India is the home to the world’s largest birth cohort, planning a healthy future for every child is very essential at all levels.

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Companies Targeting The Poor Yet Retaining Profits

By: Hilleman Laboratories on September 05, 2016

“Innovation is a change that unlocks new value.”

-  Jamie Notter

Innovations in today’s time have paved way for the Multi-National Companies to reach out to people, catering to their needs and making their life simple and easy. It is so phenomenal that companies who sell products targeting customers at the poverty line still manage to make profits despite selling the products at very lower cost.

In order to understand the different facets of such companies’ marketing approach,  Amrit Gill a sophomore, majoring in Business & Finance at the University of South Florida completed a project on a very distinctive area of interest- ‘How companies retain profits while selling goods at a cheap price to consumers at the poverty line’. His initial research showed that such companies face difficulties finding customers in the starting, but after changing their business model and tactics they are able to become profitable. Such companies manoeuvre helps develop a case for other companies to analyze the consumer behavior and compeer their business and marketing approach.

1.       Green Light Planet- Sun King

The product originated in Orissa, is made by two Indian and one American college student in order to improve agricultural productivity, but the villagers later utilised it as a source of electricity. It’s estimated that around two billion population of the world lives in darkness and this product comes as a life-saver by illuminating their lives with bright light. The product is an alternative to the pollution causing kerosene lamps and also reduces the risk of catching fire. The company has sold around 3,000,000 lamps with 6,000 active sellers across India, Kenya and Uganda. The product will be able to add up to 30,000 sellers.

Nearly 20% of the Indian population do not have access to electricity and dwells heavily on kerosene lamps. Kerosene is one of the sources for global warming and also responsible for lung cancer, strokes and other respiratory diseases. With the Green Light Planet’s product Sun King coming into picture will help in reducing such issues. The development of this product took approximately 3 years. The initial investors in this product were from ZS Associates.

 The marketing strategy of Green Light Product was different. They tried to convince important people in the villages such as teachers, police and other officials to gain their trust, as the villagers had a bad experience with the Chinese products of such kind breaking down at a very early level of usage.

After their products were successful among few people, they encouraged their customers to spread its importance by Word of Mouth. In order to gain more trust they partnered with an NGO who helped them in adding more customers to their bucket.

In the near future the company plans to expand with adding more products such as cooking stoves and water filtration systems, once they are able to reach the saturation levels. The company’s projecting a 5-7 year sustainability programme, then depending upon their market they will expand on the product range.

2.       Mpedigree

An organization started by Bright Simmons, an entrepreneur who wanted to terminate counterfeit drug production in Ghana. The company produces labels in order to regulate the sales of counterfeit products. Mpedigree initially worked with pharmaceutical companies, but has now expanded to electrical products, clothing, cosmetics and seeds used in agriculture.

For developing the product, Simmons hired engineers to develop software that creates unique 12 digit codes, which is printed on a label in China costing $0.09 per unit. The software was used to store the codes in a database, in- case when a customer texted the code they were able to receive instant counterfeit verification. It came as valuable tool for manufacturers as they were able to get notifications if the code had been used more than once.

Pharmaceutical companies, venture capitalists, and regulators for future investments/partnerships did not take Mpedigree seriously, because it was a small nonprofit organization and charities were not much successful in Ghana. In 2009 Simmons transformed his organization into a for-profit social enterprise, he made calls until he obtained a meeting with Hewlett Packard to obtain cloud servers for data storage and partnership. HP saw initiative in the rising mobile industry in West Africa and East Asia. In December 2010 HP announced that it would run the data that host Mpedigree’s code, which saved the company 10 million dollars or the infrastructure costs. The pharmaceutical world started taking the company seriously when Nigeria’s food and drug administration endorsed Mpedigree.

Mpedigree is developing a system, in which the customers and the seller can contact each other directly in order to ensure customer satisfaction. They are in the process of presenting the idea to various telecom mobile carriers in India and Nigeria.  The company has expanded to the cosmetic and textile industries and is on the verge of signing 7 new deals, 5 in Ghana and 2 in Nigeria.

What Hilleman Laboratories can do?

Hilleman laboratories can increase the transaction size by using upselling. They can increase the total number products sold to a consumer by selling upgrades or additional accessories. The organization should negotiate long term supply deals in order to buy the products for lower prices and create better terms with the supplier.

The organization can incorporate efficient promotion by effectively using promotion expenses to create as many connections as possible. This will help increase sales volume, which can lead to a larger profit margin.

There is also a need to reduce cost of production which can be done by reducing energy consumption, and taking precautionary steps to prevent accidents. The organization should focus on avoiding overproduction and reducing waste.

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Workshop on Nutrition and Immunity for Infant and Child health

By: Hilleman Laboratories on August 23, 2016

MSD-Wellcome Trust Hilleman Laboratories is a first of its kind joint venture between Merck & Co., USA and Wellcome Trust, UK Hilleman Laboratories is dedicated for improvement of child health by developing affordable vaccines for the developing world.

It is well known that appropriate functioning of the human immune system is dependent on nutritional status. There are a lot of insights gathered about interrelationship between nutrition and immunity and its role in reducing childhood morbidity and mortality.

Hilleman Laboratories understands and recognizes this interplaying role of nutrition and immunity in improving child health and its impact on the economic sustainability of our nation. To further our understanding of this key area, Hilleman Laboratories aims to convene a workshop on 21^st and 22^ndSeptember 2016 in NewDelhi, India. The workshop plans to provide a platform to spur a dialogue between esteemed academicians, researchers, public health experts and policy makers responsible for planning nutrition programs across the country. The workshop will have key-note presentation, theme presentations and discussions.

The workshop scopes to address the two-way association between nutrition with immune parameters in infants and young children. Infancy and early years of a child’s development represents the most nutritionally vulnerable stage of life cycle. Young children pay a lifelong price of undernutrition. Improvement in nutrition status is vital for saving young lives and thereby creating an impact on economic sustainability of a nation. The impact of nutrition is multi-faceted. Nutrition in early years of life is known to make a huge impact on immunity of an individual.

The workshop aims to cover key topics like integrating role of nutrition and immunity and provide insight for the nutrition focal persons/managers on key technical updates on child nutrition and immunity. Some of the key topics to be covered are: Nutrition requirements of children, Nutritional epidemiology for infant and child health,Nutritional deficiency associated Immune disorders in infants and children and Role of nutrition in prevention of disease, environmental eneteropathy, vaccines and nutritional health.

The first segment of this workshop session will throw light on importance of nutrition on immunity in infants and young children. It aims to landscape the trends and determinants in infant and child nutritionacross the country . The second segment aims to appraise and evaluate the nutritional requirements of infants and young children, and consider prenatal nutrition too. The third segment will shed light on ill effects of poor nutrition and its adverse impact on physical and cognitive growth of children.The fourth session will focus on how good nutrition in early years can strengthen immunity or vaccination against a disease can be chosen to prevent disease. It is well known that nutrition status alters response to vaccine and therefore, this session will explore the concept in conjunction with the role of environmental factors for infants and child health. The fifth and final session is planned to focus on the promotion of good health through nutrition and primary prevention of nutrition related illness in infants and young children. Apart from discussions on nutritional education and counseling programs for children, this session is also aimed to address integrated issues such as sanitation and hygiene which could indirectly affect infant and child health.

This workshop thus aims to highlight and resolve the gaps in current scenario while discussing malnutrition, immunity and vaccinesby providing a great opportunity to distinguished professionals to discuss the latest advancement, practices and challenges in the field to achieve the common goal of improving infant and child health. 

To register log on to http://www.hillemanlabs.org/registration.aspx

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Undernutrition And Diminished Immunity: Breaking The Lethal Cycle

By: Hilleman Laboratories on August 11, 2016

Healthy children are the bedrock of a healthy society. Good nutrition is the core pillar for healthy and productive communities and nations. The benefits of good nutrition are carried across generations, binding and supporting various facets of nation’s development. Hence it is in a nation’s best interest to safeguard its children’s health. As per UNICEF, around 3 million children die due to undernutrition every year. Asia alone is believed to be home to approximately 70% of the world's malnourished children, while India has the highest percentage of undernourished children in the world. Ironically when the economic development of India is growing at nearly 10% annually, the rate of undernourished children remain very high. As per the third National Family Health Survey (NFHS) India, 48% of children under the age of five are stunted due to chronic undernutrition. Undernutrition, often referred to as “hidden hunger”, is a form of malnutrition. It has long been a sore point for India, adversely impacting the overall social and economic development.

Without aggressive efforts, the undernutrition issue in India is escalating with devastating consequences on children’s development-physical growth retardation, increased susceptibility to diseases, hampered cognitive development.

Undernutrition issues among the age of under-five children is an important concern for the health authorities in India. It is acknowledged widely that infections are as much a cause of malnutrition as they are a consequence. Malnourished children have increased risk of mortality from infectious diseases. Investing in elevating maternal and child nutritional status is a long-term investment that will benefit the present generation and their children as well.

The nutrition of mothers and children is closely linked. When malnutrition starts at conception, most of the damage is already done as the child enters the second year of life. The first 1000 days of a child’s life is a critical window and represents the most vulnerable period to the impact of poor nutrition. Deficits during this period can have irreversible consequences for the child. Other than adversely impacting the cognitive ability, a child’s nutritional status also influences the immune responses in varied and complex ways. A common thread links nutrition, immunity and infections. Nutritional deficiencies are known to affect various components of the immune system putting a child at a greater risk of developing a disease. The severity of malnutrition and the age of onset of nutritional deprivation often decide the extent of immunological impairment. A stunted, undernourished child is at a greater risk of various diseases. Infection and malnutrition overlap and interact; infact they form a vicious cycle. Undernutrition weakens the immune system, putting children at higher risk of more severe, frequent and prolonged bouts of illness. Looking at this from other end of the spectrum, undernutrition appears to be a consequence of repeated infections, which can further worsen the child’s nutritional status. Thus recurrent infections contribute to pathogenesis of malnutrition. This interaction between under nutrition and infection creates a potentially lethal cycle of worsening illness and deteriorating nutritional status. Critical nutrition interventions have the potential to break this cycle and are important for accelerating progress. Scrimshaw et al (1968) first described this vicious cycle of infection and under nutrition. His research stated that infections predispose to malnutrition, through reduced intake and absorption and diversion of nutrients away from growth, while malnutrition reduces immune function and increases the risk and/or severity of infections.

Immunization and improved nutrition are among the key factors in a multi-sectoral package of interventions for reducing childhood mortality and feature prominently in the Gates Grand Challenges in Global Health. Vaccination programs also stand to hugely benefit the malnourished population as well. Vaccination programs are particularly valuable health resource for settings that are in high-disease environment. Reforming children’s health status translates into higher worker productivity promoting economic success and poverty reduction for a nation. Improving nutritional status will further add to the overall success of the multi sectoral interventions that include immunization and vaccination programs undertaken by the government.

It is reassuring that the enormity of the adverse impacts of poor nutrition on a child’s growth and development are being recognized and acted upon aggressively. Entities such as Hilleman Laboratories understand and recognize the interplaying role of nutrition and immunity in improving child health and development and its impact on the economic sustainability of our nation and are looking ahead and promoting actions for transforming lives.

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India: Current Vaccination Scenario

By: Hilleman Laboratories on July 29, 2016

India’s immunization program is one of the largest Universal Immunization Programs (UIP) in the world. In India, the Universal Immunization Program targets 27 million infants and 30 million pregnant women every year. Effective vaccine utilization is an integral component of vaccine security and vaccine wastage is one of the key factors to be considered with regards to vaccine forecasting and need estimation. Heat sensitivity of most vaccines calls for the need of adequate cold-chain system and ensure its maintenance to preserve the potency of the vaccine before it is administered. The World Health Organization (WHO) recommends that all childhood vaccines except the oral polio vaccine be kept at 2–8 °C during their in-country distribution.

In a bid to ensure success of the immunization program, India has a five-level supply chain. It commences at the government medical supply depots (n=4) which supply state vaccine stores (n = 35), which, in turn, supply regional vaccine stores (n = 116). Vaccine is sent from the regional stores to district vaccine stores (n = 626), and thereon the last links in the chain: the primary or community health centers function as the peripheral vaccine stores (n = 26 439).

In spite of all the positive efforts there are ongoing challenges and shortcoming in the program that hamper the coverage rates.Within the entire chain, storage of vaccines at optimum temperature is critical. Most vaccines(except the oral polio vaccine) need to be stored at temperature between 2–8 °C.This is either achieved by building walk-in coolers or ice-lined refrigerators or transported in cold boxes with ice packs that have been allowed to reach 0 °C.Immunization services in the public sector are mostly provided at district hospitals, urban health centers and primary or community health centers. However, outreach vaccination sessions at health subcenters or in remote villages are also conducted, using vaccine transported from the nearest primary or community health center.

A study by Galhotraet al in the year 2007 highlighted incidence of avoidable errors like uninterrupted power supply, in adequate number of exhaust fan, voltage stabilizers, etc. were the identified reasons for the errors and cited a room for improvement.

Use of thermo stable vaccines is on the anvil and is likely to change the dynamics in future.

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Need Of The Hour: Heat Stable Vaccines

By: Hilleman Laboratories on July 19, 2016

It is estimated that vaccination programs save about 3 million lives worldwide from the adverse impact of infectious diseases. However it is also reported that about 3 million individuals succumb to vaccine –preventable diseases and the fact that many vaccines not being thermo stable plays a part in this tragedy.

The World Health Organization (WHO) estimates that annually 10-50 percent of vaccines may be wasted globally because of temperature control, logistics and shipment-related issues.
The vaccines currently available need to be kept constantly cold at temperatures between 2°C to 8°C from the point of manufacture until reaching the recipient. Considering the variable stability of vaccines, for a country like India, which experiences a tropical climate, the cold chain remains a highly vulnerable point. Low resource setting areas, which are not only isolated but lack reliable electricity for refrigeration, pose a major obstacle. This impacts the overall immunization rates negatively.

Storage of vaccines at optimum temperature is critical. Inadequate refrigeration systems lead to unintended interruption of the cold chain. Further lack of quality monitoring apparatus, exposure to high heat and damaging exposure to temperatures below 0°C harm the vaccine efficacy. Currently, the requirement for a vaccine to be transported and stored in a constant cold chain, from the time it leaves the manufacturer until it is used at a vaccination point, places huge logistical challenges on vaccination providers who must ensure that the cold chain is maintained each step of the way.
Development of thermo stable vaccines, vaccines that can withstand elevated or fluctuating temperatures is an emerging thought. Use of thermo stable vaccines has the potential to ease such logistical hurdles imposed by the ‘cold chain’. Thermo stable vaccine formulations that would be resistant to damage caused by freezing or excessive heat can reduce the dependence on the cold chain.

Benefits of thermo stable vaccines are huge, including cost savings, preventing vaccine damage, and, most importantly, making it easier to reach children living in remote places who would otherwise remain unvaccinated.

A clinical study published in “Vaccine” in the year 2012; by Lee BY et al has another interesting perspective, “Eliminating the need for refrigerators and freezers should not necessarily be the only benefit and goal of vaccine thermo stability. Rather, making even a single vaccine (or some subset of the vaccines) thermo stable could free up significant cold storage space for other vaccines, and thereby help alleviate supply chain bottlenecks that occur throughout the world.
Nevertheless, making individual vaccines thermo stable could still have benefits if their removal from the cold chain could relieve bottlenecks in the vaccine supply chain.”

Read more:

http://apps.who.int/iris/bitstream/10665/64980/1/WHO_GPV_98.07.pdf)

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Mission Indradhanush: Spectrum of seven will now be eleven

By: Hilleman Laboratories on June 27, 2016

Mission Indradhanush was launched by Ministry of Health and Family Welfare (MOHFW) on 25th December, 2014. The health ministry’s flagship programme, which provided immunisation against seven life threatening diseases, is all set to be renamed as four new vaccines have been introduced to fight against various life threatening diseases.

Mission Indradhanush, signifies the spectrum of seven colours of the rainbow, which provides vaccination against seven vaccine-preventable diseases including diphtheria, whooping cough, tetanus, polio, tuberculosis, measles and Hepatitis B.

"We have added four new vaccinations - rotavirus, measles rubella, inactivated polio vaccine biavalent and Japanese Encephalitis for adults. In that, very important is rotavirus. 10 lakh children get hospitalised every year suffering from diarrhoea and 80,000 lose their lives every year," said Health Minister JP Nadda.  The four added vaccines had been made a part of the ‘India Newborn’ action plan in January this year.

With an aim to fight against various vaccine preventable diseases and to reach out to the unvaccinated and partially vaccinated children by 2020, the project has additionally brought 1.62 crore children under the ambit of immunization within a year of its launch. India had been facing the problem of low immunization coverage since many years as period between 2009-2013 saw just 1 per cent increase in coverage year-on-year.

"Mission Indradhanush has brought change in the lives of people. We have to keep some other name in place of Indradhanush as the vaccinations have gone up from seven to eleven," added the Union Health Minister.

However regardless of the name, the project has shown improvements in immunization coverage and with the added new four vaccines, a new set of unvaccinated  and partially vaccinated children will be brought under the scope of Immunization.

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Implementation Of Routine Immunization

By: Hilleman Laboratories on June 05, 2016

Routine immunization is the foundation through which countries provide access to lifesaving vaccines and control and eradicate vaccine-preventable diseases. It is the process of timely vaccination on a regular basis with vaccines considered important for a given country to reduce morbidity and mortality. This process is enabled by a country's health system and maintained through a set of management subsystems needed to continuously supply the full complement of scheduled vaccines, monitor their safety, control population coverage, and measure their epidemiological impact 

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National Immunization Schedule (NIS)

By: Hilleman Laboratories on May 29, 2016

India's Universal Immunisation Programme (UIP) is one of the largest in the world in terms of quantities of vaccine used, the number of beneficiaries, the number of Immunisation session organised, the geographical spread and diversity of areas covered. Under UIP, Government of India provides vaccination to prevent many vaccine preventable diseases.

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A Giant Leap to Fully Immunize Every Child

By: Hilleman Laboratories on May 16, 2016

Ministry of Health and Family Welfare (MOHFW) had launched Mission Indradhanush on 25th December 2014. The ultimate goal of Mission Indradhanush is to ensure full immunization with all available vaccines for children up to two years and pregnant women.

With an aim of expanding immunization coverage to all children across India by year 2020, Union Minister of Health and Family Welfare Shri J.P. Nadda launched the NHP-Indradhanush mobile app for immunization at the National Family Planning Summit 2016. The mobile app has been developed to cater to parents to help them in tracking the immunization of their children.

Following are some of the key features of the App:

• User can add baby and corresponding details
• User can set reminders for each baby on immunization
• User can add new immunization in addition to the recommended ones
• The application is designed to work on Android phones for now.

Available in two languages (Hindi and English) the app details out each aspect of immunization. The app helps to provide Vaccine Schedule for a child and keep a track of vaccinations given and due.

As per the April statistics by Mobbo, the app has got good response across all age groups. The maximum app downloads, i.e 37.78% were recorded from the age group of 25-34 followed by 26.67% from the age group of 18-24. The gender details show that the 65.6% of the app users are Females and 94% of the users use mobile device to use the app.

The NHP Indradhanush App aims to take away pressure of having to remember life critical information amidst handling work and home for the parents. It has paved a new way for young parents in tracking the immunization of their children and has added more scope for the nation to fully immunize every child.

References:

https://play.google.com/store/apps/details?id=com.linchpin.childcare.view

http://www.mobbo.com/Android/App/com.linchpin.childcare.view/3081075

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Hilleman Laboratories advances two vaccines into clinical stage

By: Hilleman Laboratories on April 27, 2016

• Initiates clinical trials for heat-stable Rotavirus vaccine and next-generation Cholera vaccine
• Aims to boost GAVI and Government of India’s universal immunization programs with heat-stable and affordable Rotavirus vaccine for improved coverage
• In response to WHO’s global call for increased Cholera vaccine supply, advances on clinical development of innovative oral Cholera vaccine

New Delhi, 27^th April 2016: Advancing closer to its vision of bridging the vaccination gap in developing nations, Hilleman Laboratories, a first-of-its-kind joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust, today announced the initiation of Phase I/II clinical trial of its innovative vaccine, an oral, lyophilized, heat-stable Rotavirus vaccine, against Rotavirus disease. After successful completion of the preclinical stage and obtaining regulatory clearance, Hilleman Laboratories has initiated a clinical study to establish proof-of-concept for its heat stable Rotavirus vaccine candidate.

Hilleman Laboratories also obtained regulatory clearance for its innovative oral Cholera vaccine to conduct a Phase I/II clinical study that is intended to lead to an affordable vaccine against devastating Cholera infection. 

Commenting on these developments, Dr. Davinder Gill, CEO, Hilleman Laboratories said, “These are exciting times at Hilleman Laboratories with several of our initiatives moving closer to meeting their objectives. There is a real need for safer and more effective vaccines to address the unmet needs of low-income nations. We have designed both Rotavirus and Cholera vaccine candidates keeping in view the socio-economic and demographic needs of developing nations. While on one hand, our heat-stable technology will offer longer stability to the Rotavirus vaccine in extreme climates, the next-generation oral Cholera vaccine will be affordable and easy-to-administer.”

Dr. Gerd Zettlmeissl, Chairman of Board of Directors, Hilleman Laboratories said, “I congratulate the entire team at the Hilleman Laboratories on achieving this significant milestone. These developments further strengthen my belief in our vision of saving millions of lives lost due to preventable diseases in low income settings.”  In light of the World Immunization Week themed ‘Close the Immunization Gap’ by WHO, the new developments gives a massive impetus to the company’s commitment towards realizing this goal.

The clinical trials for both the vaccine candidates will be conducted at Bangladesh-based International Centre for Diarrheal Disease Research (ICDDR, B), an international health research organization. Dr. John David Clemens, Executive Director, ICDDR, B, who is spearheading the trials said, “Increasing access to high impact vaccines will be the key to eradicate enteric diseases that are a leading cause of deaths in developing countries. Since beginning our collaboration with Hilleman Laboratories, we have been closely monitoring the development of both the Rotavirus and Cholera vaccines. We are now thrilled to get an opportunity to translate research into preventable treatment.”

Lauding the Indian government’s efforts to reduce child mortality by including Rotavirus vaccines under the Universal Immunization Program, Dr. Gill added, “This is a welcome step taken by the Government of India. However, high dependence on cold-chain for vaccine preservation, is a major gap in the delivery system. With our heat-stable Rotavirus vaccine, we aim to further support the government’s efforts of expanding coverage and reducing child mortality.”

Rotavirus is the leading cause of severe diarrhea and death among children less than 5 years of age, 90% of these deaths occur in developing countries. According to the Ministry of Health and Family Welfare[1], nearly 80,000 to 100,000 children in India die due to Rotavirus diarrhea annually while nearly 900,000 children are admitted to hospitals with severe diarrhea. 

According to the World Health Organization, Cholera Vaccine production is low, with demands currently exceeding supply. Cholera is endemic in over 50 countries with estimated mortality of 100,000 - 120,000 deaths and a morbidity of 3.8 - 4.4 million annual cases attributed to this disease[2].

In 2014 Hilleman Laboratories partnered with Gotovax AB of Sweden and Incepta Vaccines of Bangladesh for the development of an affordable Cholera vaccine. “In less than two years, with the strong assistance of our partners, we have successfully advanced our Cholera program from signing our partnership agreement to initiating clinical trials. This only enforces our aim to contribute in enhancing the supply of a much-needed vaccine across the world,” added Dr. Gill.

About Hilleman Laboratories

Hilleman Laboratories is a first-of-its-kind joint-venture partnership formed between MSD a global research-driven pharmaceutical organization and Wellcome Trust, a global charitable foundation dedicated to human and animal health by supporting the brightest minds. Hilleman Laboratories has been named after renowned scientist and father of modern vaccines Dr. Maurice Hilleman. His dedication to making a difference through the practical application of vaccine research and delivering vaccines to people in need forms the core mission of Hilleman Laboratories.

Hilleman Laboratories aims to become a global voice for vaccine development and access for public health in the developing world. For further information please visit: www.hillemanlabs.org.

About Merck Sharp & Dohme (MSD)

For 125 years, MSD has been a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., Kenilworth, N.J., USA. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.msd.xx (for country-specific website).

About Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to improving health. We support bright minds in science, the humanities and the social sciences, as well as education, public engagement and the application of research to medicine. Our investment portfolio gives us the independence to support such transformative work as the sequencing and understanding of the human genome, research that established front-line drugs for malaria, and Wellcome Collection, our free venue for the incurably curious that explores medicine, life and art. www.wellcome.ac.uk

Media Contact:

Clayton Dsouza +91 9930011602 clayton.dsouza@spag.asia

Ann Marie De Souza +91 9819099110 ann.desouza@spag.asia

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