Sunday, 15 January 2017

Immunizing India and its various Challenges

Immunization has played an integral role in improving children’s health and survival in India. The Ministry of Health and Family Welfare has been consistently working towards reducing the mortality rates from vaccine-preventable diseases through its Universal Immunization Programme (UIP).  Immunization doesn’t just save medical costs, but also yields indirect economic benefits like educational attainment, enhanced productivity. The unimmunized individuals are also offered protection through “herd immunity” by many vaccines.  

India has made significant progress towards reducing child deaths and has set multiple child health targets to achieve. The government of India has taken multiple steps to accelerate child survival, including strengthening the routine immunization (RI) programme of the country. Since 1990, the child mortality rates of the country have declined by 58%. So far, Vaccines have successfully eradicated smallpox and polio from the country. Measles have brought to an all- time low and tetanus has been reduced to a large extent. As of 2013, 18 states were estimated to have eliminated maternal and neonatal tetanus. Over the years, India has seen progress in expanding immunization coverage, with nationwide coverage of the third dose of the diphtheria-tetanus-pertussis (DTP) vaccine increasing to an estimated 72% in 2012 from 60% in 2003.    

The industry stands on remarkable success that exemplifies “Make in India” while the road ahead calls for strategic maneuvering and funding. The global foothold is consistently strengthened which is crucial to remain successful, however, the need of the hour is to evaluate the evolving domestic market landscape.

Vaccines have transformed public health throughout the world, for children particularly, the burden of vaccine-preventable diseases in India is still substantial and hence the usage of this powerful tool is still not optimal in our country. The Indian healthcare industry presents new vistas of growth, provided, challenges in terms of policy barriers, lack of awareness and affordability issues, are successfully tackled. Some of the challenges can be explained as -

Technical Challenges: -
Technology has been a conspicuous obstruction in the case of few emerging vaccines. Hence, this results in significantly higher product risk, higher than it has been in all previously developed vaccines.

IP Policies: - We need stringent IP policies and an ecosystem where research is prized and not just encouraged. Hence, at the end its not only a question of sustained industry competitiveness, it is a question of appropriate and active public response to a critical national need. 

Regulatory Challenges: -
Many a times procedural hold-ups delay product development and launch, which in turn have proven truly expensive – not only to the industry but to the country as such. While the industry stakeholders have now begun a constructive dialogue to wash out certain regulatory delays, the magnitude of the problem calls for a collaborative approach that is as aggressive as it can be. 

In a wake to address the regulatory issues of Indian vaccine industry, Union Health Ministry has recently announced that it will be forming an expert group to examine regulatory issues for Indian vaccine industry. "Indian vaccines manufacturers should accord prime importance to meeting domestic demand, upscale research and development related work, and also take initiatives in developing critical vaccines such as Pneumococcal conjugate vaccine (PCV) and Human Papillomavirus (HPV) vaccines" said Union Health Secretary C K Mishra. The expert group will work towards speedy resolution of issues in time-bound manner without compromising critical aspects like quality, patient safety and patient management.

More of such initiatives and planned multi-stakeholder approach is required for conquering challenges of complex emerging vaccines that lie ahead. It is critical that policymakers and regulators alike, maintain the pace in such efforts and work in full force to help India win over the next set of public health challenges.
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Friday, 30 December 2016

The Rising Incidence of Diarrhea in India

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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Thursday, 15 December 2016

Blog: Evolution of Universal Immunization Programme (UIP)

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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Wednesday, 30 November 2016

Immunization Catch Up Chart Schedule in India 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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Thursday, 24 November 2016

Pneumonia Vaccine to be introduced under Universal Immunization Programme in 2017

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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Monday, 31 October 2016

Cholera Vaccines: Need of the Hour in Haiti

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 4th 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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Tuesday, 25 October 2016

Securing Our Children’s Future

"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 21st and 22nd 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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Hilleman Laboratories is a global vaccine research & development organization focused on making affordable vaccines using innovation to address gaps that exist in low resource settings. Hilleman Labs acts as a catalyst in bridging the gap between academic research and product development by targeting novel vaccines and increasing the efficiency of existing vaccines. Know More

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