Tuesday, 13 June 2017

Three solutions setting the pace of Immunisation - Thermostability, Affordability and Availability




The vaccine landscape is shifting, and new opportunities, challenges, and debates have pushed vaccines to the center of global health discussions. Thanks to vaccines and systematic immunization, the polio disease saw its final death knell. It is estimated that vaccines avert about 2-3 million deaths each year in all age groups and protect 83% (107 million) of infants worldwide from vaccine preventable diseases .

Immunity is gained without the consequence of being ill and without the risk of potential life-threatening complications from the disease. However, access to vaccines has been a critical issue in ensuring the health of children, especially in the developing countries. Access is currently limited due to limited money available for vaccine procurement, high prices of new vaccines for existing and emerging diseases and poor health delivery infrastructure in developing countries . Not just access, thermostability has been another cause for concern in case of vaccines. 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. In low-resource settings, factors like tropical temperature, scarce resources, unreliable power, and long distances between healthcare facilities pose risks.

Innovation is the key to success!

As already discussed, a lot of factors contribute to vaccines not completely catering to those in need of it. The temperature sensitive nature of these vaccines leads to a loss in production as well as the supply chain. However, the last decade saw significant advances in developing, introducing and expanding the reach of vaccines globally. One of such measures was the ‘vaccine cold chain’ wherein vaccines are stored at refrigerated temperatures throughout the transport, storage, and handling of vaccines. The cold chain implies that the vaccine, from the time it is produced till the time it is consumed, stays in refrigerated conditions. Besides that, some companies are even researching methods to enhance the thermostability of vaccines. They have invented measures to maintain all the attributes of a vaccine even in unfavorable temperature conditions. Thermostable vaccines also help to decrease logistics cost by eliminating cold chain, which, in turn, allows for more economical pricing. As a result of this, vaccines can also be made available in remote and far-flung areas where temperatures are not naturally favorable.

Hence, it is fair to say that Thermostability, Affordability, and Availability go hand-in-hand and they hold the key to the success of immunization. The heart and soul of this field is innovation. Innovation is required to improve vaccine production as well as optimizing the supply chain. The recent wave of changes has created a tremendous opportunity for innovative technologies in this space, as companies that can help discover and deliver new vaccines could create enormous value.
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Tuesday, 30 May 2017

Improving Vaccine Supply Chain System in India




The Ministry of Health and Family Welfare through its Universal Immunization Program has taken numerous initiatives to maximize the vaccines coverages in India. Since 2005, the strengthening support provided by National Rural Health Mission (NRHM), shows an increasing trend in immunization coverage and quality but still, critical gaps remain in the vaccine logistics management system in the country.


According to the report released by the Confederation of Indian Industries, India still fares poorly as compared to other countries as far as expenditure and vaccines coverage is concerned. In terms of full immunization coverage, Brazil and Mexico’s portfolio is far superior as that of China and India. The astonishing fact – 70% of the world’s unvaccinated children live in only 10 countries, 52% of which live in just 3 countries: India, Nigeria and the Democratic Republic of Congo.


India covers 2.7 crore children under the immunization program, whereas 14.5 lakh still don’t receive vaccination. Vaccines are efficacious against prevalent areas, making it easier to overlook their success. For example, between the year 2000 and 2015, the measles vaccine alone saved 17 million lives, as reported by the World Health Organization (WHO). Despite the availability of safe and effective vaccines, the coverage of immunization against the six main vaccine-preventable diseases is still variable across different regions of the country. In 2015, one in every 5 children was unable to receive the needed routine vaccination. In an attempt to improve the immunization numbers, especially countries consisting of few vaccine manufacturers face extreme difficulty due to weak health-care systems, inadequate and poor infrastructure, interrupted links in the cold chain system and even issues related to technical capacities of staff.

While on a contrasting scenario, the facts state that India is amongst the largest vaccine manufacturers in the world. Despite that, the country is unable to provide maximum vaccine coverage. Why?


It is because districts in India face challenges related to vaccine coverage, equipment breakdowns, overstocking and stock- outs, storage issues during transportation and a discontinuous cold chain. The purpose of ensuring effective delivery becomes moot when the final destination in rural health clinics has issues with electricity. The complication is worsened when there are power outages for extended hours at a time, the vaccines requiring refrigeration are damaged.

India is solely responsible for wasting 25% of the vaccines due to the paucity of the cold chain. Therefore, the Ministry of Health and Family Welfare has planned over 27,000 cold chain points for storing the distribution of vaccines. In order to maximize the reach of vaccines, the Ministry in collaboration with United Nations Development Programme (UNDP) rolled out Electronic Vaccine Intelligence Network (eVIN) across 12 states in India.


Due to these supply chain challenges, Hilleman Laboratories recognized the needs of the changing world and took the opportunity to introduce thermostable vaccines which drive down the logistics cost by eliminating the cold chain. Thermostable vaccines reduce the risk of ineffective vaccines and thereby, maximize the impact on public health. In order to expand the immunization coverage, Hilleman Laboratories is currently advancing technologies that aid in maintaining the quality attributes of the vaccines.
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Friday, 7 April 2017

Hilleman Laboratories signed an MoU with NICED, ICMR to develop the first ever: Shigella Vaccine




A Kolkata based National Institute of Cholera and Enteric Diseases (NICED), Indian Council of Medical Research (ICMR) inked an MoU with Hilleman labs, for further development and commercialization of the Shigella Vaccine and other enteric vaccines for diarrheal diseases. The agreement was signed as an effort of Hilleman Labs mission to make affordable and accessible vaccines for the developing world.   

At the signing-in, Dr. Davinder Gill, CEO, Hilleman Labs said, "Shigella is the second most fatal organism after Rotavirus that causes severe diarrhea in children with no approved vaccine available at this time. We are pleased at this opportunity to
collaborate with NICED and jointly develop Shigella vaccine for a disease whose basic pathology is not yet properly understood."

 

Dr. Shanta Dutta Director, NICED said, "Vaccines are the most, simple, powerful and cost-effective health intervention and an effective public health tool. Our association with Hilleman Labs is in alignment with NICED's mission to identify enteric infections, initiate appropriate multidisciplinary research and develop strategies for treatment, control and prevention of enteric infections."


"Till now Shigella infection was treated with antibiotics and currently there is no vaccine to prevent shigellosis. We look forward to this as a strong partnership aspiring to unlock new knowledge behind the enteric disease like shigellosis and to come up with appropriate and effective preventive tool against this disease.", she added.

Shigellosis the leading cause of mortality and morbidity in under five children with bloody diarrhea worldwide, especially affecting low income developing countries of Africa and South Asia. According to the 2015 Global Burden of Disease report, 1.3 million deaths related to diarrhea occur not only in children but adults as well across the world. Out of these, India had the highest mortality rates with 500,000 deaths in children less than 5 years of age. India’s population is severely affected by water borne diseases. Poor quality of water, hygiene and sanitation results in 30.5 million disabilities adjusted life years in India. While the Government of India is working towards improving these basic needs, the vaccine industry is contributing to public health by developing vaccines for various pathogens: Shigella, adenovirus, Campylobacter & E. coli which are identified to cause diarrhea.

Dr. Soumya Swaminathan Director General of ICMR and Secretary, Department of Health Research - Ministry of Health and Family Welfare added by saying, “India has immense potential in clinical research, drug and device manufacturing and we would like to see more of these partnerships within the country to realize the ‘Make in India' dream. We are keen that ICMR becomes more collaborative and partners with organizations in this direction and mutually expand capacities through cross-functional partnerships".   

 

In addition to understanding the role of NICED better with Hilleman Laboratories, Dr. Davinder Gill, CEO, Hilleman Laboratories said,’ The good thing about this collaboration is that we can offer our expertise in vaccine development to the work that is done at NICED and quickly accelerate the process of development of the vaccine, so that within the next year we can bring the vaccine from research stage to clinical trials.”    
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Monday, 6 March 2017

Realizing The Potential of Public Private Partnerships in Developing Effective Vaccines For Disease-Endemic Countries



Immunization is the most cost effective tool for preventing death among children less than 5 years of age. Vaccines for leading global diseases - Diarrheal diseases, acute respiratory infection and Tuberculosis are largely unavailable in developing countries. However, the overall cost for completely vaccinating a child has increased in the last 30 years. (WHO SEAR, 2010) Introducing vaccines in developing countries, carries its own set of limitations- cost, affordability and sustainability, cold chain, adverse effects, safety, short and long-term issues.

The advent in technology presents itself as a paradox. Equipped with a deeper understanding of the genomics and access to sophisticated research tools, science now has the potential to target diseases like never before. Despite the advances, critical gap between industrialized and developing countries remain. Although, Private sectors have capitalized new technological capabilities for creating new drugs and vaccinations aimed at chronic diseases affecting the industrialized countries, the same have not been exploited to treat infectious diseases plaguing the developing countries. A number of distinct factors make it difficult to attract the necessary investments in research and development of these diseases. Factors like low market returns, distribution challenges in developing countries and most importantly, lack of awareness of these diseases in developed countries. Unless diseases such as malaria, tuberculosis and acquired immunodeficiency syndrome (AIDS) account for millions of deaths, threatening the economic stability of the nation, there are limited number of drugs and vaccines available to treat the diseases of the developing countries.

To address the critical gap, Public Private Partnership’s represent an important approach. The Public Health sector for example - WHO, UNICEF or any non-governmental organization offers its expertise and combines it with the private sector where financial resources and market experience aid in meeting the developing countries health needs while also fulfilling the corporate social and fiscal responsibility objective. Understanding the need for vaccine developments in disease endemic countries, Hilleman Laboratories took an innovative approach, by collaborating with National Institute of Enteric Diseases (NICED), Indian Council of Medical Research (ICMR) in Kolkata to develop a vaccine against Shigellosis, which cause severe diarrheal diseases.

“Hilleman Laboratories will lead the vaccine development efforts, and that’s really where our expertise is whereas NICED is a center of excellence monitoring diseases in India where they will be contributing to various aspects of clinical research, clinical & pre- clinical trials, regulatory submissions” says Dr. Davinder Gill, CEO, Hilleman Laboratories. The combined efforts between Hilleman labs and NICED, ICMR offering their expertise will bring this collaboration to a successful completion contributing the make in India initiative.

“India has immense potential in clinical research, drug and device manufacturing” says
Dr. Soumya Swaminathan, Director General, Institute of Medical Research.

The Public Private Partnerships offers several opportunities for Indian Pharma companies such as low cost of innovation, quality chemical capabilities where the cost of drug discovery is 80-90% cheaper as compare to other countries. In order to move past the significant barriers to give rise to more such partnerships, the government must create an environment for innovation and entrepreneurship, strong patent protection and predictable regulatory mechanisms.
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Tuesday, 14 February 2017

History of Cholera and its burden on Developing Countries



In modern history, cholera occupies an important place as a public health challenge. It was the first pandemic of the 19th century. It’s an infectious and life-threatening diarrheal disease which is endemic in many Asian and African countries. Initially originated in the swamps of Bangladesh, it spread across the world from its reservoir which is part of the Ganges River Delta. The existent brackish waters were the birthplace of vibrio cholerae, a bacterium that infects the waters and when ingested emits a toxin so virulent that all the human body’s fluids are forced to flush out.  Deprived of electrolytes, people begin to die of shock and organ failure, sporadically, within six hours of the first abdominal rumbling. 


History of Cholera and its burden on Developing Countries 

Since 1871, pandemics of cholera has affected millions. As per researchers at World Health Organization, cholera contributes to 1.3 to 4 million cases each year. (WHO, 2016) The increase in access to safe drinking water and sanitation facilities has eliminated the transmission in high-income countries. However, the causative agent, Vibrio cholerae continues to affect millions of people in less developed countries where, unfortunately, clean water and sanitation infrastructure is not available in abundance. 

Over the last 25 years, major cholera epidemics have seen to originate in coastal areas. Currently, the regions of cholera endeminity include the coasts surrounding the Bay of Bengal, both Bangladesh and the Indian subcontinent. In these geographical regions, the patterns of the frequency of the disease show a similar trend that are explained by same physical or environmental drivers. The diarrheal disease, caused by bacteria that lives in water and faeces, is not spread by contact with an infected person. A large number of the population is infected due to drinking this contaminated water. Experts suggest an occurrence of 4,50,000 - 1,000,000 cases of cholera in Bangladesh each year, whereas Data from population-based diarrhea surveillance in an endemic area of Kolkata, India, revealed a cholera incidence of 2.2 cases per 1000 person-years.  

For effective aversion of cholera transmission, it’s imperative the afflicted countries are provided with safe drinking water through a well-maintained water and sanitary infrastructure. Oral cholera vaccines are additional ways to control the disease but should be used in conjunction with improvements in water & sanitation. Even though the disease is preventable and can be controlled despite the existence of a vaccine, many countries still remain affected.

“HILLCHOLTM  - This low-cost Cholera vaccine can be used to create a healthy stockpile to be used in epidemic situations.”  Says Dr Tarun Sharma, Associate Director, R&D, Hilleman Laboratories


Representing a significant healthcare burden globally, Hilleman Laboratories is awarded global patents for Oral Cholera Vaccine (OCV) in offices including USA, European Union, Australia, China, Canada and South Africa. Mass vaccination would be made a reality in cholera endemic zones due to ease of manufacturing and low cost. Hilleman Labs single-strain vaccine with process and manufacturing optimisation significantly reduces the cost of the vaccine production, thus, aiding in improving vaccine affordability and accessibility.
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Tuesday, 31 January 2017

Immunization against Measles – Rubella in India

The World Health Organization has congratulated India for launching the world’s largest immunization campaign against Measles – Rubella. The campaign targets Measles, a highly contagious disease caused by a virus. The virus is from the paramyxovirus family and it is normally passed through direct contact and through the air. It is spread by sneezing, coughing or direct contact with infected nasal or throat secretions, infecting the respiratory tract. The campaign is additionally targeting, the congenital rubella syndrome (CRS); responsible for permanent effects such as irreversible birth defects, deafness and cataracts.  

In India, Measles affect 2.5 million children annually whereas the congenital rubella infection, also known as the German Measles, affects 25,000 children born in the country. In recent years, due to consistent efforts, the mortality rate has declined by 51% from the year 2000 to 49,000 in the year of 2015.
   

The Union Health Ministry has launched the Measles – Rubella (MR) vaccination campaign
in Bengaluru on 5th February, proving India’s commitment to improve the country’s health by protecting children against vaccine preventable diseases. The campaign targeting two diseases will cover nearly 3.6 crore children will start from five states and union territories (UTs), namely, Karnataka, Tamil Nadu, Puducherry, Goa and Lakshadweep. 



In the nationwide campaign, the ministry will reach out to and cover 41 crore children in the age group of 9 months to 15 years,” says MoS Health Faggan Singh Kulaste.  

A specified age group will get a single shot of Measles - Rubella vaccine irrespective of the previously introduced Measles/rubella vaccine status or disease status. The Measles Rubella vaccine will be provided free of cost across states from schools as well as to health facilities. Earlier, in 1985, Measles vaccine was part of the Universal Immunization Programme (UIP), but due to the introduction of the Measles - Rubella vaccine, the monovalent vaccine (Measles) will be discontinued and replaced by the bivalent vaccine (Measles - Rubella).    

The World Health Organization has set a Sustainable Goal Target, which aims to prevent the deaths of newborns and children under five years of age by 2030. Thus, the elimination of Measles and congenital rubella syndrome by the bivalent vaccine will contribute to the achievement of the set goal.
We, at Hilleman Laboratories, believe that by not getting vaccinated you are not only putting yourself at risk but also the people around you. To ensure the effectiveness of the campaign, it’s important that throughout its duration, no individual is left behind. An important learning taken away from the polio eradication programme was to further the strengthening of surveillance for Measles- Rubella and to identify infected and vulnerable areas. The parents, caregivers, community leaders, teachers and the frontline healthcare providers are urged to become active participants and advocates for the campaign. Consistent efforts are the only way to rapidly build up immunity and thereby reducing the huge socio-economic burden on the susceptible cohort.

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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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