Thursday, 15 June 2017

Heat stable Rotavirus Vaccine: India Combats Diarrheal Deaths

Rotavirus is a highly contagious virus, usually spread through contaminated water and food. The disease causes uncontrollable diarrhea leading to severe dehydration which can even cause death. It is the most common cause of diarrheal disease in young children throughout the world. According to the estimations of World Health Organization, nearly 215,000 children aged less than 5 years die globally from vaccine preventable rotavirus infections. The maximum number of children affected reside in low-income countries where children are malnourished and lack access to proper medical care. However, In India, it is the leading cause of moderate to severe diarrhea accounting for 40% of cases which require treatment. The vast majority of children in the country are affected by diarrhea than as compared to AIDS, malaria, and measles combined.



According to the Union Health Ministry, rotavirus diarrhea is responsible for about 78,000 deaths, 3.2 million outpatient visits and nearly 0.9 million hospitalizations every year. Therefore, in 2014, the rotavirus vaccine was included in the Universal Immunization Programme in 4 states, Himachal Pradesh, Andhra Pradesh, Haryana and Odisha and then in February 2017, the vaccine was included in Assam, Tripura, Rajasthan and Tamil Nadu. Even though the government is striving for maximum coverage where no child should die from vaccine-preventable diseases, it faces difficulties such as reaching remote areas, untrained health workforce, equipment, logistics and sub-optimal cold chain management.

The available vaccine for rotavirus vaccine loses its potency when exposed to temperatures outside the specified range which lie between 2° to 8° Celsius.As emphasized in a peer-reviewed medical journal, outdated vaccine supply, and distribution systems not only delay, but also limit the impact that vaccines have in safeguarding people’s health. Thus, understanding the global disease burden of rotavirus has on childhood mortality, Hilleman Laboratories leverages its research functions to establish a proof of concept for the development of an optimized oral heat-stable vaccine that will impact the health of millions of children in developing nations.

Hilleman Laboratories is improvising the existing oral rotavirus vaccine for which will be thermostable i.e. the vaccine will be functional over a wider range of temperature thereby reducing the dependability on storage & refrigeration. This kind of Research & Development is needed to make effective vaccines that have a high efficacy percentage available in resource-limited countries so that they can be more easily used to decrease the impact of vaccine-preventable diseases. Hilleman Laboratories is using innovative technology for simple novel packaging, making it affordable and the vaccine will be lyophilized for easier administration. If the vaccine proves to be safe and immunogenic the vaccine could be brought to India, as early as 2020, aiding in bridging the gap in vaccine delivery says Dr. Davinder Gill, CEO, Hilleman Laboratories.
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Monday, 22 May 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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Monday, 15 May 2017

The Low Cost Meningococcal ACYWX Conjugate Vaccine: A Boon For The Developing World




Meningitis is the inflammation of the membranes that outline your brain and spinal cord. These membranes are called meninges, therefore, giving the illness, its name - “meningitis”. While viral meningitis is the most common, bacterial meningitis is more consequential. Lack of timely treatment can cause paralysis, stroke, seizures, sepsis, and even death. The symptoms of bacterial meningitis can begin quickly, sometimes as quick as in a couple of hours. In cases of development of the disease, one experiences nausea, vomiting, sensitivity to light, confusion and a rash of purple discoloration. There are several cases of bacterial meningitis –
1.) Streptococcus pneumoniae, also called pneumococcus
2.) Neisseria meningitidis, also called meningococcus
3.) Haemophilus influenzae type B, also called Hib
4.) Listeria monocytogenes
5.) Group B streptococcus
6.) E. coli

Amongst the leading causes of bacterial meningitis is “Neisseria meningitidis”; causes pneumonia, sepsis and other such infectious manifestations. The invasive disease affects 50,000 to 1.2 million people and is responsible for 135,000 deaths annually. As in the case of other infectious diseases, the majority of disease burden lies in developing countries. This includes meningococcal countries in the African meningitis belt, regions in South-East Asia as well as in the United States of America. Meningitis is also prevalent in Europe, the Eastern Mediterranean region and in Saudi Arabia. The recorded incidence of the endemic meningococcal disease is relatively low in India but such cases have occasionally appeared in the last 100 years. The disease is deadly and is contagious in people with close contact and can spread through coughing and sneezing. A person develops bacterial meningitis when bacteria gets into the bloodstream from the sinuses, ears or other parts of the upper respiratory tract.

There are 13 serogroups, but the majority of invasive meningococcal infections are caused by organisms from the A, B, C, X, Y, or W serogroups. While polyvalent conjugate vaccines targeting serogroups A, C, Y and W, are available, they are too expensive and therefore not widely used in developing countries due to affordability and accessibility issues. There are currently no low-cost polyvalent conjugate vaccines in the market that cover all five A, C, Y, W and X serogroups. Therefore, Hilleman Laboratories is currently working on a low - cost meningococcal ACYWX conjugate vaccine which provides protection against five types of serogroups. Researchers adopted a two- pronged strategy to develop low-cost combination vaccine for the treatment of invasive meningococcal disease.

“The role of the formulation in the vaccine scenario in terms of accessibility, affordability, and acceptability, besides the contribution in bridging the immunization gap in the country would also be assessed,” says Dr. Davinder Gill, CEO of Hilleman Laboratories. Developing Countries with high endemicity place an immense strain on the public healthcare system. The disease includes long-term risk of cognitive deficit, bilateral hearing loss, motor deficit, seizures, visual impairment, and loss of limbs due to tissue necrosis; the highest risks in low-income countries, where the burden of bacterial meningitis is greatest.

The novel cost Meningioccocal - ACYWX conjugate vaccine has the potential to significantly reduce costs and create new intellectual property allowing developing country manufacturers undertake more conjugate vaccine development projects. Technical success of the vaccines has been demonstrated in animal models. With accessibility and affordability issues in low-income countries, the vaccine could prove to be a boon for the developing nation.
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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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Thursday, 23 February 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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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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