Vaccine Trail in Space

By: Hilleman Laboratories on December 07, 2015

Over the next year, twin astronauts play a role in an experiment that involves the International Space Station.

Orbiting at about 249 miles above our terrestrial home is the International Space Station (ISS), the largest peace-time international project in human history. It is also one of the sites for a yearlong experiment which involves the twin astronauts Mark and Scott Kelly.

Subject of Experiment: Flu shots with a twist!

Kelly brothers are a part of an exciting experiment that involves the study of the behaviour of immunity system of humans in space and what effect does it have on a long term basis. Earlier this year both the brothers received their flu vaccinations. But while Mark stayed home, Scott took the ride up to ISS for a year long stint. Both the brothers will continue to be studied by NASA researchers to track how extended stays in space affect the human immune systems. Both the brothers received their second flu shot this November, this time Mark on earth and Scott aboard the ISS.

Most of us will think it’s very difficult to get sick aboard the ISS. Contrary to this belief, bacteria and viruses adore the environment of a space craft. It’s warm, it’s sealed, its climate controlled, and the best part, it’s full of people who have nowhere to go and no way of avoiding any stray germs they might have brought with them. That’s especially true aboard the International Space Station (ISS), where crews rotate in and out and can stay for many months at a time, and where residents’ immune systems—flummoxed by long-term exposure to zero-g—are unable to function as they should.

The Kelly brothers’ immune system had already been studied in the run-up to Scott’s launch last March, and both were certified fit. But they should slowly be diverging, with Scott having more problems. In space, some of the immune system’s billions of cell start to display changes in terms of shape and function, especially the critically important T-Cells, and none of it to the better. T-Cells can be most aptly defined as the generals who coordinate the entire immune system’s responses.

Video: http://ti.me/1Tb43oB

The experiment that will help us study all of this began a few months before Scott left Earth, when both the brothers received a similar trivalent flu vaccine – one that is capable to protect against three strains of the virus. The NASA researchers will be looking not just at how Scott’s immune system is changed by his time in space, but also how well it recovers once Scott is back on Earth.

The Kelly brothers are hardly the only people to get flu vaccination this year, but if everything works according to plan, they might just be the most important ones!  

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A simple text message can do a lot of difference!

By: Hilleman Laboratories on November 26, 2015

Vaccines are responsible for millions of lives being saved each year. They are responsible for eradication of smallpox, a 74% reduction in childhood deaths from measles over the past decade, and the near eradication of Polio.

Despite these great achievement, there remains an urgent need to reach all children with life-saving vaccines. One in every five children worldwide are not fully protected with the most basic vaccines. As a result, an estimated 1.5M children lose their life to vaccine preventable diseases – one every 20 seconds. One of the biggest operational problem is that even if there is a vaccination drive going in the vicinity, people are largely unaware about it especially in the low economic settings.

According to a research by Columbia University, sending text messages to mobile phones can help increase immunisation rates and reduce the spread of vaccine-preventable infections.

According to Dr. Melissa Stockwell, Associate Professor of Paediatrics and Population Family Health at Columbia University, text reminders can be more effective than traditional communication methods.

According to Stockwell, parents feel that it shows the healthcare providers care for them, even when they are not right in front of them. Traditional form of communication like phone and postcards often don’t work in low income, adolescent and rural population. Sending a text message which has an upper limit of 160 characters is not always easy. Text messages are usually no more than 160 characters long, yet it is essential that texts from doctors’ practices get the tone right; that speak a language that is well understood without being too informal.

According to Dr. Stockwell, the character limit actually ends up being helpful because it forces one to be brief, thus ending up using language that is understandable to the patients and their families.

As evidence continues to build behind the value of sending text reminders, she expects more healthcare professionals to embrace the technology.

Source: VaccinesToday

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And it's a wrap, The Merck Fellowship Program

By: Hilleman Laboratories on November 17, 2015

All good things must come to an end eventually, but the next experience awaits!

Carrying this thought in mind, we at Hilleman Labs congratulate the four RTC fellows from MERCK, Ms. Kim Bishop, Ms. Melissa Wooters Mr. Garth Meihoff and Mr. David Peed on successful completion of their three months long fellowship program here at Hilleman Labs, Delhi.

From creating new vaccines/drugs that prevent/treat diseases to addressing key health issues for people in need, Merck is committed to improve health and well-being around the world. The Merck Fellowship for Global Health is one such initiative aimed at fulfilling the global health needs of the underserved. Merck employees who participate in the program are called Richard T. Clark Fellows (RTC Fellows) in honour of retired Chairman and CEO Richard T. Clark and his philosophy of "passion, purpose and commitment to corporate responsibility."

Launched in 2012, the program offers Merck employees opportunities to share their skills and expertise with people around the world. As many as 30 Fellows are selected each year; the expertise of the applicants is matched to the needs of the partner organizations. During the three-month assignments, the Fellows are embedded within a non-profit organization in the field.

The fellowship team which commenced on August 3^rd 2015, comprised of a 4 member team from Merck US, which included:

·         Kimberly Bishop

Global Human Health – Tampa, FL, USA

·         Garth Meihoff

Global Human Health – Lake Oswego, OR, USA

·         David Peed

Global Human Health – Charlotte, NC, USA

·         Melissa Wooters

Merck Research Labs – West Point, PA, USA

The fellowship team was at MSD Wellcome Trust Hilleman Laboratories, Delhi, India working on specific projects assigned to them prior to their visit.

A succinct overview of their three months long fellowship program is detailed below:

·         Kimberly Bishop

Ms. Kimberly Bishop works as a Retail Pharmacy Representative in Tampa, FL at Merck US. She is a Consummate Sales Professional with 20+ years of experience in identifying and capturing market opportunities to accelerate expansion, increase revenues and improve profit.

Project: Create a set of organisational guidelines to present the case for vaccine innovation

According to Kim, despite improvements in global vaccine coverage during the past decade, their continuous to be regional and local disparities. With 18.7 M infants still unvaccinated, no one can doubt Kim’s claims.

The primary objective of Kim’s fellowship program was to establish steps to build a health economic model that can be presented to global organisations and procurement agencies to communicate the long term societal rewards of vaccine innovation. The scope of work also included development of guidelines to build advocacy, to facilitate the introduction of innovative vaccine to developing nations.

According to Kim three key components required to build a case for vaccine innovation are

·         Identifying the need

·         Developing appropriate strategy

·         Building effective advocacy

Understanding the disease burden of a specific geographical region is undeniably the primary requirement. This is the first step towards identifying the need. Having a better understanding of a geography’s requirement helps in dealing with the policy makers and governance bodies of the region better and also helps in designing region compatible products, as disease patterns vary considerably with location.

The next component that requires considerable attention would be to develop effective strategies. As per Kim, introducing an ’Advocacy Development Plan’ in each strategic plan is also key in developing an effective strategy. Kim feels it is important to have as much interaction as possible with key policy makers and stakeholders in order to build a rappo. Typically the advocacy begins when the vaccine is at Phase2/3 of development but it should actually start as early as preclinical trails.

·         Melissa Wooter

Ms. Melissa A. Boddicker Wooter is Research Microbiologist at Merck & Co., West Point, PA. She joined Merck in October 2002 and has 18 years of rich experience. She is presently working as Lead conducting all molecular cloning work for the Chlamydia program including identifying vaccine candidates, designing cloning approaches, expression evaluation and optimization of protein expression. She is also developing and designing cloning strategies for multiple Chlamydia and GAS vaccine targets.

Project: Conduct Experiments on an ETEC Vaccine

ETEC is one of a major cause of travellers’ diarrhoea and endemic in underdeveloped countries. With nearly 840M annual cases of ETEC in developing countries it poses high risks. This creates a high demand for an effective vaccine that can help in mitigating the threat posed by ETEC. This led to the development of the HL ETEC Vaccine. Melissa joined the ETEC team at Hilleman Labs as a strategic advisor to the research team.

·         Garth Meihoff

Mr. Garth J. Meihoff is a Senior Account Executive, Merck Vaccines, Portland since 2014. He has 13 years of vaccine and 11 years of pharmaceutical public and private sector sales/marketing experience in broad areas including account management, business strategy and planning, sales management, customer marketing, product and promotion management and field sales.

Project: Conduct a Quantitative Assessment of the Health Impact of IP Vaccines

Garth’s project scope included quantitative examination of health impact due to relative difference in cost of manufacture including intellectual property between vaccines made using conventional methods and a novel method developed at Hilleman Labs. His scopeof work also included development of skills that will aid Hilleman Labs to analyse the cost effectiveness of novel methods, health impact and IP related matters.

Broadly Garth’s project agenda was to research the Meningococcal market and influence of intellectual property on it as well as a detailed cost analysis for vaccine processes. The market research methods employed by him broadly included telephonic and one-on-one interviews. The respondents ranged from vaccine manufacturers, experts, chemical manufacturers, worldwide IP experts to global health organisations.

Garth’s research showed synthetic vaccine manufacturing processes to have above average advantage over conventional methods.

Some notable advantage of synthetic processes over conventional processes would be

·         Reduced facility start-up cost (India: $3M vs. $10M)

·         Manufacturing Advantage

o   Less stringent requirements

o   Decreased Labour

o   Increases Flexibility

o   Reduced QC Issues

·         Greater product stability resulting in fully liquid formulation

·         Greater characterization leading to faster approvals

Although there are a lot of advantage of synthetic vaccine manufacturing over conventional methods, it does possess some weaknesses as well. Majorly the drawbacks are at the manufacturing front like increased processing time, residual chemical safety and trained staff constraints to name a few.

Also lack of a comparator in case of synthetic process could additionally delay approvals.

·         David Peed

Mr. David A. Peed is a Senior Account Executive within US Managed Markets and Policy at Merck. He has 28 years of experience with major job responsibilities. He joined Merck in 1987 as a Professional Hospital Representative. His current position as a Senior Account Manager in Integrated Delivery Systems and Federal Accounts – this position involves formulating and implementing strategic plans for key targeted accounts, leading cross-functional teams to implement the plans, strategy and ensuring profitable access for all Merck products at key integrated health systems.

Project: Explore potential option for long term sustainability

David’s scope of work primarily revolved around conceptualisation of a sustainable model for Hilleman Labs. His reports were developed through extensive literature review and on research regarding for-profit and non-profit organisations focussing on global health. The research effort included interviews with key leaders in the global health marketplace as well as key advisors to Hilleman Labs. The project also included detailed research of many global health company business and finding models like IVI etc.

David Peed additionally focused on how Hilleman Labs should improve their external and internal communication. He also stressed on creating a strategic advocacy approach in addition to effective and innovative external and internal communications. 

We at Hilleman Labs are overwhelmed and thankful to the fellowship team for their invaluable contribution and time. As Mr David mentions in his presentation, every person’s life matters and everyone is important regardless their nationality, religion or race. We hope this knowledge sharing experience armed with our vision would help us in doing our bit for humanity and help us in our endeavour of reshaping healthcare and making it accessible to all. 

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Robust Supply Chains: Key enablers of life saving vaccines

By: Hilleman Laboratories on October 30, 2015

Vaccines have been widely recognised as the backbone of the public health system. They help creating the first line of defence against contagious diseases, are highly cost effective and supposed to be available at every health facility in the world, to save lives.

But the vaccines are powerless if we can’t deliver them safely and efficiently to those who need them the most. This is where the importance of having a robust and efficient supply chain comes into play.

Below is a picture, illustrating some important clues to a strong immunization supply chain system.

Notice the cooler, the vaccine worker is carrying, which helps keeping the vaccines at just the right temperature after a long journey from the manufacturer to the health post. Also you can notice the health worker carrying her ledger to track the number of vaccines given and vials consumed. As defined by Vaccines Work, Supply chains are the human resources, technologies, and systems required to get vaccines safely and efficiently from the point of manufacture to the point of immunization without compromising potency or availability.

Present Status of Immunization Supply Chains

We have presently entered a new era for immunization. An era where diseases like cervical cancer, rotavirus diarrhoea and pneumonia can be prevented by using vaccines and the vaccines are available even at the poorest countries. And dozens of other vaccines targeted for different diseases is currently under the development pipeline waiting to address some of the world’s biggest health challenges. The growth is exciting but it adds pressure to the already stressed immunization supply chain.

The primary reason of the overtly stressed immunization supply chain is that these supply chains were designed nearly about 30 years ago, when immunization schedules were smaller and simpler, vaccines were less expensive, and immunization was primarily aimed at infants. But today, vaccines protect against twice as many diseases and also are administered to a much broader age group.

To manage today’s immunization programs, countries are starting to recognize the need to build stronger and much more efficient supply chains to meet the demand.

A peek at the next generation supply chain

• According to Gavi’s immunization supply chain strategy (2014), the next generation supply chain should be built on five fundamentals:
• Designed to optimize safety, reliability, and efficiency of immunization programs.
•  Led by competent, professionally trained supply chain managers.
• Use a continuous improvement approach for assessing, planning, and implementing supply chain changes over time.
• Should consider collected data for decision making.
• Should use, monitor, and maintain high-quality cooling equipment to ensure proper temperatures along the supply chain.

Efficient supply chains can have a significant effect on immunization programs, especially in low resource settings. While several countries are piloting new supply chain solutions, more political leadership is required before major, systematic changes can be made and scaled up.

Policies supporting the five fundamentals would bring about a major change for the better. By endorsing such initiatives we would be helping achieve the objectives of vaccines that is to improve health and save lives around the world.

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Launch of State-level Disease Burden Initiative

By: Hilleman Laboratories on October 15, 2015

In collaboration with the Ministry of Health and Family Welfare

India has been going through a major epidemiological transition over the past 25 years. The burden of premature death and health loss due to NCDs and non-infectious conditions remains unacceptably high. The extent of this burden is expected to vary appreciably across the various population groups and states in India. The national level estimates fail to provide enough insights and data to contemplate a targeted action. Hence a sub national, region specific estimation of disease burden is essential for India in order to develop an informed health system response to improve the population’s health.

The Indian Council of Medical Research (ICMR), the Public Health Foundation of India (PHFI) and the Institute of Health Metrics and Evaluation (IHME) under the aegis of the Ministry of Health and Family Welfare, Government of India have launched a collaborative initiative on state level disease estimation in India. This effort would extensively employ the robust methods of the Global Burden of Disease (GBD) study, developed by a global network of researchers coordinated by IHME. This will help in generating rigorous estimates of all major drivers of health loss at the state level in India. This would also include the state-of-the-art GBD interactive visualisation tools which would help bring to life the initiative’s findings.

India has a vast landscape with tremendous regional health variations. Well researched estimations can enable the government to adopt a more targeted approach and help decide what needs to be done where, for whom and when. As rightly identified by Prof.Lalit Dandona, who will serve as the Director of the joint initiative, many Indian states are bigger than most countries in the world. Planning effective health improvements for one sixth of the world’s population without taking into consideration the variation in disease burden trends across the states cannot yield optimal outcomes. This collaborative effort of the state level disease burden initiative, is a unique opportunity that would help generate better evidence for the disease trend variation across India and also help developing useful data generation systems to aid in effective health planning on an ongoing basis at local levels in India.

This initiative would work closely with a network of academic partners across India, and primarily with policy makers at the national and state level for guidance and utilization of the findings to improve health programs and planning.

The contribution of risk factors such as high blood pressure, blood sugar and cholesterol, and that of poor diet and alcohol use, to health loss has doubled in India over the past two decades, and air pollution and tobacco smoking continue to be major contributors to health loss. However, the extent of these risk factors varies considerably across the states of India. The efforts of the State-level Disease Burden Initiative would help refine the understanding of these variations across India, which would in turn form appropriate strategies for the different states of Indiaas well as aid in the improvement of systems to produce these estimates on an ongoing basis to monitor changing trends at the local levels.  

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How india missed the 2015 child mortality target?

By: Hilleman Laboratories on September 28, 2015

An Info-graph illustrating the key reasons that led India to miss the child mortality targets which are a part of the MDGs.

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All you need to know about ‘Herd Immunity’

By: Hilleman Laboratories on September 11, 2015

Herd Immunity is a form of immunity that occurs when a significant portion of a population is vaccinated and in turn provides a measure of protection for the individuals who have not developed immunity. When this critical percentage of the population is already protected through vaccination against a virus or bacteria, it makes it difficult for a disease to spread because there are few vulnerable individuals left to infect.

The term herd immunity was first coined in 1923, recognized as a naturally occurring phenomenon in the 1930s when it was observed that after a significant percentage of children had become immune to measles, the number of new infections temporarily decreased, including among vulnerable children. Mass vaccination in order to actuate herd immunity has since become common and proved successful in preventing the spread of many contagious diseases.  During the smallpox eradication campaign in the 1960s and 1970s, the practice of ring vaccination, of which herd immunity is integral to, began as a way to immunize every person in a "ring" around an infected individual to prevent outbreaks from spreading.

This is highly effective in stopping the spread of a disease in a community. It is particularly crucial for protecting people who cannot be vaccinated. These include infants who are too young to be vaccinated, immunocompromised people, and those whose medical condition doesn’t allow them to receive vaccination (such as cancer patients).

However the percentage of a population which must be immunised in order to achieve herd immunity against a specific disease varies for each disease. Once a certain threshold has been reached, herd immunity gradually starts eliminating a disease from a population. This elimination, when achieved worldwide, results in the permanent reduction in the number of infections to zero, called eradication. Till date, two diseases have been eradicated using vaccination and herd immunity: smallpox and rinderpest.

However, when immunisation rates decline, it becomes difficult to retain herd immunity, leading to an increase in the number of new cases.

Following is an animated video by VaccinesToday, explaining how herd immunity works and what happens when it breaks down.

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MEET THE MERCK FELLOWSHIP TEAM

By: Hilleman Laboratories on August 23, 2015

From creating new vaccines/drugs that prevent/treat diseases to addressing key health issues for people in need, Merck is committed to improve health and well being around the world. The Merck Fellowship for Global Health is one such initiative aimed at fulfilling the global health needs of the underserved. Merck employees who participate in the program are called Richard T. Clark Fellows (RTC Fellows) in honour of retired Chairman and CEO Richard T. Clark and his philosophy of "passion, purpose and commitment to corporate responsibility."

Launched in 2012, the program offers Merck employees opportunities to share their skills and expertise with people around the world. As many as 30 Fellows are selected each year; the expertise of the applicants is matched to the needs of the partner organizations. During the three-month assignments, the Fellows are embedded within a non-profit organization in the field.

The Fellowship program represents what is possible in private-public partnerships for global health. One such fellowship program currently undergoing is at MSD Wellcome Trust Hilleman Labs Pvt. Ltd. – India. The fellowship program which commenced on August 3^rd 2015 comprises of a 4 member team from Merck US which includes:

·         Kimberly Bishop

Global Human Health – Tampa, FL, USA

·         Garth Meihoff

Global Human Health – Lake Oswego, OR, USA

·         David Peed

Global Human Health – Charlotte, NC, USA

·         Melissa Wooters

Merck Research Labs – West Point, PA, USA

The fellowship team would be at MSD Trust Hilleman Labs Pvt. Ltd. – India for three months and would be working on various assignments, designated to them prior to their visit. The detailed explanation of their respective projects and their views about the fellowship program is detailed below:

·         Kimberly Bishop

Ms. Kimberly Bishop is working as Retail Pharmacy Representative, Tampa, FL at Merck. She joined Merck in 1999 as Senior Sales Representative and became Retail Pharmacy Representative in August 2013. She is Consummate Sales Professional with 20+ years experience in identifying and capturing market opportunities to accelerate expansion, increase revenues and improve profit

Project: Create a Set of Organizational Guidelines to Present the Case for Vaccine Innovation

Kim’s take on the Fellowship program: “The Merck Fellowship for Global Health is a life-changing experience that goes beyond the scope of any individual assignment. This program allows a mutual opportunity to exist, sharing ideas between cultures and creating innovative product and business solutions for similar national health issues. It is an opportunity to serve others while establishing our presence as healthcare ambassadors. I believe that this is our moral responsibility.”

·         Garth Meihoff

Mr. Garth J. Meihoff is a Senior Account Executive, Merck Vaccines, Portland since 2014. He has 13 years of vaccine and 11 years of pharmaceutical public and private sector sales/marketing experience in broad areas including account management, business strategy and planning, sales management, customer marketing, product and promotion management and field sales.

Project: Conduct a Quantitative Assessment of the Health Impact of IP Vaccines

Garth’s take on the Fellowship program: “Working with underserved populations has always been important to me. I am honoured and excited to represent Merck as an RTC Fellow and grateful for the opportunity to help protect some of the poorest populations against vaccine preventable diseases. In New Delhi, I look forward to working with Hilleman Labs to increase access to life-saving vaccines. I am excited to apply my skills on a global level and gain a broader perspective toward a variety of populations. This life-changing experience will enhance my ability to better serve those in the U.S.”

·         David Peed

Mr. David A. Peed is a Senior Account Executive within US Managed Markets and Policy at Merck. He has 28 years of experience with major job responsibilities. He joined Merck in 1987 as a Professional Hospital Representative. In 1990 he was promoted to various internal positions within Merck administration and marketing including a role as Promotion Manager for Mefoxin in 1992. Mr. Peed was then promoted to Business Manager in Charlotte, NC where he managed a sales team responsible for many key Merck products. In 1997 he moved into the managed markets group at Merck where he was responsible for the Managed Care accounts in North and South Carolina until finally moving to his current position as a Senior Account Manager in Integrated Delivery Systems and Federal Accounts – this position involves formulating and implementing strategic plans for key targeted accounts, leading cross-functional teams to implement the plans, strategy and ensuring profitable access for all Merck products at key integrated health systems.

Project: Business Model Review and Operational Strategy

David’s take on the Fellowship program: “It is truly an honor to work for a company that provides an opportunity to participate in a program like the Merck Fellowship for Global Health that will have an impact on the lives of thousands in developing countries. I am extremely excited to be part of a group that will be working with Hilleman Labs in New Delhi, India, as they continue their work to develop high impact, affordable vaccines for people in developing countries in an innovative and sustainable manner. This program allows me to bridge my professional career with my personal desire to make a positive impact on those around me. I know the Fellowship will stretch me both personally and professionally, and I have no doubt that it will be life-changing.”

·         Melissa Wooter

Ms. Melissa A. BoddickerWooters is Research Microbiologist at Merck & Co., West Point, PA. She joined Merck in October 2002 and has 18 years of rich experience. She is presently working as Lead conducting all molecular cloning work for the Chlamydia program including identifying vaccine candidates, designing cloning approaches, expression evaluation and optimization of protein expression. She is also developing and designing cloning strategies for multiple Chlamydia and GAS vaccine targets.

Project: Conduct Experiments on an ETEC Vaccine

Melissa’s take on the Fellowship program: “I’m very excited to have been selected as an RTC Fellow. I look forward to my assignment at the Hilleman labs in New Delhi, India. I feel privileged to work for a company whose impact is felt globally and for being selected for this unique opportunity. As a Fellow, I will get up each day with the opportunity to contribute to the greater good and common purpose, an expansion of the work I do every day at Merck.  This program will help me to be more connected to the work I’m doing and understand how our work benefits people worldwide.”       

We at Hilleman Labs are overwhelmed with the fellowship visit and wish them all the luck in achieving their project goals and do their part in improving global healthcare and hope each Fellow walks away with something he or she never expected and becomes a richer person for the experience.

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How important is a Hib vaccine for India?

By: Hilleman Laboratories on August 17, 2015

Nelson Mandela once said, “There can be no keener revelation of a society’s soul than the way in which it treats its children.”

According to TOI, India witnessed more child deaths, than any other country, accounting for a staggering 21% of the global deaths. It is estimated that about 4% of all the under-5 deaths in India is due to Hib disease, a figure exhibiting the importance of a Hib vaccine in India. The fastidious nature of the Hib bacterium and the poor infrastructure in the developing countries like India, makes the diagnosis of the disease extremely difficult.

Hib is a deadly bacterium that causes severe diseases like pneumonia and meningitis, which are the leading causes of child deaths in India, accounting for nearly 21% of the global death figures. Hib capsular polysaccharides (Hib-PRP) are poorly immunogenic in children less than two years of age and require conjugation to a protein carrier. Moreover the Hib conjugate vaccine, which plays a vital role in national immunization programs and also forms a main part of the pentavalent vaccine, is the costliest component.

The new conjugate vaccine developed by Hilleman Laboratories is a more immunogenic preparation of Hib capsular polysaccharide (PRP)–tetanustoxoid (TT) conjugates using optimized PRP chain length and conjugation conditions. This new and unique cost-effective formulation developed by the company will significantly reduce the cost of Hib vaccine, which in turn, will help in reducing the market price of the pentavalent vaccine, thus making it accessible to a larger number of people. This will definitely have a larger economic impact on the public health system and subsequently bring down the expenditure in the system.

Thus introducing a Hib vaccine is of paramount importance for a country like India. It will have a positive impact in reducing child illness and death, as we have seen in the case of the industrialized part of the world where the disease has been virtually wiped out through immunization.

Hib vaccines are currently being used in over 185 countries worldwide, which represent over 95% of WHO member nations. The Hib-pentavalent vaccine is currently available in 18 states across India.

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A Social Task: Regularizing Routine Immunization in India

By: Hilleman Laboratories on July 28, 2015

Despite numerous medical breakthroughs and developments, maternal and child mortality in India continues to be one of the major health concerns, primarily due to childbirth, inadequate neonatal care and childhood diseases. A staggering 1.3 million under-5 deaths are reported each year and a significant number are caused by vaccine preventable diseases like pneumonia, diarrhoea and measles.

India’s Universal Immunization Program (UIP) is the largest in the world, but only 65% of children receive all the essential vaccines in their first year of life. According to certain surveys it is unlikely to reach its Global Immunization Vision and Strategy goals, which set targets for children reached and new vaccines adopted.

To help meet these challenges a great degree of help from the society is required. Civil Society Organizations (CSOs) and platforms such as Alliance for Immunization in India (Aii) can play a vital role in acting as an intermediary between grass root communities and the government. Thanks to their healthy and direct links to community, CSOs can contribute to a great extent in promoting equitable access to vaccines by informing families about outreach immunization facilities.

The role of CSOs in community mobilization and awareness is of critical importance in a country where myths and misconceptions often cloud the truth of the power of vaccines. It is important to raise awareness through activities such as effective information dissemination and making special efforts to reach out to those who live in hard-to-reach areas, are migrants or belong to a culturally diverse background.

Increasing community participation in immunization program is not only important to raise awareness but also leads to higher coverage and greatly reduces the incidents of vaccine preventable diseases. Immunization programs need continued support with proven strategies and fresh approaches to permit the ‘effective’ introduction of new vaccines. Here, the emphasis is on ‘effective’-meaning thereby introduction of a vaccine in to national immunization schedule that has a measurable impact on the epidemiology of the disease. Merely making the vaccine available in few pockets, for certain sections and for limited duration will not have any impact at national level. The ‘equity’ needs to be ensured so that the vaccine reaches to the section of the society who needs it the most.

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The Status of Challenges of Vaccination in Developing Economies

By: Hilleman Laboratories on July 13, 2015

Vaccination has appreciably reduced the spread of infectious diseases across the globe. However, the importance of vaccination, especially in developing and underdeveloped countries is exceptionally great, given the fact that the risks of contracting contagious diseases like Hepatitis, Typhoid etc. are alarmingly high in such economies. 

The eradication of Smallpox and Polio are a stark reminder of the defensive power of vaccination against baneful communicable diseases in developing countries. However, despite such impressive achievements, a few seminal problems and challenges still remain unaddressed.
 
Common Challenges and Roadblocks: 

Limited Resource Setting 
The limited resources in developing countries act as the biggest deterrents on the way to maintaining the quality of citizens’ health. Owing to the depreciating currencies and lack of governing commitments, the immunization coverage and people’s ability to avail of vaccines fall flat in many parts of such countries. 

Unavailability of Vaccines 
In many parts of developing countries, vaccines against some of the most common and communicable diseases like Typhoid, Malaria and Dengue still remain unavailable. The reason directly owes to infrastructural and logistical challenges. Also, the point explained in the preceding paragraph acts as one of the reasons. 

Research Inhibitors 
Despite the success rate of vaccination, the need to better the existing vaccines still remains a point of concern. Most of the current vaccines were developed by determining the components that consistently stimulated antibody responses in infected patients, and often without having a very detailed knowledge of the immune mechanisms required for protection. A lot of vaccines were simply formulated with aluminium hydroxide as the adjuvant and are administered by injection. 

Although such approaches have been evidently effective in many cases, unfortunately, they have been proven completely inadequate for several important pathogens. 

As it is, developing countries have weak surveillance, limited data on diseases, and poor scientific base which consequentially culminate into a major roadblock on the way to medical research. Hence, discovering better vaccines for diseases is still a distant dream for such countries. However, with a helping hand from developed economies and responsible corporate this situation can be addressed to a great extent. After all everyone deserves a shot at life! 

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Hilleman Laboratories’ preclinical trial report on Hib vaccine offers hope to millions of children

By: Hilleman Laboratories on June 30, 2015

~The unique formulation will not only be cost effective but also scalable for commercial manufacturing

New Delhi,29 June 2015:Global vaccine research and development organisation, Hilleman Laboratories, today announced the publication of an original scientific report in the journal Vaccine based on the success of a preclinical trial conducted for Haemophilus influenzae type b (Hib) vaccine. The unique formulation derived from the ongoing research will not only bring down the cost of the vaccine, but will also provide a scalable platform for commercial manufacturing. This break-through research is another milestone achievement for Hilleman Laboratories with a vision to bridge the immunization gap.

Speaking on this new development Dr. Davinder Gill, CEO, Hilleman Laboratories said, “Capsular polysaccharide conjugates of Hib are important components of several mono-or multivalent vaccines for children. However, the access to needy people is limited due to the relative high cost of the Hib vaccine. This new formulation will be a step towards developing a cost-effective and a more immunogenic vaccine. It is an encouraging breakthrough in bridging the gap and making Hib vaccine accessible and affordable.”

“A strategic three-step approach was used to identify the efficacy of polysaccharide in preparing a vaccine for Hib. Our original research published in the journal Vaccine shows that when the length of the polysaccharide was optimized, it dramatically improved immunogenicity in preclinical models, thus making it more powerful and effective. It was also found that the new formulation was 4 to 10 times more potent when compared to the existing licensed vaccines,” added Dr. Manoj KumarChhikara, Head of the Conjugate Vaccines R&D program at Hilleman Labs.

Hib is a deadly bacterium that causes severe diseases like pneumonia and meningitis, which are the leading causes of child deaths in India, accounting for nearly 20% of the global death figures. Hib capsular polysaccharides (Hib-PRP)arepoorly immunogenic in children less than two years of age and require conjugation to a protein carrier.Moreover the Hib conjugate vaccine, which plays a vital role in national immunization programs and also forms a main part of the pentavalent vaccine, is the costliest component and hence developing countries such as India can benefit from more cost effective formulations.

The new conjugate vaccine developed by Hilleman Laboratories is a more immunogenic preparation of Hib capsular polysaccharide (PRP)–tetanustoxoid (TT) conjugates using optimized PRP chain length and conjugation conditions. This new and unique cost-effective formulation developed by the company will significantly reduce the cost of Hibvaccine, which in turn, will help in reducing the market price of the pentavalent vaccine, thus making it accessible to a larger number of people. This will definitely have a larger economic impact on the public health system and subsequently bring down the expenditure in the system.

“We have already completed the preclinical immunogenicity trial phase which has shown predictive results. Our next step now would be to look at collaboration with like-minded stakeholders who can work together towards cost effective solutions with the aim of bridging existing gaps in a significant way” said Dr. Gill.

About Hilleman Laboratories:

Hilleman Laboratories is a first-of-its-kind joint-venture partnership formed between Merck & Co., 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.

Operating on a not-for-profit principle, Hilleman Laboratories aims to become a preferred partner for Low Cost Vaccine Manufacturers and the ‘global voice’ for vaccine development and usage for public health in the developing world. For further information please visit: www.hillemanlabs.org

Clayton Dsouza +91 9930011602

Ann Marie De Souza +91 9819099110

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The Status of Challenges of Vaccination in Developing Economies

By: Hilleman Laboratories on June 26, 2015

Vaccination has conspicuously abated the spread of infectious diseases across the globe. However, the importance of vaccination, especially in developing and underdeveloped countries is exceptionally great, given the fact that the risks of contracting contagious diseases like Diarrhoea, Hepatitis, Typhoid etc. are alarmingly high in such economies.

The eradication of Smallpox and Polio are a stark reminder of the defensive power of vaccination against baneful communicable diseases in developing countries. However, despite such impressive achievements, a few seminal problems and challenges still remain unaddressed.

Common Challenges and Roadblocks

Economic Crises

The economic crises in developing countries act as the biggest deterrents on the way to maintaining the quality of citizens’ health. Owing to the depreciating currencies and lack of governing commitments,  the immunization coverage and people’s ability to avail of vaccines fall flat in many parts of such countries.

Unavailability of Vaccines

In many parts of developing countries, vaccines against some of the most common and communicable diseases like Typhoid, Malaria and Dengue still remain unavailable. The reason directly owes to infrastructural and logistical challenges. Also, the point explained in the preceding paragraph acts as one of the reasons.

Research Inhibitors

Despite the success rate of vaccination, the need to better the existing vaccines still remains a point of concern. Most of the current vaccines were developed by determining the components that consistently stimulated antibody responses in infected patients, and often without having a very detailed knowledge of the immune mechanisms required for protection. A lot of vaccines were simply formulated with aluminium hydroxide as the adjuvant and are administered by injection.

Although such approaches have been evidently effective in many cases, unfortunately, they have been proven completely inadequate for several important pathogens.

As it is, developing countries have weak surveillance, limited data on diseases, and poor scientific base which consequentially culminate into a major roadblock on the way to medical research. Hence, discovering better vaccines for diseases is still a distant dream for such countries. However, with a helping hand from developed economies and responsible corporate this situation can be addressed to a great extent. After all everyone deserves a shot at life!

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The Future of Immunization

By: Hilleman Laboratories on June 11, 2015

The development of vaccines, followed by its mass scale adoption is often hailed as the greatest public health triumph of the 20^th century. The worldwide vaccination campaign has helped eradicate small pox, a disease responsible for millions of deaths, and immunization has eliminated polio in all but a handful of countries. Childhood vaccination has significantly reduced the mortality and morbidity from infectious diseases in a large part of the developed world. The success of vaccines is validated largely due to their impact on acute infectious diseases like Polio and Influenza.

Having said that, it is important to note that until a vaccine reaches the people who need it, it’s not saving lives. Children living in the poorest part of the world, who are under the constant threat of diseases, often are the last to receive the vaccines that has the potential to change their lives. In fact according to a study, upto 15 years may pass between the introduction of a new vaccine in the developed world to be in routine use in the developing world. Thus a lot is at stake when it comes to the success of vaccines, accessibility being one of the foremost requirements.

Below are some of the important issues that would define the success and future of immunization in the coming years:

·         Accelerating access to vaccines

According to John Wecker, former director of PATH’s Vaccine Access and Delivery program, “Introducing a vaccine is a long-term commitment”. Before countries can commit to add a certain vaccine to their public health programs, they need to have the best of information possible about the need for vaccine and its possible effects. Despite, this critical information is often hard to come. So the need of the hour is to form a highly connected, effective and informative channel which would suffice this gap, thus reducing the time lag.

·         Forecasting Supply and Demand

Once a promising new vaccine is added to a countries immunization program, another important question arises: will there be enough vaccines for every child?

With dozens of developing economies from around the world claiming to roll out a range of vaccines, meticulous coordination becomes essential. A need to analyze the demand for vaccines and their available supply arises. A need to size the market arises, as the donor need to understand how much is needed in terms of financial resources. In addition the industry partners also need to be informed to ensure a sustainable market in terms of supplies. While dealing with the supply and demand functions, there are other things like the country’s burden of diseases, available infrastructure etc. which also needs to be taken into consideration in addition to the respect to a country’s preferences as well.

·         Unplugging the supply chain bottlenecks

One of the most common supply chain bottlenecks when it comes to vaccines in developing countries is the cold chain, the system that keeps vaccines at the proper temperature all the way to the most distant health centre, which is often challenging in the low resource settings. But if the requirement of the vaccine can be forecasted earlier with much higher degree of accuracy, the supply chain can be modified well in advance. The need of the hour is however to develop ways to stabilize vaccines so that one day refrigeration will be no longer necessary.

A single shot in the arm or a few drops in the mouth can mean the difference between a family’s sorrows or a child’s healthy future. Where the population has a sound access to vaccines, children have a great chance of surviving some of the most common illness, growing, thriving and eventually protecting their own children from a preventable disease.

Each year immunization reaches 106 million children and saves about 2.5 million children from vaccine preventable disease. Still about 24 million children lack the basic immunization, and the new vaccines that reach the developed world may take decades to become available for the poorer nation. Thus the future of immunization greatly lies on the accessibility of it by the world population. The challenges facing researchers, industry and policymakers are many, but optimism thrives. Experts believe immunology is on the cusp of a renaissance.

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