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

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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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