Stable liquid technology will enable vaccines to be stored for long periods without refrigeration and reconstitution

Oct 25 2004

A UK vaccine technology that is set to revolutionise the industry has received £950k funding from the Department for International Development (DFID) to bring to production a pentavalent childhood vaccine that can be stored without refrigeration.

The award was made today by the Rt Hon Hilary Benn, Secretary of State for International Development at The Royal Society of Medicine, London.

The new ‘stable liquid’ technology, developed by Cambridge Biostability Limited (CBL), will enable vaccines to be stored for long periods in a range of environmental conditions, removing the need for refrigeration and reconstitution. Currently 50 per cent of all vaccines are wasted partly due to suspected or real temperature damage.

The new technology also offers the potential of slow release vaccines, which may overcome the need for boosters. In addition, thermostable vaccines do not require reconstitution, which is a major cause of vaccine safety and wastage problems.

The World Health Organisation estimates the cost of vaccinating a child at approximately $30 . The cold chain is a major burden to vaccine programmes with an estimated cost of $200-300m per annum. Savings from removing the ‘cold chain’ alone would enable the vaccination of an additional 10 million children worldwide within existing budgets.

In collaboration with CBL, the vaccine is to be manufactured by Panacea Biotec, based in New Delhi, rated as India’s second largest biotechnology company.

The stable vaccines will enable children in remote areas of the world to be reached by vaccination programmes. It will also allow emergency response teams to store vaccines in readiness for outbreaks of disease, and business travellers and the military to carry vaccines with them.

The Rt Hon Hilary Benn, Secretary of State for International Development, comments:

“The good health we take for granted in the UK is due in great part to our vaccination programme. The widespread and effective use of vaccines has protected children in the UK against diseases such as measles, rubella, tetanus, whooping cough and diphtheria and given parents piece of mind. We want to make this a reality for children and their parents in the developing world.

Two million children die each year from preventable diseases. This new British technology, funded by DFID, allows vaccines to be used in remote areas and at extreme temperatures and will mean more children than ever before will have access to life-saving vaccinations.”

Martin Friede, World Health Organisation, was asked to evaluate the applicability of the new stable-liquid technology on behalf of DFID he comments:

“The World Health Organisation recognises the need for developing thermostable vaccines that do not require a cold chain for storage or reconstitution, and promotes the research and development of technological solutions to achieve this objective. WHO would like to see continued research of such technologies to render them broadly applicable.”

Thermostable Vaccine Technology

The new technology is based on a natural phenomenon where some plants and creatures can remain in a desiccated state for hundreds of years and then return to life. They do this by increasing the sugar content of their bodily fluids. When rehydrated they ‘return to life’.

Cambridge Biostability’s stable liquid vaccine technology uses a similar process. Embedded in sugar beads or microspheres and suspended in an inert liquid, the vaccines can be stored without refrigeration until needed. When injected, in the same way as a traditional vaccine, the sugar beads dissolve in the bodily fluids to release the vaccine.

Sugar beads also prevent the interaction of vaccines prior to injection therefore, multiple or multivalent vaccines can be developed using this technology and given in the same shot. The sugar can also be adapted to dissolve more slowly, thereby releasing vaccines over time. This would remove the need for boosters.

The technology has been developed in Cambridge UK by Dr Bruce Roser, who comments that all the components are currently in use in medicine and that the stable liquid vaccines meet the requirements for WHO and PATH.

“A completely stable, ready-to-inject vaccine overcomes many of the current issues identified by WHO. In addition, since the CBL stable liquid formulations are anhydrous, they are inherentlbacteriostatic because bacteria require water to multiply. Thus the need for antiseptics is eliminated.”

Vaccines are exposed to temperature extremes as Debra Kristensen, Senior Technical Officer, PATH comments:

“Recent studies are revealing astonishingly high incidences of exposure to sub-zero temperatures. A PATH study with the Ministry of Health of Indonesia found that 75% of freeze-sensitive hepatitis B vaccine vials were exposed to sub-zero temperatures at one or more points during distribution. In most countries, this problem is largely unrecognised and is likely to be damaging the effectiveness of immunisation.”

Of the 132 million children born each year almost one third (34m) are not reached by routine vaccination. Two million will die from a vaccine preventable disease and many more will be maimed for life. Tetanus killed 30,000 people last year, and yet it costs only US$1.20 to protect mother and child.

The pentavalent vaccine is to be produced by Panacea Biotec, Rajesh Jain Jt. Managing Director, comments:

“In the last two decades, Indian companies have made significant progress in providing much needed health solutions to the people of India and their role is being recognised in various international markets as well.

The vaccine world is undergoing a radical rethink about how vaccines might be stored and administered. At Panacea Biotec we feel that all stakeholders should be given access to innovations, which are proved to be effective and efficient. We are delighted that Panacea Biotec is taking a world leading role by manufacturing this revolutionary vaccine.”

CBL plans to licence the technology to vaccine companies and discussions are already underway with a number of organisations. It will also provide outsourced production on shorter runs using its own facilities in Cambridge this will shorten the time to market.

http://biostability.com/