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Revolutionary vaccine technology breaks the cold chain
Newsdesk Revolutionary vaccine technology breaks the cold chain pensed faster and more effectively. 25% of children around the world currently
Cambridge Biostability
A new stable-liquid vaccine technology could revolutionise global immunisation programmes, allowing vaccines to be used in remote areas and at extreme temperatures. Cambridge Biostability Ltd (CBL) who developed the technology, was awarded a grant of under £1 million by the UK’s Department for International Development. Together with their partners PATH and Panacea Biotec, India’s second largest biotechnology company, the funding will drive the product into clinical trials in India, the results of which are expected in about 3 years. The “cold chain” is a major burden to vaccine programmes with an estimated cost of $200–300 million per year. Savings from removing this alone would enable the vaccination of an additional 10 million children worldwide within existing budgets. Ian Cubitt, CEO of CBL says, “with no need for refrigeration, vaccines can be delivered anywhere easily and dis-
Vaccine safe in its sugar bead
remained unvaccinated—our technology can change that”. The new technology is based on a natural phenomenon that enables organisms to survive for years in a dessicated state, and return to life by raising sugar levels in their body fluids. Embedded in sugar beads or microspheres and suspended in an inert liquid, the vaccines can be stored without refrigeration until needed. When
injected, the sugar beads dissolve in the bodily fluids, releasing the vaccine. Because the stable-liquid formulations are anhydrous, they are inherently bacteriostatic and thus the need for antiseptics is eliminated. Sugar beads also prevent the interaction of vaccines before injection, therefore, multiple or multivalent vaccines can be developed and given in the same shot. The sugar can also be adapted to dissolve more slowly, thereby releasing vaccines over time, removing the need for boosters. The vaccine trialed in India will be the pentavalent vaccine against diptheria, tetanus, pertussis, Haemophilus influenzae type b, and hepatitis B. John Lloyd, associate director of the Children’s Vaccine Programme adds, “the holy grail has always been to develop technology that does away with cold chains and means vaccines can be delivered as easily as aspirin. I am very excited about the new technology.” Pam Das
MSF tuberculosis report criticises DOTS strategy Charity Médecins Sans Frontières (MSF) has called for a radical change in the WHO-recommended tuberculosis control strategy, DOTS (directly observed treatment, short-course). “We are concerned that DOTS is excluding a large number of people with tuberculosis because it is based on sputum microscopy that detects, in the best of circumstances, only about 50% of all those with tuberculosis”, Francine Matthys of MSF complained. “In many places, this proportion is even lower, and with HIV/AIDS, things have got even worse”, she told TLID. MSF’s call came on the eve of 4th annual meeting of DOTS Expansion Working Group (DEWG, Oct 27–28, Paris, France). While tuberculosis-related deaths have surged, methods of its detection and treatment have remained almost “the same”. For example, “sputum smear microscopy test—one of the cornerstones of DOTS, which was developed in 1882, is becoming obsolete in the HIV era. Furthermore, drugs still used to treat tuberculosis
were invented between 1940 and 1960 and require 6–8 month regimens”, Matthys explained. MSF called on the WHO, and agencies and researchers backing DOTS to “publicly admit” that there are problems with the current approach. She argued that the scientific community, by launching DOTS as a brand that will solve the tuberculosis crisis, has discouraged development of more effective diagnostics and drugs, which is essentially why the world is now in a situation where tuberculosis is spiraling out of control. At the DEWG meeting, Mario Raviglione, head of the WHO’s Stop TB programme presented the concept of DOTS.2, which is still based on the five essential elements of DOTS, but emphasising the need for, among other things, proper laboratory performance, and new, modern ways to diagnose tuberculosis, especially where tuberculosis/HIV and multidrugresistant tuberculosis are common. “This new version of DOTS covers all the issues raised by MSF, who obviously
Infectious Diseases Vol 4 December 2004
http://infection.thelancet.com
is unaware of the progress in tuberculosis control made over the past few years [that forms] the basis for DOTS.2”, Raviglione explained. MSF, he said, based its criticism on experiences in some extreme situations and ignored the 4 million cases treated by DOTS programmes with an 82% cure rate all over the world per year recently. “To call this a failure is offensive to country programmes. Besides, MSF did not offer any operational alternative to DOTS today.” However, he agreed that detection methods need to be updated in poor countries to address the challenges posed by HIV and multidrug-resistant tuberculosis. To accelerate transfer of rapid culture methods from the north to the south, he said agreements with producers of these methods are being sought. Regarding lack of progress in drug development, he said: “we all would like to have a wonder one-shot drug [but] there is nothing like that on the horizon.” Khabir Ahmad
719
Cambridge Biostability
A new stable-liquid vaccine technology could revolutionise global immunisation programmes, allowing vaccines to be used in remote areas and at extreme temperatures. Cambridge Biostability Ltd (CBL) who developed the technology, was awarded a grant of under £1 million by the UK’s Department for International Development. Together with their partners PATH and Panacea Biotec, India’s second largest biotechnology company, the funding will drive the product into clinical trials in India, the results of which are expected in about 3 years. The “cold chain” is a major burden to vaccine programmes with an estimated cost of $200–300 million per year. Savings from removing this alone would enable the vaccination of an additional 10 million children worldwide within existing budgets. Ian Cubitt, CEO of CBL says, “with no need for refrigeration, vaccines can be delivered anywhere easily and dis-
Vaccine safe in its sugar bead
remained unvaccinated—our technology can change that”. The new technology is based on a natural phenomenon that enables organisms to survive for years in a dessicated state, and return to life by raising sugar levels in their body fluids. Embedded in sugar beads or microspheres and suspended in an inert liquid, the vaccines can be stored without refrigeration until needed. When
injected, the sugar beads dissolve in the bodily fluids, releasing the vaccine. Because the stable-liquid formulations are anhydrous, they are inherently bacteriostatic and thus the need for antiseptics is eliminated. Sugar beads also prevent the interaction of vaccines before injection, therefore, multiple or multivalent vaccines can be developed and given in the same shot. The sugar can also be adapted to dissolve more slowly, thereby releasing vaccines over time, removing the need for boosters. The vaccine trialed in India will be the pentavalent vaccine against diptheria, tetanus, pertussis, Haemophilus influenzae type b, and hepatitis B. John Lloyd, associate director of the Children’s Vaccine Programme adds, “the holy grail has always been to develop technology that does away with cold chains and means vaccines can be delivered as easily as aspirin. I am very excited about the new technology.” Pam Das
MSF tuberculosis report criticises DOTS strategy Charity Médecins Sans Frontières (MSF) has called for a radical change in the WHO-recommended tuberculosis control strategy, DOTS (directly observed treatment, short-course). “We are concerned that DOTS is excluding a large number of people with tuberculosis because it is based on sputum microscopy that detects, in the best of circumstances, only about 50% of all those with tuberculosis”, Francine Matthys of MSF complained. “In many places, this proportion is even lower, and with HIV/AIDS, things have got even worse”, she told TLID. MSF’s call came on the eve of 4th annual meeting of DOTS Expansion Working Group (DEWG, Oct 27–28, Paris, France). While tuberculosis-related deaths have surged, methods of its detection and treatment have remained almost “the same”. For example, “sputum smear microscopy test—one of the cornerstones of DOTS, which was developed in 1882, is becoming obsolete in the HIV era. Furthermore, drugs still used to treat tuberculosis
were invented between 1940 and 1960 and require 6–8 month regimens”, Matthys explained. MSF called on the WHO, and agencies and researchers backing DOTS to “publicly admit” that there are problems with the current approach. She argued that the scientific community, by launching DOTS as a brand that will solve the tuberculosis crisis, has discouraged development of more effective diagnostics and drugs, which is essentially why the world is now in a situation where tuberculosis is spiraling out of control. At the DEWG meeting, Mario Raviglione, head of the WHO’s Stop TB programme presented the concept of DOTS.2, which is still based on the five essential elements of DOTS, but emphasising the need for, among other things, proper laboratory performance, and new, modern ways to diagnose tuberculosis, especially where tuberculosis/HIV and multidrugresistant tuberculosis are common. “This new version of DOTS covers all the issues raised by MSF, who obviously
Infectious Diseases Vol 4 December 2004
http://infection.thelancet.com
is unaware of the progress in tuberculosis control made over the past few years [that forms] the basis for DOTS.2”, Raviglione explained. MSF, he said, based its criticism on experiences in some extreme situations and ignored the 4 million cases treated by DOTS programmes with an 82% cure rate all over the world per year recently. “To call this a failure is offensive to country programmes. Besides, MSF did not offer any operational alternative to DOTS today.” However, he agreed that detection methods need to be updated in poor countries to address the challenges posed by HIV and multidrug-resistant tuberculosis. To accelerate transfer of rapid culture methods from the north to the south, he said agreements with producers of these methods are being sought. Regarding lack of progress in drug development, he said: “we all would like to have a wonder one-shot drug [but] there is nothing like that on the horizon.” Khabir Ahmad
719