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Mr. Adar C Poonawalla, Executive Director Operations, Serum Institute of India Ltd at the launch of Indian Vaccine Manufacturers Association
Serum Institute of India is a manufacturer of immunobiological containing vaccines in India. The company is controlled by the Poonawalla group wholly owned by Cyrus Poonawalla. The company is the fifth largest vaccinemaker by volume, the four main ones GlaxoSmithKline, Sanofi-Aventis, Merck and Novartis. Half of all children worldwide are immunized with vaccines made by the company, which is the world's largest manufacturer of measles and DTP vaccines. The serum produced billion doses per year selling in 140 countries. It is one of the producers the lower cost of vaccines worldwide and had sales of $ 250 million and net earnings of $ 107 million.
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Serum Institute of India was founded by Cyrus Poonawalla and his brother Zavary in 1966. Poonawalla has sold horses to raise the initial $ 12,000 needed to build the company. Use the money and a lot of 12 acres of buried horses, the brothers founded the company. Since they had no science background, they hired 10 doctors and scientists at the institute Haffkine India. After a number of legal obstacles, the company has finally received permission to produce vaccines. Sales have finally started to pick it up when the company won contracts to provide governments and state hospitals. Today, 80% of sales are serum groups UNICEF and Pan-American Organization of health as well as the immunization program, for example. charity for the welfare of children in India, Germany, the majority of which are in developing markets. Serum became accredited by the World Health Organization in 1994, after which it began exporting vaccines to India. The company plans to enter western markets soon, to increase its income through a partnership with U.S. firm Akorn. Last year the firm paid $ 22 million for a stake in Lipoxen, UK. biopharmaceutical company.
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Towards an improved vaccine against meningitis in Africa
Wednesday, March 15, 2006
Dakar, 15 March (APS) - The "Meningitis Vaccine Project (MVP) and the Serum Institute of India Limited announced in a statement released Wednesday, the success of Phase I clinical study of a new conjugate vaccine against meningococcal A - a bacterium responsible for deadly outbreaks of meningitis and terrible human suffering in sub-Saharan Africa.
The positive result of the Phase I study will enable testing in Africa the new conjugate vaccine that will strengthen the elements of the fight made against meningitis epidemics ravaging the continent for over 100 years, the statement said.
"We are pleased to have embarked on this adventure because this new vaccine can really make a difference in some African countries are among the poorest in the world," said Dr. Cyrus Poonawalla, chairman of the Serum Institute of India Limited.
The technology that helped develop the new conjugate vaccine, which could be more effective than the current polysaccharide vaccines due to its high immunogenicity in young children and its ability to induce immunologic memory, reduce the carriage of the bacteria, and to create herd immunity has been developed by the Center for Biologics Evaluation and Research U.S. Food and Drug Administration in the U.S., says one.
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"The results achieved in Phase I are extremely encouraging and pave the way for key studies in Gambia and Mali later this year when we have obtained regulatory approvals," said Dr. F. Marc LaForce, director of the Meningitis Vaccine Project, a project through a partnership between the World Health Organization and the nonprofit PATH.
If clinical trials continue to go well, the new vaccine whose price was set at approximately 0.40 U.S. dollars (about 250 CFA francs) the dose could be introduced in Africa within the next 3-4 years.
The Phase I study was to determine the safety and immunogenicity of the new conjugate vaccine "PsA-TT in healthy volunteers recruited from three clinical sites in India, and a total of 74 subjects participated in the study comparaitle PsA-TT vaccine with a reference vaccine currently used to fight against epidemic meningitis in sub-Saharan Africa and a commonly used vaccine against tetanus.
Meningitis is an infection of the meninges, the thin lining that surrounds the brain and spinal cord. This is one of the most feared diseases in the world. Even with antibiotic treatment, at least 10% of patients die and up to 20% left with permanent problems such as mental retardation, deafness, epilepsy, or necrosis requiring amputation of limbs.
In 1996-1997, Africa has been hit by the outbreak of epidemic meningitis in the largest ever, with over 250,000 cases and 25,000 deaths reported to the World Health Organization.
A large outbreak of meningococcal serogroup A hits actuellementl'ouest of Burkina Faso, where some 3 000 cases were identified.
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Ferney-Voltaire, FRANCE (March 18, 2003) - The Meningitis Vaccine Project (MVP), a partnership between the World Health Organization and the Program for Appropriate Technology in Health / Program for Appropriate Technology in Health (PATH) has announced today that a milestone has been reached in the fight against epidemics of meningitis A rampant in sub-Saharan Africa for over a century. A scientific panel said the vaccine candidate against meningococcal conjugate Presented by MVP is likely to confer long-term immunity against meningitis A in Africa.
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Meningitis, an infection of the fluid surrounding the brain and spinal cord, mainly affects infants, children and young adults. Its victims can die within 24 or 48 hours after onset of symptoms.
Met in England at the request of MVP (www.meningvax.org) and the National Institute for Biological Standards and Control (NIBSC), scientific experts have given the green light for vaccine development based on scientific data presented by MVP. MVP has signed agreements with three companies that develop and test the vaccine which will cost significantly less than one U.S. dollar so it can be bought by the African countries concerned.
"Clinical trials could begin as early as 2004, and the new vaccine could be ready for wide distribution in sub-Saharan Africa by four to five years," said Dr. F. Marc LaForce, director of the project. "Our mission is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa, and thereby relieve social disasters, human and economic damage caused by these epidemics."
Although the current polysaccharide vaccine effective in controlling epidemics of meningitis, they do not provide lasting protection, they are only relatively effective in infants and they do not provide group immunity because they do not reduce the transmission of the disease in the population at risk. The meningococcal conjugate vaccine against A that develops the Meningitis Vaccine Project would provide protection in the longer term while providing herd immunity.
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The conjugation technology is well known and has been used to develop vaccines against Haemophilus influenzae type B (Hib). The first meningococcal C conjugate has been introduced in the United Kingdom in 1999. Two other vaccines against meningococcal group C conjugates have since been introduced in the United Kingdom and Ireland and recent reports indicate that vaccines are safe and effective in reducing cases of meningitis in these two countries.
Meningitis is one of the most feared diseases in the world. Despite Antibiotic treatment, at least 10% of patients die and between 10 and 20% of survivors left with permanent problems such as mental retardation, deafness or epilepsy.
Researchers have identified no fewer than 13 strains of meningococcal bacteria that cause meningococcal disease. The most important strains are A, B, C, Y and W135. If the strains A, B and C are responsible for most cases of meningitis worldwide, strain A causes outbreaks in the so-called "African meningitis belt," an area that s extends from Ethiopia in the east to Senegal in the west and over 250 million. The last epidemic in 1996 affected nearly 200,000 people and caused about 20,000 deaths. Last year, that was not even an epidemic, at least 44,280 cases of meningitis and 5,531 deaths have been reported to surveillance systems of the World Health Organization for the African region.
MVP has agreements with three partners to develop the vaccine: SynCo in Amsterdam (Netherlands), Biosynth in Siena (Italy) and the Serum Institute of India in Pune (India). SynCo provides the polysaccharide of meningococcal group A, one of the two components essential to the development of the vaccine. Biosynth develops the conjugation process and transfer this process to Serum Institute of India, which provides the tetanus toxoid, the second component needed to manufacture the vaccine, and is responsible for the large scale production of vaccine.
According to Dr. LaForce, "MVP represents an innovative approach to the development of vaccines for developing countries. This is the first time a consortium including the private sector, public sector and non-profit organization working with a charitable foundation (the Bill & Melinda Gates Foundation) in order to develop a vaccine that is critically needed in Africa. This vaccine would perhaps not have been developed otherwise. "
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By partnering with the Meningitis Vaccine Project, Biosynth becomes a key player in the fight against epidemic meningitis in Africa. "We feel very close to children in Africa and we are delighted to bring our expertise and experience in scientific MVP service," said Dr. Massimo Porro, company president.
The Serum Institute of India has become one of the largest manufacturers and exporters of vaccines worldwide. "We believe in health for all, including those living in poorer regions or the most distant planet," said Dr. Cyrus Poonawalla, Chairman of IIC.
Mic Hamers, SynCo General Manager said: "We know how urgent it is to create a vaccine against meningitis in Africa and we are very pleased to participate in the development of this vaccine. "
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