Bharat Biotech and Shantha Bio stand to gain as WHO includes global use of rotavirus vaccine

Indian vaccine makers including Bharat Biotech and Shantha Biotechnics see a bigger opportunity as the World Health Organisation (WHO) recommended that oral rotavirus vaccines be included in all national immunisation programmes.

Rotavirus is the main cause of severe diarrhea in preschoolers and leads to 500,000 diarrhoeal deaths and 2 million hospitalisations a year.

Children in Europe and the Americas have had access to the rotavirus vaccine since 2005. Studies conducted in US and Europe showed that the rotavirus vaccine were safe and effective. New data from trials to check efficacy in developing countries like India where the disease kills more children led to the recommendation that the inoculation should be used globally, WHO said.

Indian vaccine makers have started working on the rotavirus vaccine following the technology transfer arrangement with National Institute of Health (NIH) of US in the year 2005.

Eight organizations, one in the United States and seven based in the developing world, were granted licenses from Public Health Services (PHS) under NIH to manufacture and distribute the rotavirus vaccine.

Bharat Biotech International, Biological E., Ltd., Shantha Biotechnics, Ltd., and Serum Institute of India, Ltd., all India-based companies are the Indian vaccine makers who were granted licences as part of the NIH initiative.

The other licensees are U.S.-based Aridis Pharmaceuticals; Fundação Butantan, a Brazilian government institution; and Chengdu Institute of Biological Products and Wuhan Institute of Biological Products, both funded by the government of China.

The vaccine technology is covered by issued patents (and pending patent applications) in the United States, Europe, Canada, Japan, China, India, Korea, Brazil and Australia, thus NIH decisions regarding the license agreements were based on thorough evaluation of the applicants and their capabilities with regard to vaccine research and manufacturing.

The license agreements with the companies are based on territorial rights and include both rights for the intellectual property and to biological materials. The biological materials include all the vaccine strains, as well as the analytical reagents necessary to develop the vaccine.

Now with WHO recommendation of rotavirus vaccine for global use vaccine makers see a huge demand several hundred million doses of rotavirus vaccine by all countries in the world in the coming years.

India alone will require 100 million vaccines, at three doses per child, it is estimated.

Currently rotavirus vaccine is produced by Merck & Co. and GlaxoSmithKline Plc.

Rotateq is made by Merck and Rotarix is London-based Glaxo.

Rotateq, given in a three-shot series, was approved in the U.S. in 2006 and generated $664.5 million last year. Glaxo gained approval for its two-shot Rotarix vaccine in 2008. It had sales last year of 167 million pounds ($268 million), according to Bloomberg.

Among the Indian players, Bharat Biotech’s rotavirus vaccine 116E has entered phase 3 human studies in March this year.

Bharat Biotech and its funding partners have already invested $28-30 million in vaccine development so far. The Hyderabad-based Bharat Biotech is planning to spend another $30 million on phase three clinical trials alone.

The phase three trails will be mainly in India and will enroll 6,800 healthy infants Bharat Biotech expects to launch the rotavirus vaccine by 2011 in India.

Shantha Biotechnics is currently developing a multivalent vaccine against rotavirus in collaboration with the global nonprofit health organization PATH. PATH is an international, nonprofit organization enabling communities worldwide to break longstanding cycles of poor health

Shantha was expected to carry out the clinical trials following completion of preclinical toxicology studies in the year 2008.

“We are excited about working on the multivalent rotavirus vaccine, which has the potential to save many lives,” Varaprasad Reddy, Managing Director of Shantha Biotech was quoted as saying.

Serum Institute of Pune and Biological Evans of Hyderabad are the other Indian companies having the rotavirus vaccine technology. 

GlaxoSmithKline’s (GSK) launched Rotarix in India last year. Merck too plans to launch its vaccine, RotaTeq in India soon. Both versions for the vaccines are oral vaccines. GSK has priced its vaccine at Rs 1,000 per dose.

Rotavirus infection in India

About 527,000 young children die from rotavirus-induced diarrhea annually, 85 percent of them in lower-income countries of Africa and Asia, WHO says. Fourteen of those nations are eligible for funding to buy vaccines through the GAVI Alliance, a group supporting childhood immunization in poor countries.

Rotavirus is prevalent in India and the sub-Saharan African region. In the US alone. A vaccine against rotavirus is expected save one lakh children in India every year.

The biggest challenge to developing a vaccine against rotavirus is its diversity. The rotavirus strains have been classified into seven groups. The most harmful rotavirus occur in group a, which is sub-divided into categories such as g1, g2 and g3, depending on the way they react with the host’s blood, or their serotype, in medical parlance. g serotypes 1-4 and 9 are found widely. g9 strains, believed to have originated in India in the 1990s, have now become the predominant rotavirus variants in several nations.

A major reason for the presence of large number of rotaviral strains in India (and in other Asian countries, too) is the proximity between people and animals such as cattle and pigs.