Serum, Shantha begin the race for 4-in-1 combination vaccines

Shantha Biotechnics Ltd, a biotech healthcare products company, announced the availability of its four-in-one vaccine, Shantetra on August 23, 2005. The vaccine protects children against four life-threatening infections including Diphtheria, Tetanus, Pertussis (DPT) and Hepatitis B. "We are proud to be the first Indian company to indigenously develop (all components) this combination vaccine. This is the outcome of our concentrated efforts in developing new generation vaccines. Our new vaccine formulation, Shantetra, combines high degree of safety and strong immunogenicity," said Varaprasad Reddy, managing director of Shantha Biotechnics.

Within a few days of this announcement by the company, Pune-based vaccine manufacturer major Serum Institute of India Ltd called a press conference to stake its claim as the manufacturer of the country's first indigenously developed 4-in-1-combination vaccine in India. Serum Institute's indigenous vaccine DTP and Hepatitis B combination vaccine is sold under the brand name Q-Vac.

Dr Cyrus Poonawalla, chairman and managing director, Serum Institute of India said his company was the first Indian company to have launched the country's first indigenously developed 4-in-1 combination. "On July 18, the National Control Laboratory, Kasauli issued the release of the vaccine to Serum Institute of India whereas the release of commercial production to Shanta Biotechnics was done a month later on August 19 for the same vaccine," said Dr Poonawalla.

"Because of the deluge of rain, we delayed the actual launch and dispatch of our vaccines as can be seen from the copies of company invoices in the first week of August. As on August 10, Serum Institute of India has sold over 100,000 doses of the combination vaccine," Dr Poonawalla said. He claimed the company has more than half a million doses in stock across the country whereas one cannot find the other company's products on the shelves of chemists.

Globally, companies such as GSK and Chiron are the only two companies offering this combination vaccine. While these are priced at around Rs 225 per single dose currently, Shantha Biotech plans to price it at around Rs 80 in the next two weeks. Varaprasad Reddy, managing director, Shantha Biotech said, "The trend is towards combination vaccines as they give immense advantages including reduction of administration costs and the risk of reaction on vaccines."

"We are studying the market dynamics and will be deciding the price soon. And in India, DTP vaccine is available freely in all government dispensaries. Considering all these factors, and depending on the markets, the price would be determined," Reddy said.

"Q-Vac immunization for a child will be less painful as the number of pricks will be reduced to only three instead of the six administered today. Q-Vac is priced at Rs 50 per dose, which is one fourth of the available vaccines in the Indian market," Dr Poonawalla said.

He said both the DTP and Hepatitis -B injections of his company had been qualified by WHO. Serum Institute is the fourth global player in combination vaccines and has invested Rs 50 crore for the development of the combination vaccine.

Shantha Biotechnics has approached the World Health Organization (WHO) for certification to comply with international standards and market outside India. Khalil Ahmed, executive director, Shantha Biotech, said, "Certification from WHO is a kind of standard that is acceptable by international agencies to procure doses from us. We have initiated the process and by the end of 2005, we are hoping to be certified by WHO."

According to the company, the market size for this combination vaccine is around 300 million doses a year. "As per UNICEF, there are around 130 million children requiring this vaccine and as we attain WHO certification, we are targeting to address the needs of at least 70 to 80 million children," informed Reddy. The company plans to tap overseas markets like Asia Pacific, Africa, Latin America and Europe.

Serum has also begun work on the pentavalent vaccine that is expected to hit the market in the year 2006. Pentavalent vaccine includes five antigens. The vaccine provides protection against Diptheria, Tetanus, Pertussis, Heptatitis-B and other diseases produced by Haemophilus Influenza type b (Hib).

(CyberMedia News)

Shantha works on single dose Hepatitis B vaccine

Shantha Biotechnics Ltd is making a pioneering attempt to reduce the dosage of Hepatitis B vaccine from three doses to a single dose. The company said that, at present, no other firm globally is offering the vaccine in a single dose.

Varaprasad Reddy, managing director, Shantha Biotechnics Ltd, said, "We are undertaking research and development work in developing new generation vaccines. One such activity is to bring down Hepatitis B vaccine's dosage from three doses to a single dose." Shantha Biotech's Shanvac B, which is now administered in three doses, is certified by WHO and the company is supplying this vaccine, thereby meeting 40 percent of UNICEF's requirement.

Dr Raman Rao, managing director, head, clinical research and medicomarketing, said, "We have recently started R&D work on this product. Globally, there is no other company that is offering the vaccine in a single dose as of now. It will take anything not less than two to three years for the product to be out in the market. We will be filing for patents accordingly."

Sunitha Natti
CyberMedia News, Hyderabad