Product of the Year

Q-Vac & Shantetra

4-in-1 Vaccines Win the Race

Launched in August 2005, the combination vaccines, from Serum Institute of India and Shantha Biotechnics, protect children against four life-threatening diseases, Diphtheria, Tetanus, Pertussis and Hepatitis B. These quadravalent vaccines can be administered to all children in the 6th, 10th and 14th week after birth. Only three doses need to be administered (as it is the combination of DTP and Hepatitis-B) as against six currently being given as separate doses of three each. Though combination vaccines have been available in India from MNCs, their high prices kept the vaccine out of reach of the majority of the population. The separate injections of DTP and Hepatitis-B cost Rs 45 for both the vaccines and the MNC combination vaccine costs Rs 225 per dose, which is five times the regular cost.

Q-Vac

Serum Institute's combination vaccine for DPT and Hepatitis-B

Serum Institute of India added another feather in its cap of vaccines on August 10, 2005 with the launch of Q-Vac. It sold 100,000 doses of Q-Vac during its first seven days of the launch and it is offering the combination vaccine at almost no premium. "In line with our corporate philosophy of providing high quality vaccines at affordable prices, we launched a combination vaccine, Q-Vac, at 75 percent less than MNC prices. The reason for the low price is that we want the benefits of the combination vaccines to be within the reach of the common man. The use of Q-Vac is comfortable for both the child and parents as it reduces the number of painful pricks that a child has to bear and makes immunization more affordable without pinching the parent's pockets," explained Dr Cyrus S Poonawalla, chairman and managing director, Serum Institute of India, while launching the product.

Q-Vac is sterile, opaque, uniform suspension of Diphtheria Toxoid, Tetanus Toxoid, killed Bordetella Pertussis bacilli and Hepatitis B surface antigen adsorbed on aluminum gel and suspended in isotonic sodium chloride solution. Surface antigen of the Hepatitis B virus (HBV) is obtained by culturing genetically engineered Hansenula polymorpha yeast cells having surface antigen gene of HBV. Hepatitis B surface antigen (HBsAg) expressed in the cells of Hansenula polymorpha is purified through several chemical steps using recombinant DNA procedures. Thiomersal is added as preservative. The company has conducted clinical trials of Q-Vac and compared it with the MNC vaccine. The trial proved the superior clinical efficacy and safety of the vaccine.

Q-Vac is the result of hard work of a team of 14 scientists from various faculties lead by no other than Dr C S Poonawalla, a master biotechnologist. Dr Poonawalla said, "We have worked on Q-Vac for four years and invested Rs 50 crore in developing this new vaccine. The product was developed and clinically proven with multi centric trials as per ICH/GCP guidelines."

On the USP of the product, Dr Poonawalla said, "Best quality at the lowest and affordable price. Q-Vac is priced at Rs 50 per dose, which is one fourth of the available vaccines in the Indian market. With Q-Vac, immunization for a child will be less painful as the number of pricks will be reduced to three instead of six. This will also put less pressure on logistics and administration cost of vaccine." This vaccine can be given safely and effectively at the same time as BCG Measles and Polio vaccines (OPV and IPV) Hib, Yellow Fever vaccines and vitamin A supplementation. Q-Vac is priced at Rs 50 per dose, which is one-fourth the cost of the available vaccines in the Indian market. Serum Institute is the world's largest DTP (Triple) and Measles vaccine manufacturer and was responsible in bringing down the prices of Hepatitis-B vaccines in India to make it affordable for the masses. It is well stocked with the supplies of the Q-Vac vaccines to cater to demand from the stockists and doctors across the country.

Serum Institute has already 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 Diphtheria, Tetanus, Pertussis, Hepatitis-B and other diseases produced by Haemophilus Influenza type b (Hib). Serum Institute has also signed an agreement with the international Meningitis Vaccine Project (MVP), run by the WHO and the international charity PATH. A vaccine for AIDS is Dr Poonawalla's eventual goal.

Narayan Kulkarni

Shantetra

Shantha Biotechnics' quadravalent vaccine

Shantha Biotechnics too launched its four-in-one vaccine in August 2005. "Shantetra is a totally indigenously developed and produced four-in-one vaccine. This vaccine protects children against four life-threatening infections-Diphtheria, Tetanus, Pertussis and Hepatitis B and has to be given to children from six weeks of age onwards. The use of combination vaccines is a practical and economical way to overcome the complications of multiple injections. A combination vaccine also provides higher compliance and convenience," explained Varaprasad Reddy, managing director, Shantha Biotechnics.

"This product would have been available almost three years ago. Though we had our own Hepatitis B vaccine, we did not have DPT vaccines in our portfolio three years ago. We always believe that we need to develop products that are not available in India and at affordable prices. At that point of time, there was only Serum, which was WHO prequalified for DPT vaccines in India. As Serum had refused to supply DPT vaccines for the combination vaccine, we went to PT Bio Farma, Indonesia, which was WHO prequalified for DPT vaccines and developed the combination vaccine It took us about a year and a half to develop the product and get the clinical trials for the quadravalent vaccine. But just when the product was about to be launched in the market place, PT Bio Farma decided to part ways. We had then decided to do it on our own. So we built a manufacturing plant for DPT vaccines, got it WHO-prequalified, and then went through the process of combining our Hepatitis B and DPT vaccines and got the clinical trials done for Shantetra and launched it in August this year," recounted Reddy on how Shantetra was developed.

The DPT plant was completed last September and Shantha Biotechnics spent Rs 34-35 crore on setting up the plant and another Rs 4-5 crore was spent as the development cost for the combination vaccine. The total investment has been to the tune of Rs 40 crore.

The development of Shantetra is an example of teamwork in Shantha where all the key department personnel from R&D, Quality Control, Quality Assurance and Manufacturing worked together to script another milestone in Shantha's progress. "Shantetra is also the first combination vaccine launched by Shantha. It has been introduced at a time when awareness and usage of combination vaccine is steadily growing. The launch of the vaccine also points to the fact that Shantha Biotechnics is well tuned to the current trends in vaccination," said Reddy. The vaccine has been competitively priced in the market at 30 percent less than the leading MNC brand for the single dose presentation. It costs about Rs 80. Reddy added, "Shantha has always believed in providing international quality vaccines at a price which are affordable in the country. Our vaccines are equivalent to global standards, which is borne by the fact that Shantha's Hepatitis B facility is WHO pre-qualified and recently the DTP facility was audited by the WHO." The company can manufacture 215 million doses annually for DPT and 150 million doses of the combined vaccines.

What's the next in scene in this space? "Shantha is focused on launching more combination vaccines as they are the future in vaccines landscape. We will be coming out with the Hib quadravalent (DTP-Hib) and Hib pentavalent (DTP-Hepatitis B-Hib) by second half of 2006. The clinical trials for the Hib range is set to commence shortly," concluded Reddy.

Ch. Srinivas Rao