Serum Institute of India is all set to launch its DPT-Hepatitis B recombinant vaccine in the country as it has successfully completed extensive multi-centric trials of the quadruple vaccine a month ago and currently awaiting the DCGI's marketing approval. The company's indigenously developed recombinant vaccine, which is expected to be the cheap and best alternative to the multinational brand Tritantrix-HB of GlaxoSmithKline, is likely to be launched in a couple of months in the country.

Indian Academy of Paediatrics has strongly recommended the use of a combination of hepatitis B (HB) vaccine with DTP vaccine as it has been established to enhance the efficacy of HB mono vaccine. The experts from the IAP state that the results evolved in the immunization practice, the recombinant vaccine showed an increased immunity among the children against hepatitis B. Recently, the international organizations like WHO, Pan American Health Organization (PAHO), Global Alliance for Vaccines and Immunization (GAVI) and UNICEF have also endorsed this recombinant vaccine for the same reason.

In a recent discussion forum, eminent pediatricians and members of IAP has recommended the use of DTP-hepatitis B combined vaccine for children as there is evidence from national and international studies that the efficacy of the vaccine to fight hepatitis B gets enhanced in the combination rather than in the single form.

While there are two brands of this recombinant vaccine currently available in India which were introduced by GlaxoSmithKline (GSK) in October, 2000 and Ecovac-4 launched by the Delhi based Panacea Biotech last year, the awaited brand from Serum is the only one completed a full fledged clinical trials in the country, it is learnt.

GSK's DTP-HB vaccine - Tritantrix-HB, according to experts from IAP, has not been subjected to thorough clinical trials in the country before approving for marketing. Hence, it is not yet been proved fully effective and suitable for Indian environment, though it has been in use since the approval.

However, Dr. S. S Jadhav, director (Quality Control), Serum Institute of India said that the enhanced effect of Hepatitis B immunity has been found in the technology process of this recombinant vaccine in the SIIL's trials. Hence, it is opined by the eminent doctors from the IAP that advisable dosage and efficacy of this combined vaccine for children will be scientifically established with the results of the clinical trials of this product.

However, Dr A K Dutta, a member of IAP and director of Kalawati Children's Hospital, New Delhi, said that he has initiated a comparative efficacy study of Tritantrix-HB and Serum's proposed recombinant vaccine to analyze the quality and suitability of this immunity vaccine in India, which is currently in progress.

While, Serum Institute of India is still not worked out the price of the proposed vaccine, Tritantrix-HB of GSK has priced at Rs 1000 per vial of ten doses and the Panacea's Ecovac-4 is also priced almost on par. However, the combination vaccine, which reduces total dosages of six to four for children, is likely to be identified for the National Immunisation Programme by the government of India. The WHO has recommended vaccination against hepatitis B as the seventh compulsory childhood vaccine and DTP (diphtheria, pertussis and tetanus) vaccine is already there in the NIP list.