The Pune-based vaccine major Serum Institute of India is all set to develop a pentavalent vaccine, a combination of DPT, Hepatitis B and Haemophilus Influenzae Type B (HIB).
The company is expecting to commence clinical trials of this combination vaccine during the first quarter of 2005, and a probable lunch by mid-2006, according to Adar C Poonawalla, trustee, Serum Institute of India Research foundation.
A pentavalent vaccine is an extension of the quadraple vaccine with the addition of vaccine for meningitis (HIB). It ensures protection for the five major diseases at one go. Normally 3-4 shots of the vaccine are advised for children below one year of age.
"Serum Institute will be the first Indian manufacturer to develop a pentavalent vaccine, which is vital for the infants of the country. The pentavalent vaccines available in the country are imported ones marketed by MNCs like Wyeth and Aventis, priced at about Rs 400 per dose. The price will be considerably reduced once we launch our product," said Poonawalla.
Meningitis is the inflammation of the lining around the brain and spinal cord. Meningitis is usually bacterial or viral, and occasionally is due to fungal infections, although almost any microbe can cause it. Bacterial meningitis is more serious compared to viral version.
In the meanwhile Serum is in the advanced stages of phase III clinical trials for its quadraple vaccine (DPT + Hep B), which is expected to be launched by the first quarter of 2005. "We are conducting extensive tests on the vaccine to ensure that the product is accepted well in the WHO's pre-qualification list," said Poonawalla. The company is setting up a capacity of 200 million doses for its quadraple vaccine facility, which is much higher than the current global demand of 50 million doses, he added.