As part of the strategic alliance between the Hyderabad-based Bharat Biotech and Pennsylvania-based Novavax to pursue the rapid development of pandemic influenza vaccine for India and other ASEAN markets, the partners are planning to soon initiate multi-centric human trials in India and Europe.
An estimated Rs 30 million will be spent on the trials. Human trials will begin by the end of 2006. According to Dr Rahul Singhvi, president and CEO of Novavax, technologies that match and respond to strains is a major challenge to companies working on pandemic flu vaccines.
Influenza viruses are inherently unstable. As these viruses lack a genetic proof-reading mechanism, small errors that occur when the virus copies itself go undetected and uncorrected. Specific mutations and evolution in influenza viruses cannot be predicted, making it difficult if not impossible to know if or when a virus such as H5N1 might acquire the properties needed to spread easily and sustainable among humans. This difficulty is increased by the present lack of understanding concerning which specific mutations would lead to increased transmissibility of the virus among humans, according to WHO.
Scientists do not presently know which specific mutations are needed to make the H5N1 virus easily and sustainable transmissible among humans. For example, it is not known whether the absence of a specific receptor in humans for this purely avian virus is responsible for the present lack of efficient human-to-human transmission. For this reason, virological evidence of mutational changes must be assessed together with epidemiological information about transmission patterns actually occurring in human populations.
Under the recent agreement, Bharat Biotech will fund all pre-clinical and clinical development and will be responsible for commercialisation whereas Novavax will receive unrestricted access to all pre-clinical and clinical data and a royalty on all sales. Novavax is finding the potential to develop a single dose vaccine for pandemic flu.
Dr Richard Klausner, former executive director of the Bill and Melinda Gates Foundation, who is chairing a steering committee to oversee the alliance, said, public-private-partnerships and policy initiatives of Central Government should be in place to support companies in developing vaccines.