Despite the best efforts of Indian vaccine makers to develop the H1N1(swine flu) vaccine, Swiss drug major Novartis and Australian vaccine maker CSL may be the first ones to bag the orders from the central government for its supply.
Both the companies, along with multinational drug firms such as Baxter and Sanofi Aventis, are months ahead in the race to develop a vaccine for the epidemic, Union health ministry officials feel.
In addition to the advanced stage of clinical trials, the experience of having developed flu vaccines will also come in handy for foreign vaccine makers, officials said.
Health minister Ghulam Nabi Azad had said on Monday the government would not wait for Indian-made vaccines to be ready, but will immunise all medical and para-medical staff working on the epidemic with the first available set of vaccines.
India is not alone in its pursuit to give advance orders for H1N1 vaccines. Over 35 countries have reportedly placed orders with companies such as CSL and Novartis to purchase the vaccines as and when these hit the market.
Three Indian companies have taken seed viruses from the World Health Organization (WHO) to develop the vaccine. They are the Hyderabad-based Bharat Biotech, Delhi-based Panacea and Pune-based Serum Insitute. While all three are engaged in developing live virus vaccine, Serum is also working on inactivated (killed) virus vaccine.
Indian vaccine makers are best known for the development of the Hepatitis-B vaccine, the introduction of which resulted in drastic reduction in vaccine prices. In the case of H1N1, too, officials are looking forward to Indian vaccines as a means to reduce the cost of immunisation.
Government officials said Serum, which got the first permission to conduct clinical trials, will be ready with its vaccine by the year end. “The animal studies should begin by September 2009. Even if a fast-track approval happens without human trials (in the case of an emergency), the company will not be able to launch the medicine before December,” they said.
Meanwhile, the foreign companies are expecting the vaccine launch to happen within the next two months.