Last week, Novartis announced that its pilot trials on 100 volunteers for a vaccine to immunise against swine flu gave strong immune response after one dose. That study will be further validated as Novartis gets 6,000 more people on the vaccine before rolling out its brand Celltura for the accumulating government supplies.
The speed at which these trials are being conducted symbolises the global rush to come out with a new vaccine against the virus that has claimed over a thousand lives, half of which were reported in the US. GSK and Sanofi-Aventis are firing on all cylinders to get the product out by next month.
The US and French governments have placed their orders with Sanofi-Aventis and all of it should be in place by the end of the year. GSK hopes to ready its own vaccine by the end of September and thanks to a flood of government orders, which runs over 290 million doses, the British company can hope to gross sales of over $3 billion in just six months, according to industry analysts.
AstraZeneca has tried a different delivery mode to treat people with the dreaded flu. Its Medimmune division has worked on a nasal spray that kills the virus in the upper respiratory tract, a location from where the virus enters and then multiplies.
Baxter, a company specialising in injectable hospital products, is amongst the earliest to be ready with its product Celvapan. Using a novel technology that gives the advantage of quick production, Baxter had started working on the product much before swine flu became pandemic and so it has been able to reap the benefits of its early moves. The company has already implemented on supplies to government in New Zealand, Britain and the US.
China’s Sinovac has already received approvals for production of its own vaccine after the drug authorities there gave the due clearances. It found minimal concerns that could be held true for other flu vaccines and Sinovac hopes to produce enough vaccines that can cover 5% of the population in the first batch.
Korea’s Green Cross, China’s Hualan and Novavax, which has equity participation from India’s Cadila Pharma and Belgian firm Solvay, have been well ahead in delivery of their products to the market. The urgency for the companies to produce a vaccine has been matched by the government’s preparedness in handling the crisis.
Unfortunately, India has been left far behind in the chase for a flu vaccine that shows no signs of letting up on its geographic spread. Panacea Biotec, Serum Institute and Bharat Biotech have been working on the possible vaccine for the last few weeks.
While it is understood that vaccines take their own time to reach a certain stage for use in humans, there is very less information on the approximate timing before which the product could be ready in India.
The Indian government has maintained that it will try the indigenous product before looking at import options, but it may be too late if the local vaccines get ready by May 2010, as reported in the local media.
Also, there is no clarity on whether the global vaccine makers have been permitted to conduct human trials in India. GSK was said to have responded to government calls on testing its product on Indians, but the dialogue between Indian medical authorities and drug makers on the modalities of such trials is still on.
In some quarters, it is felt that the swine flu virus may become more difficult to tackle in its full-blown form in the winter season and the current strain is known to be milder and controllable. By that time, it may be more difficult for the under-research vaccines to fight the virus.
Two shots of the vaccine instead of a single dose may be the solution for populations where the vaccine will be available in the next few months.But for India, the wait may get that much longer as we have been trailing in this global emergency. As the world has moved from treating patients with oseltamivir and zanamivir to preparing for the vaccine supplies, in India we still have no directions on the next level of crisis-management.
–Agencies