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NEW DELHI : Nearly three dozen companies, including two Indian firms, are racing to develop a vaccine for Covid-19, but experts have doubts over how quickly such a vaccine can be brought to market.

“Most people say that vaccines against the novel coronavirus will take 12-18 months. I honestly think that is a little optimistic. It is more likely to take at least two or two-and-a-half years before a new vaccine comes to the market," Rob Lambkin-Williams, an independent consultant and adviser for Virology Consult Ltd, said over phone.

Globally, firms such as Johnson & Johnson’s arm Janssen Pharmaceutical Companies, GlaxoSmithKline, Sanofi Pasteur, and Moderna Inc are among those developing a vaccine, with institutions such as the Imperial College in London, the University of Pittsburgh, and the University of Oxford also working on it.

The Serum Institute of India has partnered with New York-based biotechnology firm Codagenix Inc. to work on one possible vaccine, while Zydus Cadila plans to start pre-clinical trials soon on two possible vaccines simultaneously and narrow it down to the most feasible.

Serum Institute and Codagenix are working on a weaker strain of the virus and the up-to- 300-crore project has already entered the pre-clinical trial stage, wherein the company is testing the vaccine on animals.

“In two months, we hope to get some results on the animal studies and then based on the regulatory path we take and which countries allow for the most ethical and fastest approval clearance for the human trial phase, the way ahead will be determined," said Serum Institute CEO Adar Poonawalla. The company expects to be ready with the vaccine by early 2022.

Zydus Cadila plans to start its pre-clinical trials in four to six weeks, managing director Sharvil Patel said over phone. “It is research. So, it is very difficult to put a timeline to it. For now, I don’t have a candidate yet to immediately see it, but in four to six weeks, or in a maximum of eight weeks, we’ll have a candidate to push for clinical trials" Patel said.

Zydus Cadila is working on two potential candidates, a DNA plasmid vaccine and another that would be based on a weaker live strain of recombinant measles virus vector.

Drugmakers worldwide are looking for fast-track approvals. “One thing that the Indian regulator can do to allow for faster testing is that instead of allowing phased approval in which you do one phase and then come back for permission, they can give permission for seamless trials where all the protocols are reviewed together and permissions are given ahead of trial phases following reports of each phase," said Gagandeep Kang, executive director, Translational Health Science and Technology Institute.

Kang also suggested using challenge studies on different animals, where animals are vaccinated and then given the virus as a challenge to see whether they develop disease or not. Lambkin-Williams even suggested a challenge study on humans, wherein healthy volunteers for whom the risk is known to be small are recruited. They could then be given the vaccine candidate and then be tested with the virus under quarantine and thorough medical care.

This method is considered in more developed countries for faster trials and usually involve just 60-120 people, against the thousands needed in a normal field trial. However, the ethical questions raised by challenge studies are enormous.

Another difficulty with developing a vaccine could be the possibility of two strains though it has not been proven yet. “At the start of the outbreak, there appeared to have been two strains of the new virus, known as L and S, according to early analysis in China. It was speculated that the L strain was more common and may be more aggressive, but this has not been proven," Lambkin-Williams said.

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