Pune-based Serum Institute of India (SII), world's largest vaccine manufacturer by volume, claims to have achieved a breakthrough in developing a vaccine for the dreaded coronavirus contagion. It says the virus-vaccine strain developed in laboratories has reached the animal clinical trial stage, with possible results within two months.

Serum Institute had partnered with the US-based biotech drug research company Codagenix three weeks ago to jointly develop a live-attenuated vaccine (creating a vaccine by reducing the virulence of the pathogen, but still keeping it alive) to fight the coronavirus. The company claims it is the first vaccine to progress from the laboratory to the pre-clinical trial phase and can be market ready by 2022.

"Serum Institute and Codagenix have been working with utmost diligence and meticulous effort to develop a preventive vaccine against the novel coronavirus. The vaccine-virus strain is identical to the original virus and can generate a robust immune response. At present we are in the pre-clinical phase, i.e. the animal trial phase," said SII CEO Adar Poonawalla. In two months time, the partners hope to get some results on the animal studies, he said.

"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. The company plans to do its clinical (human) trials in India, adhering to the ethics and safety standards. We have also been approached by other companies and things are in process," said Adar. If successful, the vaccine-virus strain will be the fastest vaccine to progress to the human trials phase within six months, he added.

The cost of the project has been estimated at Rs 300 crore and SII aims to secure external funding for the project via various global partners. The major challenge is that the product will have to be handled under BSL 3 (biosafety level) conditions which basically is a very-high containment level. Not many facilities in the world have high volume manufacturing in BSL 3, including Serum Institute of India, which is the partner for Codagenix to scale up manufacturing once the vaccine is ready for the market.

"The vaccine for COVID-19 will require fast-tracking of regulatory clearances and a due diligence of ethics and safety standards for it to be market ready by 2022. We will have to see if this can be toned down and even if you have the vaccine, the main challenge will be to manufacture it at a large volume," said Adar.

Since the outbreak of COVID-19, the virus has claimed an estimated 3,300 lives worldwide while over one lakh have been infected by the virus across the world, causing huge global scare.

At prsent at least nine known and unknown drug makers are trying to develop a drug or vaccine to fight coronavirus. These include Gilead Sciences, GlaxoSmithKline, Inovio Pharmaceuticals, Johnson & Johnson, Sanofi, Regeneron Pharmaceuticals, Moderna, Takeda Pharmaceuticals and Vir Biotech. A couple of weeks ago, a team of researchers at the University of Queensland in Australia had developed a vaccine candidate in the laboratory in just three weeks. The US Department of Health and Human Services (HHS) is partnering with Sanofi Pasteur and Johnson & Johnson to develop vaccines and therapeutics to use against COVID-19.

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