While leading vaccine candidates are in advanced stages of clinical trials, a handful of indigenous players, too, is progressing slowly, albeit steadily.
Not only do these players feel there will be room for multiple Covid-19 vaccines in the market, but they may also play a crucial role in scaling up national production of the successful candidate.
The country’s largest veterinary vaccine maker Hester Biosciences, for example, is foraying into the animal vaccine space with its Covid-19 vaccine candidate. It is developing the vaccine in collaboration with the Indian Institute of Technology (IIT)-Guwahati.
The vaccine will be based on an avian virus-based vector platform (avian paramyxovirus).
Rajiv D Gandhi, managing director (MD) and chief executive officer (CEO), Hester Biosciences, said the firm had taken up space for a laboratory at IIT-Guwahati.
The animal or pre-clinical trials are yet to begin, but Gandhi said it was important to get things right. “There will be room for multiple vaccines in the market. It’s important to do the job correctly,” he said.
Similarly, a team of researchers, led by IIT-Bombay alumnus Prabuddha Kundu, is developing a triple antigen vaccine at Premas Biotech. It has successfully identified three major antigens as a recombinant novel coronavirus vaccine candidate.
According to Kundu, unlike single-protein vaccines currently under trial across the world, Premas Biotech has adopted a three-pronged approach to develop multi subunit vaccine. The triple-antigen Covid-19 vaccine candidate, PRAK-03202, has produced neutralising immune response in animal studies. Premas Biotech is now in talks with regulatory authorities for the next phase.
Its animal study of the SARS-CoV-2 vaccine candidate comprised 50 mice, divided into 10 cohorts dosed with 5, 10, and 20 micrograms of PRAK-03202. The vaccine candidate was generally well tolerated and safe at all doses, with no adverse events reported. It was safe even at higher doses and generated a robust immune response against all three SARS-Cov2 antigens.
The company, which has its specialisation in protein therapeutics, is willing to go slow with the trials since it wants to ensure efficacy of the vaccine candidate.
“We are in talks with regulatory authorities to discuss Phase-1 trials. We have put up the case to them on how our vaccine can be scaled up quickly since large-scale manufacturing of yeast is easily possible. In the next couple of months, we should be conducting Phase-1. We wanted to make sure we do it well first time rather than hurry,” said Kundu.
Premas claimed its production cycle of one week is the fastest among the world for anticipated vaccine. The company said it can make 20-30 million doses in a week since the system based of yeast is highly scalable.
On the other hand, Gujarat government arm Gujarat Biotechnology Research Centre (GBRC) has signed an agreement with Neuberg Supratech Reference Laboratory, Ahmedabad, a unit of Neuberg Diagnostics, a start-up in the pathlab chain segment.
According to the agreement, they would develop Covid-19 recombinant vaccine and diagnostics. As part of the agreement, Neuberg Supratech has been looking for immune markers for Covid-19 positive patients by using several of its in-house high throughput sequencing machines. The firm declined to respond.
These smaller players are likely to play a key role when it comes to scaling up manufacturing of the successful candidate. Gandhi said his Nepal plant is operating at 25 per cent capacity, and the company can easily use it to contract manufacture any candidate that emerges successful first. “We can also enhance the capacity easily without much investment. We will definitely chip in to scale up India’s manufacturing of the Covid-19 vaccine,” said Gandhi.
The large players have already indicated that they are repurposing their existing capacities to make way for the Covid-19 vaccine.
Some like Serum Institute are using capacities for Covid-19 vaccines, while others like Indian Immunologicals plan to use multi-product facilities to make additional volumes.