Expect COVID-19 vaccine to enter phase-1 human trial by October: Panacea Biotec's Rajesh Jain

2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.

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26 Aug, 2025 12:21

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Panacea Biotec, is the latest Indian company to join the race to develop vaccine for novel coronavirus, or COVID-19. The company last week announced its collaboration with Ireland-based biotech Refana to develop, manufacture and distribute an inactivated COVID-19 vaccine.

Under the collaboration, Panacea Biotec will be responsible for product development and commercial manufacturing, with the joint venture undertaking clinical development and regulatory submissions across the world. The management said the aim is to manufacture over 500 million doses of COVID-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year.

In an interview to Moneycontrol, Rajesh Jain, Panacea Biotec's Managing Director, said by around early October their vaccine candidate is expected to enter phase-1 human testing.

Q: Could you tell us about your partner Refana? A: It is a newly formed company in Ireland, specifically focused on bringing a COVID-19 vaccine. It was founded by Dr Phillip Schwart, a technocrat founder and President of NASDAQ listed company EnteraBio. We have entered into joint-venture with Refana to develop this vaccine.

Q: What is the status of the vaccine? A: Initial proof-of-concept is already established. Animal studies on rats and mice in the models that we have chosen have shown strong immunogencity as well as safety. We are in the process of regulatory submissions. Around early October, we are expecting the vaccine to enter phase-1 human testing. The joint venture plans to conduct parallel clinical studies at multiple sites. This trial will be global, we also have the option to include India as part of the trial.

Q: Could you explain more about the vaccine? A: It's based on SARS-CoV-2. It has been inactivated with our proprietary technology. The vaccine induces SARS-CoV-2 specific neutralising antibodies. These antibodies are so strong that they give protection against mutations that may occur in future. We have studied 10 presentations of SARS-CoV-2 strains. The vaccine has the ability to neutralise across all strains. This suggest that the approach of inactivation and proprietary adjuvant that we have added in the formulation allows this. In coming years, if SAR-CoV-2 mutates, the vaccine still provides protection. Inactivated vaccine technology is tried and tested with established regulatory pathways.

Q: What is Panacea Biotec's manufacturing capacity for the vaccine? A: Panacea Biotec has cGMP (Current Good Manufacturing Practice) manufacturing facility that can produce drug substance and the drug product. We are targeting 500 million doses. It depends on yields. We should be able to roll approximately 40-45 million in early January.

Q: How are you funding the vaccine development? A: As of now, there is enough money on the table. There are people who are willing to write cheques. From a long term perspective, the joint venture may look at fund raising. The JV is currently organising supply chain and manufacturing, and is in touch with supra-national and national governments for the purpose.

Q: What is your rationale in getting into vaccine for COVID-19 when dozens of to others are already working on it, some have advanced to human testing? A: Look at the population across the world. We are talking about seven billion people, almost all of us need the vaccine. This vaccine could be a single dose, double dose or triple dose. Just multiply the population with doses. It's huge. There is enough market for everybody. Even if you look at top three guys, nobody is talking delivering beyond 1-2 billion doses. In addition, they have to prove that their vaccine is efficacious. Even the capacities they are talking about will take at least one year. There is a probability of some of these vaccine may not be efficacious. So, there is an opportunity for a good vaccine.