Covid 19 Vaccine Procurement – No Clarity In India

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The race for developing the Vaccine to provide protection against Covid 19 is well truly on with research groups and vaccine producers moving into Phase 3 of human trials.
While US and UK Govt have officially tied up pharma majors, there is no such move by the Indian Government. Despite announcement by Serum India that they will produce over 5 million vials of vaccine, other Indian vaccine producers are waiting for clarity from the government on its procurement and allocation plans for Covid-19 vaccines and efficacy guidelines.
Despite the lack of confirmation from the Govt, the companies including Serum India, Bharat biotech, Biological E Ltd, Indian Immunologicals are in the dark about the government’s commitments and said they are developing the vaccines at risk.
The vaccine companies have also asked the government to help out the costs for their ‘fill and finish’ capacities (for vials and glass fillings) that would help them to scale up mass manufacturing.
The World Bank has allocated $2 billion for vaccine development by companies, which the Indian Govt can be drawn on.
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Two Hyderabad based companies are in various stages of human trials. Bharat Biotech, whose vaccine candidate entered phase 2 trials while Biological E will start phase 1 trials of its RBD protein vaccine candidate on the platform used to make its Hepatitis B vaccines. The platform allows the company to produce 80 million to 100 million vaccine doses.
At the heart of the issue is the allocation strategy will be – basically Pharma majors developing the vaccine want to know what will be the volume that the Govt of India will bankroll for providing the vaccine shot to a large part of the population that cannot afford to buy the vaccines.
Globally, rich countries have paid drug companies up front to secure billions of Covid-19 vaccines doses. The US, the EU, the UK and Japan have paid up or set aside at least $1 billion each to procure vaccines even before a successful candidate is out.
India, which has the largest vaccine manufacturing companies in the world by scale, has not made any advance purchase commitments, although the Department of Biotechnology has been making grants of up to Rs 50 crore available to companies.
The Govt needs to build a risk inventory and they need to back as many companies as possible because one does not which one will succeed – the lab to market with huge risks. Any side effects and complications will costs the vaccine makers billions in damages and loss of face.
Companies said there is no clarity on guidelines for Covid-19 vaccines development too in India. The US Food and Drug Administration and the World Health Organization have said a successful Covid-19 vaccine must have a minimum 50% efficacy and needs to show antibody and T-cell responses. India is yet to come out with any such guidelines.