Domestic vaccine makers wait for procurement commitment from government for Covid-19 vaccines

MUMBAI/NEW DELHI: Indian vaccine producers are waiting for clarity from the government on its procurement and allocation plans for Covid-19 vaccines and efficacy guidelines.

The companies are in the dark about the government’s commitments and said they are developing the vaccines at risk.

Some leading vaccine companies have also asked the government to foot the bill for their ‘fill and finish’ capacities (for vials and glass fillings) that would help them to scale up mass manufacturing. They said the government can reach out to the World Bank, which has allocated $2 billion for vaccine development by companies.

The government needs to call all manufacturers and tell them what it wants, said Krishna Ella, CEO of Bharat Biotech, whose vaccine candidate entered phase 2 trials on Wednesday.

“We need to understand what the allocation strategy is… given that all vaccines will not be available from day one,” said Mahima Datla, CEO of Biological E. “What is the volume you need for first responders? What is the volume you need in the second tranche? What is the overall strategy of immunisation? Is it 60% or 100% of the population?”

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.

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.

“It is a financial risk worth taking,” Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases in the US, said at a symposium organised by the Indian government last week.

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.

A government official told ET that it’s too soon to make projections of India’s vaccine requirements.

“We can make our wish list, but then it’s too early. There are only a few candidate vaccines that may prove to give protection against Covid-19. Most are two-dose vaccines and we don’t know if they can be given to everyone. These things will come into play once the companies show that their vaccines have proven effective,” the official said.

“The government needs to build a risk inventory. They need to back as many candidates as possible because you don’t know which one will succeed,” Rajesh Jain, MD of Panacea Biotech, told ET. “In the first phase, assuming we will need two doses to vaccinate 20% of the population, we will need companies that have the capacity to manufacture at least 540 million doses. We need financial grants to build that capacity.”

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.