Is the govt taking a risk on Bio E vaccine that's yet to cross the finish line?

COVID-19 vaccine (Representative image)

The government announced on June 3 that it will pay Rs 1,500 as advance to Hyderabad-based Biological E to buy 30 crore (300 million) doses of its potential COVID-19 vaccine.

The doses would be manufactured and stockpiled by M/s Biological-E  from August to December 2021, the health ministry said in a statement.

"The arrangement with M/s Biological-E is part of the wider endeavour of the government of India to encourage indigenous vaccine manufacturers by providing them support in Research & Development (R&D) and also financial support," it said.

Payment of Rs 1,500 crore for 30 crore doses, works out to advance of Rs 50 per dose. The company has not declared the price of the jab but its managing director Mahima Datla said recently that it would be among the most affordable vaccines available. The government is buying Serum Institute of India's (SII) Covishield and Bharat Biotech Covaxin at Rs 150 per dose.

BE's COVID-19 vaccine has to be taken in two doses 28 days apart, and administered via intramuscular injection.

BE is the third vaccine company to receive advance payment for supplying COVID-19 vaccines. Earlier SII was given Rs 1500 crore for supply of Covishield vaccine and Bharat Biotech received Rs 750 crore for Covaxin. Both Covishield and Covaxin were approved.

The Hyderabad-based vaccine maker is developing the recombinant protein or protein subunit Covid-19 vaccine Corbevax. The candidate is an antigen (spike protein) developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures part of Texas-based Baylor College of Medicine. Dynavax Technologies Corporation’s will provide adjuvant CpG 1018TM.

The company had received financial support from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) for the Phase I/II clinical trials and also for the upcoming Phase III trial of this vaccine candidate.

Sources told Moneycontrol that BE has begun manufacturing the vaccine at risk, and stockpiling in anticipation of approval. The company said it expects interim data from the trial to be available in Q1FY21. Moneycontrol learns that this vaccine is relatively easier to manufacture and scale up with higher yields of antigen.

To be sure, BE's COVID-19 vaccine is undergoing Phase-3 clinical trial and doesn't have any efficacy data. BE received DCGI approval on April 24 to start a phase 3 clinical trial for its COVID-19 vaccine candidate.

The government says that the results in Phase 1 and 2 clinical trials were promising. The company is yet to publish data related to those trials in any reputed peer-reviewed scientific journal.

Experts say paying an advance and stockpiling of BE's subunit vaccine by the government is worth the risk.

They say that if the protein subunit works well, it is much easier to manufacture at scale compared to viral vector and inactivated vaccines.

"About time the government took some risk," said Dr Gagandeep Kang, renowned virologist and Professor at CMC Vellore.

"I have hopes for the protein subunit vaccines, because this is a platform that can make lots of doses. Lot depends on the adjuvant, but we should get performance from phase 1/2," Kang said.

Dr KV Balasubramaniam, a vaccine industry veteran and life science industry consultant, said it will turn out to be a good vaccine and affordable to the government.

"Subunit protein vaccines will have good efficacy and safety. This will be a game changer for cost-effective Covid vaccines for low- and middle-income countries," Balasubramaniam.

But some experts have a word of caution on backing a vaccine that doesn't yet have efficacy data.

"The government is under pressure, but it probably should have used that money to buy vaccines that were approved and widely distributed," said an executive of a vaccine company who didn’t want to be named.

Please read here about BE and its plans for COVID-19 vaccines.