The Ahmedabad-based drug maker will submit the results of its phase-2 trials next week, which "will ascertain the safety, dose and efficacy of the potential vaccine", said the person who requested not to be identified.
Indian diagnostic companies had experience in developing test assays for dengue, HIV, TB and H1N1, but with Covid-19 the delay in getting hold of the genetic code of SARS-Cov2 meant the Indian government, in the initial months of the pandemic, had to wait on imported RT-PCR kits that were expensive with worldwide shortage. In March, the Indian Council of Medical Research placed an order of one million probes from Germany.
She cited reports according to which the UK's medicines and healthcare products regulatory agency (MHRA) is likely to grant EUA by mid December. A couple of weeks later, she said, the drugs controller general of India (DCGI) could allow it for emergency use in India.
The move comes as the Indian government thinks that it has sufficient doses of vaccine for its population and can also supply to other nations that might be left out in the Covid-19 vaccine race as countries in Europe and US secure their own doses, said an official.
This vaccine candidate includes an antigen that was in-licensed from BCM Ventures, which is an integrated commercialisation team of Baylor College of Medicine in Houston, and an advanced adjuvant from the US-based vaccine focused pharmaceutical firm Dynavax Technologies Corporation.
"This is India's first phase-III efficacy study for a Covid-19 vaccine, and the largest phase-III efficacy trial ever conducted in India," said Bharat Biotech in a statement on Monday, adding that the trial was registered at ICMR and approved by the Drugs Controller General of India.
The company is in discussions with the Gavi vaccine alliance to potentially provide doses to the Covax facility, a Pfizer spokesperson told ET, adding: "It is our intention to achieve equitable global distribution of vaccine supply in alignment with identified priority populations."
Pfizer and BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek U.S. emergency use authorization later this month.
The extremely stringent temperature requirement for mRNA vaccines, which is what the Pfizer vaccine candidate is based on, will also make it difficult to be used in India as part of a national immunisation strategy, experts said.
“The Board of its (Biocon’s) subsidiary Biocon Biologics has approved a Rs 1,125 Crore ($150 million) capital injection from Goldman Sachs. As per the terms of the proposed agreement, Goldman Sachs will be issued optionally convertible debentures at a post money equity valuation of $ 3.94 Billion,” said Biocon in a press release.