Mukesh Ambani-led Reliance Life Sciences has received the approval of the Subject Expert Committee (SEC) for clinical trials of its recombinant protein-based Covid-19 vaccine. The SEC, which advises the Drug Controller General of India (DCGI) on vaccines and new drugs, has recommended phase 1 clinical trials of the company’s indigenous coronavirus vaccine. However, the company can begin phase 1 trials of its two-dose Covid -19 vaccine only after receiving approval from the DCGI.
As per the company’s proposal, trials of its vaccine will be conducted at 10 sites in Tamil Nadu, Andhra Pradesh, Maharashtra, and Delhi. Phase 1 trials of the vaccine include testing on a group of 20-to-80 people and measuring the immune response of the dose. Following successful phase 1 trials, the vaccine would be tested on larger groups of people during phase 2 and 3 trials.
Reliance expects to roll out its vaccine, which entered the pre-clinical stage in October last year, in the first quarter of 2022.
So far, six vaccines —Zydus Cadila’s vaccine, Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna, and Johnson & Johnson — have received emergency use authorisation in India.
According to the media reports, the Reliance coronavirus vaccine, which is being developed at the company’s Navi Mumbai’s facility, will be priced competitively.
Reliance Life Sciences has also developed a ‘molecular transport medium’ for the collection and transportation of Covid-19 swab samples.