With this, Serum Institute also joins the race for the vaccine in India where two other potential candidates — from Bharat Biotech and Cadila Healthcare — are already conducting Phase 1 and 2 human trials.
The trials by Serum Institute will involve around 1,600 people aged above 18 across 17 selected sites, including AIIMS Delhi and Jodhpur, BJ Medical College in Pune, RMRIMS in Patna and PGIMER Chandigarh, an official said.
This would mean this is so far the largest trial for the coronavirus vaccine in the country as the other two candidates involve a relatively smaller participant base and trial size — 1,150 participants in eight sites and five sites with 1,000 participants.
The approval to Serum Institute is backed with recommendations from a subject expert committee on vaccines which had earlier raised queries on the initial proposal from the firm seeking permission for clinical trials in India. While Serum addressed the concerns within hours, the committee gave its final approval following a meeting on Friday.
Serum Institute has partnered with British pharma giant AstraZeneca for Oxford University’s Covid-19 vaccine candidate that showed promising results in early human trials (Phase 1 and 2) in the UK. The results — published in the Lancet last month — showed the vaccine to be safe and capable of inducing an immune response.
Once the trials are over successfully and the vaccine is approved, Serum plans to make one billion doses of the jab over the next one year for India and other low- and middle-income countries.
“We will start producing a few millions of doses at personal risk. Based on the success of the trials we are expecting it to be available by the end of this year. I believe by the first quarter of the next year it will start reaching the masses,” Serum Institute of India chief executive Adar Poonawalla had told TOI.
Poonawalla has also said that the company will try to price the vaccine below Rs 1,000.
Globally, around 24 vaccine candidates are in various stages of human trials while 141 others are in the pre-clinical stages.