India's first Covid vaccine-Serum Institute's 'Covishield'- will be commercialised in 73 days. Indians will be immunised free under the National Immunisation Programme (NIP) as is the case with all other vaccines under the programme.
"The government has given us a 'special manufacturing priority license' and fast-tracked the trial protocol processes to get the trials completed in 58 days. By this, the first dosing is happening from today in the final phase (Phase III) and the second dosing will happen after 29 days. The final trial data will be out in another 15 days from the second dosing. By that time, we are planning to commercialise Covishield," a Serum Institute of India (SII) top official exclusively revealed to Business Today.
Meanwhile, the Union Health Minister Harsh Vardhan stated on Saturday that "one of our COVID-19 vaccine candidates is in the third phase of clinical trial" expressing confidence that "a vaccine will be developed by the end of this year."
Earlier, the third phase trials were expected to take a minimum 7-8 months.
The trial among 1600 volunteers at 17 centres, each with about 100 volunteers, started on Aug 22.
The company, however, said in a statement: "We would like to clarify that the current media claim on COVISHIELD's availability in 73 days is misleading".
Sources, though, confirmed to BusinessToday.In that the timelines are as per ICMR guidelines and will be adhered to, barring any adverse reaction to the vaccine among volunteers in the ongoing trials.
"The phase-3 trials for the Oxford-AstraZeneca vaccine, are still underway. And only once the vaccine is proven immunogenic and efficacious, SII will confirm its availability, officially," Serum Institute says.
The source said the vaccine will belong to Serum Institute, as the company has entered into an exclusive agreement with Astra Zeneca to buy rights and pay a royalty fee for exclusively selling it in India and 92 other countries.
"Presently, the government has granted us permission to only manufacture the vaccine and stockpile it for future use. COVISHIELD will be commercialised once the trials are proven successful and all the requisite regulatory approvals are in place, Serum Institute said in a statement.
The central government has already indicated to SII that it will directly procure the vaccines and is planning to immunise Indians for free. Centre has sought 68 crore doses for 130 crore Indian citizens from Serum Institute by June, next year.
For the rest, it is likely to place orders with 'Covaxine' being developed by ICMR and Bharat Biotech and Zydus Cadila's 'ZyCoV-D' if their trials proceed successfully.
Bharat Biotech is yet to indicate when it would start and finish the trials, though Bharat Biotech's CMD Krishna Ella had said that to ensure safety and efficacy it would not expedite the vaccine with short-cuts.
Serum is starting to manufacture 6 crore doses per month which will be increased to 10 crore per month by April, 2021. This is being done by re-engineering its vaccine manufacturing lines for which it has spent nearly Rs 200 crore. SII, the largest vaccine maker in the world, has a capacity to make 150 crore doses a year.
The Bill & Melinda Gates Foundation has agreed to fund Serum with about $150 million (nearly Rs 1125 crore) to produce and supply around 10 crore doses of Covid-19 vaccine for supply to low income countries. That will help SII to reduce the price to about Rs 250 per dose from over Rs 1,000 per dose, the source said.