Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) have collaborated for clinical development of the Covid-19 vaccine, COVOVAX, by US-based firm Novavax and upscaled by SII.
Novavax has also initiated its late-phase trials of the vaccine in South Africa and the UK and plans to start the same in the US soon.
For the production of the vaccine, SII has received the bulk vaccine and Matrix-M adjuvant from the US firm and will fill and finish them in vials.
The COVOVAX vaccine formulated at SII will subsequently be used for a Phase III trial in India after getting regulatory approval.
In addition, ICMR and SII have announced the completion of enrolment in Phase III clinical trials of Covid-19 vaccine candidate, COVISHIELD, in India.
Intended to mitigate the consequences of the pandemic, the private-public partnership will add momentum to India’s role in the global race to develop Covid-19 vaccines.
SII CEO Adar Poonawalla said: “ICMR has played a huge role in coming forward and strengthening India’s fight against Covid-19.
“The collaboration will further aid us in putting India at the forefront of developing an immunogenic and efficacious vaccine.”
Developed at the SII Pune laboratory, the COVISHIELD vaccine candidate got the master seed from the UK’s Oxford University and Astra Zeneca.
While ICMR funded the trial site fees, SII provided funding for other expenses of the vaccine, which is the most advanced one in human testing in India.
SII and ICMR are currently conducting a Phase II/III clinical trial of COVISHIELD at 15 different centres across the country.
The 1,600-participant trial concluded enrolment on 31 October. The vaccine is being trialled in large efficacy trials in the UK, US, Brazil and South Africa.
Based on Phase II/III trial results, SII and ICMR will pursue the early availability of this product for India.
SII has so far manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling licence from DCGI.