Vaccine major Serum Institute of India (SII) is all set to start phase 2 and 3 paediatric trials of Covovax on 920 children — 460 each in the 12-17 and 2-11 age groups — from next month.Covovax is the Indian version of COVID-19 vaccine developed by US-based Novavax Inc
The recombinant nanoparticle protein-based vaccine —NVX-CoV2373 — developed by American biotechnology firm Novavax has been branded as Covovax in India. It will be the fourth Covid-19 vaccine to undergo clinical trials for children in India.
Centre expects 200 million doses of Covovax to be available between August and December. India will allow entry of this vaccine once the USFDA approves it.
In a tweet, on its official handle, the company said, “A new milestone has been reached; this week we began our first batch of Covovax at our facility, here in Pune.”The company has been stockpiling Covovax doses for some time now. This was in small volumes, SII clarified.
The target monthly production of Covovax is 50 million. The company is expected to scale up to that level by the September quarter, claim sources.Meanwhile, SII has also indicated that it plans to start clinical trials on children for Covovax in July.
Meanwhile, SII has also indicated that it plans to start clinical trials on children for Covovax in July.
Novavax had said this month that it got promising results from its PREVENT-19 phase 3 trials in the US and Mexico, with an overall efficacy of 90.4 per cent.
The vaccine candidate NVX-CoV2373 has shown 100 percent protection against moderate and severe disease as well as 90.4 percent efficacy overall. It also met the primary endpoint in the PREVENT-19 phase 3 trials, the company had said in a statement.
Novavax will file regulatory authorisations in the third quarter (of the calendar year), it added. Upon regulatory approvals, the company said it is on track to reach manufacturing capacity of 100 million doses a month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021.
SII chief executive officer (CEO) Adar Poonawalla had earlier said that shortage of raw material supplies from the US had affected the scale up plan for Covovax.