SII makes 1st batch of Covovax, eyes Sept rollout

Serum Institute of India (SII) has manufactured the first batch of Covovax, its version of US firm Novavax’s Covid-19 vaccine candidate that has the potential to be administered to youngsters, its chief executive Adar Poonawalla has said.“Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune,” Poonawalla tweeted on Friday. “The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team @seruminstindia!”The Pune-based vaccine maker is hoping to introduce Covovax by September, as ET had reported earlier this month.SII was facing challenges related to the disruption of supplies of key materials like nano filters, plastic bags from the US. Supplies resumed after the US government lifted the Defence Production Act (DFA) early in June.SII is conducting a phase 2/3 observer-blinded, randomised, active-controlled study with 1,600 adult participants across 15 centres in the country. The company is planning to start clinical trials of Covovax for children in July.While the ongoing trial in India that started in May is likely to conclude only by November, SII is likely to apply for a licence for Covovax by September on the back of global data.Novavax’s coronavirus vaccine candidate has demonstrated 93% efficacy against predominantly circulating variants of concern and variants of interest. The US firm’s study had enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate the efficacy, immunogenicity and safety of the vaccine.

from Economic Times https://ift.tt/3dbdPrV