Serum Institute commences production of Covovax vaccine, trials on 920 children in July
Serum will apply for DCGI approval for clinical trial of Covovax on children as the production has commenced.
FollowEven as the Phase-3 trials of Covovax, the Indian version of US-based Novavax Inc-developed vaccine began on June 18, Serum Institute of India (SII) authorities said they will also apply for permission from the Drug Controller and General of India (DCGI) to conduct a clinical trial of the same among paediatric population.
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.
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.
“A new milestone has been reached. This week we began our first batch of Covovax (a COVID-19 vaccine developed by Novavax) at our facility, here in Pune,” Serum Institute said in an official statement.
Adar Poonawalla, CEO of SII, tweeted on Friday, ““A new milestone has been reached. This week we began our first batch of Covovax (a Covid-19 vaccine developed by Novavax). Excited to witness the first batch of Covovax being manufactured at our facility in Pune.” He added that “this vaccine has great potential to protect our future generations below the age of 18”. Trials are ongoing, he said.
Poonawalla had in March this year said that clinical trials of the Covovax vaccine had commenced in the country and the company aims to launch it by September.
American vaccine company Novavax Inc had in August 2020 announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries, along with India.
Serum Institute had in January rolled out their Covishield vaccine in India after developing it in collaboration with the University of Oxford and AstraZeneca.
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