Now, Serum to apply for DCGI approval for clinical trial of Covovax on children

Covovax is the second Covid-19 vaccine candidate, which is being developed and manufactured at Pune-based SII.

The Serum Institute of India facility in Pune, which is developing Covovax, a Covid-19 vaccine by Novavax. Pictured on the left is CEO Adar Poonawalla. (Twitter/@SerumInstIndia)

Even 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.

Covovax is the second Covid-19 vaccine candidate, which is being developed and manufactured at Pune-based SII.

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.

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SII has already manufactured Covishield vaccine in technical collaboration with AstraZeneca and Oxford University. Poonawalla had also earlier tweeted that they hoped to launch Covovax by September this year. Earlier, US-based biotechnology company Novavax had announced a license agreement with SII for the development and commercialisation of NVX-COV2373, its Covid-19 vaccine candidate, in low and middle income countries and India.

When contacted, SII authorities told The Indian Express that initially they would apply for approval to conduct clinical trials of the Covovax vaccine in the 12-18 age group and then in the age group below 12 years.

Meanwhile, SII together with the ICMR, had planned the Phase-2/3 observer blind randomised controlled study to determine the safety and immunogenicity of Covovax (SARS-CoV2 recombinant spike protein nanoparticle vaccine (SARS-CoV2rS) with Matrix-M1 adjuvant in Indian adults.

Anuradha Mascarenhas

Anuradha Mascarenhas is a journalist with The Indian Express and is based in Pune. A senior editor, Anuradha writes on health, research developments in the field of science and environment and takes keen interest in covering women's issues. With a career spanning over 25 years, Anuradha has also led teams and often coordinated the edition. ... Read More

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