SII begins manufacturing Covovax; to start trial in kids in July

"Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune," he shared in a tweet on Friday.

New Delhi: The Pune-based Serum Institute of India (SII) has begun manufacturing Novavax’s protein-based vaccine Covovax, CEO Adar Poonawalla has said.

The company will also begin clinical trials of Novavax for children starting July.

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“Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune,” he shared in a tweet on Friday.

In the recently released Phase -3 trials, Covovax has shown overall 90 per cent efficacy against Covid-19. The US-based trials also demonstrated the two-shot vaccine 100 per cent protection against moderate and severe disease.

“The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team,” he said.

SII’s Phase-2 and 3 clinical trials of Covovax will reportedly be conducted in 920 children — 460 each in 12-17 years and 2-11 years groups, media reports said.

In August 2020, Novavax and SII had announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries.

In March 2021, CEO Poonawalla said Covovax will be launched by September this year.

“Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India,” said Adar Poonawalla. “Hope to launch by September 2021!” the CEO of the world’s biggest Covid-19 vaccine maker had said.

Recently, the Centre stated that Novavax Covid vaccine efficacy data in a large trial are promising and that clinical trials are being conducted and are in an advanced stage of completion in India.

“What we’re learning from data available in the public domain is that this vaccine is very safe and highly effective,” Dr V.K. Paul, NITI Aayog Member (Health) said earlier this month.

The company intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.

Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.

Hyderabad-based Bharat Biotech has also two vaccines that are being tried on children, Covaxin and BBV154, a one-shot nasal vaccine.

ZyCov-D, the Zydus’ Covid-19 vaccine has also started trials on children in the age group 12-18 years.

The government is also considering providing legal indemnity to Pfizer and Moderna to roll out their vaccines in India. Pfizer has announced that its vaccine is safe for children above 12 years of age.