Serum Institute gets nod to start Covovax trials on children above 7 yrs

India’s drug regulator on Tuesday allowed Serum Institute of India (SII) to conduct trials of the Novavax Covid-19 vaccine on children aged 7-11.

Industry sources confirmed the development. The company had already started trials on 12-17-year-olds.

The Subject Expert Committee (SEC), which is advising the Central Drugs Standard Control Organisation (CDSCO), allowed enrolling of candidates aged seven years and above. In July, the expert panel had recommended granting permission to SII for conducting phase 2 and 3 trials of Covovax, the Novavax candidate.

The trials are to be conducted for children aged between two and 17 years, but the approvals for separate age groups would come in phases. The trials would roughly cover 920 children divided in multiple age groups. The next leg of trials would be on younger children aged two years and above. The blinded, randomised, placebo-controlled study is aimed at testing the immunogenicity, tolerability and safety of the Novavax candidate on a paediatric cohort.

Covovax, the Novavax candidate, is said to have close to 90 per cent efficacy, but is yet to be approved for use anywhere.

Adar Poonawalla, CEO of SII said a few days back that the company had started trials on the paediatric population, and three to four months is the minimum timeframe for the same. By January-February, there is a possibility that the Covovax (SII-manufactured Novavax vaccine) could be ready for approval for use among children.

So far, Zydus Cadila’s DNA Covid-19 vaccine has received emergency use approval in India for children aged 12 years and above.

Meanwhile, it’s peer Bharat Biotech has completed trials on children. It is now analysing data before it can present it to the regulator.

Covaxin trials have happened on children aged above two years. Bharat Biotech CMD Krishna Ella has claimed that Covaxin is safe for use among infants. Zydus Cadila is yet to launch its vaccine, which is already approved for adolescents aged 12 years and above.

With schools slowly reopening across the country, and many states announcing the same after the upcoming festive season, the demand for paediatric vaccines is likely to increase in the weeks to come.