SII gets nod for trials of Covovax in children

NEW DELHI: Serum Institute of India (SII) on Tuesday received permission to conduct phase II and III clinical trials of Covovax, the Indian version of the US biotechnology firm Novavax’s Covid-19 vaccine, in children between 7 and 11 years of age.

This makes it the third Covid-19 vaccine to be tested in children in India, after Bharat Biotech’s Covaxin and Zydus Cadila’s ZYCOV-D.

The subject expert committee (SEC) of India’s central drugs standard control organisation recommended that the company should be allowed to try the vaccine in children between seven and 11 years of age.

“Covovax has received the approval,” a person familiar with the development said on condition of anonymity.

“The company can go ahead and recruit volunteers as per the set protocol.”

India will need to eventually vaccinate children as schools reopen across the country. Currently, only people aged 18 years and above are eligible to receive jabs under the national immunisation drive.

In July, the subject expert committee permitted SII to conduct clinical trials in the 12-17 age group. These trials are ongoing. Among adults, the company received permission from India’s drugs regulator to test the vaccine in March.

Covovax could be launched in October, SII chief executive officer Adar Poonawalla had said last month after a meeting with home minister Amit Shah.

I am “hopeful that for adults, Covovax will be launched in October, depending on DCGI approvals… The Covovax vaccine for kids will be launched in the first quarter of the next year, most likely in January-february,” PTI news agency had quoted Poonawalla as saying. DCGI refers to Drugs Controller General of India.