Corbevax, Covaxin get drug regulator nod for use in kids

The Centre is yet to open the vaccination campaign for children below 12 years

G.S. Mudur   |   TT  |  New Delhi   |   27.04.22  : India’s drug regulatory authority has approved two Covid-19 vaccines — Covaxin and Corbevax — for vaccinating children aged between 5 and 12 years, Union health minister Mansukh Mandaviya announced on Tuesday.

He said the Central Drugs Standards Control Organisation (CDSCO) had approved Covaxin for children between 6 and 12 years and Corbevax for children between 5 and 12. The Centre is yet to open the vaccination campaign for children below 12 years.

Covaxin is one of the two main vaccines India has used in its nationwide vaccination campaign that began in January 2021 with nearly 315 million doses administered so far. The CDSCO had approved Covaxin in December 2021 and Corbevax two months ago for children aged between 12 and 18 years. But the vaccination campaign is currently offering Covaxin to children between 15 and 18 years and Corbevax to children between 12 and 15 years.

The campaign will open to younger children only after a national expert group on Covid-19 vaccine policy will make recommendations.

The two vaccines use different immunisation strategies — the homegrown Covaxin made by Bharat Biotech uses inactivated (killed) coronavirus, while Corbevax developed by researchers in the US and produced by Indian vaccine maker Biological E uses a component of the coronavirus protein to generate immune responses.

The CDSCO approvals for paediatric immunisation come under “restricted use in emergency situations,” implying that the companies would need to report any adverse events in recipients post immunisation more frequently than for vaccines under general, non-emergency approval.

“We have established Covaxin as a universal vaccine for adults and children,” Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement. “We are glad to share that Covaxin has now proven data for safety and immunogenicity in children.”

Covaxin’s paediatric clinical trials in children aged 2-18 years conducted during JulySeptember 2021 have documented that 95 to 98 per cent of children display vaccine-induced immune responses four weeks after the second dose, indicating superior antibody responses compared to adults.

Earlier, studies on Covaxin had indicated the vaccine induces memory arms of the immune system that work against multiple coronavirus variants. And lab studies have shown that booster doses of Covaxin — a third dose after two doses — generate immune responses against both omicron and delta variants.

The CDSCO has also approved two doses of ZyCoVD, a Covid-19 vaccine from Zydus Lifesciences, earlier approved in a three-dose version. The two dose shots will be administered on day 0 and day 28. The earlier schedule had been day 0, day 28 and day 56.

“The two-dose regimen will help in administering the vaccine in a large population in a smaller time which is always desirable in the midst of a pandemic,” Sharvil Patel, managing director of Zydus Lifesciences, said in a statement.