Covaxin for children is likely to be approved faster, says WHO chief scientist

The process of clearing Covaxin, India’s indigenous vaccine against the coronavirus, for use on children is expected to be faster, World Health Organization Chief Scientist Soumya Swaminathan told NDTV on Thursday.

Covaxin, developed by Bharat Biotech, has been in use in India since January 16 but it got approval from the World Health Organization only on November 3. At a meeting last month, the WHO’s technical advisory group had asked Bharat Biotech for more clarification to conduct a final risk-benefit assessment for the vaccine’s emergency use listing.

Swaminathan said that WHO is yet to receive data on children from Covaxin makers. She added that assessing the vaccine for use on children is likely to take less time. “But again, it really depends on the data,” Swaminathan told NDTV.

The WHO chief scientist added: “The same thing happened with other companies also. The mRNA vaccines were first approved for adults. And as data in younger and younger groups became available, it was submitted [to WHO].”

In October, a subject expert committee on Covid-19 vaccines in India had recommended granting emergency use authorisation for using Covaxin on children in the age group of 2 years to 18 years. The Drugs Controller General of India will be the one to give the final approval for this

Covaxin for pregnant women

The WHO chief scientist told NDTV that Bharat Biotech is also planning to conduct a pregnancy sub-study. Swaminathan added that a large number of pregnant women in India had received Covaxin and there was enough data on its safety.

“We are not seeing any safety signals,” Swaminathan told NDTV. “What is still awaited in data on the newborns because one looks at both the mother and the baby when it comes to pregnancy outcomes.”

Covxin did not take longest to get approved

Swaminathan said that one an average, it took about 50 to 60 days for vaccines to get the WHO’s approval but some were cleared in 165 days.

China’s Sinovac and Sinopharm vaccines took 150 to 165 days to obtain the global health body’s approval, the WHO chief scientist said.

“Covaxin is somewhere in the middle, it took somewhere between 90 and 100 days,” she told NDTV. “The [technical advisory] committee met again and were very satisfied [with Covaxin data].”