- Covaxin will be only second vaccine cleared for use on kids in India
- Covaxin vaccine tested on children is same formulation as used on adults
- Final approval will be given by the Drug Controller General of India
An expert panel on Tuesday recommended Covaxin - Bharat Biotech's COVID-19 vaccine - for use on children between the ages of two and 18.
"Bharat Biotech has submitted data from clinical trials in the two - 18 age group for Covaxin to CDSCO (Central Drugs Standard Control Organisation). The data has been thoroughly reviewed by the Subject Expert Committee (SEC)... provided positive recommendations," the Hyderabad-based company said.
"This represents one of the first approvals worldwide for COVID-19 vaccines for the two - 18 age group... We now await further regulatory approvals prior to product launch and market availability of Covaxin for Children," the company said.
"We (always) said we will get a vaccine for children between two and 18... it will be approved soon. SEC has recommended... it will be approved soon... trials were conducted keeping in mind safety of children. We are committed to their safety," junior Health Minister Dr Bharti Pravin Pawar told NDTV.
That final approval - viewed as a formality - will be given by the Drug Controller General of India.
When it does come, Covaxin will be only the second vaccine cleared for use on kids in India; in August Zydus Cadila's three-dose DNA jab was allowed to be used on adults and children over 12.
A third potential vaccine for kids is Serum Institute's Novavax, for which the DCGI last month cleared trials for children between seven and 11 years. A fourth is Biological E's Corbevax, which has been cleared to conduct advanced trials on children above five.
Last week manufacturers Bharat Biotech said it had submitted data on vaccine trials on children.
The Covaxin vaccine tested on children is the same formulation as used on adults, but separate trials were needed to guarantee safety and efficacy on younger recipients.
Data on these trials has not been made public yet, but tests were conducted on 1,000+ children across the country. The panel, however, noted the trial on kids showed similar efficacy rates as that on adults.
Data on the vaccine's efficacy (for adults) was submitted to the DCGI in June; the data indicated Covaxin is 77.8 per cent effective in protecting against the virus.
India is slowly turning its focus towards vaccinating children against the coronavirus, having administered nearly 96 crore doses to adults.
Dr Randeep Guleria, chief of Delhi's AIIMS, has stressed that children in the two-18 age group must be vaccinated "because that's the only way to get rid of the pandemic".
Earlier this month Dr NK Arora, the chief of India's vaccine task force, told news agency ANI that children with severe comorbidities would be prioritised and that other (healthier) kids would be immunised subsequently.
"We are trying to identify (children) at highest risk... within the next couple of weeks, the list will be in the public domain. We are also making arrangements so these children do not have to travel (too far) to get the vaccine..." he said.
As schools re-open and students (and teaching and non-teaching staff) return to classrooms, concerns have been expressed over a spike in cases and the possibility of children being infected, as well as the need to also vaccinate adults working at schools.
India has so far fully vaccinated less than 30 crore of its 130 crore population.
Meanwhile, the World Health Organization has yet to grant Covaxin an EUA, or emergency use authorisation. Following delays in the process - the WHO had asked Bharat Biotech for additional trial data - a decision is expected next week.
Without an EUA, Covaxin will not be accepted as a valid COVID-19 vaccine by most countries around the world. This means Indians who received the jab will be forced to quarantine when travelling abroad, unlike those who received SII's Covishield.
With input from ANI