An expert panel on Tuesday recommended Covaxin – Bharat Biotech’s COVID-19 vaccine – to be used on children between the ages of two and 18.
“Bharat Biotech has submitted data from clinical trials within the two – 18 age bracket for Covaxin to CDSCO (Central Drugs Standard Control Organisation). the info has been thoroughly reviewed by the topic Expert Committee (SEC)… provided positive recommendations,” the Hyderabad-based company said.
“This represents one in all the primary approvals worldwide for COVID-19 vaccines for the 2 – 18 age bracket… We now await further regulatory approvals before product launch and market availability of Covaxin for kids,” the corporate said.
“We (always) said we are going to get a vaccine for youngsters between two and 18… it’ll be approved soon. SEC has recommended… it’ll be approved soon… trials were conducted keeping in mind safety of youngsters. We are committed to their safety,” junior Health Minister Dr Bharti Pravin Pawar told NDTV.
That final approval – viewed as a formality – are going to be given by the Drug Controller General of India.
When it does come, Covaxin are going to be only the second vaccine cleared to be used on kids in India; in August Zydus Cadila’s three-dose DNA jab was allowed to be used on adults and kids over 12.
A third potential vaccine for youths is Serum Institute’s Novavax, that the DCGI last month cleared trials for youngsters 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 that the same formulation as used on adults, but separate trials were needed to ensure 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 information 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 within the two-18 age bracket must be vaccinated “because that is the only thanks to get eliminate the pandemic”.
Earlier this month Dr NK Arora, the chief of India’s vaccine task force, told press association ANI that children with severe comorbidities would be prioritised which other (healthier) kids would be immunised subsequently.
“We are attempting to spot (children) at highest risk… within the subsequent few weeks, the list are within the property right. We are making arrangements so these children don’t must travel (too far) to induce the vaccine…” he said.
As schools re-open and students (and teaching and non-teaching staff) return to classrooms, concerns are expressed over a spike in cases and also the possibility of kids being infected, yet because the have to also vaccinate adults functioning at schools.
India has thus far fully vaccinated but 30 crore of its 130 crore population.
Meanwhile, the globe Health Organization has yet to grant Covaxin an EUA, or emergency use authorisation. Following delays within the process – the WHO had asked Bharat Biotech for extra trial data – a choice is anticipated next week.
Without an EUA, Covaxin won’t be accepted as a sound COVID-19 vaccine by most countries round the world. this suggests Indians who received the jab are forced to quarantine when travelling abroad, unlike those that received SII’s Covishield.
