Highlights:
- Covaxin will be the second Covid-19 vaccine recommended for use on children, pending DCGI approval.
- In August, Zydus Cadila’s three-dose DNA vaccine was authorised for children over the age of 12.
- Bharat Biotech completed Phase 2 and Phase 3 testing of Covaxin on kids under the age of 18 in September.
The Subject Expert Committee (SEC) expert panel on Tuesday authorised Covaxin, Bharat Biotech’s COVID-19 vaccine, for use on children aged two to eighteen.
The Drug Controller General of India will issue final clearance, which is considered as a formality.
Covaxin will be the second Covid-19 vaccine licenced for use on children if Drug Controller General of India (DCGI) grants approval. Zydus Cadila’s three-dose DNA shot was approved for use on adults and children aged 12 and above in August.
Subject Expert Committee (SEC) has given a recommendation to DCGI (Drugs Controller General of India) for the use of BharatBiotech's Covaxin for 2-18 year olds: Official sources
— ANI (@ANI) October 12, 2021
The DCGI permitted trials for Serum Institute’s Novavax, a third potential vaccination for children aged seven to eleven years, last month. Corbevax, developed by Biological E, is a fourth alternative that has been cleared for advanced testing on children over the age of five.
Bharat Biotech, a vaccine producer, announced this week that it has submitted data on vaccination studies on children.
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The Covaxin vaccination used on children is the same formulation used on adults, but independent studies were required to ensure the Covid-19 vaccine’s safety and efficacy on younger recipients.
The data from these trials has not yet been made public, although tests were performed on over 1,000 kids across the country. The panel, however, found that the trial on children had similar effectiveness rates as the trial on adults.
In June, the DCGI received data on the vaccine’s effectiveness (for adults); the results showed that Covaxin is 77.8 percent efficient in guarding against the virus.
After administering over 96 crore doses to adults, India is gradually shifting its attention to vaccinate children against the coronavirus.
Concerns have been voiced about a surge in cases and the risk of children becoming infected, as well as the necessity to vaccinate people working in schools, when schools reopen and kids (and teaching and non-teaching staff) return to classrooms.
So far, less than 30 crore of India’s 130 crore people have been completely immunised.
Meanwhile, Covaxin has yet to be granted an EUA, or emergency use authorization, by the World Health Organization. Following delays in the process (the WHO had requested further trial data from Bharat Biotech), a verdict is likely next week.
Most nations will not recognise Covaxin as a legitimate COVID-19 vaccination unless it has an EUA. This implies that, unlike those who received SII’s Covishield, Indians who received the jab will be required to quarantine before travelling overseas.
