DCGI panel clears Covaxin for emergency use in 2-year-olds as well
12 October 2021
The subject expert committee of the Drug Controller Genera of India (DCGI) on Tuesday cleared Covaxin for emergency use in children aged two to 18 years giving India the first approved SARS-CoV2 vaccine for use in kids as small as two years old.
Previously, the DCGI had approved Zydus Cadila’s ZyCoV-D for emergency use in children aged 12 and above as well.
The clearance to Covaxin for protection of children between two and 18 comes at a time when schools are reopening after the second wave of the pandemic that affected more people and claimed more lives than during the first wave.
Although there is no clear evidence of children being more vulnerable to a potential third wave of the virus, countries across the globe have been expanding vaccination drives to cover children as well.
The National Technical Advisory Group on Immunisation (NTAGI) is currently working on the guidance for Covid vaccination in children – especially on which segments among children should be prioritised for vaccination.
The NTAGI will now take a combined call on the use of Covaxin for vaccination of younger children, along with the earlier cleared ZyCoV-D vaccine use among 12 to 18 year olds.
The World Health Organisation, however, has given no guidance on Covid vaccine use among children, with larger evidence suggesting a natural immunity among children to viruses.
Countries are taking individual calls on the matter with the US and UK having taken the lead in inoculating children against Covid.
It, however, remains to be seen how Covid shots for children will be rolled out. The adult vaccine drive is being managed by the government, with the centre procuring 75 per cent of the vaccines from manufacturers for free distribution to states.
Bharat Biotech, a global leader in vaccine development and innovation, had, in July, announced safety and efficacy analysis data from Phase III clinical trials of Covaxin, a whole virion inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV Pune.
Efficacy analysis demonstrated Covaxin to be 77.8 per cent effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group
Efficacy analysis demonstrated Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19
Safety analysis demonstrated adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects feeling serious adverse events
Efficacy data also demonstrated 63.6 per cent protection against asymptomatic Covid-19 and 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant.