Covaxin has been approved for use in those aged 12 and above by the Drugs Controller General of India (DCGI). This would make it the second vaccine approved for use in India in those below 18.
The Hindu has seen a letter by V. Somani, DCGI, according approval for the vaccine as two doses, four weeks apart.
Also read | COVID-19 jabs for 15-18 group from January 3; booster for seniors from January 10
The DCGI in August granted emergency approval to Zycov-D , a three-dose, DNA COVID-19 vaccine developed by the Ahmedabad-based Zydus Cadilla Group, making it the first vaccine in India that could be administered to adults and those 12 and above. The company has said it can make one crore vaccines a month. Covaxin constitutes about 10% of the nearly 140 crore doses administered in India.A company spokesperson told The Hindu that about 55 million doses were produced in November and the company was on track to make a billion doses annually in 2022.
Welcoming the clearance, Bharat Biotech, the makers of Covaxin, said the vaccine Covaxin was “formulated uniquely” so that the same dosage administered to adults could be used in children as well.
Their statement noted: “COVAXIN has established a proven record for safety and efficacy in adults for the original variant and subsequent. We look forward for COVAXIN to provide similar levels of protection for adults and children alike.”
Chairman and managing director of Bharat Biotech International Limited, Krishna Ella, had said on September 21 that trials for “paediatric Covaxin” had been completed in about 1,000 volunteers aged 2-18 years and the data submitted to the Drugs Controller for evaluation.
There is no efficacy data made public yet for the vaccine and the Central Drugs Standard Control Organisation has not clarified on why only those above 12 years have been approved for the vaccine despite trials including those below 12 years. There is debate among vaccinologists and public health experts on the use of the vaccine in those below 18 years because have been concerns that the vaccines, if approved for them, would be diverted away from adults who are yet to receive their first and second doses.
“The National Expert Group on Vaccine Administration for COVID-19 and the National Technical Advisory Group on Immunisation are deliberating and considering scientific evidences related to vaccination of children below 18 years of age,” the Rajya Sabha was told by the Centre on December 21.
India has inoculated about 89% of the adults with at least one dose. Those below 18 years form a sizeable 40 crore population and while the current evidence suggests that children are less likely to be ill with the infection, they can be as easily infected and as contagious as adults. The rapid rise in instances of the Omicron variant in India has led to the worry that a future wave is imminent and several States have imposed movement restrictions.
All vaccines globally have shown to produce fewer antibodies against the Omicron variant, seeding the demand for booster doses.
