COVID-19: Covaxin approved for use among children; know all about its efficacy & safety

Shortly after the Drug Controller General of India (DGCI) gave approval for Emergency Use Authorisation (EUA) of Covaxin for children aged between 12 and 18, Prime Minister Narendra Modi also in a sudden address to the nation on Saturday evening announced about vaccinating children between the age of 15 to 18 followed by booster shots for frontline workers, healthcare workers, and senior citizens. 

In light of the growing cases of Omicron infections across the country, kids are the most vulnerable, and need to be vaccinated at the earliest. This has become more important amid reports of children getting infected by the virus, creating a tense situation among parents. 

Notably, the approval by DGCI was made on the recommendations made by the Subject Expert Committee (SEC) based on the trial data results and scientific evidence as related to the vaccination of those in the 12 to 17 age group. With the recent announcement, Covaxin has now become the second approved vaccine for use among children in India. Earlier in August, the three-dose DNA jab by Zydus Cadila was allowed to use for adults as well as children above the age of 12.

DGCA approval order on vaccination for children

As stated by the Drug Controller General of India in an official order, Covaxin will be administered to the children in two doses with a gap of 28 days between the first and second jabs respectively. Also, as per the trial data submitted to the government, the gap and dosage for the address as well as children will remain the same. 

"Based on the recommendations of SEC experts and submission of additional safety data, this directorate has no objection at this stage for the additional indication of Whole Virion inactivated corona virus vaccine for use in the age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in an emergency situation with the condition to submit SmPC, PI, Factsheet incorporating clinical information for said age group along with pharmacovigilance & risk management plan", it said. 

Similarly, the vaccine manufacturing company Bharat Biotech in its statement also said that Covaxin has been formulated in a unique manner for safe usage among children and adults.

"Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. We have documented excellent safety and immunogenicity data readouts in children. We look forward for Covaxin to provide similar levels of protection for adults and children alike", it said. 

Earlier in October, Bharat Biotech also submitted its data from clinical trials of Covaxin doses on children between the age group of 2-18 to the Central Drugs Standard Control Organisation (CDSCO). This data was already reviewed by the CDSCO and the experts later provide positive recommendations.

The vaccine-making company has also claimed doses of the indigenous vaccine Covaxin to have 77.8% efficacy in the phase 3 trials against COVID-19.  

Meanwhile, with vaccines being approved for use among children in India, regulatory processes are underway to make children's registration on the CoWIN platform, enabling them to get themselves booked for the jab.

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