Bharat Biotech’s Covaxin gets emergency approval for kids aged 2-18 years

In May this year, drugs controller general of India Dr VG Somani permitted Bharat Biotech to conduct phase 3 clinical trials of its Covid vaccine on 525 child volunteers
Covaxin clinical trials data of 2-18 years age group has been submitted to Central Drugs Standard Control Organisation. (HT PHOTO)
Covaxin clinical trials data of 2-18 years age group has been submitted to Central Drugs Standard Control Organisation. (HT PHOTO)
Updated on Oct 12, 2021 02:41 PM IST
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The national drugs regulator’s subject expert committee approved the use of Bharat Biotech’s Covaxin’s in children between 2 and 18 years of age as a layer of protection against coronavirus or Covid-19 disease, people familiar with the matter said. An official claimed that Covaxin’s efficacy among children was found to be similar to that in adults but a decision on its inclusion in the national vaccination programme was yet to be taken.

Covaxin is the second Covid-19 vaccine to be approved for emergency use among children in India after Zydus Healthcare’s ZyCoV-D, meant for children above 12 years of age.

“As per the data that the company submitted, the vaccine has been found to be safe and efficacious in children. The experts were of the opinion that it should be allowed for use in children,” a senior official said on condition of anonymity.

In May this year, drugs controller general of India Dr VG Somani permitted Bharat Biotech to conduct phase 3 clinical trials of its Covid vaccine on 525 child volunteers. After it ended in September, the trial data was submitted to the drugs regulator in the first week of October.

“However, whether it will be introduced in the national Covid-19 immunisation programme, and if yes, then how soon, will be for the expert panel on immunisation to decide,” added the official.

If introduced, the vaccination is likely to happen through pre-filled syringes for better dose accuracy, he added.

According to the experts involved in the clinical trials, the safety and efficacy of Covaxin in the paediatric age group has been found to be almost similar to that in adults, which was 77.8%, as per the phase 3 clinical trials data on adults.

“COVAXIN Clinical trials data of 2-18 years age group has been submitted to Central Drugs Standard Control Organisation (CDSCO). COVAXIN is the first Covid-19 vaccine to be tested in the 2-6 years age group. This was feasible due to the safety of the manufacturing platform and empirical evidence from phase I, II, III clinical trials in adults,” said India’s vaccine major in a statement.

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Meanwhile, WHO (World Health Organisation) experts will meet this week to take the final decision on whether to grant emergency use listing to Covaxin-- an inactivated whole virion vaccine.

The approval could greatly influence how other countries treat people vaccinated with Covaxin. Experts from WHO, and a group of independent experts, are going through the data, and are expected to carry out the risk-benefit assessment before arriving at a conclusion.

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Wednesday, October 20, 2021