DCGI needs more safety data for Covaxin nod for under 12

The panel’s job is to make recommendations to CDSCO, but the final call is taken by DCGI.


Last Updated on January 21, 2022 by The Health Master

Although India’s drugs regulator allowed Covaxin jabs for restricted emergency use in children aged 1218 years, it did not do so for younger children despite a recommendation of an expert panel because it wanted to be absolutely sure of the safety aspects, according to people familiar with the matter.

A person aware of the matter said on condition of anonymity: “Safety data is of paramount importance, and the regulator has to be convinced about the data,”

“The safety and other related data that the regulator needed in children, also for a particular time period, he got it in the age group in which the approval was finally granted.”

“In this particular age group (children below 12 years old) organs are developing and its impact on that has to be considered,” the person pointed out. “The safety data was taken for longer period as compared to adults; at least for two-three months more.”

The approval on December 25 from the Drugs Controller General of India (DCGI) came nearly 10 weeks after the subject expert committee of the Central Drugs Standard Control Organization (CDSCO) recommended Covaxin’s use in children on October 12 last year.

The panel’s job is to make recommendations to CDSCO, but the final call is taken by DCGI.

“In children and pregnant women, the drug regulator is taking extreme precaution, which does not mean that in other population groups, precaution has not been taken,” the person said.

“It is just that when it comes to children, one has to tread even more cautiously. The movement of children is greater in this particular age group, for which approval has been granted. ”

Days after the government allowed the use of Covaxin among the 15 to 18 age cohort, Covaxin’s maker Bharat Biotech said in a statement that its vaccine was found to be “safe, well-tolerated, and immunogenic” in the age group of 2-18 years in phase II and III studies.

Neutralizing antibodies in children on average were found to be 1.7 times higher than in adults, the Hyderabad-based firm said. No serious adverse events were reported during the clinical trials, it added.

Covaxin clinical trial data from the pediatric population is very encouraging. “Safety of the vaccine is critical for children, and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children,” Krishna Ella, chairman and managing director, Bharat Biotech, said on December 30.

“We have now achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children.”

As part of the firm’s phase II and III clinical trials and multicentre studies, 374 subjects in the relevant age group were inoculated with two 0.5 ml doses of Covaxin, the same formulation used in adults.

The trials in the paediatric population were conducted between June and September last year.

Researchers involved in the trial have said that the report presented data obtained up to four weeks after the second of two vaccinations, but the study was ongoing to collect data up to six months after the last vaccination, which will be reported separately.

The data was submitted to CDSCO in October, and received an emergency use nod for children aged 12-18 from the drugs controller on December 25.

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