Connect with us

Headlines of The Day

Bharat Biotech submits phase 2 & 3 trials data to DCGI

Pharmaceutical firm Bharat Biotech has submitted phase 2 and 3 trial data of its COVID-19 vaccine Covaxin for children to the Drugs Controller General of India (DCGI).

The country has been waiting for a vaccine for children to get emergency use authorisation (EUA). Bharat Biotech conducted trials for the same two-dose Covaxin, which is being administered to adults, on children. Sources have indicated that the vaccine maker has submitted the trial data to the DCGI and has sought approval for emergency use authorisation nod from the Subject Expert Committee (SEC).

The trials were conducted on children between 2 and 18 years of age and they were given the doses in a gap of 28 days. It remains to be seen how soon the regulator takes Bharat Biotech’s application forward and submits it for the SEC nod. Only after SEC’s recommendation, the government grants EUA.

Meanwhile, it’s also important to see how soon the government will come up with basic parameters about the categories and age groups of children who will be administered the vaccine first.

The World Health Organization (WHO) and an independent group of experts are also scheduled to meet next week to carry out a risk-benefit analysis to come to a conclusion on granting an emergency use license (EUL) to Bharat Biotech’s Covaxin. It must be noted that Bharat Biotech has been submitting data to WHO on a rolling basis and the latter is likely to come to a decision once all the questions are addressed. CNBCTV18

error: Content is protected !!