Getting the experts’ perspective, Health News, ET HealthWorld

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Covaxin gets SEC approval: Getting the experts’ perspectiveBharat Biotech’s Covaxin received nod from Subject Expert Committee (SEC) on Tuesday who further proffered positive recommendation to DCGI for the use of Covaxin in 2-18 years age group. Bharat Biotech has earlier submitted data from clinical trials to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab at the beginning of this month.

If approved by DCGI, Covaxin will become only the second vaccine after Zydus Cadila’s ZyCoV-D to be granted permission for inoculating children in 2-18 age group.
Here is what the experts had to say on the development:

Dr Vinit Samdani, Pediatrician, Bhatia Hospital Mumbai said, “This is a major breakthrough in vaccinating children between 2 to 18 yrs. We are now seeing the light at the end of the tunnel we have been waiting for. Trials have been conducted on thousands of kids and there are two shots with a 20 days gap. Initially, there is going to be a close watch on any side effects and to report every 15 days for the first two months and then on monthly basis. We must wait for the launch officially. Initially, there will be few challenges in the logistics of vaccination of kids as decisions haS to be taken where it should be done and whether it will be available in private set ups. Hopefully in the next few weeks it will be out to use as routine standard protocol. Also NOVAVAX 7 to 11 and CORVEVAX for 5 years and above will be coming up soon along with Zydus vaccine already ready.”

Dr. Akshay Budhraja, Senior Consultant, Pulmonology, Aakash Healthcare said, “This move will be beneficial both for the child as well as people around them. We need to achieve herd immunity and decrease the risk of further waves. No doubt, children and adolescents are vulnerable groups and if the vaccine safety data is strong enough and we immunise them, it will have a big impact in reducing the transmission of covid. This will be a major step as school, coaching centres and sport centres are gradually opening. Since the covid vaccination is yet to arrive for children and is at the trial stage, we need to see that we provide proper protection to them by giving them timely vaccination so that the severity of the infection significantly come down even in case they end up contracting covid.”

Dr. Gauri Agarwal, Gynaecologist, Seeds of innocence & Genestrings diagnostics said, “The recommendation of the Subject Expert Committee to use Covaxin in children aged between 2 and 18 years is a step towards defeating the pandemic. It is the second vaccine for children and as they resume school, having a vaccine for children will certainly help them return to normal lives faster. However, according to the principal investigator of Covaxin trials on children, vaccine safety and immunogenicity results are awaited. It is important to establish the efficacy of the vaccine by the time it is approved for administration. At the same time, efforts must be made to establish the efficacy of the vaccine globally so that the children are not subject to restrictive measures when they travel abroad.”

Himanshu Sikka, Lead – Health, Nutrition and WASH, IPE Global said, “With school opening in many states, the vaccine will help bring normalcy sooner. It is also a proud moment for the country that a homegrown vaccine is one of the first globally to get emergency use authorization for children that young. What will of course be a cherry on the cake will be if WHO also provided its approval on the vaccine sooner.”

Dr. Kanchan Channawar, Consultant Pediatrician, Kamineni Hospitals said, “Covaxin is an inactivated killed vaccine which is made by conventional method same as other vaccines we are using from decades like DPT polio Flu. It has proven very effective in adult population without significant side effects so hopefully it will have a similar effect in the pediatric population from above 2 years. It will not only give the protection but also help to restore the faith among parents to send their kids to school”

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