DCGI Seal Awaited As Its SEC Approves Covaxin For Emergency Use For Kids Of 2—18 Age Group!


The Subject Expert Committee (SEC) on COVID-19 of the Drug Controller General of India (DCGI) has today approved Bharat Biotech’s India-made Covaxin for emergency use for kids in the age group of 2 to 18 years. This comes as a big positive breakthrough in light of the reopening of schools across India and the urgent need of vaccinating the children so that they do not become carriers of the virus and bring it home to jeopardize the elders of the families. Further, in the much feared Third Wave of the pandemic in India that can actually break out after the festival season there has been a concern that the kids would be the worst affected section of the population. The final approval of the DCGI may come any time soon as it is being considered as just a formality. It is to be noted that the DCGI had already approved Zydus Cadila’s 3-dose Zycov-D, the first DNA-based non-injectable vaccine of the world, for emergency use in children of 12 years of age upwards in August this year. Thus, India becomes one of the few countries including the US, Canada, China and others that have already approved vaccines for children and even started administering the jabs.

 

The inactivated coronavirus based Covaxin has been administered in the adult population in India since January 2021 with two doses—an interval of 28 days in-between. The quantity of the doses would be same for children as for the adults and it will continue to be injectable; only the interval has been fixed at 20 days between the first and the second jabs. Bharat Biotech, Hyderabad has said to the media that the company had completed phase-2 and phase-3 clinical trials on children in September and submitted the data to the regulator early this month. The SEC had gone through the data meticulously and has now approved it for emergency use; however, with a few riders including that the company would keep on developing the vaccine and will have to submit the safety data every fortnight to the DCGI for the first two months and then every month afterward. The rollout of the vaccine in the market is being expected within a month and the pricing is likely to be similar as for the adults. Children with comorbidities will be the first priority of jabs. It becomes more ironical now that the World Health Organization is still delaying the final approval to Covaxin. 


The positive scenario at this crucial juncture is further enhanced by the facts that Bharat Biotech is already in the process of developing the vaccine in terms of nasal drops to be administered to the kids; that the rollout of the approved Zycov-D can start anytime soon; that the Serum Institute of India (SII), the manufacturer-developer of Covishield as the Indian version of the Oxford AstraZeneca, has also been developing Novavax which the DCGI had cleared for the start of clinical trials last month and this vaccine is for the age group of 7-11 years.; and that the fourth vaccine for kids, Hyderabad based Biological E’s Corbevax for children for the age group of 5—18 has also been cleared for phase-2 and phase-2 clinical trials by the DCGI in September too. This seemingly rosy picture need not make us complacent at all, and all of us must continue with the COVID appropriate behavior and avoiding big crowds. As we have said in an earlier post the next 3-4 months are going to be crucial for the final say on the Third Wave, and the Government of India has also recently warned about the aftermath of November-December if we do not adhere to the norms.

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