The Subject Expert Committee (SEC) on COVID-19 of the Drug Controller General of India (DCGI) has on 12th October 2021 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 of the world including the US, Canada, China and others that have already approved vaccines for children or 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 2021, and submitted the data to the regulator early in October. 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 on a monthly basis 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 co-morbidity will be the first priority of jabs. It becomes more ironical now that the World Health Organization is still delaying the emergency-use approval to Covaxin making the fully vaccinated Indians with this vaccine quarantine in other countries while traveling.
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 in September, 2021 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-1 and phase-2 clinical trials by the DCGI in early September, 2021. 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. The Government of India has recently warned all citizens about the likelihood of the Third Wave post November-December if they do not adhere to the norms.