The Drug Controller General of India (DCGI) Subject Matter Expert Committee (SEC) on COVID-19 approved on 12 Oct 2021 Covaxin manufactured in India from Bharat Biotech for emergency use for children in the age group of 2 to 18 years. This is a huge positive development in light of the reopening of schools across India and the urgent need to vaccinate children so that they do not become carriers of the virus and bring it home to endanger the elderly. the families. Furthermore, in the much-feared Third Wave of the pandemic in India that may break out after the festival season, there are concerns that children will be the most affected sector of the population. Final DCGI approval can come at any time, as it is considered only a formality. It should be noted that the DCGI had already approved Zydus Cadila’s 3-dose Zycov-D, the world’s first non-injectable DNA-based vaccine, for emergency use in children 12 years and older in August this year. Thus, India becomes one of the few countries in the world, including the US, Canada, China and others, that have already approved vaccines for children or even started giving the shots.

Covaxin based on inactivated coronavirus has been administered in the adult population in India since January 2021 with two doses, with an interval of 28 days between them. The amount of the doses would be the same for children as for adults and it will continue to be injectable; only the interval between the first and the second puncture has been set at 20 days. Bharat Biotech, Hyderabad has told the media that the company completed phase 2 and phase 3 clinical trials in children in September 2021 and submitted the data to the regulator in early October. The SEC had meticulously reviewed the data and has now approved it for emergency use; however, with some clauses that include that the company will continue to develop the vaccine and will have to submit safety data to the DCGI every fortnight for the first two months and then monthly. The vaccine is expected to be launched on the market within a month and the price is likely to be similar to that for adults. Children with comorbidity will be the first priority for needle sticks. It becomes more ironic now that the World Health Organization is still delaying the emergency use approval of Covaxin, resulting in Indians fully vaccinated with this vaccine being quarantined in other countries while traveling.

The positive scenario at this crucial moment is reinforced by the fact that Bharat Biotech is already in the process of developing the vaccine in terms of nasal drops to be administered to children; that the rollout of the approved Zycov-D may begin soon; that the Serum Institute of India (SII), the manufacturer and developer of Covishield as the Indian version of Oxford AstraZeneca, has also been developing Novavax which DCGI had licensed for the start of clinical trials in September 2021 and this vaccine is for the age group 7-11 years.; and that the fourth vaccine for children, Hyderabad-based Biological E’s Corbevax for children in the 5-18 age group, has also been approved for phase 1 and phase 2 clinical trials by the DCGI in early September 2021. This seemingly flattering picture need not make us complacent at all, and we all need to continue with appropriate COVID behavior and avoiding large crowds. The Government of India has recently warned all citizens that the Third Wave is likely to occur after November-December if they do not adhere to the rules.