Granted Emergency Use Authorization (EUA) for two COVID-19 vaccines on 26 April Corbevax for 5-11 year olds, and Covaxin for 6-11 year olds – is another example where the Indian drug regulator has acted in haste. even though Covaxin was granted EUA in January 2021 As a desperate measure to ensure greater vaccine availability despite no safety and efficacy data from the Phase-3 trial, the regulator apparently has no way of protecting the green light of vaccines for children at this stage. Fig is not leaf. Evidence from around the world after deadly delta version And the extremely transmissive Omicron variant has shown that unlike adults, children in general and young children in particular do not suffer from serious illness. ICMR’s fourth seroprevalence survey (June-July 2021) Immediately after the second wave peaked nationally, it was found that 57.2% of children (6-9 years) and 61.6% of children (10-17 years) were infected with the SARS-CoV-2 virus; Seroprevalence in adults was 66.7%. Since vaccination of adolescents began as early as January 2022, the only antibodies detected in children in mid-2021 were from virus infection. The highly contagious Omicron variant may have infected a large percentage of children as well. Nevertheless, the number of severe cases and deaths in children aged 5-11 years has been very small. True, the reopening of schools could put children at a higher risk of infection. But with natural infections found to provide protection in all age groups, India could wait for the evidence available on vaccines for children to be verified.
Unlike in January 2021 when the earliest approval of vaccines for adults was a top priority, and therefore the EU was seen as a necessity based on the low number of cases and short follow-up, the situation is no longer the same, especially in the case of in children under five years of age. Therefore, the urgency of the regulator to approve vaccines for children under the EUA route is highly questionable. Clinical trial data of Corbevax for children 5-12 years old were posted as a preprint, which has yet to be peer-reviewed, on the day approval was granted; Trial data for Covaxin for children 2-18 years old were posted as a preprint in December 2021. The health ministry had already set an example last month. Corbevax approved for children 12-14 years old without approval from the National Technical Advisory Group on Immunization (NTAGI), which approves vaccines for the National Immunization Program. The NTAGI is categorically against approving vaccines for children, in all likelihood the expert body will again be overlooked. Also, Prime Minister Narendra Modi’s message on 27 April, a day after the European Union, that every eligible child should be vaccinated as soon as possible, may prompt the health ministry to once again sidestep the NTAGI, saying that Type may deviate even more from evidence-based policy making.