We can now say that India will soon be able to ebb the Covid-19 pandemic as kids between 2-18yrs will now get vaccinated, and we will hopefully cover the maximum population of our nation. In good news, the Subject Expert Committee on Covid-19 has granted emergency use approval to Covaxin for children in the aforesaid age group. Although kids in the age of 12-18yrs had recently been authorized to receive the COVID vaccine shots, children below that age remained vulnerable.
Covaxin will continue its research and clinical trial and provide updated prescribing information/ Package Insert (PI), Summary of Product Characteristics (SmPC), and factsheet. Moreover, the firm will have to submit safety data including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and as per the requirement of New Drugs & Clinical Trials Rules, 2019.
Covaxin gaining approval in children above two years of age is great and timely news as this will help in stemming the spread of COVID19 and help in making the new normal safer. However, there will be many parents who can get skeptical. Here is what you should know.
It is well known that kids and young adults generally suffer a milder version of COVID19. However, the debilitating symptoms can linger for months after even a mild bout of COVID19. What we also know is that there is almost four times less chances of dying if adults were to get vaccinated and the infection rates have been highest among the unvaccinated groups
Vaccination will help to prevent kids from serious illnesses and in reducing the spread in this age group, just as in adults. Although COVID19 in children is sometimes milder than in adults, some kids infected with the Coronavirus can get severe lung infections, become very sick and require hospitalization. This is especially important to remember considering the Delta Variant, which is more contagious than other Coronavirus variants. The current vaccines are still effective in preventing severe illness
Also, this will allow kids to get back to school safely which is the foundation of a healthy productive adulthood. More importantly, they will be able to do things that they were not doing in view of the pandemic. This will go a long way in their academic, social-emotional and physical development Moreover, with kids getting vaccinated, the entire family can be protected
The National Serological Survey suggests about 60% seropositivity in children and thus some immunity to the infection because of a past infection picked up in the pandemic. However, we know that native immunity may not be as durable, resilient, and strong as compared to vaccine acquired immunity. Thus, undoubtedly, vaccine is the need of the hour in this age group not only as a means of protection, but also to help achieve herd immunity.
The Covaxin trial has shown very similar immunogenicity and safety as that seen in adults. The Subject Expert Committee under India’s drug regulator has given its nod for the vaccine based on the interim data submitted. Besides this, zyCOV-D is the first vaccine brought into the Indian market for children between 12-17 years.
Having your child vaccinated against COVID19 can therefore help restore more normal life. The only challenge will be to assure accessibility and availability for a very large vaccination target. Moreover, we will need more data from the vaccine manufacturers about aspects related to the number of children under trial, allergic reactions if any, level of antibodies developed etc., to get a clear picture. We can be hopefully that by Diwali we will receive concrete data to ward off fears.
Dr Sanjith Saseedharan and Dr Jesal Sheth are Consultant & Head-Critical Care, SL Raheja Hospital, Mahim and, Senior Consultant-Paediatrician respectively at Fortis Hospital, Mulund.