Covaxin For Kids above 2 years
Finally, there is relief for the parents. As now there is a covid 19 vaccine for kids above 2 years! Yes, for the first time in World, Covaxin got the emergency approval from DCGI (Drugs Controller General of India) on 12th October, 2021.
After this approval Covaxin is allowed to use for kids above 2 years of age. After the approval of the Covaxin for kids, India will become the first nation of vaccinating of this age group in World.
Covaxin For Kids above 2 years Dose and Timing
Covaxin got approval for the age group of kids above 2 years to 18 years. The dose is as same as the dose of the adult shots. Only the dose gap between the two shots is advised as 20 days.
As said, the gap between the first dose and the second dose for the age group 2 — 18 years will be 28 days. Here it is important to mention for adults this gap is 28 days to 40 days.
To get the maximum benefit from the vaccine maintain the 7 essential steps before and after vaccination. It will help your kid to get the more strong immunity against covid.
Other Available Covid Vaccines for Children
Although Covaxin is the not the first vaccine in India that is approved by the Indian Government for children. Previously, in August, Zydus Cadila’s ZyCoV-D vaccine was first approved to give to children. This ZyCov-D Vaccine is world’s first DNA injection less vaccine with three doses.
Although, the Zycov-D vaccine was approved for children only above 12 years of age. This is for first time, not in India but worldwide any vaccine is approved to give to kids above 2 years.
Here it is important to mention, that even ZyCoV-D vaccine is just officially approved for aged above 12 years but not yet started to administrated clinically in India. Whereas, in the USA, U.S. Food and Drug Administration (FDA) has given the Pfizer-BioNTech COVID-19 vaccine emergency use authorization for children ages above 12 years. Similarly, in many different countries in Europe this vaccine is allowed for children above 12 years of age.
Covaxin For Kids and Children Trials
The Bharat Biotech Covaxin was clinically trialed in three phases for children. The first phase trial was on an age group of between 12 years —18 years. Then the second trial phase was with the age group of 6 years —12 years. And the final stage three trial was conducted with the age group of 2 years— 6 years.
As reports coming this phase three trial was conducted on 525 child volunteers. All the trials were conducted with measuring and maintaining all safety precautions. Bharat Biotech conducted the phase 2 and phase 3 trials on the pediatric age group and the last trial is completed by September.
There is also a not verified claim from different medical sources that Covaxin shows almost equal efficacy in children as like in the adults of 77.8% among mild to moderate covid cases. Although the claim is yet to be verified. The trial report including the efficacy of Covaxin in children is not yet available in the public domain.
Covaxin For Kids and Children Approval
But as reports are coming, Bharat Biotech submitted the detailed efficacy data of Covaxin in the age group of 2 years to 18 years to the expert panel of DGCI in October, 2021. After reviewing that data, examining all the details, the Subject Expert Committee (SEC) of the drug regulator has recommended Covaxin as an emergency use for kids above 2 years. So drug controller has yet to give the final NOD to Covaxin.
Although the expert committee recommended emergency use approval of Covaxin with a prior four conditions. The four conditions are:
- The Covaxin company will continue the study of its effect as per the whole virion, Inactivated coronavirus vaccine the approval clinical trial protocol
- The Covaxin firm will provide updated Prescribing Information/ Package Insert (PI), a summary of product characteristics (SmPC), and a factsheet.
- The firm needs to submit the safety data, including the data on AEFI and AESI with corresponding analysis, every 15 days for the first two months and thereafter monthly basis as per the law of New Drugs and Clinical Trials Rules, 2019.
- The firm needs to submit the risk management plan
In a statement, Bharat Biotech stated they are waiting for the official regulatory approval from Central Drugs Standard Control Organisation (CDSCO). As CDSCO already provided their positive feedback. So hopefully by mid of November, this Covaxin will be available in the market for children.
Approval of WHO
Here it is important to note that till date the Covaxin is waiting to get approval from the WHO. Reports saying the World Health Organization (WHO) is possibly going to give the much-awaited approval to Covaxin this week as there is a meeting of members to take the final decision about Covaxin. So once it get approval from WHO, it will be easy to get the same approval for kids. Lets hope for the best. To date we parents keep protecting our child from covid 19. Stay healthy and happy.