Amidst the fear of a third wave of corona, the corona vaccine for children has been approved. The Drugs Controller General of India (DGCI) has approved Covaxin for 2 to 18 years in the country. Guidelines will be issued soon by the government regarding this Covid Vaccine.
Zydus Cadila’s DNA COVID-19 vaccine has already been approved for children over the age of 12. The decision has brought a big relief to the parents of school going children as educational institutions are now welcoming children to the physical school.
In May 2021, Canada was the first country to approve the Pfizer COVID-19 vaccine for children over the age of 12. In June, China allowed some children aged 3 to 17 to be given shots of Sinovac’s Covid Vaccine.
Some countries are trying to speed up the rollout of the vaccine for children as well. In Sweden, only children aged 12 to 15 years can get the vaccine who have lung disease, severe asthma, or another more serious disease.
According to Dr. Randeep Guleria, Director, All India Institute of Medical Sciences (AIMS), New Delhi, children in the age group 2-18 should be vaccinated “as it is the only way to get rid of the pandemic”.
Things to know:
- The SEC has submitted its application to the Drug Controller General of India (DCGI) for final approval.
- The approval comes after the SEC in May 2021 heard the company’s proposal to conduct tests among children and gave the necessary approvals to conduct the tests.
- Earlier this month, DCGI received data from Bharat Biotech’s Phase II and III clinical trials, which were conducted on children aged 2-18.
- During the trial phase, 528 children were given two doses of Covaxin at 28-day intervals.
- Data based on Phase II and III trials have not yet been made public.
- While the vaccine has been granted emergency use authorization, the World Health Organization (WHO) has not yet granted emergency use authorization to Covaxin.
- While the SEC has granted emergency use authorization, it has also set out four conditions to be followed:
- The makers of Covaxin will continue the study according to the clinical trial protocol approved by Whole Virion, the inactivated coronavirus vaccine.
- Firm to provide updated prescribing information/package insert (PI), summary of product characteristics (SmPC) and factsheet.
- The firm has to submit security data, including data on AEFI and AESI, every 15 days for the first two months and every month thereafter. Further, as per the requirement of the New Drugs and Clinical Trials Rules, 2019, it has to be submitted with proper analysis.
- The firm must also submit a risk management plan.
- While the difference between doses for adults is four to six weeks, there is likely to be a gap of 28 days between two doses given to children.
- The detailed SOP from the Center is awaited to get more clarity on when the vaccine will be available and who will get it first.
- Two vaccines have already been approved, Covavax manufactured by Pune-based Serum Institute of India and Hyderabad-based Biological E’s Corbevax are also likely to start trials for this demographic soon.
