Ground Report | New Delhi: Covid vaccine for children; The Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) has recommended the emergency use of Bharat Biotech’s vaccine for children of 2-18 years by the Emergency Use Authorization (EUA).
Covid vaccine for children
Covaccine is India’s first indigenous vaccine developed by Bharat Biotech in collaboration with ICMR and the National Institute of Virology. If it is given the green signal for emergency use, it will be the world’s first COVID-19 vaccine to be used to vaccinate 2-year-olds. In a statement issued on Tuesday, the company said that it has submitted data on clinical trials in the age group of 2-18 years to CDSCO.
The recommendations have been submitted to the Drug Controller General of India (DCGI) after due review by the SEC. A senior central government official told the newspaper that Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the data. The tests were conducted on age groups 2-6, 6-12, and 12 -18.
two doses of Covaxin
Experts said that two doses of Covaxin can be given to children within a span of 28 days. For adults, the government has set 4-6 weeks between the two shots.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the age group 2-18,” the Bharat Biotech statement claimed. The company was awaiting further regulatory approval from CDSCO before product launch and market availability of the vaccine for children.
Dr. Shuchin Bajaj, Founder, and Director, Ujala Cygnus Group of Hospitals highlights, “India has always been known as a vaccine and a drug maker, but never as a drug or drug developer. This is the first time that a vaccine has been developed and produced entirely in India and its efficacy and safety have been proven to be so high that it is now being tested in children.
Dr. (Major) Manish Mannan, Head of Department, Pediatrics and Neonatology, Paras Hospital, Gurugram, while speaking about the availability of vaccines in the private sector said that it will be a watch and wait for the scenario.
“DCGI will have to give its final approval and then start vaccination. As doctors working with children, we will be watching the data closely. I will go slow in vaccination and see how the data comes out in phase four of the trial or when the vaccine is actually being given to children in different parts of the country and in different centres. We’ll have to see the response. Even though the number of children involved in the clinical trial is small, the results have been encouraging. As soon as the vaccination process starts, we will see how it goes, and then we will go ahead and consider using this vaccine,” he remarked.