Form of words:
New Delhi: The Subject Expert Committee (SEC) on Tuesday recommended India’s ‘first’ indigenous COVID-19 vaccine Covaxin for use on children in the age group of 2-18 years.
The SEC will now send its recommendations to the Drug Controller General of India (DCGI).
However, the SEC recommends that Covaxin continue to be studied in children in accordance with approved clinical trial protocols.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the age group 2-18. Bharat Biotech extends its heartfelt thanks to DCGI, Subject Expert Committee and CDSCO for their prompt review process. Bharat Biotech said in a statement, “We now await further regulatory approval from CDSCO prior to product launch and market availability of COVAXIN for children.”
clinical trials in children
While the use of Covaxin in adults is already approved, Phase 2/3 Clinical Trials Completed last month for kids. data from clinical trials was Presented DCGI on 6th October
The clinical trials were conducted on 525 children in the age group of 2-18 admitted in several centers across India, including Meditrina Institute of Medical Sciences in Nagpur, AIIMS Patna and JLN Medical College in Ajmer.
While the vaccine is the same for adults and children, there are differences. Allegedly how it is administered.
Covid-19 vaccines for adults come in vials that contain multiple doses of the vaccine. However, pediatric Covaccine will come in pre-filled syringes, which are used for better dosing accuracy.
The vaccine dose for children will be 0.5 ml, the same as for adults.
Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is an inactivated vaccine, which means it contains an ‘inactivated’ version of the virus so that it no longer causes infection. However, parts of the virus can still be recognized by the body’s immune system and trigger an immune response.
Trials in adults have already demonstrated 77.8% vaccine efficacy against symptomatic COVID-19 disease. The efficacy against severe symptomatic COVID-19 disease has been shown to be 93.4%.
NS efficacy data Demonstrates 63.6% protection against asymptomatic COVID-19.
Bharat Biotech has stated that the vaccine can neutralize various emerging forms – B.1.1.7 (alpha), first isolated in the UK, P.1 (gamma), and P.2 (zeta), first in Brazil. Isolated in AD, B.1.617 (kappa), first isolated in India, B.1.351 and B.1.617.2 (beta and delta).
Efficacy data shows 65.2% protection against SARS-CoV-2, B.1.617.2 delta variant, which caused a devastating second wave in India.
Read also: Talking about COVID booster shots is not fair, studies show antibodies in last one year: ICMR chief
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