The Central Drugs Standard Control Organisation (CDSCO) is examining recommendations and has sought additional information on administration of Covaxin for children.
Previously, the interim phase II/III clinical trial data of Covaxin on healthy volunteers aged 2 to 18 submitted by Bharat Biotech was deliberated at a meeting of the Subject Expert Committee (SEC).
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The committee recommended the grant of market authorisation for the age group of 2 to 18 for Restricted Use in Emergency Situation, subject to various conditions, said Minister of State for Health and Family Welfare Bharati Pawar in reply to a question in Parliament on use of Covaxin for children.
Study
The statement comes close on the heels of a study conducted between March 2020 and July 2021 and published recently in The Lancet Respiratory Medicine. It said that school-aged children with asthma and previous hospital admission and two or more courses of oral corticosteroids were at markedly increased risk of COVID-19 hospital admission and should be considered as priority for vaccination.
The national incident cohort study was done in children aged 5 to 17, who were included in the linked dataset of Early Pandemic Evaluation and Enhanced Surveillance of COVID-19
Through the study, researchers were trying to provide national evidence that children and those aged 5–17 years with poorly controlled asthma are at increased risk of COVID-19 hospital admission.
“These findings can be used for informed deliberations on prioritising COVID-19 vaccination for children. Consideration needs to be given to extending the offer of vaccination to younger children also,’’ noted the study.
The Global Asthma Report 2018 estimated that 6% of Indian children have asthma and this has to be seen in the context of rising pollution levels also. Some estimates suggest that the total number of asthma patients in India could be in the range of 1.5 to 2 crore.
Booster dose
Ms. Pawar said that while there were countries which were providing booster doses of COVID-19 vaccine, “in India, the National Technical Advisory Group on Immunisation (NTAGI) and National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) are deliberating and considering scientific evidences related to dose schedule of Covid-19 vaccines as well as the need and justification for booster dose’’.
