The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory body, has recommended that the Drug Controller General of India (DCGI) give emergency use authorisation to Bharat Biotech's COVID-19 vaccine Covaxin for children between the ages of 2-18.
Once approved, Covaxin will become the second vaccine to be given to children in this age group. Zy-CoV-D, another indigenous vaccine produced by Zydus Cadila, was the first one to receive approval but is yet to be made available to the public as well as the private vaccination centres.
The vaccine made after inactivating SARS-CoV-2 at the National Institute of Virology needs to fulfil four pre-requisites for approval, the SEC has recommended. Firstly, Bharat Biotech has to continue studying the effect of the inactivated coronavirus vaccine under the approved clinical trial protocol. The pharma manufacturer submitted Phase 2/3 trial data to the committee. This data, however, has not been made public and thus the vaccine's efficacy against the virus is not known.
The SEC also wants the firm to submit their risk management plan, the packaging details which will include package insert, summary of product characteristics, and the fact sheet. Finally, safety data along with any details on adverse events following immunisation (AEFI) with due analysis every 15 days for the first two months and later monthly data is also to be submitted.
Several states have begun opening schools, backed by studies that children are not at a higher risk of developing the disease due to the infection.
Covaxin is a two-dose vaccine that has to be given within a period of 28 days. The vaccine that was given to the adults received emergency use authorisation on January 3, 2021. While its final data was still to be published, the vaccine was a part of India's vaccination campaign that began on January 16, 2021.
The company also applied for the emergency use listing provided by the World Health Organisation. If a vaccine has an approved EUL, it is recognised by most countries across the world, otherwise those who are fully vaccinated are also expected to quarantine themselves. The WHO's vaccine committee has reviewed Bharat Biotech's data and is yet to announce a final decision.