Parents in India can heave a sigh of relief as the drug regulator’s subject expert committee (SEC) has now recommended granting an emergency use authorisation to Covaxin for children aged between 2-18 years. The recommendation is now pending before the Drugs Controller General of India (DCGI) for final approval. If all goes well, the vaccine shots will be available for children soon.
Covaxin is India’s first indigenous vaccine that has been developed by Bharat Biotech in collaboration with the Indian Medical Research Council (ICMR) and the National Institute of Virology (NIV). Covaxin’s trials for children were done across three age groups of 12-18 years, 6-12 years, and 2-6 years.
“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergencies subject to the certain conditions,” said the Subject Expert Committee (SEC), in its recommendations.
However, the emergency use authorisation is subject to four conditions:
- Continue the study as per Whole Virion: The developer of the Covaxin vaccine is supposed to continue the study as per the whole-virion, inactivated coronavirus vaccine approved clinical trial protocol.
- Provide updated package inserts/SmPC: The company should provide updated Prescribing Information/Package Inserts (PI), Summary of Product Characteristics (SmPC) and factsheets in their vaccine packs.
- Submit safety data: The company is required to submit safety data with due analysis, including data on AEFI and AESI, every 15 days for the first two months and thereafter every month.
- Risk management plan: The company is required to have a risk management plan in place.
Last week, Bharat Biotech had submitted their Phase 2 and Phase 3 clinical trials’ data of the children’s trials to the DCGI for verification and subsequent approval for emergency use authorisation. Bharat Biotech had stated that this represented one of the first approvals worldwide for COVID-19 vaccines for the 2-18 years age group.
Their statement further said that they are now awaiting further regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO). The approval is necessary for the product launch and market availability of Covaxin for children.
The Covaxin dosage for children will be administered in two shots within a gap of 28 days. This is the second COVID-19 vaccine in India to get approved for children. In August, the DGCI had approved ZyCoV-D for children aged 12 years and above. However, the vaccine has not yet been rolled out.
The Serum Institute of India is currently conducting trials on children aged seven years and above for Novavax’s COVID-19 vaccine (Covovax). The next phase of trials will include children aged two years and above. Hence, Covaxin is the first paediatric product that is available in India.
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