According to the reports on 12th October, an expert panel of India's Central Drug Authority has recommended that Bharat Biotech's Covaxin be given emergency use authorisation for children and adolescents between the ages of 2 and 18, under specific circumstances. This rollout will mark a significant development in the global fight against COVID-19 and also in the field of medicine.

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After Zydus Cadila's needle-free ZyCoV-D vaccine, this will be the second COVID-19 vaccine to obtain EUA for use in individuals under the age of 18, if authorised by the Drugs Controller General of India (DCGI). To ensure that the data submitted to the Central Drugs Standard Control Organisation (CDSCO) for verification and subsequent approval for emergency use authorisation (EUA) for the vaccine is accurate, Hyderabad-based Bharat Biotech completed phase 2/3 trials of the COVID-19 vaccine Covaxin in children aged 2 to 18 years and submitted it to CDSCO in early February.

The approval

On 11 October, the COVID-19 SEC reviewed the data and debated on the EUA application. It was concluded that the vaccine should be approved for limited use in emergency circumstances under certain conditions, as indicated in SEC guidelines for vaccine market authorisation for the age range of 2 to 18 years.

With interim safety and immunogenicity results from a phase 2/3 clinical study, Bharat Biotech proposed to give market authorisation of its Whole Virion, Inactivated Coronavirus Vaccine (BBV152) to children aged 2 to 18 for limited use in emergency situations.

Safety results

Phase 2/3 safety results were examined in a committee meeting on August 26th, according to reports. It was recommended that the paediatric geometric mean titre (GMT) be compared to GMT in the adult population in the phase -3 effectiveness trial.

It is also recommended that in order to comply with the New Drugs and Clinical Trials Rules, 2019, the company submits safety data on AEFI and AESI, together with the necessary analyses, every 15 days for the first two months and thereafter monthly.

Other recent approvals

1. Although the needle-free COVID-19 vaccine ZyCoV-D, created and manufactured in the nation by Zydus Cadila, has obtained EUA from the country's drug regulator, it is the first vaccine in this age range to be given in the country.
2. For phase 2/3 clinical testing of its manufactured in India COVID-19 vaccine in children and adolescents aged between 5 and 18 years, the DCGI gave clearance to Hyderabad-based Biological E Limited on September 1st.
3. Phase 2/3 studies of Covovax on children aged 2 to 17 years with certain circumstances were also permitted by the DCGI in July, according to the Serum Institute of India (SII).

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.