The evaluation, according to Dr Bharati Pravin Pawar, Minister of State for Health, is still underway.
The COVID-19 Subject Expert Committee of the Indian government has endorsed Bharat Biotech’s Covaxin for children aged 2 to 18.
The Drugs Controller General of India, the country’s drug regulator, has recommended the COVID-19 vaccine for emergency use clearance.
DCGA has not authorized Covaxin, assessment going on: MoS Health
However, as per Dr Bharati Pravin Pawar, Minister of State for Health, the assessment is still ongoing.
She said there is considerable ambiguity, and discussions with the experts’ committee are underway. The Drugs Controller General of India (DCGA) has not yet authorized it, Dr Bharati said.
SEC makes favorable recommendations about Covaxin
However, COVAXIN (BBV152) data from clinical studies in the 2–18-year-old age range has been submitted to CDSCO by Bharat Biotech. The CDSCO and the Subject Experts Committee (SEC) have extensively evaluated the evidence and made favourable recommendations.
Covaxin to be only the second approved vaccine for children in India
The Drug Controller General of India will provide final clearance, which is considered a formality.
When it gets the final nod, Covaxin will be only the second vaccination approved for use on children in India; Zydus Cadila’s three-dose DNA vaccine was approved for use on adults and children over the age of 12 in August.
The Serum Institute’s Novavax vaccine is a third possible vaccination for children, and the DCGI approved studies for kids aged 7 to 11 years old last month. Another is Biological E’s Corbevax, which has been approved for advanced testing on children over the age of five.
Bharat Biotech to abide by certain conditions
According to the terms, the company must carry out the study according to the authorized clinical trial protocol and produce revised prescription information/package insert (Pl), Summary of Product Characteristics (SmPC), and Factsheet, according to National Herald.
Furthermore, the company must report safety data, including AEFI and AESI data, every 15 days for the first two months and then monthly afterwards, as required by the New Drugs and Clinical Trials Rules, 2019.
It is in place to mention here that after administering over 96 crore doses to adults, India is progressively shifting its emphasis to vaccinating children against the pandemic of COVID-19.