According to health ministry sources, the topic expert committee on Covid-19 vaccines has suggested that the national pharma authority award Bharat Biotech’s Covaxin an emergency use licence for the age group of 2 to 18 years.
The emergency usage authorisation, however, is subject to four restrictions, according to the statement. The expert panel also stated that the firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC), and Factsheet; the firm should submit safety data; and the firm should submit a risk management plan.
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Bharat Biotech had submitted Phase 2/3 clinical trial data from children’s trials to the DCGI last week for verification and certification of the jab’s emergency use authorisation (EUA). Children are likely to receive two doses of Covaxin separated by 28 days. The government has imposed a 4-6-week interval between the two injections for adults. Covaxin is being used on adults in India’s current COVID-19 immunisation programme, developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR).
India’s medicines authority has previously authorised Zydus Cadila’s DNA Covid-19 vaccination for children over 12. The SEC’s recommendation for Bharat Biotech’s Covaxin is based on paediatric research examining the drug’s safety, reactogenicity, and immunogenicity. It is being done in healthy volunteers over the age of two years at six locations around the country.
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The Covavax vaccine, produced by the Pune-based Serum Institute of India, is the third vaccination being tested in children in India. The shots will take place at 23 different locations around the country. The Hyderabad-based Biological E’s Corbevax vaccine is the fourth vaccination being tested in children in India. The trials will take place at 10 different locations around the country.
