Biological E’s Covid-19 Vaccine Gets DGCI Nod for Phase 2/3 Trials on Those Aged Between 5 and 18
Biological E’s Covid-19 Vaccine Gets DGCI Nod for Phase 2/3 Trials on Those Aged Between 5 and 18
This would be the fourth vaccine to conduct trials on children in India after Bharat Biotech, Serum Institute and Zydus Cadila.

The Drugs Controller General of India (DGCI) has permitted Hyderabad-based Biological E to conduct phase 2/3 clinical trials of its Covid-19 vaccine on children and adolescents aged between 5 and 18 years.

The trials will be conducted in 10 sites across the country.

This would be the fourth vaccine to conduct trials on children in India after Bharat Biotech, Serum Institute and Zydus Cadila.

With schools in several states, including Delhi, Uttar Pradesh, Rajasthan reopening in a phased manner, opinions are divided on whether this is the right time to send children back to school or should parents wait for the children to get vaccinated.

The parents are dealing with questions such as when the vaccination of children is going to start and what will be the eligibility for the first vaccine dose?

ZyCov-D

The first Covid-19 vaccine for adolescents in India is expected to be Zydus Cadila’s needle-free ZyCov-D. The National Technical Advisory Group on Immunization is in discussions to outline the roadmap to introduce the DNA-based vaccine for the general population. According to sources, the panel is soon expected to prioritise beneficiaries in the age group of 12-18.

Bharat Biotech

The next candidate is Bharat Biotech’s paediatric dose. Last week, the company presented interim safety data to the Central Drugs Standard Control Organisation (CDSCO). According to sources, Bharat Biotech will submit the final data by the end of September. Hopefully, the results will be promising.

Covovax

Finally, Covovax for children between the age of 2 and 17 years with certain conditions will be launched in the beginning of 2022—most likely in January-February — according to Adar Poonawalla of Serum Institute of India.

Biological E’s Corbevax, which is RBD sub-unit vaccine is undergoing phase 2/3 trials on adults. Biological E will supply 30 crore doses of Corbevax to the Centre by December, as announced by the health ministry in June.

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