Indian drug regulators have approved Hyderabad-based Bharat Biotech’s proposal to carry out a clinical trial of its Covid-19 vaccine on children aged between two to 18 years.
The Subject Expert Committee on the Central Drug Standards Control Organisation met on Tuesday to approve the phase-II/III trial in which the Covaxin’s ability to generate immune response among the kids and its ability to protect the kids will be examined.
The company first put forward the proposal before the CDSCO panel in February when it proposed a clinical trial for children between five and 18 years. The regulator asked the firm to revise the proposal and submit the fresh clinical trial protocol.
"After detailed deliberation, the SEC recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with Data Safety Monitoring Board recommendations to the CDSCO before proceeding to phase III part of the study," PTI reported, quoting a source.
The trial will take place in 525 kids at various sites including All India Institute of Medical Sciences, Delhi; AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
“Recently, the SEC gave permission for vaccine trials on children from two to 18 years of age to Bharat Biotech. We're waiting for the DCGI approval. Hopefully, we will soon start phase II and phase III trials,” said Sanjeev Sinha, a professor at the department of medicine, AIIMS.
Bharat Biotech’s Covaxin is one of the two Covid-19 vaccines being used in India at the moment along with Serum Institute’s Covishield. Developed by Indian scientists, the vaccine has been currently approved for use in individuals above 18 years.
Interim results from phase-III trials of Covaxin have demonstrated overall interim clinical efficacy of 78 per cent for the vaccine and 100 per cent efficacy against severe Covid-19 disease