NEW DELHI (XINHUA) – India’s drugs controller has rejected vaccine maker Bharat Biotech’s request to conduct clinical trials of Covaxin on children and asked the company to submit its report on the efficacy of the Covid-19 vaccine, local media said on Thursday (Feb 25).
The drug regulator’s rejection came after hearing an application by Hyderabad-based pharma company on Wednesday sought approval for phase three clinical trials of Covaxin on children between five and 18 years of age. The subject expert committee of the Central Drugs Standards Control Organisation asked the company to produce efficacy data on adults for its vaccine before seeking permission to test Covaxin on children.
“The efficacy data is top priority and they will also have to produce that data that has been asked for by the experts before more permissions are granted,” local daily Hindustan Times quoted drugs controller officials as saying.
Covaxin is already approved for use in India for adults in a clinical trial mode based on the safety and immunogenicity data the company submitted. The company is yet to submit the phase three efficacy data to the drugs controller.
Apart from Covaxin, India has approved Covishield from Oxford-AstraZeneca being manufactured by the Serum Institute of India, for emergency use in the country. The vaccination drive in India started on Jan 16. At present, healthcare and front-line workers are being vaccinated. The second phase will begin next month.
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