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Serum Institute of India (SII) has sought permission from the Drugs Controller General Of India (DCGI) to conduct a phase-3 study of its COVID-19 vaccine Covovax as a booster dose in adults, official sources said.
The vaccine was approved by the Indian drug regulator for restricted use in emergency situations in adults on December 28. It is yet to be introduced in the vaccination programme.
Sources told PTI that Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII had last week submitted an application to DCGI seeking nod for phase-3, observer-blind, randomised, controlled study to evaluate the safety and immunogenicity of Covovax as booster dose on those who have received primary vaccination either with Covishield or Covaxin at least three months ago.
"We are sure that your approval for conducting this clinical trial will ensure an early availability of Covovax for booster dose use for people of our country as well as the world in line with our prime minister's vision of 'Making in India for the World'," Singh is learnt to have stated in the application.
"Our firm is committed to providing world-class life-saving vaccines at an affordable price under the visionary leadership of our CEO Adar C Poonawalla. We request you to grant us permission to conduct a phase-3 clinical trial for booster dose of Covovax in Indian adults."
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