Government panel recommends permission for phase-III trial of Covovax as booster dose in adults

The Drugs Controller General Of India (DCGI) has already approved Covovax for restricted use in emergency situations in adults on 28th December

An expert panel of the Central drug authority has recommended permission for conducting a phase-III clinical trial of COVID vaccine Covovax as a booster dose in adults, official sources said recently.

The Drugs Controller General Of India (DCGI) has already approved Covovax for restricted use in emergency situations in adults on 28th December.

It is yet to be included in the inoculation programme.

The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had last week recommended giving permission for conducting a phase-III clinical trial of the single-dose vaccine Sputnik Light as a booster dose.

In February, Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum Institute of India (SII), had sought from the DCGI nod to conduct a phase-III, observer-blind, randomised, controlled study to evaluate the safety and immunogenicity of Covovax as a booster dose in adults who were vaccinated with Covishield or Covaxin at least three months ago, an official source had said.

Singh had said many countries have already started administering booster doses to their citizens considering the uncertainties of the pandemic.

“We are sure that your approval for conducting this clinical trial will ensure early availability of Covovax for booster dose use for people of our country and the world at large in line with our Prime Minister’s vision of ‘Making in India for the World.”

“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 kindly grant us permission to conduct a phase-III clinical trial for booster dose of Covovax in Indian adults,” Singh is learnt to have written in the application.

Covovax is manufactured by technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation and has also been granted emergency use listing by WHO.

In August 2020, the US-based vaccine maker Novavax Inc had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.