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The subject expert committee (SEC) of India's drug authority had granted permission to Serum Institute of India (SII) for conducting a phase-3 clinical trial of Covid-19 vaccine Covovax as a booster dose in adults, reported news agency PTI, quoting officials, on Sunday.
SII had in February sought the Drugs Controller General Of India's nod to conduct a phase-3, observer-blind, randomized, 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 3 months ago.
“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 as well as the world at large in line with our prime minister's vision of 'Making in India for the World'," Prakash Kumar Singh, director of government and regulatory affairs at SII, had written in his 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 kindly grant us permission to conduct a phase-3 clinical trial for booster dose of Covovax in Indian adults," he added.
Singh had stated many countries have already started administering booster doses to their citizens considering the uncertainties of the Covid-19 pandemic.
The DCGI had on 28 December last year approved Covovax for restricted use in emergency situations in adults. According to reports, the SEC on Saturday gave its ascent for use of Covovax in the 12-17 age group. The recommendation will be sent to the DCGI for approval
It is yet to be included in the country's inoculation programme.
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 Serum Institute of India for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries and India.
With inputs from agencies.
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