News Desk, AnyTV, New Delhi
Published by: Kirtivardhan Mishra
Updated Sun, 27 Feb 2022 06:17 PM IST
Summary
Serum Institute said in the application to DCGI, “We are sure that your approval for conducting this clinical trial is in line with our Prime Minister’s vision of ‘Making in India for the world’ of our country as well as the people of the world.” This will ensure early availability of Kovovax for use as a booster dose for
corona vaccine
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Expansion
The Serum Institute of India (SII) has sought permission from India’s drug regulator to conduct a phase III study of its anti-Covid-19 vaccine Kovovax as a booster dose in adults. The Drugs Controller General of India (DGCI) approved Kovovax on December 28 for limited use in emergency situations in adults. The vaccine has not yet been included in the country’s vaccination programme.
An official source said that Prakash Kumar Singh, director of government and regulatory affairs at SII, had last week submitted an application to the DCGI for its phase-3 controlled study by giving booster doses to those people to evaluate the safety and immunogenicity of Covovax. Approval was sought for those who have been vaccinated with CoveShield or Covaccine at least three months ago.
Singh said that many countries are already giving booster doses to their citizens in view of the uncertainties of the COVID-19 pandemic. Singh said in the application to DCGI, “We are sure that your approval to conduct this clinical trial is in line with our Prime Minister’s vision of ‘Making in India for the world’ for our country as well as the people of the world.” This will ensure early availability of Kovovax for use as a booster dose.
“Our company, under the visionary leadership of our Chief Executive Officer (CEO) Adar C Poonawalla, is committed to providing world-class life-saving vaccines at an affordable price,” he said. We request you to allow us a phase-3 clinical trial for a booster dose of Kovovax on an Indian adult.