Govt panel has approved phase-3 study of Covovax as booster dosage

Official sources informed PTI on Sunday, March 6, that an expert panel of India’s federal drug regulator has recommended clearance for a phase-3 clinical study of COVID-19 vaccine Covovax as a booster dose in adults. On December 28, the Drugs Controller General of India (DCGI) authorised Covovax for limited usage in adults in emergency situations.
It has not yet been incorporated into the country’s immunisation programme. On Friday, the Central Drugs Standard Control Organization’s Subject Expert Committee on COVID-19 recommended that approval be granted for a phase-3 clinical study of the single-dose COVID-19 vaccine Sputnik Light as a booster dose.

An official source said that Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India, had sought approval from the DCGI to conduct a phase-3, observer-blind, randomised, controlled study to assess the safety and immunogenicity of Covovax as a booster dose in adults who had been vaccinated with Covishield or Covaxin at least 3 months ago.
Given the unknowns surrounding the COVID-19 pandemic, Singh noted that several nations have already begun delivering booster doses to their populations. “We are certain that your clearance for this clinical study will result in the early availability of Covovax for booster dosage usage for people in our country and throughout the world, in keeping with our Prime Minister’s goal of ‘Making in India for the World.'”

“Under the innovative leadership of our CEO Adar C Poonawalla, our company is devoted to offering world-class life-saving vaccinations at an accessible price. We respectfully seek that you grant us permission to undertake a phase 3 clinical study in Indian adults for a booster dosage of Covovax “According to reports, Singh stated in his application.

Covovax is a product of Novavax’s technology transfer. The European Medicines Agency awarded it conditional marketing authorization, and the World Health Organization added it to the list of emergency drugs.

Novavax Inc, located in the United States, signed a licencing deal with Serum Institute of India in August 2020 for the development and commercialization of NVX-CoV2373, their COVID-19 vaccine candidate, in poor and middle-income countries, as well as India.