CDSCO panel recommends emergency use authorization for SII’s Kovovax
Highlight
- An expert panel from CDSCO has recommended emergency use authorization for Kovovax.
- SII submitted an application to DCGI in October for grant of market authorization for Covovax.
- DCGI had recently sought to know the status of approval of the application.
The Central Drugs Authority of India has recommended emergency use authorization to Serum Institute of India’s COVID-19 vaccine ‘Kovovax’ subject to certain conditions, official sources said on Monday. An expert panel of the drug authority gave the recommendation. A CDSCO panel has also recommended a restricted emergency use of the anti-Covid pill Molnupiravir in India.
Prakash Kumar Singh, director, government and regulatory affairs at Serum Institute of India (SII), in October submitted an application to the Drug Controller General of India (DCGI) for grant of market authorization for Kovovax for restricted use in emergency situations Was.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19 on Monday reviewed the Emergency Use Authorization (EUA) application for the second time and after detailed deliberations, recommended emergency use authorization to Kovovax. of,” said an official source.
Noting that the vaccine is a technology transfer of the Novavax vaccine, DCGI had recently sought to know the acceptance status of the application with regulatory authorities in the United States of America’s country of origin.
The apex drug regulator had also asked Serum Institute to provide details of the matrix component used in the vaccine. On November 27, the subject expert committee on COVID-19 had evaluated and deliberated on SII’s application and sought additional data from the pharma company.
The Pune-based firm has combined interim safety and immunogenicity data from Phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data on safety and efficacy from Phase 3 clinical trials conducted in the UK and US. submitted with your application. ,
Official sources said the government had recently allowed export of 20 million doses of COVID-19 vaccine Kovovax produced in India by SII to Indonesia, as the jab is not yet approved for emergency use in the country. it was done.
On May 17, the DCGI office had given permission to SII to manufacture and stock Covovax. Based on DCGI’s approval, the Pune-based firm has so far manufactured and stocked the vaccine doses.
(with PTI inputs)
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