DCGI Panel Aks SII For Additional Information on Covovax

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In response to Serum Institute’s application for emergency authorisation of the COVID-19 vaccine Covovax, an expert panel of India’s Central Drug Authority has sought additional data from the Pune-based firm. According to the official source, “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application on November 24, noted that the vaccine is technology transfer of Novavax vaccine and is not yet approved in the country of origin.”  

In October, the Serum Institute of India (SII) had made an application to the Drugs Controller General of India (DCGI) seeking a grant of market authorisation of Covovax for restricted use in emergency situations. As per the report, the firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country along with interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the UK and the US along with its application.

However, after detailed deliberation, the DCGI panel has suggested the SII submit additional information and data including the correct status of phase 3 clinical trials held in the U.S. and the UK as well as latest data on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the U.S., UK and another overseas phase 3 studies with data from phase 3 study in India. In addition, it has also demanded the review status of the application with regulatory authorities of the U.S. and the UK.

On May 17, the DCGI permitted the SII to manufacture and stock Covovax and the firm has already manufactured and stockpiled the jab following permission from the DCGI office. The Government has also recently given nod to the export of two crores doses of the SII-produced Covovax to Indonesia.

Right now, the Union Government is stepping up its international travel security measures at the onset of the growing Omicron variant threat. According to the revised guidelines, the Health Ministry has mandated that all international passengers entering India have to submit 14-day travel details and upload a negative RT-PCR test report on the Air Suvidha portal before the journey. The new guidelines will come into effect from December 1.

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