Govt panel seeks additional data from Serum Institute on Covovax

The DCGI office had granted SII permission to manufacture and stock Covovax on May 17


Photo: Shutterstock

New Delhi
An expert panel of India's Central Drug Authority, which recently reviewed Serum Institute's application seeking emergency authorisation of COVID-19 vaccine Covovax, has sought additional data from the firm, while noting the jab has not yet been approved in the country of origin, official sources said.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the UK and the US along with its application, official sources said.
"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," a source said.
After detailed deliberation, the committee recommended that the firm should submit additional data and information.
It has sought correct status of the phase 3 clinical trials in USA and UK along with up to date on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the US, UK and other overseas phase 3 studies with data from phase 3 study in India, besides review status of the application with regulatory authorities of the US and the UK, the source said.

Also Read

Recruitment of volunteers for trial of Covovax vaccine on children begins

Govt panel recommends against SII testing Covovax on 2-17 age group: Report

Govt recommends nod to SII for phase 2/3 trials of Covovax on children

Serum Institute gets nod to start Covovax trials on children above 7 yrs

Serum Institute applies to DCGI to manufacture Covid vaccine Sputnik V

Bihar CM asks health officials to be on guard against new Covid variant

Omicron: RT-PCR test must for passengers coming from 'at-risk' countries

Third Omicron case detected in UK, face masks compulsory from Tuesday

Omicron alert: Regular international flights' return under review

Centre should learn from its mistakes in previous Covid-19 waves: Baghel

The government recently permitted the export of two crore doses of COVID-19 vaccine Covovax to Indonesia, produced in India by the SII, as the jab has not yet been approved for emergency use in the country, official sources had said.
The DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on the DCGI's approval, till now, the Pune-based firm has manufactured and stockpiled vaccine doses, they said.
In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Nov 29 2021 | 4:30 AM IST

Explore News