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Thursday, April 15, 2021

Decision on Sputnik V: Panel seeks additional data from Dr Reddy’s

Sources said the SEC also asked DRL to submit data on the vaccine’s stability.

Written by Prabha Raghavan | New Delhi |
Updated: April 2, 2021 5:30:15 am
Sputnik vaccine, Sputnik Russia vaccine, Sputnik Covid vaccine, Sputnik V, India Russia vaccine, Coronavirus vaccineRussian-made Sputnik V COVID-19 vaccines are unloaded at the Tehran's Imam Khomeini International Airport. (AP)

An expert panel under the top drug regulator has sought additional data related to Sputnik V in order to decide whether the Covid-19 vaccine should be recommended for restricted emergency use in India, The Indian Express has learnt.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) — which on Thursday reviewed a proposal by Dr Reddy’s Laboratories (DRL) for emergency licensure of the Russian vaccine — deferred its decision due to insufficient information.

It also asked DRL, which has been testing Sputnik V in India, to submit a fact sheet as well as information related to the vaccine’s stability, according to sources close to the development.

“They have to provide more information about its safety and immunogenicity as some data is currently missing,” said one of the persons on condition of anonymity. “All data is not yet ready for analysis. They are going to present this data,” the person added.

The stability data would provide information related to Sputnik V’s potency and safety, as the liquid form of the vaccine has to be stored at -18°C, while its lyophilized (freeze dried) form can be stored at 2°C to 8°C.

During the meeting, the SEC had also looked into Bharat Biotech’s submission to conduct additional phase 3 clinical trials of Covaxin on around 5,000 participants in Brazil.

The committee, in a meeting on March 23, had asked the company to submit a “detailed revised clinical trial protocol” for inclusion of an additional cohort in Brazil.

The panel had also sought a “revised statistical calculation for assessing the efficacy of the vaccine,” at that time.

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