Expert panel defers decision on Sputnik V Covid-19 vaccine, wants more data

Earlier in November, a spokesperson for Dr Reddy’s Laboratories (DRL) had said that the vaccine required minus 18 degrees Celsius
The wait for Sputnik V in India got a little longer as the expert panel reviewing the application has sought more data on safety, efficacy, and logistics.

A source close to the development said, “No approval was given to Sputnik V on Thursday. Some queries have been asked on safety, efficacy, and logistics, which the firm will have answers to at the next meeting.”

The source quoted earlier confirmed that the queries on logistics were related to the minus 25 degrees Celsius cold chain requirements.

Earlier in November, a spokesperson for Dr Reddy’s Laboratories (DRL) had said that the vaccine required minus 18 degrees Celsius. “Current storage temperature requirement is at minus 18 degrees Celsius. We are working on other storage conditions as well,” the spokesperson had said.

Hyderabad-based DRL has partnered Russian Direct Investment Fund (RDIF) for conducting clinical trials of the vaccine candidate in India. DRL will also be responsible for distribution of the vaccine here. 

DRL had applied for restricted emergency-use authorisation of the Sputnik V in February. The Phase 3 studies ended here on February 21. The firm presented a safety profile from Phase 2 clinical study and interim data from the Phase 3 study. The vaccine underwent a bridge trial in India on 1,600 candidates. 

DRL and RDIF have lined up 250 million doses of the vaccine for Indian citizens (from manufacturing partners) over the next 12 months.

Sources had then indicated that within a few months, a new version of the Sputnik V would be developed that can be stored at a temperature range between 2 and 8 degrees Celsius. However, the new version does not seem ready, as the expert panel has raised queries on a clear logistical plan to handle the minus 25 degrees Celsius cold chain for the vaccine.

A DRL spokesperson said, “We will not be able to provide an official statement now. We have had our meeting with the subject expert committee on Thursday and will await the official outcome.”

Dear Reader,

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel