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.”