Serum Institute of India (SII) is likely to submit the final COVID-19 vaccine trial data before the end of December.
According to a report by Business Standard, SII is expected to submit the final set of Covishield trial data before the subject expert committee in the next 10 days or so. And if the data is found satisfactory, an approval for Covishield, Oxford-AstraZeneca’s vaccine candidate, can come in by the first week of January.
Last week, an expert committee of the Central Drugs Standard Control Organisation (CDSCO) sought additional safety and efficacy data from Serum Institute of India for further consideration of their emergency use authorisation applications for Covishield.
"After detailed deliberation, the committee recommended that the SII should submit the following data/information for updated safety data of Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK MHRA for grant of EUA," DCGI said.
Covishield is the COVID-19 vaccine candidate developed by AstraZeneca in collaboration with Oxford University, and is currently being tested and developed by the SII in India
The vaccine has shown 70% efficacy in its interim analysis and Poonawalla had earlier said that the shot is likely to be ready by the end of December this year.