SII submits data asked by DCGI for emergency approval of Covishield (IANS Exclusive)

By Ashish Srivastava New Delhi, Dec 22 : The Serum Institute of India (SII) has submitted additional data required by the Drug Controller General of India (DCGI) for determining the safety and immunogenicity of its Covid-19 vaccine candidate, Covishield, sources privy to the development told IANS.
The data was submitted few days ago to the Central Drugs Standard Control Organisation (CDSCO), which would be reviewed by the Subject Expert Committee (SEC) in a review meeting which is likely to take place by the end of this week, a top official of CDSCO confirmed to IANS.
The official also informed that if the SEC found the data presented by SII satisfying, India may have the vaccine for Covid-19 by the end of December.
V.K. Paul, member (health), NITI Aayog, and head of the national task force for Covid-19, also informed on Tuesday that of the two companies which were asked for additional data to receive emergency use approval for their Covid vaccines for emergency use authorisation (EUA), one has submitted them to the CDSCO.
The SII along with Bharat Biotech had applied for the emergency authorisation of their Covid-19 vaccines with the DCGI earlier this month.
Covishield has been developed at SII’s laboratory in Pune with a master seed from Oxford University/Astra Zeneca.