Serum Institute Submits Additional Data Sought By India's Drug Regulator For Emergency Approval Of Covishield Vaccine

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 (22 December) 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.

Two vaccines candidates -- Covishield by SII and Covaxin by Bharat Biotech -- are in the third stage of clinical trials.

However, their applications were not approved as the SEC found inadequate safety and efficacy data of the vaccines in a review meeting held on 9 December.

The SEC had recommended the firms to furnish further safety and efficacy data in order to receive the EUA for their Covid vaccines.

The SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.

Meanwhile, it had recommended Bharat Biotech to present the safety and efficacy data from the ongoing Phase 3 clinical trials in the country for further consideration.

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)