COVID-19 vaccine update: Serum Institute submits additional data for Covishield emergency approval
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Pune-based Serum Institute of India (SII), which is manufacturing and testing the Oxford-AstraZeneca coronavirus vaccine Covishield in India, has submitted additional data to the Drug Controller General of India (DCGI).

“Serum Institute India has submitted additional data. The regulator’s office, internally, will review these documents. Only then they will request the Subject Expert Committee (SEC) to meet,” sources told The Indian Express.

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 Central Drugs Standard Control Organisation (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 vaccine 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 December 9.

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.

(Inputs from Agencies)

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