Updated on: Thursday, December 10, 2020, 12:43 PM IST

Covishield, Covaxin emergency use authorisation: Why is CDSCO panel yet to decide on COVID-19 vaccines from SII, Bharat Biotech?


India's wait for a locally-produced coronavirus vaccine has gotten longer after an expert committee of the Drug Controller General of India (DCGI) put Serum Institute's and Bharat Biotech's applications on hold, citing lack of complete data.

On Wednesday, the expert committee of the Central Drugs Standard Control Organisation (CDSCO) sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute of India and Bharat Biotech after deliberating upon their applications seeking emergency use authorisation for the shots.

But, why CDSCO expert panel did not decide on COVID-19 vaccines from SII, Bharat Biotech?

While considering Serum Institute's application, the subject expert committee (SEC) on COVID-19 has recommended that the firm should submit an updated safety data of phases 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 Medicines and Healthcare products Regulatory Agency (MHRA) for grant of emergency use authorisation.

As for Hyderabad-based Bharat Biotech, "after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration," the recommendations by the SEC said.

"The SEC on COVID-19 of the CDSCO held a detailed deliberation on both the applications for around four hours. The recommendations by the SEC have been approved by the Drugs Controller General of India (DCGI)," an official source told PTI.

The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation on Wednesday as the company sought more time for making a presentation before the committee.

When did Serum Institute, Bharat Biotech apply for emergency use authorisation?

On December 7, Bharat Biotech had applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for its COVID-19 vaccine Covaxin. Covaxin is being indigenously developed by the Hyderabad-based pharmaceutical firm in collaboration with the Indian Council of Medical Research (ICMR).


On December 6, the Pune-based Serum Institute of India (SII) had applied to the central drug regulator for emergency use authorisation of AstraZeneca-Oxford’s coronavirus vaccine.

Apart from Bharat Biotech and Serum Institute of India, US pharma giant Pfizer Inc, whose vaccine has already been rolled out to the public in the UK, had also applied for early approval for emergency use in India on December 4.

Reports that Centre rejected SII, Bharat Biotech's emergency use authorisation of Covid-19 vaccine are fake: Health Ministry

On Wednesday, the Ministry of Health and Family Welfare dismissed a media report about the rejection of Serum Institute India (SII) and Bharat Biotech's emergency use authorisation of COVID vaccine and called it "fake". "SII has applied for emergency use authorisation to DCGI. The application will be reviewed by the expert committee and after that final call will be taken," a senior government official had confirmed to ANI.


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Published on: Thursday, December 10, 2020, 12:43 PM IST