New Delhi, December 30: The Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) on Wednesday met to consider applications of Serum Institute of India (SII) and Bharat Biotech for emergency use authorization of their COVID-19 vaccines. The SEC, reports said, sought more information from the SII and Bharat Biotech, and did not grant emergency use authorities for their COVID-19 vaccine candidates. Oxford COVID-19 Vaccine Approved for Use in UK, Regulatory Approval in India Awaited.

Pune-based Serum Institute of India has tied up with Oxford University and pharmaceutical company AstraZeneca to manufacture the vaccine Covishield in India. Bharat Biotech's vaccine is named Covaxin. America's Pfizer was the first to apply on December 4. The SII and Bharat Biotech applied on December 6 and 7, respectively. In its last meeting, the SEC had asked the SII and Bharat Biotech to submit more data and information. US Nurse Tests Positive for Coronavirus 8 Days After Receiving Pfizer-BioNTech's COVID-19 Vaccine: Report.

The SII was asked to submit the outcome of the assessment of UK-MHRA, the updated safety data of the Phase-II/III clinical trials and immunogenicity data from the clinical trial in the UK and India. Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase-III clinical trial in the country for further consideration. Both the firms had again submitted their applications last week seeking approval of the vaccine.

India currently has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorisation in near future. One of them is Russia’s Sputnik V. Other vaccine candidates are Zydus Cadila’s ZyCoV-D and one being developed by Biological E. Ltd alongside Baylor College of Medicine and Dynavax Technologies Corp.

(The above story first appeared on LatestLY on Dec 30, 2020 07:33 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).