A committee of the Indian regulator that is scrutinising the emergency use applications of COVID-19 vaccine manufacturers will reassemble on January 1 for deliberations on the issue.
The committee had earlier met on Wednesday to consider the applications made by Serum Institute of India for the AstraZeneca and Oxford University vaccine, and another vaccine of Bharat Biotech.
During Wednesday’s meeting, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) deliberated and analysed the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech.
“The Subject Expert Committee (SEC) in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt. Ltd,” the health ministry said in a statement.
“Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt. Ltd was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on January 1, 2021,” it said.
UK approved AstraZeneca vaccine
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer, has entered into a tie-up AstraZeneca to manufacture “Covishield”.
While considering SII’s application, the SEC on December 9 had recommended that the firm should submit 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 MHRA for grant of EUA.
1.02 crore COVID-19 cases
The health ministry on Thursday informed that 21,822 fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally past 1.02 crore.
Also, 299 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 1,48,738.
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