Covid-19 Vaccine India Update: The Serum Institute of India vaccine may be approved by Emergency Use. According to the ANI, the Subject Expert Committee (SEC) of the Drug Controller of India will hold a meeting of the Serum Institute of India on the application for approval of emergency use of COVID-19 vaccine. The vaccine is being developed in agreement with Oxford University and pharmaceutical company Astra Zeneca.
Subject Expert Committee (SEC) of Drugs Controller of India to take a meeting to consider Serum Institute of India’s application for emergency use approval of its COVID19 vaccine, says a government official
– ANI (@ANI) December 30, 2020
The committee asked for more data
Earlier this month, the expert committee asked for more data on the safety and efficiency of the candidate for the COVID-19 vaccine, considering the company’s application for Emergency Use Authorization. Apart from the Serum Institute, Bharat Biotech has also applied for Emergency Use Authorization.
In view of the application provided by the Serum Institute of India, the committee suggested that the company should provide safety data for phase two and three clinical trials in the updated application. The committee had sought immunogenicity data for clinical trials in Britain and India. With this, the result of the evaluation done by MHRA was also sought.
Three companies applied for emergency use
Three companies had applied to the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA). Whereas Serum Institute of India (SII) based in Pune applied on 6 December, Bharat Biotech sought approval on 7 December. The American pharma company Pfizer also applied to the EUA for its vaccine on 4 December.
Let us know that the use of the coronavirus vaccine developed by the pharmaceutical company AstraZeneca and Oxford University has been approved in the UK today. COVID vaccine is to be produced in India by Serum Institute of India, Pune.