The Subject Matter Expert Committee (SEC) on the authorization of emergency use of the Covid-19 vaccine has said that the Serum Institute of India and Bharat Biotech must submit more data on their Covid-19 vaccine candidates before they are can grant the authorization of emergency use in India.
Sources say during a meeting on Wednesday, the committee’s broader view was to wait for the UK to first grant emergency use approval to the Covid-19 candidate vaccine from Oxford University, Covishield, which the Serum Institute is manufacturing in India, and then moving the matter forward.
While the SEC does not have the authority to approve a vaccine, its views are important as it makes recommendations to the Comptroller General of Drugs of India (DCGI).
Meanwhile, the central government has clarified that the two requests for emergency use have not been rejected. “The media report on the rejection of the authorization for emergency use of the vaccine by the Serum Institute and Bharat Biotech is false,” the Union Ministry of Health and Family Welfare said in a tweet.
In India, the Serum Institute of India manufactures Covishield, the Covid-19 vaccine that is being developed by the University of Oxford and drug maker AstraZeneca. Meanwhile, Bharat Biotech is developing a indigenous Covid-19 vaccine called Covaxin.
Although both vaccines are currently in phase 3 clinical trials in India, Serum and Bharat Biotech had applied for emergency use approval from DCGI.
Apart from these, Pfizer has also applied for an emergency use permit and your application is under consideration. Last week, the UK became the first country in the world to grant emergency use approval to Pfizer’s Covid-19 vaccine and its mass vaccination has already started in the country.
On Tuesday, Oxford University researchers who have been involved in the development of the university team’s Covid-19 vaccine candidate published the first peer-reviewed results of a phase 3 trial of the candidate vaccine.
“The efficacy data is based on 11,636 volunteers in the UK and Brazil and pooled across three groups of vaccinated vaccinated people,” the Oxford researchers said in a statement.
The vaccine protects against symptomatic disease in 70% of cases with a vaccine efficacy of 62% for those who receive two full doses and 90% for those who receive half and then the full dose. (2/6) pic.twitter.com/RIXPmWE0l3
– The Lancet (@TheLancet) December 8, 2020
Based on the peer-reviewed analysis of the trial published in The Lancet, the overall efficacy of the Oxford vaccine was estimated to be 70.4 percent.
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