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Serum Institute applies for emergency approval of Covishield, submits global efficacy data

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Serum Institute has submitted four months of safety data from India trials and additional eight months data from global trials conducted by AstraZeneca.

Serum Institute applies for emergency approval of Covishield, submits global efficacy data
A day after Pfizer made an application for emergency approval for its mRNA vaccine in India, Serum Institute of India has moved ahead too. The company has approached the Indian drug regulator with submissions for Oxford-AstraZeneca's COVID-19 vaccine, which is being tested in India through phase II and III human trials.
Pfizer submitted an application for emergency use of its vaccine in India based on global trial data and sought a waiver for bridge trials in the country.

For Serum Institute, since phase 3 trials in India are currently underway, the company has made submissions based on combined data from India trials and global data from AstraZeneca's trials. Interim analysis of global trial data showed the full dose regimen for the vaccine had 62 percent efficacy, however, the regimen where first dose was half, followed by a second full dose had 90 percent efficacy.
Serum's application in India is for the full dose regimen Covishield, as the company is testing it in India. Covishield is a two-dose vaccine to be administered 28 days apart. Serum is conducting phase III trials on 1,600 participants in India.
The company told CNBC-TV18 that all volunteers have been administered the second dose of the trial vaccine and immunogenicity; and efficacy data from Indian trials is expected by the third week of December.
Serum Institute has submitted four months of safety data from India trials and additional eight months data from global trials conducted by AstraZeneca.
A serious adverse event was reported in Chennai in October, which led to a legal tussle with a 40-year-old volunteer alleging that the experimental vaccine shot led to nervous breakdown and acute neuro encephalopathy. ICMR, which is a co-sponsor of the trials in India said, "After collating all submissions from the ethics committee, drug safety monitoring board and the company, the drug regulator DCGI's initial causality report did not necessitate stopping trials." The regulator has cleared the adverse event as not related to the vaccine trials.
Adar Poonawalla, CEO of Serum Institute said in a tweet, "As promised, before the end of 2020, Serum Institute has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and PM Narendra Modi for their invaluable support."
Covishield, is a chimp adenovirus vector vaccine and has been developed by the University of Oxford and AstraZeneca. Serum Institute is a global manufacturing partner for the vaccine and has indicated initial vaccine supplies will be reserved for India, followed by COVAX countries mainly Africa. Owing to ease of storage and low pricing, Covishield is being considered as a more suitable option for India and Serum Institute has indicated that nearly 40 million doses have been kept ready. Serum Institute will be making the vaccine available at $3 a dose in countries like India.
Prime Minister Narendra Modi recently visited the Serum Institute facility in Pune on to review the development of the vaccine, along with a visit to other vaccine makers like Bharat Biotech and Zydus Cadila.

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