Indian vaccine company Serum applies for emergency use authorization of AstraZeneca COVID-19 vaccine
In India, Phase 3 Clinical Trial Underway... "Will Save Precious Lives"
[Asia Economy Reporter Jeong Hyunjin] The Serum Institute of India (SII), known as the world's largest vaccine manufacturer, has applied for emergency use authorization from Indian authorities for the vaccine being developed by the University of Oxford and pharmaceutical company AstraZeneca, PTI news agency reported on the 7th.
According to the report, the Serum Institute stated that it has submitted an emergency use authorization application to the Drugs Controller General of India (DCGI). The Serum Institute, together with the Indian Council of Medical Research (ICMR), a related agency of the Indian government, has been promoting early use of the AstraZeneca vaccine based on the results of Phase 2 and Phase 3 clinical trials, and is currently conducting Phase 3 clinical trials of the AstraZeneca vaccine in India.
Adar Poonawalla, CEO of the Serum Institute, tweeted, "As promised, we have applied for emergency use authorization for the 'Made in India' vaccine before the end of this year," adding, "This will save invaluable lives."
On the 23rd of last month, Oxford University and AstraZeneca announced that the initial data analysis of their Phase 3 clinical trial showed an average efficacy of 70%. Participants who first received half a dose of the vaccine and then a full dose one month later had a prevention efficacy of 90%, while those who received two full doses had an efficacy of 62%.
The Serum Institute has already produced 40 million doses of the AstraZeneca vaccine to be ready for distribution as soon as emergency use authorization is granted. One dose corresponds to one vaccination. In this regard, the Indian government is reported to have decided to procure 500 million doses of this vaccine.
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Meanwhile, according to Indian health authorities, the cumulative number of COVID-19 confirmed cases reached 9,677,203 on this day, an increase of 32,981 from the previous day. The cumulative death toll rose by 391 to 140,573.
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