Oxford COVID-19 Vaccine: Serum Institute seeks emergency use authorisation for Covishield in India
This Oxford-AstraZeneca vaccine candidate is currently undergoing the phase three clinical trials in different parts of the nation.
The Serum Institute of India (SII) seeks emergency use authorisation for the Oxford COVID-19 vaccine candidate 'Covishield'. As per the reports, the Serum Institute applied to the Drugs Controller General of India (DCGI) on December 6 to seek approval for the same.
As reported, the SII cited unmet medical needs of Indian citizens to fight the novel coronavirus and public interest as the major reasons to get DCGI approval.
This Oxford-AstraZeneca vaccine candidate is currently undergoing the phase three clinical trials in different parts of the nation. The vaccine trials are co-sponsored by the Indian Council of Medical Research (ICMR).
Earlier in September 2020, the ICMR announced that the SII will pursue early availability of the vaccine in India based on phase two and three results of its clinical trials.
The clinical trials & studies of the Covishield vaccine are being conducted by Oxford-AstraZeneca in the United Kingdom and Brazil as well.
The SII has already manufactured over 40 million doses of the vaccine after receiving the DCGI's at-risk manufacturing and stockpiling license.
'Covishield' Vaccine Trial Results
The Covishield vaccine is highly efficacious against the COVID-19 infection. The results of the clinical trials are in line with other anti-coronavirus vaccines and the vaccine is projected to boost COVID-19 mortality and morbidity.
As per the AstraZeneca CEO, Pascal Soriot, the vaccine, in terms or safety & efficacy, will be highly effective against the COVID-19 and will be helpful amid the public health emergency.
Is Oxford COVID-19 Vaccine feasible for distribution in India?
Logistically, the vaccine is feasible for distribution for both urban and rural parts of India as the vaccine can be stored at 2 to 8 degrees Celsius, an ideal temperature for keeping the vaccine in cold storage in India.
How is Serum Institute associated with Oxford COVID-19 Vaccine?
World's largest vaccine manufacturer, Serum Institute of India (SII) collaborated with the University of Oxford and AstraZeneca to manufacture the COVID-19 vaccine to introduce vaccine against COVID-19 in India on urgent basis.
The DCGI granted approval to the SII in August 2020 to conduct combined phase two & three clinical trials of Oxford COVID-19 vaccine in India.
The SII has already submitted over ten batches of the vaccine for testing to the Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh.
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