A senior Health Ministry official told The Hindu that Covishield is logistically more feasible for use and distribution in India, as it stores well between two and eight degrees Celsius.
The Serum Institute of India (SII) said on Monday that it had applied to the Controller General of Drugs of India (DCGI) for authorization of emergency use of its COVID-19 Covishield vaccine. Its CEO, Adar Poonawala, tweeted: “As promised, before the end of 2020, IBS has applied for emergency use authorization for the first vaccine manufactured in India, Covishield.”
The Pune-based vaccine maker has collaborated with Oxford University and pharmaceutical company Astra Zeneca to manufacture the vaccine and its trials at select sites. The SII has now requested an emergency use authorization citing unmet medical needs due to the pandemic and in the interest of the general public.
Also read: Vaccine injection is ‘painless’, say Covishield trial volunteers
A senior official from the Ministry of Health said The Hindu that Covishield is logistically more feasible for use and distribution in India as it stores well between two and eight degrees Celsius. The Indian Council for Medical Research (ICMR) said IBS had manufactured 40 million doses of the vaccine under the at-risk manufacturing and storage license it obtained from DCGI.
In response to an inquiry as to whether the efficacy figure for the IBS vaccine performed on Indian volunteers is available, the head of the National Expert Group on Vaccine Administration, VK Paul, said he “has not seen the data.”
Mr. Poonawala added in his tweet: “This will save countless lives and I thank the Government of India and Sri @narendramodi ji for their invaluable support.”
Second to apply
SII, which is the world’s largest vaccine producer by volume, has become the second company to apply for emergency authorization after Pfizer India. Pfizer India requested authorization for the emergency use of its vaccine after the parent company received authorization for the treatment from Great Britain and Bahrain.
Also read: COVISHIELD completes enrollment of phase 3 clinical trials in association with ICMR and IBS
The IBS had shared interim data with the DCGI from four clinical trials: one in India, two trials in the UK and one in Brazil, a senior official said. The Covishield phase three clinical trial, co-sponsored by the ICMR, was underway in various parts of the country, he added.
The SII had indicated that the central government could purchase between 300 and 400 million doses by July 2021 and that it planned to deliver 100 million doses of the vaccine per month by February.
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