After US drug-maker Pfizer, Serum Institute of India (SII) has approached the Drugs Controller General of India (DCGI), seeking authorisation for emergency use of the Oxford Covid-19 vaccine in the country.
The SII, which applied for DCGI approval yesterday, is India's first indigenous firm to seek such authorisation from India's drug sector regulator for its Covid-19 vaccine in the country, official sources said today.
The firm has also submitted 12 batches of the vaccine to state-owned Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh for testing, the sources said.
The phase-three clinical trial of the Oxford Covid-19 vaccine, Covishield, is being conducted by the lab of Pune-based SII, co-sponsored by Indian Council of Medical Research (ICMR), across India in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
Based on phase two and three clinical trial results, the SII will pursue early availability of the vaccine for India, ICMR, the country's apex health research body, had said last month.
According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Citing the SII application, official sources said the firm has stated that data from four clinical studies -- two in the UK and one each in Brazil and India -- shows that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections.
"In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae," the sources said quoting the SII application.
The SII, the world's largest vaccine manufacturer, has partnered with the University of Oxford and AstraZeneca to manufacture the vaccine.
"In view of unmet medical needs in the interest of the public at large to save millions of people in the country and across the globe, early availability of a vaccine against COVID-19 is a necessity. So, in the national interest, we request you to grant us emergency use authorisation of Covishield based on our application and in view of immediate need for a safe, effective, programmatically suitable and affordable vaccine for our country," according to the SII application to DCGI.
The sources said the SII vaccine can be stored at two to eight degrees Celsius.
To fast track the development of the vaccine, the DCGI had on August 2 gave the clearance to SII for holding the combined phase two and three human clinical trials of the Oxford COVID-19 vaccine in the country.
Meanwhile, a committee of experts is likely to meet this week to consider Pfizer's application, seeking emergency use authorisation of its Covid vaccine in India.
The committee gives its recommendations to the DCGI.
Pfizer has not conducted a trial of its vaccine among the Indian population and has sought a waiver for the trial in India.
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