After Pfizer India, Serum Institute of India has applied to Drugs Controller General of India (DCGI) seeking an emergency use authorisation for the Oxford COVID-19 vaccine in the country.
Yesterday, Pfizer India became the first pharmaceutical firm to seek the DCGI nod for its COVID-19 vaccine after its parent company secured clearance in the UK and Bahrain.
The Pune-based Serum Institute is conducting a phase-3 trial of its coronavirus vaccine called Covishield in different parts. In order to introduce an urgently needed vaccine against COVID-19 in India, SII, the world's largest vaccine manufacturer, has entered into a collaboration with the University of Oxford and Swedish pharma giant AstraZeneca to manufacture the vaccine.
As per the Indian Council of Medical Research (ICMR), Serum Institute has manufactured four crore doses of the vaccine under the at-risk manufacturing and stockpiling licence obtained from the DCGI.
Official sources, citing the SII application, 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.
Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm claimed. "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," a PTI source said, quoting the application.
"Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," a PTI source added.
The SII also reportedly submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing. "In line with our philosophy we assure you that for COVID-19 vaccines also, we are committed to make our country self-reliant and fulfill our prime minister's clarion call of 'vocal for local' and 'making in India' for the world," stated the application signed by Prakash Kumar Singh, Additional Director, Government, and Regulatory Affairs at Serum Institute of India (SII).
In view of all these facts and 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, it stated.
"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," the application read.
According to sources, this vaccine is logistically feasible for distribution in the country's both urban and rural parts as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.
As a rapid regulatory response, the DCGI on August 2 had given nod to SII for conducting the combined phase two and three human clinical trials of the Oxford COVID-19 vaccine in the country.
Five vaccines are in advanced phases of clinical trials in India, including the Serum Institute of India. Indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.
Drug firm Zydus Cadila has received approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine.
Dr Reddy's Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate.
(With PTI inputs)