After Pfizer, Serum Institute seeks emergency approval for COVID-19 vaccine in India

SII has sought emergency use authorisation for the Oxford Covid-19 vaccine, Covishield, in the country citing "unmet medical needs due to the pandemic and in the interest of the public at large."

Serum Institute has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing.

Just a day after Pfizer sought emergency use authorisation (EUA) for its COVID-19 vaccine in India, Serum Institute of India (SII) has also submitted the application for the same.

In its application submitted to the Drugs Controller General of India (DCGI) on Sunday, SII has sought emergency use authorisation for the Oxford Covid-19 vaccine in the country citing "unmet medical needs due to the pandemic and in the interest of the public at large", reported PTI quoting official sources.

Serum Institute is the first Indian company to seek such request from the DCGI. The Pune-based firm has partnered with British drugmaker AstraZeneca and Oxford University for the manufacture and distribution of the vaccine candidate, called Covishield in India. It is also conducting the phase-three clinical trial of the vaccine, co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country.

SII has also reportedly shared data from four clinical studies with the DCGI, two in the UK and one each in Brazil and India, which shows that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 infections.

"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 source told PTI quoting the application.

It is learnt that Serum Institute has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing.

According to the ICMR, SII has manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI, the news agency said.

Meanwhile, there are reports that the DCGI has forwarded Pfizer's application for emergency use approval before a committee of experts to examine the data of its clinical trial conducted abroad. The committee of experts is likely to meet this week to consider Pfizer's request.