Pfizer, SII seeks emergency use authorisation for COVID-19 vaccine in India

NEW DELHI, Dec. 08: Two vaccine manufacturers — Pfizer and Serum Institute of India (SII) — have applied for the emergency use authorisation for COVID-19 vaccine with Drugs Controller General of India (DCGI), officials said Monday.

While as Pfizer India has become the first pharmaceutical firm to approach the DCGI on Friday, the SII became the first indigenous company to apply for the same on Sunday.

“Pfizer India has submitted the emergency use authorisation application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s Covid-19 vaccine in India,” an official said.

However, the extremely low temperature of minus 70 degrees Celsius, required for storing the vaccine poses a big challenge for its delivery in a country like India.

Pfizer has already secured such clearance in Britain and Bahrain.

“As promised, before the end of 2020, SII has applied for emergency use authorisation for the first made-in-India vaccine, Covishield.

This will save countless lives, and I thank the government of India and Narendra Modi for their invaluable support,” SII chief Adar Poonawalla in a statement on Monday said.

At present, the phase-three clinical trial of Covishield, co-sponsored by Indian Council of Medical Research (ICMR), is being conducted in various parts of the country.

The SII has partnered with global pharma giant AstraZeneca and the Oxford University for manufacturing Covishield.

Poonawalla said India would be purchasing 300-400 million doses of COVID-19 vaccine from the SII, which is currently producing 50-60 million doses per month and plans to scale up to 100 million doses by January next year.

The vaccine can be stored in 2-8 degrees Celsius.

Indian government has initiated a backend preparation for the largest immunisation drive in the country.

At present, five COVID-19 vaccine candidates are in advanced stages of development in India.

Last week Modi said that experts are hopeful that India will get a vaccine in the next few weeks.

Meanwhile, on Monday morning the federal health ministry said the number of COVID-19 cases in the country has reached 9,677,203 and the death toll has risen to 140,573.

Globally India is the second worst-hit country due to pandemic after the United States. Xinhua/RSS