Serum Institute applies for emergency use authorisation for COVID-19 vaccine in India

Vaccine major Serum Institute of India (SII) on Monday said it has applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for AstraZeneca-Oxford COVID-19 vaccine in the country.

Earlier, the Indian arm of US pharmaceutical giant Pfizer became the first company to seek a similar approval from India's drug regulator for Pfizer/BioNTech vaccine against COVID-19 in the country, after securing such clearance in the UK and Bahrain.

Pune-based SII has collaborated with AstraZeneca and Oxford University to manufacture the vaccine and is conducting phase III clinical trials of the Covishield vaccine in India.

"As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD," Serum Institute of India (SII) CEO Adar Poonawala said in a tweet.

He further added, "This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support".

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According to the Indian Council of Medical Research (ICMR), SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it 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.

According to sources, this vaccine is logistically feasible for distribution in both urban and rural parts of the country as it can be stored at two to eight degrees celsius.

Earlier on November 29, Poonawalla in a virtual press conference had said that the company was in the process of applying in the next two weeks for an emergency use licensure for Covishield.

In another development, the first 50 National Health Service (NHS) hospitals are gearing up for what the UK government has described as the biggest immunisation programme in history as the first doses of the Pfizer/BioNTech vaccine against COVID-19 arrived at secure locations in the country from neighbouring Belgium this weekend.

Frontline healthcare staff, people over the age of 80 and care home workers will be among the first to get the vaccine as part of Phase I of the programme from Tuesday, which was approved for rollout by the UK's independent regulator earlier this week.

(Disclaimer: Additional background information has been added to this PTI copy for context)