Serum Institute seeks approval for Covid-19 vaccine; Adar Poonawalla thanks PM for support

The institute’s move comes on the heels of the US pharmaceutical giant, Pfizer, applying for a similar approval with the DCGI

The Serum Institute of India, world’s largest vaccine manufacturer by volume, has applied to the Drug Controller General of India (DCGI) for emergency use authorisation for the Oxford/Astrazeneca Covid-19 vaccine.

Vials of COVISHIELD before they are packaged inside a lab at Serum Institute of India, Pune, earlier in November.(File photo)

“As promised, before the end of 2020, @SerumInstIndia 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 Sri @narendramodi ji for their invaluable support,” said Adar Poonawalla, chief executive officer of Serum Institute of India, in a tweet.

A trial of the vaccine with 1,600 participants across 15 sites in India is underway. Results from the global studies have shown that it can be 90% effective in preventing an infection when a person receives a half dose and then a full dose.

Serum Institute of India’s move comes on the heels of the US pharmaceutical giant, Pfizer, applying for a similar approval with the DCGI. The Pfizer vaccine, which was found to be 95% effective, is likely to cost about five times more than the Oxford vaccine and has to be stored at -70 degrees Celsius.

Oxford University’s Covid-19 vaccine will be priced at Rs 500-600, Poonawalla had said during the Hindustan Times Leadership Summit. “Emergency use authorisation will be for healthcare workers and other frontline workers, and by March- April, the vaccine should be available for use to general public. Emergency use licensure is based on the positive UK results. There is a good T-cell and antibody response but nobody at this stage can answer whether these vaccines can protect long-term,” he had said.

The results of the Indian trial is likely to be announced by December. “As soon as the UK authorities approve of it, we will apply to the Drugs Controller General of India but initially for limited use. We are stockpiling millions of doses to get a head start,” he had said.

He had said that the vaccines could be made available to the general public within three to four months. Serum Institute has entered a manufacturing partnership with AstraZeneca to produce their Covid-19 vaccine.

Serum Institute of India currently has two dedicated facilities with the capacity of manufacturing about 50-60 million doses a month that will be scaled up to a 100 million doses by February when two more facilities are likely to be added.