The Serum Institute of India, the 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.
“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, reports The Hindustan Times.
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 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 the 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.
On November 5, Bangladesh government has signed a Memorandum of Understanding (MoU) with Serum Institute of India Pvt Limited and Beximco Pharmaceuticals Ltd (BPL) to get three crore doses of SARS-Cov-2 AZD 1222 (Oxford/Astrazeneca Vaccine).
As per the MoU, Serum institute will provide SARS-Cov-2 AZD 1222 (Oxford/Astrazeneca Vaccine) to Beximco Pharmaceuticals Ltd (BPL).
(Source: UNB)
