India’s Serum Institute seeks approval for COVID-19 vaccine

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India’s Serum Institute seeks approval for COVID-19 vaccine

Peoples Time Desk

Published : Monday, 7 December, 2020 at 10:36 AM, Count : 763

India’s Serum Institute seeks approval for COVID-19 vaccine

The Serum Institute of India, the world’s largest vaccine producer by volume, has sought government approval for emergency-use authorisation of the coronavirus vaccine that it has developed in partnership with the University of Oxford and British drugmaker AstraZeneca.

“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,” the company CEO Adar Poonawalla tweeted on Monday.

The experimental vaccine can be stored at two to eight degrees Celsius and can be distributed more easily in India, which has the world’s second-highest number of infections at 9.6 million.

The company has applied to the Drugs Controller General of India (DCGI), with Poonawalla saying the vaccine will “save countless lives” without giving details.

The move comes close on the heels of Pfizer Inc applying for a similar authorisation of its coronavirus vaccine in India on Saturday.

Last month, Pfizer and BioNTech said their experimental vaccine was 90-percent effective while the US biotech firm Moderna Inc said its COVID-19 vaccine showed 94.5 percent effective in preventing COVID-19.

Vaccine trials in India

According to Indian media reports, Serum’s application stated that data from four clinical studies, two in the UK and one each in Brazil and India, showed that the vaccine, Covishield, was highly effective against severe COVID-19 infections.

Last month, a 40-year-old man from the southern city of Chennai had alleged that he suffered serious “neurological and psychological” symptoms after receiving the vaccine in a trial being run by the Serum Institute of India.

But the Indian government last week said it had found no reason to stop the Oxford vaccine trials in India after reviewing the volunteer’s allegation of serious adverse effects. The vaccine is currently in the Phase III clinical trial in India.

After a spike in the daily cases last month, India has seen a drop in the daily infections in the past week several weeks.

India’s Ministry of Health and Family Welfare on Monday said that 512 people died in the last 24 hours taking the total COVID-19 fatalities to 139,700.

On Friday, India’s Prime Minister Narendra Modi told an all-party meeting that in next few weeks, Indian manufacturers would be able to produce the much-awaited COVID-19 vaccines.

“Experts believe we don’t have to wait for a long period to get a vaccine. It is understood that in next few weeks, Covid vaccines will be ready. The government is waiting for a go-ahead from the scientists,” Modi said during the virtual meeting with leaders from different parties.

He also said that eight COVID-19 vaccines are at different stages of preparedness in India which includes the three indigenous vaccines that are at different stages of trials.

Phase three trials of India’s first indigenous vaccine started last month. Hyderabad-based Bharat Biotech Company has been developing the vaccine, Covaxin, in collaboration with the Indian Council of Medical Research (ICMR) - India’s premier medical research body.

“The world is looking at a cheap but effective vaccine against COVID-19. The world is looking at India. You can be assured our scientists are working hard,” he said.

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