Oxford’s COVID-19 vaccine: Phase III human trials begin in India

• Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations.
• On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice.
• However, the Drugs Controller General of India, on September 15, asked the SII to resume human trials.
• Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites.

Serum Institute of India (SII) is likely to begin the phase III human trials of Oxford’s coronavirus vaccine at Sassoon General Hospital in Maharashtra on September 22, Hindustan Times reported.

“We have started the phase-III trials of the vaccine (candidate Covishield). We will administer dose to 150 to 200 volunteers,” said Dr Muralidhar Tambe, Dean, Sassoon General Hospital.

Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations.

On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice, reported Business Today.

SII said there have been no issues in India, and this is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. AstraZeneca has resumed trials in the UK but not yet in the US.

Drugs Controller General of India, on September 15, asked the SII to resume human trials.

Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites.

SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries.

SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Earlier, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India.

The Serum Institute of India would introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute partnered with Bill & Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India.

There are at least 30 COVID vaccine candidates in preclinical or clinical stages in India. While three of them are in the advanced stage of Phase I/II/III trials and 4 are in the advanced preclinical development stage, Union Health Minister, Dr Harsh Vardhan, told the Parliament.

Vardhan believes India may get a coronavirus vaccine by early 2021.

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