Coronavirus vaccine update: Serum Institute of India to start Phase II clinical trials of Oxford COVID-19 vaccine; here is all you need to know

The second phase of human trials of Oxford University’s COVID-19 vaccine is all set to commence from today (Tuesday). Pune-based Serum Insitute of India, which is also the largest vaccine maker in the world by volume will start conducting the clinical trials at the Bharati Vidyapeeth Medical College and Hospital in Pune. The vaccine candidate developed by the Jenner Insitute of the Oxford University will be launched under the brand name ‘COVIDSHIELD’ in India. Serum Institute of India has tied up with British-Swedish pharmaceutical company AstraZeneca to produce a billion doses of the Oxford vaccine candidate for low-income countries in India.

Phase II clinical trials of Covishield will kickstart at Bharati Vidyapeeth Medical College and Hospital, Pune. For the unversed, the second phase of human trials involves dosing hundreds of healthy volunteers with the potential vaccine to understand the safety and efficacy of the vaccine candidate. The observer-blind randomised controlled study will also determine the Oxford vaccine’s ability to induce a strong immune response in the body of the volunteers.

“We have got all approvals from the Central Drugs Standard Control Organisation (CDSCO). We are going to start the human clinical trial process at the Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital from August 25," Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs, Serum Institute of India (SII) told PTI.

350 healthy volunteers, above the age of 18 will be enrolled for the Phase II testing at the Pune trial site. The volunteers should not have been infected with COVID-19 in the past and will undergo the diagnostic tests to rule out the same.

The Drugs Controller General of India (DCGI) had given the go-ahead to SII to conduct Phase II/III trials of the vaccine candidate developed by the Oxford University. 17 medical institutes across India are selected to conduct these clinical trials including AIIMS Delhi, AIIMS Jodhpur, The King Edward Memorial (KEM) and Nair hospitals in Mumbai.

To conduct the trials, around 1600 healthy volunteers will be enrolled above the age of 18. The volunteers should not suffer from any chronic illnesses and/or must not have a compromised immune system. As of now, there is no upper age limit to participate in Covishield trials in India.

Currently, there are more than 165 vaccine candidates across the globe in different stages of trials and 32 of them have reached the crucial stage of human testing. In India, there are 3 potential vaccine candidates in clinical trials, including the Oxford-AstraZeneca candidate ChAdOx1 nCoV-19, which has shown promising results in early trials. The other two candidates include Covaxin, which is the country’s first homegrown vaccine jointly developed by Bharat Biotech International Limited (BBIL) and ICMR (Indian Council of Medical Research) and Ahmedabad-based Zydus Cadila’s

‘Zycov D.’

Touted as one the frontrunners in the race of developing an effective vaccine candidate to battle the novel coronavirus, the Oxford COVID vaccine was developed in a record-breaking time of 3 months. As the SII has already begun late-staging testing of the Oxford vaccine candidate in India, the country is hopeful that it may get the vaccine by the year-end.