Status of Oxford Coronavirus vaccine trials in India
Ever since positive news about Oxford-AstraZeneca developed COVID-19 vaccine came to light, Serum Institute of India (SII) has been in the centre of production. The leading vaccine manufacturer has announced ambitious plans of scaling up vaccine production in the country, reserving a big percentage of doses for the population to meet the need. The company has also sought licensing from government authorities to start Phase II and III trials in the country. Research centres are also being readied for the same.
Serum Institute of India to conduct trials, asked to revise protocols
While the initial licensing and approvals are being overseen by the Department of Biotechnology (DBT), India, the private vaccine manufacturer based out of Pune has been asked to submit revised protocols regarding the clinical trials of the experimental vaccine, AD-1222 in India.
What is Serum Institute of India's role in vaccine development?
Serum Institute of India had partnered with drug manufacturer AstraZeneca to conduct part of the phase III trials in India and simultaneously conduct phase II trials of the novel vaccine under development. As per earlier plans, the vaccine company planned to test the vaccine on 4000 to 5000 people in the selected trial centres across Pune and Mumbai so as to see whether the vaccine provides sufficient immune response. The trials were expected to take place between the months of August to December.
According to reports, the company has planned to perform a randomized, blind controlled study on participants to test the safety and immunogenicity response of the vaccine, which will be called 'Covishield' in India.
Serum Institute to manufacture millions of doses
By ramping up production, the Pune-based company would be able to manufacture upwards of 20 million doses before 2020 and further boost production to meet the need.
Will trials happen pan India?
The move asking SII to submit a revised protocol comes after the Central Drugs Standard Control Organisation (CDSCO), evaluated the submission on several scientific and medical parameters.
“Our Subject Experts Committee reviewed the Serum Institute thoroughly and it has observed several recommendations like--assessment and statistical analysis, drop-out rate, immunity analysis etc. It is a comprehensive scientific analysis,” a senior official from the health ministry was quoted speaking to a media agency.
Further reports also revealed that the committee has asked SII for additional information, as well as has advised the company to demarcate phase II/III trials in India. One of the recommendations from the meeting also makes a case for pan-India trials to happen, instead of limiting them to certain regions so as to achieve a wider response.
A statement from the Serum Institute regarding the same is still awaited.
Focus on immunity, say authorities
The focus of conducting trials in India is to see whether it can elicit a good immune response in the body, does not cause side-effects and delivers a safe response just as what was seen in early phase studies. In a statement, SEC said, “Immunogenicity shall be either primary or secondary objective”, adding that analysis should be done “only after day 58 both for safety and immunogenicity.”
What other trials are being conducted in India?
Currently, phase I trials for homegrown vaccines, Covaxin and Zydus Cadila's ZyCOV-D are being carried on in research facilities across India. The first batch of participants have been administered dosage for the same. Experts say that Oxford vaccine trials being carried out in India will not only help officials collate wide data, but increase the odds of a vaccine being made available in the country earlier than expected.