Covishield: 2nd – 3rd Phase trails

Covishield: 2^nd – 3^rd Phase trails

Recently, the Drugs Controller General of India (DCGI) has given approval to the Serum Institute of India (SII), Pune to conduct Phase II/III clinical trials of Covishield in India. SII is the world’s largest maker of vaccines and it has a tie-up with AstraZeneca, the Swedish-British pharma giant, to manufacture the Covid-19 vaccine for low- and middle-income countries.

Covishield:
It is the name given to an Oxford-AstraZeneca Covid-19 vaccine candidate which is technically referred to as AZD1222 or ChAdOx 1 nCoV-19.
It is already being tested in the UK, South Africa and Brazil, where participants are being administered two doses nearly a month apart.
It had triggered an immune response in humans against the novel coronavirus in early trials and is considered to be one of the global frontrunners for the Covid-19 vaccine.

Background: The Subject Expert Committee (SEC) for Covid-19-related therapies of the Central Drugs Standard Control Organisation (CDSCO) felt that the SII needed to take a ‘pan India’ approach while considering trial sites.

It recommended that authorisation to market Covishield should be granted after considering clinical data generated from both the India and international trials.
Trials: SII can now start its larger phase II/III trials, ahead of other vaccine candidates like Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D which are still in phase I/II trials.
However, the exact timings of the trial beginning are not clear yet. It would take at least a week to get the ethics committee’s approval before starting the trials. If everything goes well, the vaccine could be out by the end of 2020.
The trials for Covishield will have around 1,600 participants at 18-odd sites across the country including those identified by the National Biopharma Mission and Grand Challenges India Programme.

Current Trend in India: India continues to improve the Case Fatality Rate (CFR-number of deaths per positive case) and maintain its global position of having one of the lowest Covid-19 fatalities rates. The current CFR is 2.11%.

Grand Challenges India Programm

It is a partnership framework for the Department of Biotechnology (DBT) in India, its Biotechnology Industry Research Assistance Council (BIRAC) and the Bill and Melinda Gates Foundation. BIRAC is a Public Sector Enterprise, set up by the DBT.
Aim: To launch joint initiatives aimed at catalyzing innovative health and development research within India.

National Biopharma Mission

It is an industry-academia collaborative mission for accelerating biopharmaceutical development in the country.
It was launched in 2017 at a total cost of Rs. 1500 crore and is 50% co-funded by a World Bank loan.
It is being implemented by the BIRAC.

Source: TH

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