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Tuesday, September 22, 2020

Explained: Significance of having the Oxford phase-III vaccine trials in India

In clinical trials for any new drug or vaccine, the third phase of testing looks for the effectiveness of the product in thousands of participants. India has the second largest population in the world, making it crucial for this demographic to be represented in these trials.

Written by Prabha Raghavan , Edited by Explained Desk | New Delhi | Updated: August 6, 2020 10:01:58 am
A nurse prepares a shot as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc. (AP Photo/File)

India’s top drug regulator has approved the application of Serum Institute of India (SII) to conduct late-stage human trials in the country for the Oxford-AstraZeneca Covid-19 vaccine candidate. While the vaccine is already being tested in other countries, it is important for India to be a part of these global trials.

Why is it important to conduct phase III studies of these vaccines in India?

The world, including India, is still learning how this virus works in different populations because it is relatively new. India, for instance, is now planning on rolling out a registry to collect data from patients in hospitals across the country to understand how they can improve treatment strategies.

In clinical trials for any new drug or vaccine, the third phase of testing looks for the effectiveness of the product in thousands of participants to get an idea of whether it will work in a large and diverse population. It is also important to note that these late stage trials check for any adverse reactions in the population that the product is intended for.

Researchers have often highlighted the need to have adequate representation of a racially and ethnically diverse set of subjects in trials for clarity on how they react to a medical product.

The Oxford vaccine candidate is intended for the global population, which is why phase III trials are currently being conducted in thousands of participants in the UK, South Africa and Brazil. Trials are to start in the US too. While some of these countries do consist of a diverse racial and ethnic population, researchers have pointed out in the past that minorities are not properly represented in trials.

Explained

Hope and caution

The Oxford vaccine offers one of the most promising weapons against the virus. Despite the promise, it is important to remember though, that the road ahead remains uncertain, and that the vaccine is still only a candidate.

India, with an estimated 1.4 billion people, has the second largest population in the world, making it crucial for this demographic to be represented in these trials. It also has the world’s third largest caseload at the moment, and will almost certainly go on to add hundreds of thousands of more cases.

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Where does SII come into the picture?

SII, the world’s largest maker of vaccines, has a tie-up with AstraZeneca, the Swedish-British pharma giant, to manufacture the Covid-19 vaccine for low- and middle-income countries. As part of the Indian government’s own requirements, any new vaccine that is expected to be marketed in the country has to undergo late stage clinical trials here before a launch.

As a partner in this agreement, SII will not only be manufacturing millions of doses of the vaccine, but will also be in charge of conducting the late stage trials in India.

What is the significance of the regulator’s nod to SII for these trials?

The regulator’s clearance not only puts the Pune-based Institute ahead in the race for developing a vaccine against the disease in India, it also increases the chances of Indian citizens — especially vulnerable groups and healthcare workers serving on the frontlines of this ongoing pandemic — getting access to a vaccine sooner.

With the nod of the Drug Controller General of India, SII can now start larger phase II/III trials of the candidate in India, ahead of Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D–other candidates that are still in phase I/II trials.

What happens next?

Serum’s trial of Covishield — the name given to the candidate technically referred to as AZD1222 and ChAdOx 1 nCoV-19 – will cover around 1,600 participants at 18-odd sites across the country.

While it is unclear when exactly the trials will start, SII CEO Adar Poonawalla had earlier said that the Institute intended to conduct these trials in August as soon as the regulatory clearances were granted. However, the sites will require an approval from their ethics committees to start enrolling and then dosing participants.

Some of the sites chosen for these trials may include the All India Institute of Medical Sciences (AIIMS) in Delhi and Jodhpur, as well as those identified by the National Biopharma Mission and Grand Challenges India Programme (a partnership between the government and the Bill and Melinda Gates Foundation).

Also in Explained | Why are so many vaccines being developed all at the same time?

These include the INCLEN Trust International in Palwal, Haryana, KEM Hospital in Pune, Society for Health Allied Research in Hyderabad, National Institute of Epidemiology in Chennai, and Christian Medical College in Vellore.

Other sites are likely to include Bharati Hospital and Jehangir Clinical Development Centre in Pune.

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