Coronavirus vaccine: Why the DCGI nod for Oxford candidate trials in India is significant

By: |
August 6, 2020 2:39 PM

India has decided to roll out a registry that would collect the data of COVID-19 patients from across the country and would be used to figure out better treatment strategies.

The third phase of the clinical trials of any vaccine candidate tests its effectiveness in thousands of participants.The third phase of the clinical trials of any vaccine candidate tests its effectiveness in thousands of participants.

Coronavirus vaccine: The Pune-based Serum Institute of India (SII) recently received the approval from the Drugs Controller General of India (DCGI) to conduct the late-stage human clinical trials of the coronavirus vaccine candidate developed by Oxford and AstraZeneca. The worldwide race to find a vaccine against the virus that has caused a global pandemic is escalating every day, and it is important that India is also a part of these trials, according to a report by the IE.

COVID-19 vaccine: Why India must be a part of trials

According to the IE report, much still remains unknown about the novel coronavirus that has caused this outbreak and the entire world, including India, is still trying to figure out how SARS-CoV-2 works in different populations of the world. The report stated that in order to understand this better, India has now decided to roll out a registry that would collect the data of COVID-19 patients from across the country and would be used to figure out better treatment strategies.

The third phase of the clinical trials of any vaccine candidate tests its effectiveness in thousands of participants to understand if it would be suitable for treatment among a large and diverse group of people. It also tests if the vaccine candidate is inducing any kind of adverse reaction among members of the intended population. During such trials, it has been emphasised time and again by researchers that adequate representation of racially and ethnically diverse participants is very important to clearly understand what kind of reaction the medical product is inducing.

The vaccine candidate developed by Oxford-AstraZeneca is intended to be used by people all around the world, and therefore, the vaccine trials are currently underway in the UK, Brazil and South Africa, with trials in the US about to start too. These countries have a diverse set of racial as well as ethnic populations, but in the past, it has been pointed out that in these trials, minority groups are not properly represented.

On the other hand, India has a population of around 140 crore people, the second largest population in the world. Therefore it is important that the Indian population and its diverse demographic is represented in the trials. Moreover, India is also the third country in terms of the highest caseload of coronavirus in absolute numbers, with the peak not seeming to be over yet.

What does this have to do with SII?

According to the IE report, SII is the largest maker of vaccines in the world, and it has a tie up with Swedish-British pharmaceutical company AstraZeneca to manufacture a vaccine for COVID-19 for countries falling in the low and middle-income countries.

In India, it is necessary that any new vaccine that could be marketed in the country must conduct late-stage human clinical trials before it is launched. Since SII is a partner in the agreement, it would not only look after the manufacture of the vaccine, but would also conduct these trials in India.

Why is the nod of DCGI significant in these trials?

The DCGI nod to late-stage clinical trials has not only benefitted the SII in the race to develop the vaccine for COVID-19 in India, but it has also helped increase the chances of Indians, especially those who are vulnerable or in the frontline defence, to get access to vaccine against coronavirus sooner, the IE report stated.

With this approval, the institute can now begin the phase II/III trials for the Oxford-AstraZeneca vaccine candidate, giving it an advantage over the Covaxin candidate developed by Bharat Biotech and ZyCov-D by Zydus Cadila, which are in phase I/II of the trials.

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