The coronavirus pandemic has changed life in a very short span of time. The world today is grappling with the ongoing impacts of the Covid-19 and since our bodies aren’t well equipped to deal with being infected by it. A vaccine would allow the body to safely develop an immune response to Covid-19 that could prevent or control infection.
However, despite all efforts, it takes almost five to ten years, or even more, for a new vaccine to be developed before it can be used in humans as per standards. But in the hour of the pandemic, these timeframes are reduced and effective trials are done to ensure the safety of mankind.
It is essential that clinical trials are conducted with great care to ensure the safety of the participants and to fully establish the safety profile of the new products.
The University of Oxford and partner AstraZeneca paused the global trials of the vaccine on September 6, after a trial participant suffered from mysterious neurological symptoms including limb weakness or “changed sensation”, new research papers show.
“After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine,” the document said.
Understanding Clinical Trials
This step is where many promising potential vaccines fail. There are three phases of a clinical trial:
- Testing on a few dozen healthy volunteers, looking at how safe the vaccine is, and if it has any adverse effects
- Testing on several hundred people for efficacy (a ‘target population’ who are ideally those most at risk of the disease)
- Testing on several thousand people for efficacy and safety – through these phases the vaccine needs to show it is safe, leads to a strong immune response, and provides effective protection against the virus.
Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial.
The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trials in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of “an unexplained illness” in a participant in the study.
The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by Serum Institute of India (SII).
The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.
As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford. https://t.co/ThIU2ELkO3
— Adar Poonawalla (@adarpoonawalla) September 12, 2020
It must be noted that vaccine development is a long process with multiple stages and most important of all is human trials and in any trial fast-tracking the process could lead to severe consequences for the safety and the health of people. Therefore, patience is the key today; we are not far behind the world in terms of vaccine development till then we have to follow Covid protocols and guidelines of the government.