While technological advancements have come a long way, the numerical realities of clinical testing on a critical mass scale, and the improbabilities thrown up by a mutating virus cannot be ignored.
Chennai: The global pursuit for the coronavirus vaccine has been witnessing dramatic developments, with not just reports concerning the side-effects of the vaccine, but even remarks regarding its distribution model. On Saturday, Haryana’s Health Minister Anil Vij tested positive for COVID-19, two weeks after he joined a trial for Covaxin, which is under development by Bharat Biotech. The event triggered doubts concerning the vaccine which led to the company clarifying that the shot offers protection 2 weeks after the second dose, which is administered 28 days post the first dose.
Troublingly, last month, a 40-year-old native of Chennai, and a volunteer in phase 3 of the Covidshield vaccine trial alleged that he suffered psychological and neurological symptoms after taking the experimental vaccine. He has also sued Serum Institute of India (SII), seeking compensation of Rs 5 cr and stoppage of clinical trials. The SII refuted the allegations and warned of a counter suit seeking damages of over Rs 100 cr.
This case drew eyeballs as the Centre flew into action last week, and said the findings of the adverse event about the Oxford-AstraZeneca COVID-19 vaccine did not necessitate halting of the trials, adding that the timeline of the vaccine roll-out will not be affected in any manner. India is currently witnessing two indigenous COVID-19 vaccines undergoing trials, which includes Covaxin, and another vaccine by Zydus Cadila. Trials of Oxford-AstraZeneca vaccine is also being conducted here.
But the recent reports are reminders of the perils that endanger the fast-tracking of any vaccine. It is worth recalling that the timeline involved in formulating drugs for some of the most dangerous diseases known to man, has been nothing short of years, and in many cases, several decades. While technological advancements have come a long way, the numerical realities of clinical testing on a critical mass scale, and the improbabilities thrown up by a mutating virus cannot be ignored.
Way back in May, it was reported that in the course of a 45-person study being conducted by Moderna, four participants had experienced what is medically termed as Grade 3 adverse events. These are side effects that are medically significant or severe but not immediately life-threatening. The participants were part of Phase 1 clinical trials which helps in determining the right dosage of the vaccine, that causes the body to produce antibodies but does not end up in several side-effects. Experts had expressed optimism, saying such side effects are noteworthy, but not a reason to halt the research. “The goal of studies is to establish a threshold at which something might go wrong,” a professor of preventive medicine at Vanderbilt University Medical Center, was quoted as saying.
If it’s the threshold one is bothered about, there is a lot to chew on considering Prime Minister Narendra Modi’s declaration in October that all Indians will be vaccinated once the vaccine becomes available. That seems puzzling as the Director General of the ICMR, Dr Balram Bhargava had said it may not be necessary to vaccinate the entire population as inoculating a critical mass of the populace could be sufficient to break the chain of viral transmission. Bhargava’s words need to be weighed in the context of identifying who needs to be vaccinated and the distribution plan for India. A consensus is that frontline workers like healthcare staffers and professionals in the line of fire must be given priority treatment. Following this, the elderly and those with co-morbidities could be considered.
The constantly shifting goalpost when it comes to the COVID-19 narrative and the way forward is disorienting and problematic. Close to a year into the pandemic, there is a clear and present requirement to freeze on a few fundamentals – chief among them being – to vaccinate or not.
Troublingly, last month, a 40-year-old native of Chennai, and a volunteer in phase 3 of the Covidshield vaccine trial alleged that he suffered psychological and neurological symptoms after taking the experimental vaccine. He has also sued Serum Institute of India (SII), seeking compensation of Rs 5 cr and stoppage of clinical trials. The SII refuted the allegations and warned of a counter suit seeking damages of over Rs 100 cr.
This case drew eyeballs as the Centre flew into action last week, and said the findings of the adverse event about the Oxford-AstraZeneca COVID-19 vaccine did not necessitate halting of the trials, adding that the timeline of the vaccine roll-out will not be affected in any manner. India is currently witnessing two indigenous COVID-19 vaccines undergoing trials, which includes Covaxin, and another vaccine by Zydus Cadila. Trials of Oxford-AstraZeneca vaccine is also being conducted here.
But the recent reports are reminders of the perils that endanger the fast-tracking of any vaccine. It is worth recalling that the timeline involved in formulating drugs for some of the most dangerous diseases known to man, has been nothing short of years, and in many cases, several decades. While technological advancements have come a long way, the numerical realities of clinical testing on a critical mass scale, and the improbabilities thrown up by a mutating virus cannot be ignored.
Way back in May, it was reported that in the course of a 45-person study being conducted by Moderna, four participants had experienced what is medically termed as Grade 3 adverse events. These are side effects that are medically significant or severe but not immediately life-threatening. The participants were part of Phase 1 clinical trials which helps in determining the right dosage of the vaccine, that causes the body to produce antibodies but does not end up in several side-effects. Experts had expressed optimism, saying such side effects are noteworthy, but not a reason to halt the research. “The goal of studies is to establish a threshold at which something might go wrong,” a professor of preventive medicine at Vanderbilt University Medical Center, was quoted as saying.
If it’s the threshold one is bothered about, there is a lot to chew on considering Prime Minister Narendra Modi’s declaration in October that all Indians will be vaccinated once the vaccine becomes available. That seems puzzling as the Director General of the ICMR, Dr Balram Bhargava had said it may not be necessary to vaccinate the entire population as inoculating a critical mass of the populace could be sufficient to break the chain of viral transmission. Bhargava’s words need to be weighed in the context of identifying who needs to be vaccinated and the distribution plan for India. A consensus is that frontline workers like healthcare staffers and professionals in the line of fire must be given priority treatment. Following this, the elderly and those with co-morbidities could be considered.
The constantly shifting goalpost when it comes to the COVID-19 narrative and the way forward is disorienting and problematic. Close to a year into the pandemic, there is a clear and present requirement to freeze on a few fundamentals – chief among them being – to vaccinate or not.
Conversations