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PARIS: The COVID-19 vaccine trials currently underway evaluate mostly mild cases and are not designed to show that they can save lives or help the most vulnerable, a prominent said on Wednesday (21 October) public health expert.
The World Health Organization (WHO) has identified 42 candidate vaccines in clinical trials, 10 of which are in the most advanced phase 3.
This is where the efficacy of a vaccine is tested on a large scale, usually tens of thousands of people on various continents.
But even the most advanced trials are evaluating mild illnesses rather than severe, said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy.
“None of the vaccine trials are designed to detect a significant reduction in hospital admissions, admission to intensive care or death,” Doshi wrote in the medical journal BMJ.
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BUILT FOR SPEED
Doshi, who is also associate editor of the journal, said vaccine protocols “should be scrutinized by as many readers as possible” and questioned whether the correct end points are being studied.
Instead of studying severe illness, he added, the primary endpoint for symptomatic COVID-19 in current “mega-trials” is set to “any severity.”
“A positive laboratory result plus mild symptoms such as cough and fever count as outcome events. These studies seem designed to answer the easiest question in the shortest amount of time, not the most clinically relevant questions,” Doshi said.
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GAPS IN PEOPLE WHO ARE EVALUATED, SEVERITY OF THE DISEASE
This may be due to the number of people involved in the trials, he said, noting that the majority of confirmed COVID-19 infections involve little or no symptoms.
And few, if any, of the current trials are designed to find out whether there is a benefit among the elderly, a key group at risk.
Without enrolling frail and elderly volunteers in the trials in sufficient numbers, Doshi said there may be little basis for assuming any benefit against hospitalization or mortality.
He added that children, immunosuppressed people, and pregnant women had been largely excluded from the trials, so the experiments are unlikely to address key gaps in understanding how COVID-19 develops differently among women. people.
“Sixty years after influenza vaccination was routinely recommended for people 65 and older in the US, we still do not know if vaccination reduces mortality,” he wrote.
“There have never been any randomized trials with this outcome.
“Observational studies with results in both directions can be cited, and without definitive random evidence, the debate will continue. Unless we act now, we run the risk of repeating this unfortunate situation with COVID-19 vaccines.”
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Several trials have already stopped after participants got sick.
Many countries plan to prioritize vulnerable people once a vaccine is available, but Doshi said those hoping for a miraculous end to the pandemic would have to wait.
He said that several pharmaceutical companies had designed their studies “to detect a relative risk reduction of at least 30 percent in participants who develop laboratory-confirmed COVID-19.”
Recent studies have also confirmed that it is possible for someone to be reinfected with COVID-19, a development that can affect the way governments shape their vaccination plans.
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