Why Halting COVID Vaccine Trials is No Reason to Worry
COVID vaccine trials have been halted lately, but experts say these pauses are good signs and no reason to worry.
Johnson & Johnson and Eli Lilly both put a halt to their late-stage COVID vaccine trials and treatment trials last week because of possible safety concerns.
A month earlier, AstraZeneca also announced a pause on their COVID vaccine trials as two volunteers fell seriously ill.
Halting these clinical trials, expert say, is comforting news. As said in an article from The Hill, putting a pause to trials mean they are following proper safety procedures.
But while pausing vaccine trials are usual, treatment trials rarely take breaks, said a New York Times report. Eli Lilly's treatment features an antibody drug expected to fight COVID-19, and pausing its trial can be worrisome.
Patients that go through a treatment trial, not a COVID vaccine trial, are already sick. Naturally, declines in health are going to be expected in them, so safety concerns have to significant to signal a halt.
Why Pause COVID Vaccine Trials?
There is an independent group of experts called the data and safety monitoring board (DSMB). They ensure the safety of clinical trial participants and recommends a pause if there is an "adverse event" that arises.
Isaac Bogoch, an infectious disease specialist that the University of Toronto told CNBC that pauses don't take long. They also don't necessarily mean there is a problem with vaccines or treatments.
As Bogoch explained, the DSMB will investigate whether the patient was part of a placebo group or not. They will also note the actual illness experienced by the patient and find out if it is related to the medication.
The DSMB also decides if a clinical trial is safe to get back on track.
What Would it Take for COVID Vaccine Trials to Resume?
According to The Conversation, the decision to resume a study depends the assessment of by the DSMB committee.
This committee will decide on resuming trials and, to a large extent, the investigators will have to comply with their recommendation.
Vaccination of participants will only resume after the board has given its approval to do so.
Those who are already enrolled to the study at that point can go about their scheduled visits and will continue to be tested for the virus.
Global Pressure and COVID Vaccine Trials
With the pandemic still ongoing, COVID vaccine trials and treatment progress have been under intense scrutiny.
"No one before Covid-19 cared when there was a pause on a clinical trial for an antibiotic or heart medication," noted Bogoch.
It was clear the world is watching closely, following any bit of information they can gather on the progress of medications.
But since companies and regulators have kept mum on the reasons behind their halts, some worry the secrecy would backfire.
Since people don't know the reason for delay, drug makers could face some kind of public distrust.
Eric Topol, a clinical trials expert at the Scripps Research Institute said pharmaceutical companies are facing an unprecedented level of public interest.
"There has never been this type of interest and scrutiny," he said. The scrutiny was quite understandable.
As Topol noted, many people will be affected by the results of these trials.
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