It was on Tuesday that AstraZeneca, the U.K.-based pharmaceuticals giant and its partner, the University of Oxford, confirmed it had halted its Covid-19 vaccine trials after a person in the U.K. who was participating in one of their studies got sick.
A day after the announcement, the head of the National Institutes of Health told a U.S. Congress panel that the pause of AstraZeneca's trials shows that safety of vaccines will not be compromised.
AstraZeneca said it had paused global trials, including large late-stage trials, of the experimental vaccine following the development to allow an independent committee to review safety data.
The NIH is providing funding for the company's vaccine trial.
"This certainly happens in any large scale trial where you have tens of thousands of people invested in taking part in. Some of them may get ill. And you can always have to try to figure out, is that because of the vaccine or were they going to get that illness anyway? And with an abundance of caution, at a time like this, you put a clinical hold, you investigate carefully to see if anybody else who received that vaccine or any other vaccines might have had a similar finding of a spinal cord problem.
So, this ought to be reassuring to everybody listening when we say we are going to focus first on safety and make no compromises. Here is exhibit-A about how that is happening in practice."
However, AstraZeneca Chief Executive Officer Pascal Soriot told investors on a conference call Wednesday there had been no final diagnosis in the case and there wouldn't be one until more tests are done.
The British drugmaker's vaccine has been considered one of the most likely contenders to reach the market in the near term, along with shots being developed by Moderna and the tandem of Pfizer and BioNTech thus the latest pause serves as a reminder of the importance of safety and efficacy of such trials.
But what does this mean for other subjects in the Phase 3 trial, other drugmakers, and in our battle against the Covid-19 pandemic?
It's the topic of our News In-depth. Joining us live in the studio is Dr. Chulwoo RHEE, Project Lead of Covid-19 vaccine clinical trial at the International Vaccine Institute.
Dr. Rhee, thanks for coming in to speak to us.
This AstraZeneca Oxford vaccine trial is deemed the frontrunner in the race for a Covid-19 vaccine, one of nine coronavirus vaccine candidates in the final Phase 3 stage.
Perhaps this is why they were the first ones to have confronted with an unexpected setback.
But the Phase 3 trial enrolled 30-thousand adult volunteers in the United States.
Was the British subject that showed adverse reaction from the late stages of the ongoing Phase 2 trials that recruited 10-thousand subjects in the UK?
Help us understand what's caused this pause to this Phase 3 trial.
The NIH Director Francis Collins says it's a spinal cord problem. How serious of an adverse reaction did this British subject show? What could possibly be the factors that affected the trial?
Now, it's important to note that this is not an end to the trial, but a pause.
In the anxious and impatient state that we are in for a cure to this pandemic, we're focused more on this pause being a setback, but this is a normal part of a vaccine development?
And this isn't the first time this has happened to the Oxford vaccine?
Subjects that volunteer for clinical trials are made well aware of the safety risks involved. They're reminded that sometimes vaccine trials can deliver more harm than good.
With this first interruption, where does it leave the thousands of subjects involved in the trials of this particular vaccine?
How does this affect other drugmakers like Johnson & Johnson, Pfizer, Moderna, Sanofi, or SinoVac, that are relying on similar technology, or running rival trials?
What does this mean for South Korea? We know that South Korea's SK Bioscience inked a deal with AstraZeneca back in July to supply a candidate material for a coronavirus vaccine.
You lead the Covid-19 vaccine clinical trial project at the International Vaccine Institute. How far along are we in terms of vaccine progress?
How do you see the timeline of a vaccine being available for the public?
In a U.S. election year, pharmaceutical companies want to ensure that politics won't interfere with science.
What are some of your concerns as the race continues for delivering a vaccine for COVID-19?
Dr. Rhee Chul-woo of the International Vaccine Institute, many thanks for speaking with us this evening. We appreciate it.