Shares of AstraZeneca’s stock declined as a volunteer participating in the Phase 3 clinical trial in Brazil died, reports Brazil’s food and drug regulator Anvisa. According to Reuters’ reports, the national coordinator of the study, the Federal University of Sao Paulo, disclosed the subject was Brazilian. This study, still on hold by the U.S. Food and Drug Administration (FDA), resumed in the UK, India, and Brazil. This latest incident doesn’t appear to be associated with the actual experimental vaccine. TrialSite reported on the strange anomaly associated with this study—the unprecedented compression of timeline involving an estimated start date and estimated primary completion date for a Phase 3 COVID-19 vaccine trial.
Brazil represents the second-worst pandemic hotspot next to the United States. The South American nation has recorded at least 115,914 deaths to date, according to Johns Hopkins University.
What’s the basis for the underlying “Oxford” vaccine?
This vaccine uses genetic material from the coronavirus with a modified adenovirus. The vaccine candidate was developed at Oxford and licensed by AstraZeneca. By July, disclosed data revealed that the vaccine held much promise—with a safety profile and good toleration.
Is this the same study drug that the U.S. FDA has put on hold due to safety issues in the U.K.?
Yes. At least two subjects experienced neurological issues, including a purported case of transverse myelitis.
Why did the FDA put the study on hold, but the U.K., Brazil, and India resumed the clinical trial?
We cannot be certain at this point.
What’s the Study # in the USA?
The study number is NCT04516746.
Is there a CRO helping to manage the study?
Status of the Trial in Brazil?
Thus far, the study teams have recruited 8,000 out of 10,000 planned volunteers.
When will the U.S. resume the trial?
According to a Reuters report, anonymous sources tell the study will commence later this week.
What was the anomaly associated with this clinical trial picked up on by TrialSite News?
Out of all Phase 3 COVID-19 vaccine clinical trials, the average duration from estimated study start time to estimated primary completion was about 15 months—the AstraZeneca trial duration: 3.5 months and unprecedented compression TrialSite documents here.
Does AstraZeneca have any comments on this latest news?
AstraZeneca had no comments via their spokesperson, citing “medical confidentiality and clinical trial regulations.”
Why can’t the company (AstraZeneca) make a comment?
The company cannot discuss this matter until all significant medical events are carefully assessed by trial investigators, and thus far, the concerns don’t seem to indicate risk to the study itself.
Is this the University of Oxford vaccine?
Yes. The AZD1222 investigational product is the rebranded Oxford vaccine called ChAdOx1 nCoV-19.
Does the University of Oxford have any concerns?
No. According to a statement from a prestigious university spokesperson, “there have been no concerns about safety of the clinical trial” after the assessment of this incident.
What’s the recommendation of the independent safety review board?
To continue, the study reported Oxford’s Alexander Buxton. Reuters reports sources familiar with the situation report that the trial isn’t suspended because the subject who died didn’t receive the vaccine (implied is that they’re part of the control group given meningitis vaccine).
Did the volunteer actually get inoculated with AZD1222?
It would appear not.
So overall, it sounds like the issue was deemed not a threat to the overall trial?
Correct. The trial will commence according to recent reports. But that situation is subject to change.