AstraZeneca COVID-19 vaccine trial's volunteer dies, testing to continue
What's the story
A volunteer involved with the trial of coronavirus vaccine developed by AstraZeneca and Oxford University has died, Brazil's health authority Anvisa informed on Wednesday. This setback, however, won't affect the trial and it will continue. While the news affected AstraZeneca's shares, Bloomberg reported that the deceased never received a shot of the vaccine, dubbed as the front-runner in the race. Here are more details.
Recommendation
Decision to continue trial was taken after recommendations
Anvisa was told about the death on Monday. It also received a recommendation from the International Evaluation and Security Committee, which is overlooking the trial, to not halt the process. As per CNN, in Rio, the vaccine trial is being conducted by D'Or Institute. Till now, 8,000 volunteers were administered either the vaccine or a placebo. The institute also recommended the study to continue.
Details
Oxford made a similar comment, said trial won't be affected
After the unwelcome development, Oxford University also said the trial won't stop. "All significant medical incidents, whether participants are in the control group or the COVID-19 vaccine group, are independently reviewed," a statement read. In this case, a careful assessment was done and no concerns about safety were raised, the statement added. Separately, AstraZeneca said it follows all review processes ardently.
Quote
None of the assessments cast doubts on safety: AstraZeneca
"All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee, and the regulatory authorities. These assessments have not led to any concerns about the continuation of the ongoing study," a spokesperson of the pharma giant said.
Aftermath
AstraZeneca's shares turned negative after word of demise got out
After news of the death surfaced, AstraZeneca shares plunged 1.7%. On Wednesday afternoon (local time) the company's American depositary receipts in New York fell by 3.3%. However, following Bloomberg's report, that suggested the deceased was never given the vaccine, the losses are expected to be trimmed. Details about the Brazilian who died, like where they lived or how old they were, weren't revealed.
Looking back
Last month, AstraZeneca's trial was paused after volunteer fell ill
To recall, the trial of the AstraZeneca vaccine is halted in the United States for over a month after a participant took ill. The late-stage trial, notably, resumed in most parts of the world after a brief pause. Earlier this month, Johnson & Johnson also stopped testing after a volunteer fell ill. Effectively, the enrollment of participants for J&J's trial was also stopped.
Details
AstraZeneca and J&J's trial could resume soon in US
As experts have been demanding more transparency from J&J and called upon the pharma giant to shed light on when the process will resume, Moncef Slaoui, the head of Operation Warp Speed, said trials of both the aforementioned vaccines could resume this week, reports Bloomberg. "It's for the FDA to announce and decide but I understand that this is imminent," Slaoui said.