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AZ’s US-based COVID-19 vaccine trial could restart this week

Sources briefed on the matter disclosed possible timeline to Reuters

The US arm of AstraZeneca’s (AZ) COVID-19 vaccine, which was put on hold in September after a study participant developed a serious illness, could resume this week.

According to Reuters, four sources briefed on the matter have been told that the trial could resume later this week, although they added it is ‘unclear’ how the US Food and Drug Administration (FDA) would characterise the illness.

On 6 September, a standard review process triggered a volunteer pause across all global trials after a participant in AZ’s UK vaccine trial experienced a serious adverse event.

The volunteer developed transverse myelitis according to the New York Times, a condition which is associated with viral infection and affects the spinal cord.

The UK arm of the trial has since resumed after the illness occurrence was reviewed, with regulators deeming that there was “insufficient evidence to say for certain” that the event was related to the vaccine or not.

Trials in Japan, Brazil and South Africa have also restarted following careful reviews by international regulators, which determined that the studies are safe to resume.

However, the FDA broadened its investigation into the event, asking AZ for additional data before the US trial could resume.

The agency asked for data from earlier trials of similar vaccines developed by the same scientists – AZ’s vaccine candidate, AZD1222, was developed by researchers from Oxford University and comprises a modified chimpanzee adenovirus.

According to one of the sources, AZ’s trial researchers are required to add information concerning the event to consent forms signed by the study participants.

Last week, Johnson & Johnson (J&J) also paused a phase 3 study of its investigational COVID-19 vaccine after a participant in the trial fell ill.

In a statement, J&J confirmed that it had paused the trial due to an “unexplained illness in a study participant”. The company offered no further details regarding the nature of the adverse event and added that the vaccine study is not currently under a clinical hold.

While AZ and J&J have suffered delays, Moderna and Pfizer have both revealed that they are expecting to have initial efficacy data for their respective COVID-19 vaccines in the coming months.

Yesterday, Moderna’s chief executive officer Stéphane Bancel said he expects interim results from the company’s COVID-19 vaccine trial in November, while Pfizer’s CEO Albert Bourla said earlier this week that the company may know whether or not its vaccine is effective by the end of October.

Article by
Lucy Parsons

21st October 2020

From: Regulatory



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