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The US arm of AstraZeneca’s (AZ) COVID-19 vaccine, which was suspended in September after a study participant developed a serious illness, could resume this week.
According to Reuters, Four sources briefed on the matter were told that the trial could resume later this week, although they added that it is not “clear” how the US Food and Drug Administration (FDA) would characterize the disease.
On 6 September, a standard review process caused a volunteer hiatus in all global trials after a participant in the AZ vaccine trial in the UK experienced a serious adverse event.
The volunteer developed transverse myelitis according to New York Times, a condition that is associated with a viral infection and affects the spinal cord.
The UK arm of the trial has since been resumed after disease occurrence was reviewed, and regulators deemed there was “insufficient evidence to say for sure” that the event was related to the vaccine or not.
Trials in Japan, Brazil, and South Africa have also been restarted after careful reviews by international regulators, which determined that it is safe to resume studies.
However, the FDA expanded its investigation into the event and requested additional data from AZ before the trial could be resumed in the US.
The agency requested data from previous trials of similar vaccines developed by the same scientists: AZ’s candidate vaccine, AZD1222, was developed by researchers at the University of Oxford and comprises a modified chimpanzee adenovirus.
According to one of the sources, AZ trial investigators should add information about the event to consent forms signed by study participants.
Last week, Johnson & Johnson (J&J) also halted a phase 3 study of its investigational COVID-19 vaccine after a trial participant fell ill.
In a statement, J&J confirmed that it had stopped the trial due to “unexplained illness in a study participant.” The company did not provide further details on the nature of the adverse event, adding that the vaccine study is not currently on clinical hold.
While AZ and J&J have suffered delays, Moderna and Pfizer have revealed that they expect to have initial efficacy data for their respective COVID-19 vaccines in the coming months.
Yesterday, Moderna CEO Stéphane Bancel said he expects interim results from the company’s COVID-19 vaccine trial in November, while Pfizer CEO Albert Bourla said earlier this week that the company You can know if your vaccine is effective or not by the end of October. .
