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Japan resumes AZ’s COVID-19 vaccine trial, but US study remains on hold

Trials have also resumed in the UK, India, South Africa and Brazil

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has authorised the resumption of a phase 1/2 trial of AstraZeneca’s COVID-19 vaccine, almost a month after the study was paused due to a reported serious adverse event in the British trial.

On 6 September, a standard review process triggered a volunteer pause across all global trials after a participant in the UK trial experienced a serious adverse event. According to the New York Times, the volunteer developed transverse myelitis, which is associated with viral infection and affects the spinal cord.

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

However, the US Food and Drug Administration (FDA) is expected to broaden its investigation into the suspected adverse event, and has asked for additional data from AZ before it resumes US trials.

The agency will ask for data from earlier trials of similar vaccines developed by the same scientists, sources close to the matter told Reuters. AZ’s vaccine candidate, AZD1222, was developed by researchers from Oxford University and is comprised of a modified chimpanzee adenovirus ( a weakened version of a common cold virus).

In a statement, AZ commented that it is “continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial”.

In May, the US government’s Biomedical Advanced Research and Development Authority (BARDA), under its Operation Warp Speed initiative, agreed to provide up to $1.2bn to support the development of AZ’s vaccine.

This collaboration agreed to make at least 300 million doses of the AZD1222 available for US citizens. The funding was provided to support advanced clinical studies, as well as process development and scaled-up manufacturing for the vaccine.

When BARDA first agreed on the collaboration with AZ, it said that the first doses could be delivered as early as October, a timeline which is becoming increasingly unlikely.

The expansion of the FDA’s review into the unexplained side effect will no doubt delay the ongoing development of AZ’s vaccine, dampening its ambitions for speedy development and rapid regulatory approval – at least in the UK.

The European Medicines Agency (EMA) said its human medicines committee is starting to evaluate the first set of non-clinical laboratory data on AZ’s vaccine candidate  and will continue to analyse additional data on a ‘rolling review’ basis.

Article by
Lucy Parsons

2nd October 2020

From: Regulatory

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