Covid-19: AstraZeneca vaccine trials resume in Japan but talks with US continue
AstraZeneca says Covid-19 vaccine trials have resumed in Japan after authorities gave it the all clear.
The pharmaceutical company, which developed the Covid-19 vaccine “AZD1222” in collaboration with the University of Oxford, voluntarily paused all global trials on 6 September following an adverse reaction in one patient.
A safety review by an independent committee was undertaken and it was recommended trials resume.
This was supported by international regulators in the UK, Brazil, South Africa and India, who deemed that the trials were safe to resume, and now by Japan as well.
However, trials in the US have not yet been allowed to continue while the Food and Drug Administration (FDA) continues to review the information.
The issue stems from a trial participant in the UK falling ill with unexplained neurological symptoms, previously believed to be consistent with transverse myelitis.
AstraZeneca said it would continue to work with the FDA and provide it with the necessary information to make a decision, adding that the “safety of trial participants is of paramount importance”.
“Regulators in each individual country determine when trials can start and they do this in their own timeframe,” said the drugmaker. “We are continuing to work with the FDA to facilitate a review of the information needed to make a decision regarding resumption of the US trial.”
The vaccine is in the final stages of clinical trials in the UK.
It was joined in late-stage trials last week by another vaccine produced by US biotechnology firm Novavax, which is set to enrol 10,000 participants across the UK from 250,000 volunteers aged between 18 and 84 over the coming weeks.
Pfizer and Moderna are other pharmaceutical companies with vaccine candidates in the final stage of the regulatory approvals process.
There are just under 40 potential vaccines being tested around the world and more than 140 others in the early stages of testing, according to the World Health Organisation.