- Clinical trials of AstraZeneca and Oxford University’s vaccine have begun in Japan, AstraZeneca said Friday.
- The drug-maker said the trial resumed after consultation with the Japanese Pharmaceuticals and Medical Devices Agency.
- But the company said its US trial is still on hold and it is working with the US Food and Drug Administration in order to begin its US trial.
- The drug-maker’s phase 3 COVID-19 vaccine trial was put on hold on September 6 after a participant suffered an adverse reaction to the drug.
- The US this week widened its safety inquiry into the event.
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Clinical trials of AstraZeneca and Oxford University’s COVID-19 vaccine have resumed in Japan, almost one month after the company halted large-scale global tests after a participant fell ill.
The company said trials had restarted in Japan after consultation with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
“The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA),” AstraZeneca said in a statement Friday.
AstraZeneca’s phase three coronavirus vaccine trial, which is said to be one of the most advanced right now, was put on hold on September 6 after a participant in the UK reportedly fell ill with a rare spinal inflammatory disorder called transverse myelitis.
The drug maker has already resumed trials in the UK, Brazil, South Africa and India and now Japan.
The company still kept its US trial on pause and said it continues to work with the Food and Drug Administration to “facilitate review of the information”.
The FDA broadened its safety investigation this week into the reaction in the participant in the UK trial.
This could delay the company’s efforts to roll out its vaccine at a time just as cases of Covid-19 are rising again, with the global count now above 34 million and over 1 million dead this year alone.
The US has bagged almost a third of the first one billion doses planned for AstraZeneca’s experimental COVID-19 vaccine by pledging up to $1.2 billion, as countries scramble for effective treatment for the disease.
Bloomberg reported this week European regulators have started an accelerated review of AstraZeneca’s vaccine, meaning it could be the first vaccine to gain approval in the region.
The head of the European Medicines Agency Marco Cavaleri announced in July the agency will announce “rolling reviews” of potential vaccines after the summer, which might mean one could be available in the region by the end of the year.
A rolling review is a regulatory tool that the agency uses to speed up the assessment of a promising medicine or vaccine during a public health crisis.
Moderna, another company in the lead to develop a vaccine, told the Financial Times this week a vaccine won’t be ready before the US election.
Shares in AstraZeneca were last down 1% in London on Friday, in line with weakness across the broader stock market.