AstraZeneca’s COVID-19 vaccine trials resume in Japan but still on hold in US

pharmafile | October 2, 2020 | News story | Medical Communications COVID, coronavirus 

AstraZeneca’s experimental coronavirus vaccine has resumed clinical trials in Japan after a patient illness halted the global study, but the US trials remain on hold. 

The trials resumed in Japan after the company consulted with the Japanese Pharmaceuticals and Medical Devices Agency. This follows the resumption of the study in Brazil, South Africa, India and the UK.

The reason the US trials have not yet resumed is due to the FDA widening its investigation into the patient illness that suspended the study. It is believed the ill participant could have suffered from transverse myelitis, which is an inflammation of the sheath containing the nerves of the spinal cord. It can be treated with steroids but the condition can be permanent. 

It is an illness that has been associated with vaccinations before, although it is rare. A 2018 study published in Neurology, which analysed more than 30 years of data on US vaccines, found 119 cases of the condition in 29 men and 90 women, with half being recorded after vaccinations for hepatitis B.

The FDA wants to look at data from earlier trials of similar vaccines developed by the same scientists. Astrazeneca said in a statement on Friday that the safety of its trial participants was of the highest importance and they were applying the strictest safety standards in its global trials.

Conor Kavanagh

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