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AstraZeneca’s clinical trials for the vaccine were halted in July after one of the participants complained of neurological disorder.
Foremost COVID-19 vaccine pharmaceutical firm AstraZeneca Plc (LON: AZN) has disclosed that it has resumed its mid-late stage COVID-19 Vaccine trial in Japan, following the earlier global suspension of the process. As reported by Reuters, the resumption of clinical trials by AstraZeneca (AZN) in Japan also comes with reports that the firm is in talks with United States authorities to recommence the vaccine trial process.
Meanwhile, AZN stock is trading at 8,406.00 GBX, it is 0.86% down from the previous close.
The global trial of the COVID-19 vaccine candidate AZD1222 or ChAdOx1 nCoV-19 being developed by the duo of AstraZeneca and Oxford University following claims that one of the participants in the trial developed a rare spinal inflammatory disorder called transverse myelitis. With the temporary disruption caused, the company go a clearing approval dissociating the cause of the disease from the company’s experimental vaccine, a move that has caused the resumption of trials in the UK, Brazil, South Africa, and India. The resumption of the trails in Japan after consultations with the Japanese national health regulator, the Japanese Pharmaceuticals and Medical Devices Agency.
“A standard review process triggered a voluntary pause to vaccination across all global trials on 6 September to allow review of safety data by an independent committee. Their recommendations have been supported by international regulators in the UK, Brazil, South Africa, India and now in Japan, who have deemed that the trials are safe to resume,” the company said in a statement. It was also noted:
“AstraZeneca continues to work with the Food and Drug Administration (FDA) to facilitate review of the information needed to make a decision regarding resumption of the US trial. The safety of trial participants is of paramount importance and we are committed to upholding the highest standards of conduct in clinical trials.”
AZN Trial Resumes in Japan, Safety of Participants Reaffirmed
At the core of the company is the participant’s safety, following two major halts owing to the illness of drafted participants with the first experience recorded in June. AstraZeneca’s clinical trials for the vaccine were halted in July after one of the participants complained of neurological disorder. Commenting on the brick walls the company is facing in its clinical trials, World Health Organization (WHO) Chief Scientist Dr. Soumya Swaminathan said:
“I think this is a good … perhaps a wake-up call or a lesson for everyone to recognize the fact that there are ups and downs in research, there are ups and downs in clinical development and we have to be prepared for those”.
Other COVID-19 researching pharmaceuticals including Moderna Inc (NASDAQ: MRNA), Pfizer Inc (NYSE: PFE) are also at the late stages of their vaccine trials. All are hoping to get approval before the end of the year.