The US FDA has authorised to resume the clinical trial of Oxford’s COVID-19 vaccine on Friday, according to AstraZeneca
The trial has been paused since September 6 worldwide in light of a reported case of a rare spinal inflammatory disorder known as transverse myelitis in the wider programme. “The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial,” said the company.
The trial resumed shortly thereafter in Britain, as the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) supported the resumption of the COVID-19 vaccine clinical trial after finding there was insufficient evidence to link the investigational product to the illness.
It explained that transverse myelitis can be triggered by physical trauma and virus, complicating the task of determining a causal relationship to the vaccine. In the following weeks in South Africa, Brazil, Japan and India resumed the trial with authorities determining the illness was not apparently linked to the vaccine. However, the USFDA has taken longer to review the situation, forcing AstraZeneca to wait to resume the U.S. phase 3 trial.
AstraZeneca said it was hoping to have results later this year, “depending on the rate of infection within the communities where the clinical trials are being conducted.”
The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic. It is one of 10 vaccine candidates being tested on tens of thousands of people in phase 3 trials.
In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna both of which expect to request approval in November, according to sources.
Shortly after the announcement from AstraZeneca, Johnson & Johnson announced that it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill.