Oxford University Covid-19 vaccine trial resumes after pause over illness

Clinical trials for the AstraZeneca coronavirus vaccine restarted after an investigation

Laboratory technicians handles capped vials as part of filling and packaging tests for the large-scale production and supply of the University of Oxford’s COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologics’ manufacturing facility of multinational corporation Catalent in Anagni, southeast of Rome, during the COVID-19 infection, caused by the novel coronavirus.  Catalent Biologics’ manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxford’s Covid-19 vaccine candidate, AZD1222, providing large-scale vial filling and packaging to British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca. / AFP / Vincenzo PINTO
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International drugs manufacturer AstraZeneca and Oxford University have resumed a coronavirus vaccine trial after an investigation into how a volunteer developed an unexplained illness.

The AZD1222 project is one of the most promising of the potential vaccines in development and one of the furthest along the safety and efficacy testing programme.

“Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority that it was safe to do so,” the company said.

“The standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators,” AstraZeneca said.

“The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.”

The company said it could not disclose further medical information.

“All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards,” the company said.

The New York Times has reported that a UK volunteer was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. The volunteer is expected to recover.

The potential vaccine is in its Phase 3 trials, which focus on the effectiveness of vaccines in protecting against infection, testing thousands of volunteers in the UK, Brazil and some other countries.

In the United States, the company started enrolling the first of 30,000 volunteers on August 31.

The AZD1222 vaccine uses a weakened version of a common cold-causing adenovirus engineered to code for the spike protein that the Covid-19 coronavirus uses to invade cells.

It is one of nine currently in Phase 3 trials.