Last Sunday, AstraZeneca suspended its trial after a participant in Britain became seriously ill. The company did not announce the decision. On Wednesday, after the news organization Stat reported that the trial had paused, AstraZeneca released a statement that described it only as a “potentially unexplained illness.”
The New York Times reported that a person familiar with the situation, who spoke on the condition of anonymity, had said that the symptoms were consistent with inflammation of the spinal cord, known as transverse myelitis. The condition can be treated and is typically resolved in a few months, but severe attacks can cause major disabilities.
In announcing that it had resumed the trial in Britain on Saturday, AstraZeneca said that an outside panel of experts had reviewed the case and had told the British government’s Medicines and Healthcare Products Regulatory Authority that the trials could be safely resumed. The authority agreed, giving the green light to start again.
The British health secretary, Matt Hancock, cheered the restart.
“Good news for everyone: The Oxford vaccine trials are back up and running,” he said. “This pause shows we will always put safety first. We will back our scientists to deliver an effective vaccine as soon as safely possible.”
Michele Meixell, a spokeswoman for AstraZeneca, said that the company could not disclose any further medical information about the sick volunteer.
“All trial investigators and participants will be updated with the relevant information and disclosed on global clinical registries, according to the clinical trial and regulatory standards,” she said in an email.
Ms. Meixell did not say when she expected the trials in other countries to restart. “AstraZeneca will continue to work with health authorities across the world and be guided as to when other clinical trials can resume,” she said.
Article source: https://www.nytimes.com/2020/09/12/health/astrazeneca-coronavirus-vaccine-trial-resumes.html