A patient has died in the global study of AstraZeneca and the University of Oxford’s COVID-19 vaccine, Brazil’s health authority, Anvisa announced on Wednesday. But despite the death, the study will carry on as normal, Reuters reports.
The person who died was Brazilian, said the Federal University of Sao Paulo, which is helping coordinate the trial in Brazil, the news service said. It's not yet clear whether the death was related to the vaccine candidate.
"We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed,” an AstraZeneca spokesperson said in an email.
“All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities," the spokesperson added. "These assessments have not led to any concerns about continuation of the ongoing study."
The news comes a month after AstraZeneca, along with partner Oxford University, paused the study because a patient developed transverse myelitis, or inflammation of the spinal cord that can be triggered by infections. The duo has since restarted the trial in certain countries, including Brazil, but the U.S. phase 3 study remains on hold—though that may be changing soon, Reuters reported on Tuesday.
U.K. regulators supported the resumption of the trial a week after the pause, with their counterparts in Brazil, India and South Africa following suit soon after. However, the FDA has taken longer to review the situation, forcing AstraZeneca to wait to resume a U.S. phase 3 trial that only began shortly before the safety concern emerged.
The U.S. trial could be back on track as soon as this week, Reuters reported, citing comments from four unnamed sources and a draft letter to U.K. trial participants dated Oct. 14. The FDA “has come to the same conclusion as the other drug regulators," and the U.S. study would resume shortly, the letter said.
AstraZeneca isn't the only COVID-19 vaccine maker that's hit a roadblock. Just last week, Johnson & Johnson suspended its own study because a patient developed an "unexplained illness." Like AstraZeneca, J&J did not immediately know if the patient had received the vaccine candidate or placebo.