Brazilian Regulator Announces Patient Death in AstraZeneca Vaccine Trial

Brazil’s health regulator ANVISA (Agência Nacional de Vigilância Sanitária) disclosed Wednesday that a participant had died in AstraZeneca’s Brazilian late-stage COVID-19 vaccine trial, though the UK drugmaker said the incident was not grounds for stopping the study.

ANVISA said that it had been given data from the ongoing investigation into the death but declined to share details, noting that the committee evaluating the incident recommended continuing the study. According to a Brazilian publication that cited anonymous sources, the patient had been given a placebo, not AstraZeneca’s vaccine candidate.

AstraZeneca (AZ) declined to provide details but told FDAnews that “all required review processes have been followed” regarding the participant’s death and stated that “these assessments have not led to any concerns about continuation of the ongoing study.”

Meanwhile, the company could soon be given the all-clear to restart its late-stage trial in the U.S.  after pausing it to assess an adverse event more than a month ago, according to reports circulating this week.

The reports cite an Oct. 14 draft letter to UK trial participants signed by the Oxford COVID-19 Vaccine Team that indicate the FDA has finished its analysis of the safety event and said that vaccinations in the U.S. trial will begin again shortly. But a spokesperson for the UK’s drug regulatory agency said Wednesday that the agency has not been officially informed that the FDA is in fact finished with its analysis.

Both FDA and AstraZeneca told FDAnews Wednesday that they could not comment on their discussions about the safety event at this point.

HHS Deputy Chief of Staff Paul Mango suggested earlier in this month that more information may be coming out soon about the FDA’s safety review. The agency “continues to review safety information, and we’ll just have to see over the next week or so where that turns out,” he said during an Oct. 9 briefing (DID, Oct. 16).

It hasn’t been confirmed that the patient safety issue, which was announced on Sept. 9, was caused by the vaccine candidate, and trials have begun resuming elsewhere in the world, including in the UK, Japan, South Africa and India. — James Miessler