10.22.20

Suspected Control Group Participant in AstraZeneca COVID-19 Vaccine Study Dies; Trial Continues

Source: FirstWord

Brazilian health authority Anvisa said that a participant in a clinical trial there of AstraZeneca’s experimental COVID-19 vaccine AZD1222 died earlier this week, but added that the study would nevertheless go on. AstraZeneca stated it cannot comment on individual cases because of confidentiality rules, but said an independent assessment of the case has “not led to any concerns” about continuing with the trial, while a person familiar with the matter is quoted in one report as saying the volunteer had not received the company’s vaccine.

Meanwhile, the University of Oxford, which is co-developing the AZD1222 candidate, has no concerns about the safety of the vaccine trial after an independent and careful review, and Brazil’s regulators have recommended that it continue, according to university communications head Stephen Rouse.

May have taken placebo dose

Brazilian press reported that the volunteer was a 28-year-old man who had died of complications from COVID-19. Carlos Fortaleza, an epidemiologist at São Paulo State University, remarked that “the fact that the trials were not suspended could indicate that the person took a placebo dose.”

This latest news follows a global hold placed on AstraZeneca’s phase 3 trial in early September after a study participant in the UK fell ill with what was suspected to be transverse myelitis. The trials have since resumed in the UK, as well as other countries including Brazil, though they remain on hold in the US, where the FDA was conducting its own review of the incident. However, sources suggested recently that the US trial might start up again as early as this week.

Last week, Johnson & Johnson also suspended further dosing in a phase 3 trial of its coronavirus vaccine candidate JNJ-78436735 due to an “unexplained illness” in a participant.

Related Content