A participant who died in Brazil during a trial of UK-based pharmaceutical company AstraZeneca’s COVID-19 vaccine had not received the company’s shot, sources said.
Anvisa, Brazil’s health authority, said it had been notified of the death of the study volunteer and had received a partial report from an international committee reviewing the safety of the experiment. The committee recommended that the trial should proceed, Anvisa said in a statement.
Because of confidentiality and clinical trial regulations, AstraZeneca, which is developing the vaccine with the Oxford University, said it cannot comment on specific cases. After an independent and thorough study, Oxford has no reservations about the safety of the vaccine trial and Brazil’s regulators have recommended that it proceed, Stephen Rouse, Oxford university’s head of communications said in a statement.
After news of the participant’s death came out, AstraZeneca’s shares fell 3.3 percent.
So far, 8,000 of the 10,000 planned trial volunteers have been recruited and given the first dose in six Brazilian cities, and many have already received the second shot, a university spokesman said.
A vaccine clinical trial in the US has been on hold for over a month. In September, when a UK participant became ill, studies were suspended internationally, but in recent weeks they have resumed in the UK, Brazil, South Africa and India. Although temporary delays are normal in vaccine studies, AstraZeneca and Oxford have faced pressure to reveal more about the UK episode.
The US trial disruption raised questions about the potential for one of the fastest-moving shots in the world and demonstrated the challenges facing researchers when developing a vaccine. Earlier this month, another vaccine maker, Johnson & Johnson, announced it would delay its trial to examine a study participant’s disease.
Adenoviruses, cold germs that researchers have used in experimental therapies for decades, are the basis of both the AstraZeneca and J&J vaccines, and the two halted trials posed concerns about the approach.
In early October, AstraZeneca told analysts that it anticipated the US research could restart this year meanwhile recent reports suggested that it is likely to be allowed to resume this week itself.