A participant who died during a trial of AstraZeneca Plc’s Covid-19 vaccine in Brazil had not received the injection from the company, according to a person familiar with the matter.
The person asked not to be identified because the information is not public.
Brazil’s health authority Anvisa said it had been informed on Monday of the death of the study volunteer and had received a partial report from an international committee assessing the safety of the trial. That committee suggested that the trial should continue, Anvisa said in a statement.
AstraZeneca, which is developing the vaccine with Oxford University, said it cannot comment on individual cases due to confidentiality and clinical trial rules. Oxford has no concerns about the safety of the vaccine trial after careful independent review, and Brazilian regulators have recommended that it continue, the university’s communications director Stephen Rouse said in a statement.
AstraZeneca’s US deposit receipts fell as much as 3.3% in New York on Wednesday afternoon after news of the person’s death, but they trimmed most of those losses in recent trading.
Test break in the US
A clinical trial of the vaccine in the US has been on hold for more than a month. Studies were stopped globally in September when a UK participant fell ill, but have been resumed in the UK, Brazil, South Africa and India in recent weeks. While temporary pauses in vaccine studies are common, AstraZeneca and Oxford have faced pressure to reveal more information about the UK episode.
The discontinuation of the trial in the US raised concerns about the prospects for one of the world’s fastest vaccines and highlighted the hurdles researchers face in developing a vaccine. Another vaccine maker, Johnson & Johnson, said earlier this month that it would halt its trial to investigate a disease in a study participant.
Both the AstraZeneca and J&J vaccines are based on adenovirus, cold germs that researchers have used in experimental therapies for decades, and the two trials on hiatus have raised questions about the approach.
AstraZeneca told analysts in early October that it expected the US study to be able to resume this year and that global approval would be determined by the results of tests outside the US.
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