Brazilian pediatrician Monica Levi, one of the volunteers who received the COVID-19 vaccine, works at the Specialized Clinic for Infectious and Parasitic Diseases and Immunizations (CEDIPI) in Sao Paulo, Brazil on July 24, 2020. The doctor is one of the 5,000 volunteers who took part in the phase 3 trials in Brazil – the last before homologation – of the ChAdOx1 nCoV-19 vaccine developed by Oxford University in cooperation with the British pharmaceutical company AstraZeneca.
Nelson Almeida | AFP | Getty Images
AstraZeneca shares turned negative Wednesday after a Brazilian health agency, Anvisa, said a volunteer died in its coronavirus vaccine study.
The Federal University of Sao Paulo, which helps coordinate late-stage studies in Brazil, separately stated that the volunteer was Brazilian, according to Reuters.
Shares in AstraZeneca, a leader in the Covid-19 vaccine race, gave up slight gains after the news broke. Shares fell around 1% in the early afternoon.
An AstraZeneca spokesman declined to comment on the volunteer, referring to "Medical Confidentiality and Clinical Trials Regulations".
The spokesperson added that "(a) all significant medical events are carefully assessed by investigators" and "(t) these assessments do not raise concerns about the continuation of the ongoing study".
In a statement, a spokesman for Oxford University, which is developing the vaccine with AstraZeneca, said that "there are no concerns about the safety of the clinical trial" following an assessment of the case in Brazil.
"The independent review in addition to the Brazilian regulator recommended that the process should continue," said Oxford spokesman Alexander Buxton.
Oxford did not provide any further details about the volunteer's death, and it is unclear whether the volunteer received the vaccine. According to the Johns Hopkins University, Brazil currently has the second deadliest outbreak in the world after the US, with at least 115,914 deaths.
A source familiar with the situation told Reuters that if the volunteer had been part of the group that received the shot, the trial would have been suspended.
The news comes as the Food and Drug Administration puts yet another late clinical trial from AstraZeneca in the US on hold. This means the company will not be able to give US participants second doses of its vaccine dose with two doses.
The company announced on Sept. 8 that its study had been suspended because of an unexplained disease in a patient in the UK. The patient is believed to have developed an inflammation of the spinal cord known as transverse myelitis. The process has since resumed in the UK and other countries.
The US is expected to resume the process as early as this week after the FDA completes its review, Reuters reported Tuesday, citing four anonymous sources.
AstraZeneca is one of four drug companies supported by the US in late-stage testing of a potential vaccine. AstraZeneca's vaccine, called AZD1222, uses genetic material from the coronavirus with a modified adenovirus.
In July, the company released data showing its vaccine produced a promising immune response in an early study and was well tolerated.
According to the researchers at the time, the vaccine did not cause any serious adverse events in volunteers. Fatigue and headaches are the most commonly reported side effects. Other common side effects were injection site pain, muscle pain, chills, and fever.