Patient dies on AstraZeneca COVID-19 vaccine trial, but didn’t receive vaccine dose
pharmafile | October 22, 2020 | News story | Research and Development |
The University of Oxford and AstraZeneca say they will continue their coronavirus vaccine clinical trials after a volunteer had died while on the study.
This was confirmed by the Brazilian health authority Anvisa, but Oxford Uni said there were no safety concerns after they investigated the matter. Anvisa said in a statement that the trial should continue.
“Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue,” a spokesperson commented. “All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities.These assessments have not led to any concerns about continuation of the ongoing study.”
According to a person familiar with the matter, the participant who died did not actually receive the vaccine but a placebo. The volunteer was a Brazillain doctor in his 20s who reportedly died from complications after contracting the virus, but the exact cause of death is unknown. He would not have been intentionally exposed to the virus as part of the trial; the UK is set to be the first country to purposely infect healthy volunteers with SARS-CoV-2 when it conducts challenge trials in January.
The news follows a US study of the vaccine being put on hold for more than a month when a participant became ill in the UK. Oxford Uni and AstraZeneca have not revealed detailed information about what happened in the UK study, but the patient is thought to have fallen ill due to a rare inflammatory condition called transverse myelitis. The study is continuing in Brazil, the UK, South Africa and India, but these incidents run the risk of denting public confidence in the vaccine. The Japanese Ministry of Health has requested details from AstraZeneca on the death in the Brazil trial.
Conor Kavanagh
