Brazilian Doctor Dies Participating in AstraZeneca’s COVID-19 Vaccine Clinical Trial
Story Highlights
- A COVID-19 vaccine trial participant, who was a physician working with COVID-19 patients at hospitals in Brazil, has reportedly died from coronavirus infection complications.
- It has not been confirmed, but sources indicate the victim was given the trial “placebo” (a meningococcal vaccine) and not the experimental AZD1222 vaccine developed by pharmaceutical company AstraZeneca and Oxford University.
- In September, AstraZeneca temporarily halted its COVID-19 vaccine trials when a participant developed inflammation of the spinal cord after vaccination in one of its trials in the United Kingdom.
A 28-year-old physician volunteer in Brazil, who was participating in a Phase 3 clinical trial of the experimental AZD1222 (formerly ChAdOx1 nCoV-19) for COVID-19 developed by AstraZeneca plc and Oxford University, died on Oct. 15, 2020. Early reports did not specify whether he had received the AZD1222 vaccine or a meningitis vaccine used as a “placebo.” It has since been reported that the man did receive the meningococcal vaccine used as a placebo in the trial instead of the experimental coronavirus vaccine, although no official confirmation has been released by AstraZeneca, which has cited privacy concerns for not making more information available to the public.1
The Brazilian National Health Surveillance Agency (ANVISA) released a statement saying, “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”2 However, the Brazilian newspaper O Globo reported that the victim was a physician working with COVID-19 patients at three hospitals in Brazil and died from complications arising from an infection with the SARS-CoV-2 virus. That information has been verified by other sources and the deceased has been identified as Joao Pedro Feitosa of Rio de Janeiro.3
“Laypersons Are Being Given Information They Can’t Understand”
In the comment section to Medscape’s article, “Brazil Confirms Death of Volunteer in COVID-19 Vaccine Trial,”4 which is limited to commentators from the medical community, the source was chastised for publishing a “misleading and inflammatory headline,” for adding to public confusion and creating possible misgivings about a future COVID-19 vaccine because “laypersons are being given information they cannot understand” and for fear mongering in reporting on the death at all when so much was unknown.
Several commenters alluded to the victim’s status as a front-line health care worker, noting that he was likely exposed to higher viral loads than other trial volunteers and that “those getting large repeated viral load inoculum no matter their health status is a huge risk the virus will just over run their immune system before it can even mount a appropriate response.” It was further suggested that this doctor might not have been a suitable candidate for the trial at all at this stage because his close contact with COVID-19 patients from three different hospitals would have put him at risk for a much higher than usual viral load.
Many Unknowns About the COVID-19 Vaccine Trial Participant Who Died
One person who commented on the Medscape article pointed out that, in addition to unconfirmed assumptions about whether the deceased volunteer was in the experimental or placebo arm of the trial, other questions also remain. It is not known, for example, whether other than his profession that made him more vulnerable to being infected with SARS-CoV-2 virus infection, the participant had underlying health conditions that placed him at high risk for COVID-19 complications. There is also no information about the timeline between his potential exposure relative to receiving the meningitis “placebo” vaccine injection or between injection and death. No details are yet known about the cause of death, aside from the attribution to “complications of COVID-19” and it is not known whether he mounted any type of antibody or other immune system response to the coronavirus infection.
Further, there is little information about the type of meningococal vaccine “placebo” the physician was given in the trial and a potential interaction between his apparent SARS-Cov2 viral infection and the administration of a meningitis vaccine that could have caused a serious adverse response.
The Clinical Trial in Brazil is Expected to Continue
In a public statement, Oxford University said, “All significant medical incidents, whether participants are in the control group or the COVID-19 vaccine group, are independently reviewed. 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.”5
AstraZeneca’s Phase 3 trials on the AZD1222 vaccine had been halted last month when a trial participant developed inflammation of the spinal cord after vaccination in the United Kingdom. That trial was resumed in the U.K. after a review by Britain’s Medicines Health Regulatory Authority (MHRA). The trial on AZD1222 vaccine in the United States remains on hold pending an investigation by the U.S. Food and Drug Administration (FDA).6
AZD1222 (formerly ChAdOx1 nCoV-19) uses a genetically engineered adenovirus that causes common cold symptoms in chimpanzees (ChAdOx1 – chimpanzee adenovirus Oxford 1) and contains the genetic material of the SARS-CoV-2 virus surface spike protein. The AZD1222 vaccine induces production of the coronavirus surface spike protein, priming the immune system to attack the coronavirus if it later infects the body and causes COVID-19 disease.7
No adenovirus-based vaccine has been successfully developed for use in humans, and questions have been raised about the approach.8 9
References:
ANVISA, AstraZeneca, AZD1222, Brazil, Brazilian National Health Surveillance Agency, ChAdOx1 nCoV-19, COVID-19, Joao Pedro Feitosa, Kate Raines, Medicines Health Regulatory Authority, Medscape, meningococal vaccine, MHRA, National Vaccine Information Center, NVIC, Oxford University, placebo, SARS-CoV-2, The Vaccine Reactio
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