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The Oxford Covid-19 Trial Vaccine. (Photo by Gallo Images / Beeld / Felix Dlangamandla)
The South African Health Products Regulatory Authority and two ethics committees have given approval for the resumption of the Oxford Covid-19 vaccine trial in South Africa. The trial was halted globally nearly a week ago after a recommendation from the independent safety and data monitoring committee to review the case of a sick participant.
On Tuesday, September 15, Wits University resumed vaccinating participants in the Oxford Covid-19 vaccine trial after approval from the South African Health Products Regulatory Authority and two ethics committees.
While the pause caused a delay in the enrollment of 206 participants and administration of the vaccine, the research teams are confident that this will not affect the integrity of the trial findings.
The entire trial pause and resume process has been spearheaded by research teams in the UK and South Africa and overseen by independent expert safety committees as well as relevant country medical authorities. Between them, they evaluated whether it was safe to restart.
This entire process has been completed in less than a week.
British pharmacist AstraZeneca halted the global trial on September 9 after a participant fell ill in the UK. The independent data and safety monitoring committee recommended the pause to allow an assessment of whether the disease was related to the participant who received the Covid-19 vaccine.
The South African arm of the trial is overseen by this same committee. As a result, the Wits University team took the recommendation of press pause.
Many participants in South Africa had already received both the first and second doses of vaccine, but vaccination was discontinued for those who had not yet received them. Nonetheless, the research team continued with follow-up visits without vaccination with the participants, according to Dr. Clare Cutland. She is a scientific advisor to the African Leadership in Vaccinology Expertise Consortium with regulatory, ethical and protocol supervision of the Covid-19 trial.
Numerous medical experts said at the time that the hiatus itself should not be a safety concern and that it showed the research team’s commitment to safety and quality.
On September 12, the UK branch was rebooted after approval by the UK Medicines and Health Products Regulatory Agency and committee. The University of Oxford has explained that more detailed medical information about the participant’s illness could not be released due to confidentiality. However, the committee’s review concluded that the disease was unlikely to be related to the vaccine.
Following this, the South African Medical Devices Regulatory Authority and the ethics committees of Wits University and the University of Cape Town approved resumption of vaccination in South Africa. The Brazilian arm of the trial has also resumed.
Those who were scheduled to receive the second dose of the vaccine during the break will have that visit rescheduled for this week, Cutland says. She explains that because this is now outside of the usual 21-35 day period between doses, investigation teams must submit reports on the motive and send them to the national coordination team.
Those who had been screened before the break will also be contacted, retested for Covid-19 and then scheduled a vaccination if they test negative. They hope to do this as soon as possible, Cutland adds.
She explains that those who enroll and those who receive the second dose sign an informed consent form that explains why the trial was paused. This is to ensure that each participant is fully informed before continuing.
Throughout this process, each of the seven test sites was in contact with the participants, primarily via SMS or WhatsApp. Wits University said all trial participants were informed when vaccination was paused and resumed. Those who needed to reschedule their visits were contacted.
Trial participant Sharon Ekambaram | received an SMS as soon as the test was paused. She is the Head of the Refugee and Migrant Rights Program at Lawyers for Human Rights.
The SMS briefly explained why the trial had been stopped, that a safety committee was evaluating the incident, that more information would be sent out in the coming days, and that the break showed the researchers’ commitment to safety. He also provided a phone number that participants could contact if they had any questions.
This week he received an SMS explaining that the trial was restarted after its safety was approved and saying once again that safety is highly valued. He provided the same contact number again.
Ekambaram explains that participating in a trial has given him an idea of what it takes to run a trial. She says that while many people suffer from fatigue due to the stressful conditions that Covid-19 has created, the Wits research team “… never shows any signs of this enormous pressure that they must be under. Much respect!”
She adds that she felt informed in a way that allowed her to understand why the trial was being paused. “This is very reassuring.”
Professor Francois Venter also received these SMS. He is the deputy executive director of the Wits Institute for Reproductive Health and HIV and is a participant in the vaccine trial.
He says the messages did a good job of clearly explaining what is happening in the trial and that the media and vaccinologists have also helped inform the general public. “In general, it is good to be transparent in this way because it generates the trust of the public and the participants,” he adds.
He says he has had mild and typical side effects from the vaccine and was not concerned about safety when the trial was stopped. She said that because she lives in Johannesburg, she would be at greater risk walking out the door than trying the vaccine. She was glad that the trial had been restarted, as it brings us one step closer to finding an effective vaccine.
“Many people say that Covid-19 is just a serious flu; Covid is going to kill a lot of people … it may be the most common cause of death in 2020, to be honest. It is not a minor thing, ”he says.
“Getting herd immunity without a vaccine will kill a lot of people unnecessarily. I want to emphasize to everyone that this vaccine is really critical, especially since it looks like we are going to live with this for years to come. “
Ekambaram had been destroyed in the face of the possibility that the trial would be canceled.
“This would be a setback. Covid-19 has forced us to face our mortality and has stolen the lives of thousands of people prematurely. And it is a known fact that people living in poverty are disproportionately affected by this disease. A vaccine is an important part of mitigating such devastating consequences. That, along with the eradication of poverty, of course ”. DM / MC
