MAVERICK CITIZEN: South Africa resumes Oxford Covid-19 vaccine trial after reassurance on safety

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The SA Health Products Regulatory Authority and two ethics committees have given their approval for the resumption of the Oxford Covid-19 vaccine trial in South Africa. The trial was paused globally almost a week ago after an independent data and safety monitoring committee recommendation to review the case of an ill participant.

said at the time that the pause in and of itself should not be a cause of safety concern and that it showed the research team’s commitment to safety and quality.

Those who were scheduled to receive the second dose of the vaccine during the pause will have that visit rescheduled for this week, says Cutland. She explains that because this is now outside of the usual 21- to 35-day period between doses, the research teams have to file reports on why this is so and send this to the national coordinating team.

Throughout this process, each of the five trial sites was in contact with the participants, mainly through SMS or WhatsApp. Wits University said all trial participants had been informed of when vaccination was paused and resumed. Those who needed their visits rescheduled were contacted.

She adds that she felt informed in a way that enabled her to understand why the trial was being paused. “This is very reassuring.”Professor Francois Venter also received these SMSes. He is the deputy executive director of the Wits Reproductive Health & HIV Institute and is aHe says the messages did a good job of explaining clearly what is happening in the trial and that the media and vaccinologists have played their part in informing the general public too.

 

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