The African Centre for Biodiversity (ACB) has expressed concern over the planned trials of a genetically modified (GM) vaccine on COVID-19 in South Africa, demanding for transparency in the entire process as well as public hearing.
ACB made a submission to the Registrar of GMOs in South Africa, following an application made by Professor Shabir Ahmed Madhi, from the Respiratory and Meningeal Pathogens Research Unit (RMPRU), Chris Hani Baragwanath Academic Hospital, for approval for release of ChAdOx1 nCo-V-19, a genetically modified (GM) vaccine, for clinical phase I/II trials on 2,800 both healthy and HIV-positive adults over a period of 12 months.
The Centre said it made submission in the public interest, and also in the context of it’s sharing the global community’s common sense of urgency to find long-term life-saving solutions to the current pandemic.
The group noted however that while effective treatments are being developed as rapidly as possible, “this cannot and should not come at the cost of the highest standards of safety, efficacy, transparency, and ethics in clinical research”.
ACB said: “These trials are to take place in three locations in the province of Gauteng: Respiratory and Meningeal Pathogens Research Unit (RMPRU), Chris Hani Baragwanath Academic Hospital; Wits RHI Shandukani Research Centre and Setshaba Research Centre.
In its submission, the ACB raised several concerns, which include:
- Non-disclosure of vital safety data and information, which have been redacted as “confidential business information”,
- Lack of literature references throughout to substantiate health and ecosystem safety claims, making it difficult to evaluate some of the claims being made as to safety,
- Lack of evidence of efficacy of the trials,
- Lack of information on the test procedures being used, and
- Concerns regarding the safety claims made.
The group stated that scientific integrity in the time of a pandemic is needed more than ever to ensure trust in the safety and efficacy of future treatments going forward. It urged that full public participation in the decision-making process governing fair administrative procedures should not be sacrificed.
ACB added: “With any treatment, whether it is a drug or non-therapeutic intervention, such treatments must be designed as a public good, with full access to information, underpinning any project and its progress through the stages of research to clinical approval.
“We call upon the Executive Council: GMO Act (EC) to ensure that the applicant ensures full disclosure of the safety data and information to the public to enable us to exercise our rights to administrative justice.
“Further, the public has the right to fair administrative decision-making and the right to democratic participation. We are of the view that these rights of the public cannot be said to be upheld unless there is full and meaningful public participation and that decision-making is done in a procedurally fair, open and transparent manner.
“In this regard, we strongly urge the EC to set up an independent panel comprised of multi-disciplinary experts to conduct an open and transparent process to assist the EC in reviewing this application and to conduct public hearings in an open and transparent way, on the concerns being raised in this submission and that may be raised by other sections of the South African society, online still in June 2020.”