COPY AND PASTE THE LETTER BELOW INTO YOUR OWN EMAIL AND SEND IT.
The Registrar
GMO’s
Private Bag x973
Pretoria
Email: GMOappComments@daff.gov.za
Re: GENETICALLY MODIFIED ORGANISMS REGARDING THE APPLICATIONS FOR IMPORT AND TRIAL RELEASES OF AZD1222 (CHADOX1 NCO-V-19) VACCINE CLINICAL TRIALS FOR COVID-19
I refer to your notice, which was published in the Sunday Times on 10
May, 2020 TO WHICH THERE WAS NO CLOSING DATE FOR OBJECTIONS re the above application. I hereby wish to submit my objection based on the reasons in the submission to you by the African Centre for Biosafety (ACB) submission to you which deals principally with the application for approval for release of ChAdOx1 nCo-V-19 vaccine for clinical phase I/II trials on 2 800 both healthy and HIV-positive adults over 12 months.
As stated in the ACB submission, I emphasize that I am also fully in agreement with the global sense of urgency to find long-term, effective solutions to the current pandemic. However, I also urge decision-makers to be cautious that in light of such urgency, caution and safety is not disregarded. Rather, scientific integrity at the time of a pandemic is needed more than ever to ensure trust in the safety and efficacy of future treatments going forward. The necessary urgency in solving the corona virus crisis has already put pressure on research integrity standards, with the flood of pre-printed, non-peer-reviewed ‘research’ papers. This has had direct implications for policy decisions, with the World Health Organisation’s trials being terminated and then reinstated following the retraction of substandard publications on trial drugs.
Lack of transparency has also diminished trust in government responses in nations such as the UK, where the vaccine under discussion was developed, threatening public adherence to corona virus advice and health and safety policy. With the Oxford program described as undergoing a ‘very aggressive clinical development program’, we urge that full public participation in the decision-making process, as defined in the South Africa’s Genetically Modified Organisms Act in particular and its legal regime governing fair administrative procedures in general, are not sacrificed.
Considering the involvement of South African citizens in this trial, we urge that the Executive Council: GMO Act, require that the applicant address the concerns and comments raised in the ACB sumission to ensure the integrity of this trial and the protection of the trial participants, some of whom will also be HIV positive. It is unclear from the application of how health complications will be addressed after the 12-month study period.
I call upon the 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. These rights of the public cannot be said to be upheld unless there is full and meaning public participation and that decision making is done in a proceduraly fair, open and transparent manner. In this regard, I 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. I further request that such a panel is free of people/organisations who have vested interests in the outcome.
It is of foremost concern that the claim that the vaccine is safe because it is replication-defective is relevant. While some of the information provided regarding reproductive capacity has been CBI was deleted, the available information states that:
“The ChAdOx1 (AdvY25) viral vector is replication-deficient as the essential E1 gene region –which is essential for viral replication – has been deleted. The virus is unable to replicate within vaccinated animals or humans.”
This is however, not by any means proof of safety as evidenced by the vaccine production system itself. The defective vaccine virus can replicate in human HEK 293 cells because it is rescued by the human adeno virus 5 E1 locus being inserted into this cell line to replace the lost gene that was removed from the viral vaccine.
Yours sincerely
…………………….
Click here to read the full ACB submission.
Click here for the public notice of the application.
To view the application to do the trial, click here.
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