Statement on the proposed emergency roll-out of vaccine program in Africa for monkeypox

The South Africa "Vaccine" Injury Medico-Legal Study-Group does NOT support the Africa CDC and WHO declaration of a global health emergency for monkeypox.

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Savims Statement On Proposed Emergency Roll Out Of Vaccine Program In Africa For Monkeypox

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IMMEDIATE RELEASE: Statement on proposed emergency roll-out of vaccine program in Africa for monkeypox.

We are deeply concerned about the recent announcements made by Africa CDC Director General Jean Kaseya on 13 August 2024 and WHO Director-General Tedros Adhanom Ghebreyesus on 14 August 2024.

It is important to address these announcements openly to the public.

In his statements, Director General Jean Kaseya declared regarding monkeypox vaccines, “We have a clear plan to secure more than 10 million doses in Africa, starting with 3 million doses in 2024.”

We at SAVIMS would like to point out pertinent facts to both institutions and other relevant bodies of interest:

1. There is no prescribed vaccine with documented level 1 scientific evidence for monkeypox. The current WHO recommended live virus vaccines, Jynneos and ACAM2000, are (a) intended for smallpox and are thus experimental for monkeypox; (b) have reported serious adverse effects and (c) contain live viral strains which may instigate a resurgence of the eradicated smallpox virus.

2. The potential use of mRNA vaccines. There is no scientific evidence supporting the use of any mRNA vaccine to prevent or mitigate any infectious disease. The observed data of adverse reactions to experimental mRNA vaccines far outweighs any benefit.

3. Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed, and not coerced. It is not possible for any recipient of these vaccines to receive a legitimate informed consent based on the current research.

4. The article by Allan-Blitz et al, “A position statement on Mpox as a Sexually Transmitted Disease,” concluded that monkeypox is a sexually transmitted disease.” Preventative measures for this scenario should necessitate and provoke relevant clinical and primary health care and education initiatives directed at the high-risk group. There is no merit for the recommendation of experimental vaccines to the general population.

5. The statistics and analysis, regarding the collated monkeypox data in the DRC and other countries in Africa by the WHO, warrant further investigation, and must be independently audited. The areas in which the highest statistics were collated should detail the criteria for testing, the procedures for testing, equipment sensitivity and specificity, personnel skill, clinical scenarios, and provocation for testing these specific communities. What tests were done to investigate and exclude other diseases, including communicable diseases?

6. There have been no autopsy reports published on the deaths related to monkeypox. The lack of formal documented autopsy, lack of information regarding equipment test sensitivities and specificities, and lack of information on procedures validating random collation of data, further reduces and invalidates the authenticity of the statistics.

SAVIMS POSITION STATEMENT REGARDING EMERGENCY MONKEYPOX VACCINE ROLLOUT IN AFRICA:

We have reviewed the literature and analysed the data on monkeypox, as well as its etiopathogenesis. Based on our understanding of this disease:

1. We do not support the Africa CDC and WHO declaration of a global health emergency for monkeypox.

2. It is established that monkeypox is predominantly a self-limiting condition. This does not warrant vaccine intervention.

3. We strongly object, based on the scientific evidence, to the “emergency” rollout of repurposed smallpox vaccines or any other proposed monkeypox vaccine to the people of Africa.

4. We question the authenticity of the number of deaths associated with monkeypox, as reported by the Africa CDC, unless it can be verified through autopsy.

5. We warn members of the public about the inherent risks of taking any vaccine, including those proposed for Mpox, of which the effectiveness and safety have not been reliably determined by Level 1 clinical trials. There can be no justification for a vaccine with unknown adverse effects.

6. We urge the public to exercise their inherent human rights to refuse to give consent to any medical intervention that they do not feel comfortable in taking.

We are open to dialogue and discussion with the Africa CDC on the issues raised above and on all matters of health and well-being concerning the African population.

SAVIMS South Africa Vaccine Injury Medco-Legal Study Group

85 St Patrick Road
Houghton | Johannesburg | 9301
South Africa
savims@savims.org.za

Directors:

• Dr. Herman Edeling (Chair)

• Pierre van Niekerk (Vice-Chair)

• E. Oswald

• Gerhard Kriel

• T. Madi

• Dr. S. Schmidt

• Dr. S. Snyman

Supporting references:

1. Allan-Blitz LT, et al. A Position Statement on Mpox as a Sexually Transmitted Disease. Clin Infect Dis. 2023 Apr 17;76(8):1508-1512 https://pubmed.ncbi.nlm.nih.gov/36546646/

2. Bloch DA. Comparing two diagnostic tests against the same "gold standard" in the same sample. Biometrics. 1997 Mar;53(1):73-85. Erratum in: Biometrics 1998 Mar;54(1):399. https://pubmed.ncbi.nlm.nih.gov/9147604/

3. Cocanour CS. Informed consent-It's more than a signature on a piece of paper. Am J Surg. 2017 Dec;214(6):993-997. https://pubmed.ncbi.nlm.nih.gov/28974311/

4. Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015 Feb 26;372(9):855-62. https://pubmed.ncbi.nlm.nih.gov/25714163/

5. https://africacdc.org/news-item/speech-of-the-director-general-africa-cdc-on-the-declaration-of-mpox-as-a-public-health-emergency-of-continental-security-phecs/

6. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-ihr-emergency-committee-meeting-regarding-the-upsurge-of-mpox-2024---14-august-2024

7. https://www.who.int/health-topics/smallpox

8. https://www.cdc.gov/poxvirus/mpox/interim-considerations/overview.html

9. https://jynneos.com/

10. https://www.who.int/publications/m/item/multi-country-outbreak-of-mpox--external-situation-report-35--12-august-2024

11. https://clinicaltrials.gov/study/NCT05988203

12. https://clinicaltrials.gov/search?term=mrna%20vaccine

13. Ogoina D, et al. Clinical review of human mpox. Clin Microbiol Infect. 2023 Dec; 29(12):1493-1501. https://pubmed.ncbi.nlm.nih.gov/37704017/

14. Zidan M, et al. What you need to know about statistics, part II: reliability of diagnostic and screening tests. Pediatr Radiol. 2015 Mar;45(3):317-28. https://pubmed.ncbi.nlm.nih.gov/25726014/

James Roguski

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JamesRoguski.substack.com/archive

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