Further Ethical Concerns on a Recent Self-Amplifying RNA Vaccine Study

Yesterday, I shared concerns over a recent self-amplifying RNA vaccine study:

I called for the ongoing study to be ceased given the mass safety signal pointed out by The McCullough Foundation.

Today, I outline further ethical flaws:

1. Informed Consent:

• Participants must be fully informed about the novel nature of srRNA technology, including potential unknown long-term effects. Ensuring that informed consent is genuinely informed is critical.

• Detailed information about the potential risks and benefits, including those observed in preclinical and early-phase clinical trials, should be provided.

• Since the long-term risks are unknown, this seems impossible.

2. Conflict of Interest:

• The authors are employees of Replicate Bioscience Inc., which raises concerns about bias. The review should disclose how the conflict of interest was managed.

• Independent oversight or review by third-party experts who do not stand to benefit financially from the vaccine should be conducted.

3. Safety Monitoring:

• Continuous monitoring for adverse effects is essential, especially given the novel nature of srRNA vectors.

• Clear protocols for reporting and managing adverse events, including long-term follow-up, and plans to mitigate the ill-health effects of AEs and SAEs, must be transparent and outlined up-front.

4. Methodological Issues

Cause of Death Determination:

• Accurate determination of causes of death in clinical trials is crucial. There should be a standardized protocol for post-mortem analysis to ascertain whether deaths are related to the vaccine or underlying conditions. Doctors working for the company determining that the vaccine was not the cause of death is insufficient: it’s a novel vaccine: how do they know they are not confusing deaths from COVID19 with deaths from vaccines? PCR is known to be fraught with errors in this context. How do they know that the vaccine does not interact with COVID19 infection and increase mortality?

• Independent medical reviews of cause-of-death determinations can mitigate bias.

Manufacturing Quality:

• The article mentions impurities from poor manufacturing that lead to systemic inflammatory responses. To minimize such risks, strict quality control measures and validation processes should be in place.

• Detailed documentation and transparency regarding manufacturing practices are essential to ensure reproducibility and safety.

Dose-Limiting Toxicities:

Observed toxicities at low doses indicate the need for careful dose escalation studies. These should be designed to identify the optimal therapeutic window that balances efficacy and safety.

• Comparative studies with treatment protocols can help contextualize the toxicity and efficacy profiles.

Long-Term Follow-Up:

• Given the novel nature of srRNA technology, long-term follow-up studies are necessary to monitor for delayed adverse effects and evaluate sustained efficacy.

• Participants should be tracked over multiple years, not just 12 months, and data should be transparently reported.

All of this is beside the point; given the mass safety signal, the study should be terminated.