The Ixchiq Suspension: A Wake-Up Call for COVID Vaccine Reassessment, By Mrs. (Dr) Abigail Knight (Florida)
On August 25, 2025, the US FDA suspended the license for Valneva's Ixchiq chikungunya vaccine, citing serious adverse events (SAEs) that rendered it unsafe for public use. The decision, detailed in Tyler Durden's ZeroHedge article, was driven by 32 reported cases, including 21 hospitalisations, three deaths, and one confirmed case of encephalitis directly linked to the vaccine's weakened virus strain. This abrupt reversal, coming just weeks after the FDA lifted a pause on Ixchiq's use, raises a stark question: if a vaccine with such risks can be pulled, why hasn't there been a serious reconsideration of the COVID-19 vaccines, which have faced similar concerns over adverse events and rushed approvals? The logic is inescapable: the FDA's own precedent demands a rigorous re-evaluation of the COVID vaccines' safety and efficacy.
The Ixchiq Precedent: Safety Over Haste
The FDA's suspension of Ixchiq, approved in 2023 under an accelerated pathway, was grounded in a clear risk-benefit failure. The ZeroHedge article notes 38 SAEs across 32 cases, including five where the vaccine strain was confirmed in patients, with one fatal encephalitis case directly attributable to Ixchiq. The agency's Center for Biologics Evaluation and Research (CBER) concluded that "the risks of the vaccine outweigh its benefits, and that it poses a danger to health." This wasn't a knee-jerk decision, but a response to mounting evidence: 21 hospitalisations, three deaths, and symptoms like neurologic and cardiac issues mirroring chikungunya itself. The label's warnings of "severe or prolonged chikungunya-like illness" proved insufficient, as post-marketing data exposed risks not fully captured in trials.
This case exposes a critical flaw in accelerated approvals. Ixchiq's initial green light relied on immune response data, not confirmed clinical benefits, as the FDA admitted. When real-world adverse events piled up, particularly in older adults, with four new cases (including a 55-year-old) tipping the scales, the agency acted decisively. The logic here is straightforward: when post-marketing data reveals significant harm, suspension is warranted until risks are fully understood. Valneva's CEO, Thomas Lingelbach, acknowledged the symptoms were consistent with trial data, yet the FDA deemed the vaccine's continued use untenable. This sets a clear standard: safety trumps expediency.
The COVID Vaccine Parallel
The Ixchiq suspension casts a long shadow over the COVID-19 vaccines, which were also rushed to market under emergency use authorisations (EUAs) in 2020-2021. Like Ixchiq, these vaccines, Pfizer, Moderna, and others, were approved based on early data showing immune responses, not long-term clinical outcomes. By 2025, the Vaccine Adverse Event Reporting System (VAERS) has logged over 1.5 million reports for COVID vaccines, including 37,000 deaths and 200,000 hospitalisations, per CDC data, and VAERS is thought to massively under-report. While correlation isn't causation, the scale dwarfs Ixchiq's 32 cases. Myocarditis, blood clots, and neurological issues have been documented, particularly in younger men and older adults, with a 2023 study in Vaccine linking mRNA vaccines to a 2-3% risk of myocarditis in males under 30.
Yet, unlike Ixchiq, the COVID vaccines remain in widespread use without a comprehensive reassessment. The FDA's logic for suspending Ixchiq, unacceptable risk-benefit ratio, applies equally to COVID vaccines, where benefits (e.g., reduced hospitalisation in high-risk groups) are weighed against rare but serious risks. A 2024 Lancet study found waning efficacy against newer variants, with boosters offering only 40-60% protection after six months. Meanwhile, natural immunity, per a 2023 Nature review, provides comparable or superior protection for many. If the FDA pulled Ixchiq for 32 cases, why does the COVID vaccine program, with orders of magnitude more reports, escape scrutiny?
A Broken Risk-Benefit Framework
The Ixchiq case exposes a deeper issue: the FDA's inconsistent application of risk-benefit analysis. For Ixchiq, the agency acted swiftly when four new foreign cases, including one in a 55-year-old, shifted the calculus. Yet for COVID vaccines, despite millions of adverse event reports and studies flagging risks, the response has been to double down on mandates and boosters. A 2022 BMJ analysis criticised the FDA's reliance on outdated trial data for COVID vaccine approvals, ignoring real-world evidence of diminishing returns. The CDC's 2024 recommendation for annual boosters, even for low-risk groups, lacks the granular risk stratification applied to Ixchiq, where use was paused for those over 60 due to specific SAEs.
This inconsistency fuels distrust. The ZeroHedge article notes that Ixchiq's suspension followed the resignation of CBER Director Dr. Vinay Prasad, who had questioned the vaccine's safety. His memo cited "reasonable grounds" for suspension, a standard that could apply to COVID vaccines given VAERS data and studies like the 2023 European Heart Journal report linking mRNA vaccines to increased cardiac events. If the FDA can reverse course on Ixchiq based on 32 cases, logic demands a similar review of COVID vaccines, where the data volume is exponentially larger.
A Call for Accountability
The Ixchiq suspension is a precedent, not an anomaly. It proves the FDA can act decisively when evidence of harm outweighs benefits, and it suits them. Applying this logic to COVID vaccines requires a transparent, independent review of post-marketing data, focusing on SAEs like myocarditis, thrombosis, and neurological disorders. The agency must prioritise real-world evidence over initial trial data, especially as variants evolve and immunity wanes. A 2025 Journal of Medical Ethics paper argues for pausing booster campaigns in low-risk populations until long-term safety is clarified, a step the FDA ignored but should now consider.
The public deserves answers, not assurances. If 32 cases can sink Ixchiq, the millions of COVID vaccine reports demand scrutiny. Anything less is a betrayal of the FDA's own standard: safety first, no matter the cost. The chikungunya vaccine's fall is a warning, ignore it, and the credibility of the entire vaccine enterprise risks collapse, which many argue, would be a good, long-overdue, thing.
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