Petition Challenges Safety of IPOL Vaccine, But Media Misrepresents as Anti-Polio Vaccine Stance

A petition filed by the law firm Siri & Glimstad LLP on behalf of the Informed Consent Action Network (ICAN) has sparked controversy over the safety of the IPOL vaccine, leading to widespread media reports inaccurately claiming that attorney Aaron Siri is petitioning against the polio vaccine itself. However, the petition clarifies that IPOL, licensed in 1995, is not the same vaccine originally introduced in 1955 by Jonas Salk, and it has not undergone the same safety studies as its predecessor.

The petition calls on the U.S. Food and Drug Administration (FDA) to suspend or withdraw approval for IPOL until new, properly controlled, double-blind clinical trials of sufficient duration are conducted to assess the vaccine’s safety. The current version of the inactivated polio vaccine uses a different production method and higher concentrations of vaccine antigens compared to earlier versions, and the safety data relied upon for its approval reportedly assessed adverse reactions only for three days after administration. The petitioners argue that this limited timeframe and the lack of a proper control group fail to meet federal statutory and regulatory requirements for vaccine safety.

Additionally, the petition seeks amendments to the vaccine’s labeling to clarify that IPOL does not prevent infection or transmission of the poliovirus. This aligns with statements from the Centers for Disease Control and Prevention (CDC), which note that while IPOL protects against polio disease, it does not halt the spread of the virus in communities.

The petition also raises concerns about the use of vero cells—monkey kidney cells with modified chromosomes—in the vaccine’s production. These cells, known for their ability to multiply indefinitely, are used to cultivate the virus, raising questions about potential risks.

Media coverage has broadly misrepresented the petition as opposing polio vaccination in general, despite its focus on this specific version of the vaccine. The petitioners emphasize that their concerns are about the adequacy of safety evaluations and the public’s misunderstanding of the vaccine’s capabilities.

The petition, submitted by attorneys Aaron Siri, Elizabeth A. Brehm, and Catherine Cline, includes a certification that all relevant data, including unfavorable information, has been provided to the FDA. It underscores the FDA’s responsibility to ensure that all licensed vaccines comply with federal safety and efficacy standards.

Story by multiple RFHC contributors

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