A Call for Robust Safety Testing and Transparent Labeling of the IPOL Polio Vaccine
The views and opinions expressed in this article are my own and do not necessarily reflect the official policy or position of any organizations with which I am affiliated.
The Informed Consent Action Network (ICAN), represented by attorney Aaron Siri, filed a petition with the FDA in 2022 calling for stronger safety testing and transparent labeling for the IPOL vaccine. Contrary to media misrepresentations, this petition is neither an attack on the polio vaccine nor an effort led by RFK Jr. Instead, it raises legitimate concerns about regulatory oversight, safety assessment timelines, and public health transparency.
What the Petition Requests
The petition urges the FDA to:
Withdraw or suspend the approval of the IPOL vaccine for infants and children until a properly controlled, double-blind clinical trial of sufficient duration (aligned with FDA drug standards) is conducted to evaluate its safety.
Update the IPOL label to explicitly state: "IPOL does not prevent intestinal infection and therefore does not prevent poliovirus transmission."
These requests aim to address gaps in testing protocols and product messaging to ensure public confidence in the vaccine's safety and efficacy.
See the interview with lead attorney, Aaron Siri where he responds to the misleading claims in the media regarding this petition.
Shortcomings in IPOL Safety Testing
The petition highlights troubling issues in the clinical trials used to license the IPOL vaccine in the 1990s. Notably:
Short Safety Monitoring: Safety data were collected for only three days post-injection—far short of the 1–4 years recommended for drug approvals by the FDA’s own clinical research guidelines.
Insufficient Control Groups: Trials lacked proper placebo groups, which are crucial to establishing a true safety profile.
The petition references key studies utilized in the approval process:
A serologic study (McBean) did not evaluate safety.
Two protocols featured inconsistent safety monitoring, with one relying on telephone reports over three days.
A journal article reported adverse events within 48 hours, with no long-term follow-up or safety assessments.
This limited data raises legitimate questions: How can the long-term safety of a mandated product be assessed with only three days of monitoring?
Effectiveness and Labeling Confusion
The Centers for Disease Control and Prevention (CDC) acknowledges that IPV, including IPOL, does not prevent intestinal infection or transmission of poliovirus. This fact undermines claims that IPV alone can prevent the spread of polio, yet product labeling and public messaging remain ambiguous. Updating the label to reflect this limitation would align with the FDA’s mandate for clear and accurate information.
Changes in Formulation: Cause for Further Study
While the polio vaccine has a storied history, the IPOL vaccine approved in the 1990s differs significantly from its predecessors. The IPOL formulation uses Vero cells—a cell line with modified chromosomes that proliferate indefinitely, akin to cancer cells. These cells are known to be susceptible to infection by numerous viruses, including SV40, measles, and HPV.
Given this significant formulation change, a rigorous placebo-controlled trial should have been conducted to evaluate safety under modern regulatory protocols. Without such testing, concerns about potential long-term effects remain unaddressed.
The Landscape of Polio Vaccines
It’s important to recognize that IPOL is just one of several licensed polio vaccines globally. There are two main types: Inactivated Polio Vaccines (IPV) and Oral Polio Vaccines (OPV). Below is a list of other polio vaccine products and their manufacturers:
Should the IPOL product be suspended for further safety testing, multiple alternatives could be utilized in its place.
Regulatory Gaps and the VICA Act
The Vaccine Injury Compensation Act (VICA) of 1986 shields vaccine manufacturers from product liability, placing the burden of vaccine injury claims on a federal trust fund. Since its inception, the fund has paid over $4.5 billion for vaccine-related injuries. While vaccines remain critical to public health, the absence of traditional market forces—like litigation and discovery—creates a regulatory blind spot where safety oversights can persist unchecked.
The widely publicized case of Vioxx, where product liability revealed internal knowledge of cardiovascular risks, underscores the importance of external scrutiny. Critics argue that without product liability, similar safety issues in vaccines may go unexposed.
The Need for Stronger Post-Market Surveillance
Long-term side effects cannot be adequately detected in a three-day safety window, and the current Vaccine Adverse Event Reporting System (VAERS) has been widely criticized for underreporting and incomplete data. If nearly all infants and toddlers are administered IPOL, what population serves as a comparison group to identify disproportionate health outcomes that take years to develop?
This concern aligns with the recent July 2024 publication in the New England Journal of Medicine titled "Funding Postauthorization Vaccine-Safety Science" by Dr. Stanley Plotkin and colleagues. The authors state:
"The slow speed of science contributes to public concern about vaccines and reduced immunization coverage. Postauthorization safety research requires timely funding linked to the introduction of new vaccines."
This reinforces the petition’s call for robust long-term safety assessments and improved pharmacovigilance.
Balancing Public Health and Safety Standards
The body of published evidence suggests that vaccines are essential to global health. However, insufficient safety testing risks eroding public trust and increasing vaccine hesitancy. Holding vaccines to the highest safety standards—including long-term clinical trials and transparent labeling—would strengthen public confidence and compliance.
The petition filed on behalf of ICAN is not an attack on vaccines but a necessary effort to compel regulators to fulfill their statutory obligation to license products that are both safe and effective. Without these guardrails, we risk undermining the very public health goals vaccines are meant to achieve.
The petition to the FDA calls for:
A properly controlled, long-term safety trial for the IPOL vaccine.
Updated labeling to clarify that IPOL does not prevent intestinal infection or poliovirus transmission.
Ensuring vaccines meet rigorous safety standards is not just a regulatory obligation—it is the foundation of public trust in immunization programs.