Confronting Health Misinformation Surrounding COVID-19 Vaccines in the State of Florida

Abstract

COVID-19 vaccination is estimated to have averted more than 2.4 million deaths globally. In the United States (U.S.) alone, more than 120,000 deaths and 700,000 hospitalizations are reportedly estimated to have been prevented during the first six months of the vaccine campaign. Despite the overwhelming evidence regarding the safety and efficacy of vaccination, COVID-19 vaccine hesitancy continues to pose a significant threat to public health. Notably, an unexpected source of vaccine misinformation has been the Surgeon General of the State of Florida, Dr. Joseph Ladapo. While both a tenured faculty member of the University of Florida, College of Medicine and the Surgeon General of Florida, Dr. Ladapo has delivered official Florida Department of Health statements regarding COVID-19 vaccines that run contrary to those of the U.S. Centers for Disease Control and Prevention (CDC). While tenure is designed to protect those with contrarian views, we believe that the University has an ethical obligation to condemn misleading statements that put public health at risk. Herein, we explore the challenges of managing misinformation disseminated by someone who is simultaneously a tenured professor at a public, state-supported university, and a politically appointed public health official.

On September 13, 2023, the Florida Department of Health (FL-DOH) released guidance from the State Surgeon General and University of Florida College of Medicine (UFCOM) Professor of Medicine, Dr. Joseph Ladapo, discouraging people under age 65 from receiving the updated 2023–2024 COVID-19 vaccine.¹ Specifically, the recommendation stated:

“While the initial mRNA COVID-19 vaccines were authorized by the United States Food and Drug Administration (FDA) utilizing human clinical trial data, the most recent booster approval was granted in the absence of any meaningful booster-specific clinical trial data performed in humans. In both cases the federal government has failed to provide sufficient data to support the safety and efficacy of the COVID-19 vaccines.”¹

On October 23, Dr. Ladapo sent an official FL-DOH email to Florida healthcare providers prompting providers to discuss “research demonstrating unfavorable COVID-19 vaccine results.”

This guidance represented the latest in a series of official statements from FL-DOH, and specifically from Dr. Ladapo, that include vaccine misinformation in the form of misrepresenting of research performed by others, selective representation of the literature, and even manipulation of FL-DOH data and analysis. The September guidance states that “Studies across geographic regions have found that mRNA COVID-19 vaccines are associated with negative effectiveness after 4 to 6 months”, contradicting the conclusion of the referenced study that “negative estimated effectiveness likely reflects an effect of [behavioral] bias and not true negative biological effectiveness.”² Many studies have demonstrated that waning vaccine effectiveness is driven by bias, often due to early vaccine recipients being members of high-risk professions.³

The question that this guidance attempts to address falls within an area of active and ongoing debate: specifically, the cost and benefit of annual COVID-19 vaccination for individuals who are not in a specific risk group. Indeed, many nations have recently revised their recommendations to no longer support repeated COVID-19 vaccination in children, a decision largely influenced by economic considerations and the high cost of mass vaccination. Legitimate arguments have also been made for or against annual vaccination for low-risk groups, citing the risks and benefits of vaccination in these groups.^4,5 There are risks of adverse cardiovascular outcomes, although the literature is in agreement that these events are rare and generally mild.^6,7 On the other hand, studies have shown the benefit of COVID-19 boosters in reducing infection and illness even in younger individuals.^8,9 However, by providing official guidance promoting the claim that COVID-19 vaccination makes the recipient more susceptible to infection (“negative effectiveness”), the FL-DOH detracts from this debate, while lending official weight to an unfounded claim.

Other guidance released by FL-DOH has had a similar effect of inserting vaccine misinformation into the scientific literature. An analysis conducted by the FL-DOH,¹⁰ and later shown to have been manipulated by Dr. Ladapo,^11,12 was used to support the claim that young men aged 18–49 years old were at increased risk of cardiac death following COVID-19 mRNA vaccination. While other analyses have shown a possible signal of increased risk of severe cardiac outcomes,¹³ the FL-DOH analysis was an outlier in the size of this effect, and despite concerns about the validity of the results, they have continued to be used to support guidance recommending against the use of COVID-19 vaccines. Notably, in late 2022, the UFCOM faculty council approved a task force to determine if Dr. Ladapo’s analyses on this issue violated policies governing university faculty. Indeed, the task force concluded that Dr. Ladapo may have violated the research integrity policy of the University of Florida.¹⁴ Nevertheless, as his activities were deemed to have been performed solely in his role as the Surgeon General and not in his role as a UF Faculty member, the research integrity office declined to pursue the matter.

Most recently, on January 3, 2024, Dr. Ladapo released an official FL-DOH statement in which he called for a halt in the use of all COVID-19 mRNA vaccines.¹⁵ This guidance is based on a theoretical concern that mRNA vaccines pose risks to the “integrity of the human genome” and are, therefore, “not appropriate for use in human beings.”¹⁵ Based on rigorous toxicology studies conducted in animals, the amount of DNA present in COVID-19 mRNA vaccines is orders of magnitude lower than the threshold for genotoxicity, and no component of the vaccine encodes the proteins required for genomic integration.¹⁶ The weight given by the FL-DOH guidance to a theoretical concern, which is negligible based on the best available evidence, over the benefits of COVID-19 mRNA vaccination seems out of proportion, particularly given the strength and potential consequences of the recommendation.

As the COVID-19 pandemic has progressed, evidence supporting different non-pharmaceutical and pharmaceutical interventions has continued to evolve, and policymakers and members of the scientific community are grappling with the question of how to reduce the burden of COVID-19 in the context of widespread immunity and vaccine availability. Dr. Ladapo’s assertions ignore the overwhelming preponderance of global safety and efficacy data¹⁷ and stand in opposition to United States Centers for Disease Control and Prevention (CDC) guidance.^18,19 Seasonal influenza vaccines do not undergo clinical trials, as this process would be unnecessarily costly and cumbersome,²⁰ but Dr. Ladapo’s commentary implies that COVID-19 vaccines should be held to a different standard because of outstanding safety concerns. Unfortunately, official analysis and guidance from FL-DOH have comprised a mixture of legitimate safety concerns, manipulation of existing literature and data, and unfounded claims with no empirical evidence to support them. Such claims could conceivably lead to decreased rates of COVID-19 vaccine uptake, which is particularly timely as U.S. pediatric hospital admissions related to COVID-19 rose fivefold between June 17 and September 9, 2023, with COVID-19-related hospitalization rates climbing further thereafter to nearly 35,000 per week across all age groups in early January, 2024.²¹

Importantly, these statements do not comprise a standalone event as Dr. Ladapo has previously made several public health declarations in defiance of CDC recommendations.²² Nevertheless, a tenured university professor should have the right to express a minority opinion. Undoubtedly, there should not be a rush to stifle free speech in academia especially when Dr. Ladapo’s statements have not been made in his role as a UFCOM professor. It is important to consider that more than 232,000 American deaths could have been prevented among unvaccinated adults if they had been vaccinated with just a primary COVID-19 immunization series.²³ How many Floridians have not been vaccinated because their Surgeon General has repeatedly focused on unsubstantiated risks of vaccination while seemingly ignoring the well-established benefits of the same?

Given the potential negative effects on the citizens he is obligated to serve, we ask: who is ultimately responsible for ensuring that faculty members at an academic medical center do not cause harm to individual patients or, in this case, the population at large? In our opinion, UFCOM has an ethical obligation, as Dr. Ladapo’s employer, to denounce Dr. Ladapo’s misleading public health decrees.

On September 15, 2023, a response to this matter was requested of the UF faculty senate. Given the senate’s representation of faculty from disciplines without the requisite expertise to opine on the concerns raised (e.g., Law, Humanities, Business), the faculty senate president reasonably declined to move forward until the UFCOM faculty council brought forward an approved resolution. Surprisingly, however, when faculty requested consideration of a resolution to formally critique or censure Dr. Ladapo’s guidance, UFCOM leadership determined it was “not within the purview” of the UFCOM faculty council. This, despite the fact that the bylaws of the UFCOM faculty council note its purpose is “to promote the advancement of medicine by […] directing the energies of the members in the interest of public health and welfare.” Faculty were instead advised to await a response from institutional leadership. On November 6, 2023, nearly six weeks after Dr. Ladapo first released recommendations contrary to those of the CDC, UF Health leadership emailed staff and faculty, noting the availability of the updated COVID-19 vaccine and acknowledging CDC guidance. Although the institution’s ultimate support for CDC guidance is laudable, many faculty and staff questioned the lack of a more timely and direct response to combat misinformation. In our opinion, such “careful” statements do not serve our patients and instead, put them and the greater public’s health in harm’s way.

Related to these issues, a number of individual UFCOM faculty members have exercised their First Amendment rights to speak to the media and write editorials urging the community to follow CDC recommendations for vaccination.²⁴ Notably, the Federation of State Medical Boards issued a strong statement warning physicians about promulgating vaccine misinformation and the Florida Academy of Family Physicians publicly countered the Surgeon General’s recommendations.^25,26 However, none of Florida’s medical schools, private or public, has publicly critiqued Dr. Ladapo’s recommendations or analyses.

Some UF faculty and leadership perceived the above noted efforts to refute misinformation in Dr. Ladapo’s statements as seeking to “politicize” the faculty council or the institution. Yet, it must be noted that the processes related to the development and propagation of rules, regulations, and guidance for population health and healthcare within an entire state or country are undeniably and unavoidably political.²⁷ Public health should not, however, be partisan, based on flawed logic or substandard scientific methodology. Ultimately, this situation highlights the unfortunate circumstance that shared governance (the concept that faculty, administration, governing boards, and staff participate in the development of policies and decision making) may exist in name only when evidence-based healthcare guidelines are subject to partisan undermining, and efforts to hold state-level leadership accountable (including the submission of this very Perspectives) are met with valid concerns regarding the potential for retribution (e.g., loss of funding, removal from state advisory boards, efforts to restrict scope of practice through board of medicine rules), that could negatively impact an institution or its programs.

And so, it must be asked, what is the institutional responsibility for supervising its own faculty in the face of potentially significant public harm? When an institution is unable or unwilling to speak, due to perceived or real political pressures, what then? Does the UFCOM faculty council have a responsibility to proceed in the void left by institutional leadership? Or, is the onus solely on individual experts in the field or organizations external to the institution to push back on misinformation and disinformation promoted by state entities?

In seeking solutions to these challenges, the leadership of academic institutions should be committed to making clear and deliberate statements to counter misinformation emanating from their own faculty. In this case, appreciating the complex political ramifications of a state institution criticizing a state official, it is notable that none of the University of Florida’s Colleges of Medicine, Nursing, or Public Health has directly addressed the statements from Dr. Ladapo.

If institutional leadership is unable or unwilling to speak directly to these issues, they should alternatively create and promote open forums to allow discussion among faculty with appropriate expertise to direct guidelines related to public health. Those who may have differing opinions and relevant expertise should be actively sought out and invited to take part in these conversations. As the UFCOM faculty council is a democratic body that represents the voice of the faculty, we believe it is an ideal setting to raise such concerns. Alternatively, settings such as grand rounds, public debates, or roundtable discussions may be preferred. In addition, professional societies seeking to accurately reflect both the available data and the clinical recommendation of their membership should be encouraged to produce and promote timely statements confirming their positions. Importantly, such statements should be unambiguous as to if and how they differ from guidance provided by state entities.

Regardless of which solutions are ultimately applied, academic institutions, especially those that depend on state funding, should actively formulate plans for responding to similar situations in the future as they appear likely, if not inevitable, given the current climate.

Declarations:

Conflict of Interest:

The authors declare that they do not have a conflict of interest.