Our Descent Into Vaccine Lunacy

Last Thursday, Health and Human Services Secretary, Robert F. Kennedy, Jr., testified before the Senate Finance Committee in what turned out to be a highly contentious confrontation. What made this hearing so alarming was the nature of the criticisms hurled at Kennedy and the fact that many of those criticisms came from high ranking Republican members of the Committee all of whom had voted in support of Kennedy’s nomination to head the HHS only seven months ago. Among the many pointed questions directed to Kennedy were the following:

• Why did you terminate CDC Director Susan Monarez who has impeccable medical research credentials and who had only been confirmed by the Senate a month before;

• Why did you replace all 13 members of the CDC’s Vaccine Advisory Board with individuals who had made public statements denigrating the safety and efficacy of vaccines;

• Why did you terminate an estimated 3,000 employees of the NIH (which funds medical research) and 600 employees of the CDC (which is charged with identifying and combatting infectious diseases);

• Why did you cut the annual budget of the NIH by 40% causing the termination of over 1,800 research grants including all research involving vaccines utilizing the mRNA technology;

• Why are you proposing cuts totaling 50% of the annual budget of the CDC; and

• Why did you cause HHS to limit access to Covid vaccines as well as those for Measles when the incidences of both of these diseases are again starting to rise.

What is perhaps even more disconcerting is President Trump’s own recent lament that he CAN’T tout his initiation of Operation Warp Speed which facilitated the extraordinarily rapid development of at least four highly successful Covid vaccines which many commentators consider the most outstanding achievement of his first term as president. As troubling as these events were, they are only symptoms of our nation’s rapid descent into the realm of vaccine lunacy. What caused that descent is described below.

As crazy as the Trump administration’s abandonment of the latest advances in vaccine technology may seem, they actually have a rational (albeit a troubling) explanation. That explanation lies in the history of vaccines as well as the politics of our current President. 

It has long been recognized that the costs of preventing illnesses is but a small fraction of the costs to cure them. This is the whole theory behind vaccines. In fact, the use of vaccines is the principal form of preventative medicine practiced in the U.S. which for the last 75 years has led the world in developing vaccines. During that period millions of lives have been saved by U.S. vaccines which include vaccines for chickenpox, smallpox, diphtheria, polio, influenza, hepatitis A and B, measles, mumps, rubella, shingles whooping cough, HIV, Ebola and pneumonia. What has enabled the U.S. to become a leader in the development of vaccines are two important agencies currently within the Department of Health and Humans Services: the CDC which seeks to identify pathogens that can cause serious health issues and can be easily transmitted, and the NIH which funds medical research projects that form the foundation for vaccines developed by the nation’s pharmaceutical companies.

It must be appreciated that the concept of vaccines against infectious diseases is not new and dates back several centuries. Early vaccines were discovered by accident or through trial and error and generally involved exposing a healthy individual to a known pathogen in the hope that he/she would develop an immunity to it. This process was based on the callous premise of “that which doesn’t kill me will make me stronger.”

Like therapeutic drugs, vaccines are first tested on animals to determine whether they cause the animal to develop an immune response. Those that do are then tested on a small group humans to determine if they also stimulate human immune systems (Phase I testing). If all goes well, they are tested in a group of a few hundred humans for both safety and efficacy and to determine potential side effects and population groups for which they are not efficacious (Phase II testing). Lastly, they must be tested in TWO large-scale double-blind clinical trials involving up to tens of thousands individuals, again testing for safety, efficacy and side effects as well as to identify groups for which the vaccine may not be efficacious.

The process for testing a vaccine, however, generally takes longer and involves significantly more individuals than the testing for therapeutic drugs. That’s because therapeutics are tested on individuals who have been previously identified as having the malady which is the subject of the clinical trial. Consequently, the effectiveness of a therapeutic drug being tested can generally be ascertained within a few days, whereas it may take several weeks, if not months, to assess the effectiveness of a vaccine. By contrast, clinical trials for vaccines are tested on individuals without symptoms in order to determine whether those receiving the vaccine are more successful in avoiding being infected by the pathogen being targeted than those who received a placebo. Because many of the individuals enrolled in a clinical trial of a vaccine may never encounter the subject pathogen or may simply be asymptomatic to it, many more participants are required to achieve a statistically significant finding.

  One of the problems associated with vaccines has always been that they might not be effective against a rather substantial percentage of individuals because of differences in individual immune systems. In addition, in some cases vaccines have caused recipients to contract the very disease they were designed to prevent. That’s because those vaccines have traditionally incorporated a weakened specimen (or merely a fraction) of the pathogen they are designed to cause the human immune system to identify and combat.

The Food and Drug Administration (FDA), another major unit within HHS, has the unenviable task of determining whether vaccines (as well as therapeutic agents) are both safe and effective. In the 1960s the FDA approved Thalidomide, a drug designed to combat morning sickness in pregnant women. It was quickly discovered that numerous children of the women who had taken Thalidomide were born with serious bodily deformities causing the drug to be withdrawn. Thereafter, the FDA has been extremely cautious in approving new pharmaceutical products, often requiring years of testing and long and careful analyses of the testing results.

As discussed above, regulatory approval for vaccines is a particularly tricky process and the FDA has no fixed threshold of effectiveness for approving a vaccine. Specifically, the  FDA will assess a variety of factors like the disease's severity and the presence of unmet medical needs. Also among the FDA’s primary considerations will be how well the vaccine protects people from outcomes like infection, symptomatic illness, hospitalization, and death. Other factors considered by the FDA in approving a vaccine is the severity of the vaccine’s side effects which frequently include headaches, muscle aches, chills and fever and, on rare occasions, may even trigger life-threatening conditions.

Another problem associated with vaccines is that the viruses being targeted tend to mutate; and a vaccine that is generally effective against one form of the subject pathogen may not be effective (or as effective) against mutations of that same pathogen. This explains why influenza vaccines have to be altered almost annually. On top of this, many enrolled in clinical trials of a vaccine might incur adverse reactions. These factors explain why many individuals being tested drop out of clinical trials for vaccines and why others conclude that even approved vaccines are simply not effective or are even dangerous.

These and other problems associated with the process of approving a vaccine create a fertile environment for the birth and spread of conspiracy theories. The result is that the public’s acceptance of the safety and efficacy vaccines is to a large degree a function of its trust in the governmental agencies that regulate the production and sale of vaccines.

This brings us to the election of Donald J. Trump and the Covid-19 pandemic. When Trump ran for president in 2016 he emphasized that our nation’s government was inept and corrupt and that he would “drain the swamp” and “make America great again.” He not only attacked his predecessors but almost everything that they had achieved. A particular target of his attacks was President Obama and his most notable achievement, the Affordable Care Act, which Trump tried, but failed, to repeal.

There was nothing particularly new about a presidential candidate attacking the record of his predecessor, especially one associated with the other political party. What distinguished Trump’s campaign was that it was built upon the disaffection of millions of working class Americans who had come to believe that the entire federal government was being operated almost exclusively for the benefit of the nation’s wealthiest individuals. Trump’s attacks were not simply ad hominem attacks on his predecessors, but rather were attacks of the trustworthiness of their federal government. His message resonated with working class Americans and, together with the assistance of Russian propaganda and the over-confidence of Hilary Clinton, he became our nation’s 45th president.

It's also important to remember that during the first three years of his presidency Trump had relied heavily on conspiracy theories in an effort to convey that there were many factions, both within and outside of government, that posed a threat to Americans and that he was the only person who could restore the good life that working class Americans had once enjoyed. He had also carefully and systematically cultivated right-wing TV and radio news organizations, as well as online podcasters, to echo his propaganda. Therefore, in early 2020 when the nation was thrown into turmoil by the Covid-19 pandemic, there was a high level of panic making the American public even more vulnerable to conspiracy theories.

Although coronaviruses (like SARS and MERS) were not new, Covid-19 was far more transmittable and lethal than these two predecessors. Trump’s initial reaction was to ignore it, then to label it a “hoax” being propagated to defeat his re-election and then to minimize its highly lethal nature. When those efforts proved insufficient to overcome the alarm the virus had caused among the American electorate, he reluctantly decided that he must take action. By then, however, the virus had been able to infect large numbers of Americans, making its spread far more difficult to combat

Always uppermost in Trump’s mind was that he was not going to allow the virus to upend the nation’s economy which he viewed as the key to his re-election. He formed a committee which was ostensibly chaired by Vice President Pence and barred all public health officials (save Drs. Anthony Fauci and Deborah Birx over whom he exercised tight control) from making any public statement about Covid-19 or his administration’s efforts to combat it. At the committee’s daily press conferences he dominated the conversations and on a few occasions offered suggestions as to possible ways that individuals might protect themselves, including ingesting a disinfectant like Lysol. I can still remember Dr. Birx’s distressed facial expression when he made that very dangerous suggestion.

Although Trump vehemently resisted shutting down all non-essential business activities (which many nations had opted to do), he did accept the advice of his public health advisers to initiate Operation Warp Speed which allocated $10 billion to the rapid development of  vaccines to combat the virus. This was an almost unheard of sum especially when you consider that he had spent the first three years of his presidency weakening the nation’s defenses against infectious diseases. The importance of this decision, however, cannot be overstated. The Covid vaccines that were developed as a result of Operation Warp Speed likely saved the lives of as many as one million Americans. To appreciate just how phenomenal an achievement that was you need only recall that in World War II the U.S. only lost less than half that many lives (416,800 to be exact).

By the time of the 2020 election, two U.S. pharmaceutical companies, Pfizer and Moderna, had developed Covid-19 vaccines and were in the process of submitting new drug applications to the FDA. Their vaccines utilized the mRNA technology which had been first conceived in the 1960s but had yet to be successfully incorporated into a vaccine. Sadly for Trump, neither of these vaccines was approved prior to the 2020 election; and Trump’s frequent references to their expected approval were insufficient to gain the public support he need to gain his re-election.

Part of the problem was that Trump’s earlier words and actions had been highly inconsistent with the mounting number of Covid deaths raising the skepticism of the American public as to both the threat posed by the virus and the likelihood that the new vaccines would be effective. For example, Trump’s refusal to personally wear a face mask even after he had personally contracted the virus certainly undermined public confidence that the administration knew what it was doing.  Similarly, even the health warnings distributed by the CDC to businesses were devoid of commands or instructions, but rather were expressed in the form of mere suggestions. 

It's also worth noting that the FDA approved each of the Pfizer and Moderna vaccines in late December 2021 on the basis of a single phase III clinical trial as opposed to the customary two phase III studies. The FDA’s haste in approving these vaccines was altogether prudent considering the desperate need at the time to combat the spread of the virus. That’s because on that same day these vaccines were approved, the Covid virus claimed the lives of almost 3,400 Americans, more than had been killed on 9/11. Still, the truncated approval process served to heighten the suspicions of conspiracy theorists that the new vaccines were simply half-baked efforts intended to placate an increasingly apprehensive public.

What may not have been appreciated by most vaccine skeptics (commonly referred to as “anti-vaxxers”) is that the vaccines utilizing the mRNA technology were significantly different from prior vaccines. The principal difference was that mRNA based vaccines did not incorporate even a weakened version of the Covid virus or indeed any part of the virus itself. Thus, there was no danger that a recipient of the vaccine could actually become infected by it. Instead, mRNA-based vaccines simply incorporated the virus’ ribonucleic acid (or RNA) which is the genetic code underlying the virus’ architecture. This technology nevertheless enables the human immune systems to quickly recognize and combat the virus. More importantly, whereas prior successful vaccines may have been effective for roughly 60% of the population, the mRNA based Covid vaccines were initially effective for more than 90% of the population and remained significantly effective even against most of the later mutations of the virus.

Added to this, during his last three months in office, Trump generated a blizzard of conspiracy theories as to how the 2020 election had been stolen from him. In stark contrast to those who had previously left the office of the president, Trump did not remain quiet and allow his successor to administer the nation. Instead, he immediately began to rally his supporters by attacking Biden’s every action including the efforts of the new administration to have Americans to quickly become immunized against Covid. Although Trump initially tried to convince his supporters to become vaccinated, he quickly ceased doing so when he discovered that his voting base, which had been saturated with false rumors about the vaccines, had already become disinclined to do so.  As a result, many of his loyal supporters chose not to become vaccinated.  Thus, by mid-summer of 2021 there was a stark differential (almost 2-1) in the percentages of Republican and Democratic voters who had died as a result of the Covid-19 virus.

In May of 2023, the Covid-19 virus was declared to no longer be a pandemic. By that time, however, over 1.1 million Americans had died of it. Although there was much confusion in the death counts at the beginning of the pandemic (because many of those who died had never been tested for the virus), the total death count is believed to be reasonably accurate. That count, however, has been estimated to be roughly 300,000 to 400,000 higher than it would have been had Trump simply followed the advice he had been receiving from his infectious disease advisers. As badly as Trump had mishandled the pandemic while in office, most of the Covid deaths in the U.S. came in the two succeeding years as anti-vaxxer sentiment continued to grow. For further insight into the thinking of Covid vaccine skeptics, see “Understanding Anti-Vaxxer Motivations.” The politization of the Covid pandemic has also been well-documented by the National Library of Medicine.

In his effort to regain the presidency in 2024, Trump embraced Robert F. Kennedy, Jr. who had long been a critic of vaccines largely based upon his refusal to accept the validity of healthcare statistics published by the U.S. government. In doing so, Trump realized that his followers included a significant number of anti-vaxxers who embraced the vaccine conspiracy theories that Kennedy was espousing. Even though Kennedy did not have any medical training or experience, Trump nevertheless chose him to become our current Secretary of the Department of Health and Human Services. Once confirmed by the Senate, Kennedy, with Trump’s blessing, has been radically dismantling the public heath establishment that once was the envy of the entire world.

Just as Trump rode the disaffection of working class Americans into the White House in 2016, he rode the anti-vaxxer movement in his 2024 re-election. Ironically, even though President Trump facilitated the creation of the phenomenally effective Covid vaccines, he now feels unable to tout that achievement. Karen Tumulty of The Washington Post summed it up it this way: “Conspiracy theories helped elect Trump. Now he can’t shake them.”