A rebuttal to ‘A call to save arms’

Cloe Poisson :: CTMirror.org

Alan Miller, 78, of Marlborough, receives the first dose of the Pfizer vaccine from Valerie Faiella, RN, at Connecticut’s largest drive-through vaccination clinic administered by Community Health Center, Inc. The 10-lane clinic, which opened January 18 at Pratt & Whitney Runway in East Hartford vaccinates eligible individuals in Phase 1a and 1b by appointment only.

A Response to A call to save arms: is vaccination really the solution? published January 25.

The aforementioned article, written by Genevieve Diamant, stands to do potentially significant damage to the efforts by the citizens and government of the State of Connecticut to bring under control the COVID-19 pandemic. The author has made a number of significant errors in data interpretation, and thus the conclusions of the article are not supported by scientific data. It is my belief that the readership of the CT Mirror should be made aware of this fact and of the true facts surrounding the author’s topics of discussion.

Respiratory illness represents a leading cause of preventative death the world over, especially among those with incomplete or compromised immune systems (i.e. the very young and very old, or those receiving therapies for cancer or with chronic conditions). According to research published in the Annals of the American Thoracic Society, Acute Respiratory Illness is “the greatest single contributor to the overall burden of disease in the world” as measured by disability adjusted life years, a measure of years of life lost to poor health, disability, and/or death.

Additionally, the estimated annual mortality from lower respiratory illness neglects the immense role of underlying chronic respiratory conditions, including asthma and chronic obstructive pulmonary disease (COPD), on disease outcomes of individuals infected with respiratory tract infections. COVID-19 is a disease well-known for the association between pre-existing medical conditions and poor clinical outcomes of infection.

Diabetes, obesity, chronic kidney disease, COPD, sickle cell disease, compromised immune status due to chronic infection or cancer treatment, and heart disease all contribute to increased susceptibility to COVID-19. Of the above, the CDC has identified Heart disease and Cancer as the top two leading causes of death in the United States annually, and a significant burden to the health of the nation. Data from the American Heart Association suggests that upwards of 120 million U.S. adults live with some form of heart disease, and are therefore at increased risk of poor clinicals outcomes should they become infected with COVID-19.

The capability of vaccines to reduce the burden of preventable infectious disease, and therefore to prevent unnecessary human suffering and loss of life, is undeniable. Thus, I believe that the author has failed to grasp the significant impact that pre-existing chronic illness will have on the susceptibility of the U.S. population to severe outcomes of COVID-19, and therefore the extensive benefits vaccination against COVID-19 can provide to the United States and the world at large.

There are a number of instances within the article where the author either states factually incorrect information regarding vaccines and vaccine testing, or where they incorrectly apply mathematics to published data in such a way as to draw fundamentally incorrect conclusions.

The author incorrectly states that there “is not a lot of evidence” that a focus on vaccination has not been successful at preventing many infectious diseases. This statement is fundamentally untrue. Vaccines have been largely hailed as one of the greatest public health interventions in the history of human healthcare, and vaccination for preventable infectious diseases save an estimated 6 million lives annually, and mass adoption of vaccines has resulted in a 99% decrease in 9 preventable diseases in the USA over the course of the last several decades. Any statement to suggest that vaccination and prevention of disease is not an effective means of improving the health of the nation is indefensible.

The author incorrectly states that “once a vaccine has been developed and approved, there is little incentive to keep monitoring efficacy or impact on disease prevention.” This statement is factually incorrect, as FDA clinical trial structure includes post-rollout efficacy and safety monitoring by the vaccine producer, denoted as Phase IV. Vaccines are routinely monitored post-approval to ensure that the vaccine continues to meet its established protective efficacy, and to identify any potentially rare side-effects of vaccine administration to those with rare health conditions.

The data generated during phase IV testing is additionally used in investigation of infectious disease burden in the U.S. and elsewhere, and is published frequently in peer-reviewed scientific journals. These extended post-rollout investigations allow for a more complete understanding of vaccine efficacy and safety, and long-term safety monitoring is an expected phase of vaccine rollout in the United States.

The author additionally incorrectly interprets data from the Pfizer/BioNTech Phase III clinical trial, finally arriving at a conclusion per her “memory of cross-multiplication” that “the vaccine was about 1% more effective than the placebo.” However, this interpretation of the values is inappropriate, because evaluating vaccine efficacy in comparison to placebo is not done by simply subtracting the total percentage of infected individuals in one group from that of the other.

Vaccine efficacy is calculated by various statistical means, with Pfizer/BioNTech conducting their analysis by comparing the rates of COVID in vaccinated individuals, adjusted for patient life years, to the rates in those who received the placebo. This evaluation is conducted to determine the relative reduction in the risk of acquiring COVID-19 in vaccinated individuals in comparison to those who receive the placebo. Identification of this value is a fundamental part of vaccine efficacy analysis.

When evaluated by the appropriate statistical means, the efficacy of the Pfizer/BioNTech vaccination at preventing COVID-19 infection after two doses is greater than 95%. More information on the Pfizer/BioNTech trial and the associated data outcomes can be found on the FDA’s website and in a well-written expert opinion piece from the UK’s Scientific Media Center, as well as in peer-reviewed literature in the New England Journal of Medicine.

The author states that the vaccine has not been formally shown to prevent death by COVID-19. A death by COVID-19 infection is predicated on an infection with SARS-CoV-2, the causative agent of COVID-19, which the vaccine has been shown to robustly protect against. As such, it is expected that increased rates of vaccination with vaccines like the Pfizer/BioNTech vaccine will be associated with decreased rates of COVID-19 infection, and therefore, decreases in the number of COVID-19-associated deaths.

I would additionally like to provide context to the interpretation of the author’s provided data on vaccine-associated side effects. The author states that large numbers of individuals vaccinated with the Pfizer/BioNTech vaccine reported mild side-effects including headache, fatigue, and rarely, vomiting in the wake of their vaccination. These reported side-effects are not uncommon for a vaccine, and are in fact a sign that the recipient’s body is mounting an appropriate immune response to their vaccine, a requirement for protection. Indeed, these side effects are common to many vaccines with high safety ratings, including the MMR vaccine, Chicken Pox vaccine, Influenza vaccine, and others.

Most importantly, these listed side effects pale in comparison to the potential complications associated with a natural COVID-19 infection. Of all individuals infected with coronavirus, an estimated 20% will experience a significant course of disease, and will require special treatment to recover. Of these individuals, 15% can be expected to require hospitalization and elevated care, and 5% can be expected to require ICU support and/or ventilator support.

Data from John’s Hopkins suggests that hospitalized patients presenting with pneumonia due to COVID-19, especially those with pre-existing conditions mentioned previously, have a roughly 50% chance of failing to maintain healthy blood oxygen levels, and have upwards of a 15% chance of Acute Respiratory Distress Syndrome and Multiorgan system failure. None of these listed complications are associated with vaccination with coronavirus, and I believe the author would be hard pressed to argue that the potential for headache, fatigue, or vomiting in the hours immediately following vaccination outweighs the benefits of avoiding severe COVID-19 infection altogether.

Finally, and potentially most importantly, the author fails to convey the significance of one of the greatest threats COVID-19 poses to the health of the United States’ citizenry: the overburdening and potential collapse of a functioning U.S. hospital system. Since the very beginning of this outbreak in the United States, a common theme in discussions regarding COVID case burden has been protecting the U.S. hospital system. Uncontainable spread of COVID-19 cases within the United States has one unavoidable outcome; an overwhelmed healthcare system incapable of responding to the needs of their patients. The healthcare system of the United States is finite in terms of manpower (i.e., employees capable of working at any given time), bed space both in ICUs and general treatment areas, and resource availability.

At any given time, the U.S. healthcare system can reasonably accommodate approximately 920,000 hospitalized patients, and potentially about 78,000 adult ICU patients. At time of writing, the American Hospital Association estimates that the United States hospital system is currently using about 61% of all hospital capacity, and 102% of all ICU capacity, reflecting the conversion of non-ICU hospital areas into temporary ICUs to deal with the COVID-19 pandemic.

Overburdened hospitals are forced to turn away patients, even patients dealing with medical emergencies, because they simply do not have the space or staff to deal with them. This means that individuals with gunshot or car accident wounds, those having strokes or heart attacks, or those with other significant medical emergencies may not receive the care they need simply by merit of COVID-19 cases absolutely inundating hospitals. Dramatically increasing COVID-19 cases in the United States stand to do significant damage to the healthcare access of millions of American citizens, and COVID-19 vaccines can help offset this.

In many ways, vaccination for COVID-19 can and should be viewed as a civic duty.

In many ways, vaccination for COVID-19 can and should be viewed as a civic duty. Those healthy enough to receive the vaccine should educate themselves on the vaccine, its safety and efficacy, and the impact that their decision can have on the health of the nation. There are individuals who, by merit of health conditions they possess, will not be able to receive the COVID-19 vaccination, and it is the responsibility of the healthy to help assure the health of those individuals. The overwhelming evidence suggests that the COVID-19 vaccines are both safe AND effective, and will work to reduce disease burden in the areas where they are used. We, as citizens, owe it to our neighbors to do what we can to protect them, and we owe it to the millions of healthcare workers who have worked tirelessly, often at the cost of their own mental or physical health, to try to save lives jeopardized by this virus.

To conclude, the published article directly misinterprets a great deal of published scientific fact, and neglects to appreciate the nuances of infectious disease, epidemiology, and the burden of disease on the U.S. healthcare system. COVID-19 vaccination has the capability to drastically limit COVID-19 infection rates in the United States and the world at large, and represents one of the most directed and efficacious scientific tools at our disposal to decrease case burden, decrease stress on the US hospital system, and prevent unnecessary and preventable loss of human life.

The arguments made by the author do not hold up to scientific scrutiny and fall staunchly within the category of misinformation, purposefully or otherwise. It is my recommendation that the above stated article either be removed from print, or published only in conjunction with links to appropriate sources of trustworthy scientific information.

Tyler D. Gavitt is a doctoral candidate in Pathobiology at the University of Connecticut. The opinions presented in this article are entirely his own, and do not represent the official stance of any entity at the University of Connecticut.

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