January 26th 2021
TL:DR Vaccines work. Vaccines save lives.
Safety and efficacy will continue to be monitored for the life of any FDA approved vaccine. There are reasonable scientific and ethical concerns which remain with respect to COVID-19 vaccines—however, the benefits of taking either the Pfizer-BioNTech or Moderna vaccine outweigh the costs of not doing so.
There have been many unprecedented events as a direct consequence of the ongoing COVID-19 pandemic. In the past week, the number of new COVID-19 cases and deaths continued to rise, with 93 million cumulative cases and over 2 million deaths globally. The Region of the Americas accounts for 52% of all new cases and 47% of all new deaths globally in the last seven days. As of December 18th, two vaccines in the US—Pfizer-BioNTech and Moderna—have received emergency FDA authorization, holding promise to an end to what has been a decidedly terrible year.
With the turning of the tide, we also are starting to see increased confidence by the American public in their willingness to take the COVID-19 vaccine compared to earlier this year—yet it is estimated that 4 in 10 Americans will not get vaccinated against COVID-19.
“37% of Americans who would not get a vaccine say the rushed timeline for the development of the vaccine is the main reason they would not be vaccinated. Another 26% say they want to wait to confirm the vaccine is safe. Rounding out the reasons for some Americans’ hesitancy are 12% saying they don’t trust vaccines in general and 10% who want to wait to see how effective the vaccine will be.”
These significant proportions begs the question of why? There is no single explanation for this. Instead, nuance is needed to understand the crisis of trust in science that has been perpetuated by news agencies and leadership unto the public. In this piece, we will highlight some of the pertinent issues that have led to this juncture and offer suggestions for restoring public confidence in the science behind vaccinations.
A crisis of confidence perpetuated by politically driven policy decisions
The process of developing/drafting policy based on scientific research, and sometimes with respect to doing science, is rarely a politically unbiased endeavor. Over the last four years, we have observed a crisis in confidence relating to scientific research and scientists—largely due to policies implemented by the previous administration—and it is no more obvious than when we consider the COVID-19 pandemic response.
As case and death counts continued to rise, it became increasingly obvious that the lack of an effective response to the pandemic was politically driven with little, if any, emphasis on science. While many scientists were concerned about the decision-making process, many refrained from being vocal about these issues. Some were concerned about making causal claims without data, while others viewed science as being separate from politics and refused to speak—to name a few scenarios—and, by the time scientists did speak (e.g., here), too much damage had been done.
In October of 2020, the Select Subcommittee on the Coronavirus Crisis released an analysis examining instances of political interference in the Trump Administration’s response to the coronavirus pandemic. They concluded:
“The analysis demonstrates that over the last eight months, the [Trump] Administration engaged in a persistent pattern of political interference—repeatedly overruling and sidelining top scientists and undermining Americans’ health to advance the [former] President’s partisan agenda.” Emphases added for clarity given the recent change in leadership.
In line with the subcommittee findings, scientists reported strong associations between the actions of the previous administration and the public’s response to guidance from scientific experts related to the COVID-19 pandemic. For example, one article concluded:
“Contrary to our predictions, the observed partisan gap strengthened over time and remained when stay-at-home orders were active. Additionally, county-level consumption of conservative media (Fox News) was related to reduced physical distancing. Finally, the observed partisan differences in distancing were associated with subsequently higher COVID-19 infection and fatality growth rates in pro-Trump counties. Taken together, these data suggest that US citizens’ responses to COVID-19 are subject to a deep—and consequential—partisan divide.”
Another pre-print article (not yet peer-reviewed) found that Democrat-led, as opposed to Reublican-led states, have fewer cases of COVID-19—and a third pre-print article has found the same relationship.
There are two important takeaway points from these data. First, early on in the pandemic, i.e., until July 2020, Democrat-led states were the most strongly hit with respect to case counts and deaths—unsurprisingly coinciding with heavily populated urban areas as well as racially and ethnically diverse areas that have, historically, had access to fewer resources such as adequate healthcare. Subsequently, Republican-led states have been hit harder. That shift, in contrast, coincides with many federal- and state- level Republican policymakers downplaying the severity of the pandemic and flouting guidelines from the scientific bodies as new information about this emergent threat was obtained. Secondly, while it is unclear whether there is a causal relationship between political affiliation and likelihood of infection and death from COVID-19, the scientific data does suggest, however, that policy decisions such as no- or late- adoption of mandatory social distancing or mask-wearing guidelines positively relate to COVID-19 infection rates and deaths.
Why nuance is required for policy decisions in relation to scientific knowledge
Science through the use of the scientific method is a process of knowing. As new knowledge accumulates through the testing of hypotheses, theories may be revised and, over time, sufficient evidence can lead to causal claims and the declaration of a theory as fact (e.g., evolution via natural selection).
When the first news of COVID-19 hit, there was little known about this specific virus which hampered scientific guidance—fortunately, however, over a decade of research with people and animals on other coronaviruses allowed work on the COVID-19 vaccine to be expedited. Scientists got to work and in an unprecedented effort, multiple companies were able to not only produce vaccine candidates but to present sufficient evidence from clinical trials for emergency authorization of the vaccines to occur.
At the same time, the past administration downplayed the severity of the COVID-19 virus in terms of morbidity and mortality, cast aspersions, did not mandate that guidance based on scientific evidence be followed with respect to social distancing and mask wearing, and re-opened the economy too quickly. As the death toll increased, myths perpetuated by ignorance or willful stupidity prevailed, such as masks don’t work or are not needed or that social distancing was ineffective in reducing virulence. Members of the public who ascribed to the two primary partisan affiliations—Republican or Democrat—became more polarized in terms of their opinions about the scientific guidance.
It is here that reflection on the process of science rather than exploitation of that process for political ambition was needed. For example, in October of 2020—close to the election—a clip of a video of Dr. Fauci from March 8th 2020 was widely circulated across certain news groups and social media circles. In that clip, Dr. Fauci was quoted as stating:
“There’s no reason to be walking around with a mask. When you’re in the middle of an outbreak, wearing a mask might make people feel a little bit better and it might even block a droplet, but it’s not providing the perfect protection that people think that it is. And, often, there are unintended consequences—people keep fiddling with the mask and they keep touching their face.”
Importantly, the context of this clip as well as the science informing mask wearing must be considered here in order to draw any conclusions. First, Dr Fauci began this interview by stating the fact that masks are used to prevent the individual wearing the mask from spreading virus to another individual. Importantly here, at the start of the pandemic, when the interview was conducted there were 432 cases of the virus reported. At that time there was a shortage of Personal Protective Equipment (PPE), including masks, for our frontline workers. In fact, this in conjunction with the low case counts at the start of the pandemic, was the rationale for Dr. Fauci’s comments.
“….it could lead to a shortage of masks for the people who really need it”.
Narrow decontextualized focus to produce soundbites and as a means of justifying inaction by the Trump administration, however, led to right-leaning news agencies and individuals sharing shortened clips of Dr. Fauci’s interview and, as a consequence, too many of those individuals concluded that masks were ineffective, resulting in individuals refusing to wear masks. Importantly, at the time this clip was disseminated across social media and became viral (e.g., here), there were approximately 7.3 million cases in the US. The sharing of that clip, rather than the full interview which highlights nuanced decision-making by Dr. Fauci, seemingly, was a partisan political ploy. For example, those same individuals don’t specify that by April 3, 2020, the CDC updated its previous advice—given reduced shortfall of PPE and current scientific information about the disease transmission process of COVID-19—recommending that people wear cloth face coverings “in public settings when around people outside their household, especially when social distancing measures are difficult to maintain.” This guidance has, to date, been reasonably uniform.
Similar criticisms have been raised with respect to the scientific guidance concerning social distancing, herd immunity and, more recently, with respect to vaccinations. In all of these cases, the arguments have been that changing CDC guidance across time somehow reflects incompetence—rather than the fact that such changes are predicated on new scientific knowledge, and seemingly a failure in understanding the process of science.
Here, we return to our original point. Science is a process of knowing and it is distinct from opinion. While both opinion and science may share, at times, commonalities with respect to the degree of uncertainty, only science, through the use of the scientific method, can produce disconfirmatory evidence allowing one to make firm conclusions.
**Read more, Fact-Checked posts on Mask wearing: here, and here; Social Distancing: here and here; Herd Immunity: here and here
What are some of the open scientific and ethical questions pertaining to COVID-19 research?
When the COVID-19 pandemic hit, scientists got to work and accomplished within a year a process that generally can take between four to ten years—not one but two COVID vaccines approved for emergency use within the US.
But what does emergency authorization mean?
“An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.” [emphases added]
This simply means that given the evidence of efficacy in preclinical and clinical research as well as knowledge of the context in terms of public willingness to follow scientific guidance, rate of infections and deaths, hospital capacity and the economy—to name a few—the vaccines have been approved for use in humans. Does this mean that all that is needed to be known about COVID-19 is known and that safety and efficacy is guaranteed? The answer to this is no, but considering the relative risks and benefits, the preponderance of scientific evidence is clearly in favor of the benefits.
Open questions, however, include ethical and scientific dilemmas involving humans involved in ongoing clinical trials for approved vaccines. One question is whether the trials should be continued. For example, one half of the trial participants are given placebo injections. Now that a vaccine is available, should the trial continue? Conversely, in a situation where participants drop out of trials because a vaccine is available, the interpretation of data on safety and efficacy is made difficult. Other questions relating to, for example, allergic reactions, long term immunity, effects on the brain and other organs, and understanding why severe COVID-19 infections happen in subsets of individuals will continue to be researched using animal models and data from humans.
What can we do to restore confidence in science and scientists?
The question now becomes, what can we do to restore confidence in scientific guidance relating to COVID-19, as well as for future, as-yet unknown diseases. As we have highlighted, this crisis in confidence did not happen overnight and, equally likely, will not be overcome quickly—and there may be some individuals who will never be reached.
So what can you do? We have previously written about how individuals can #FactCheck information and why it is extremely important to vet information. This infographic by the International Federation of Library Associations and Institutions (IFLA) may be helpful in your decision making process.
At the same time, news agencies, social media companies and the like can all do a better job of moderating their content. For example, a recent study has found that blocking certain political figures from online platforms was sufficient to dramatically reduce misinformation by 73%. We note here that freedom of speech is not synonymous with freedom of consequence—a fact that is now abundantly clear.
In addition, individuals in policy-making and leadership positions should pay attention to scientific experts in decision-making and use decades of research to help promote COVID-19 vaccinations, for example, here. Ultimately, we have a long and hard road ahead, especially considering the partisan divide that has been amplified for political and not societal gain.
~Speaking of Research
Speaking of Research 