While debates surrounding COVID-19 vaccines continue, late-night talk shows and popular news outlets have sought to sort the general public into two different camps: the “rational” pro-vaccine side that trusts the science and the “irrational” vaccine-hesitant side that does not. However, as is the case with most issues concerning the human race, it isn’t that simple.
Bias is simply a cognitive shortcut. It is a way for the human brain to conserve energy by finding patterns and relying on those patterns to make sense of the world. However, this inherently human quality can be taken to extremes — hijacked even. A classic example is when a group of people is led to believe that a different group, or even an opposing tribe, consists entirely of morally and/or intellectually inferior people.
This phenomenon can be observed throughout human history. Our natural tendency to divide ourselves into tribes is nothing new and in many cases, tribalism has served humanity well. In the very early days, it was necessary for the survival of the species.
Today, there are instances of extreme tribalism; where tribal loyalties are so intense that ingroup biases interfere with one’s ability to reason objectively causing everything to be viewed through an “us vs them” lens.
Extreme tribalism can be dangerous. Not only can it lead to groupthink, where the majority share the same idea so they assume it’s a good one even when it’s not — but it can also lead to hatred and violence, like the racism and segregation in South African and American history, or even religious violence between Catholics and Protestants in the 17th century.
A present example is the current political polarization in America, which has increased rapidly since the Trump administration, George Floyd riots, and the onset of COVID-19. This left vs. right division is exaggerated and exploited by media corporations — from late-night talk shows to Instagram accounts — that profit off the tribal biases (and in some instances hate) of their audience.
A recent extension of this political divide is the rise of vaccinated vs. unvaccinated rhetoric. A phrase developed in 2021 is the “Pandemic of the Unvaccinated.” Higher-ups, including U.S. President Joe Biden, have amplified this phrase across the net.
Additionally, as news corporations know that divisive and incendiary stories sell, many of them reported on a Gene Simmons’ quote which referred to unvaccinated people as “enemies.”
Whether or not it’s intentionally used to pit one side against the other, this sort of rhetoric that feeds on tribal biases is not only divisive but dehumanizing.
Vaccine-hesitant Americans have quickly been villainized as the media blames them for the ongoing pandemic — a notion that feeds tribal biases and perpetuates the us vs. them mentality. Though the science indicates that unvaccinated people are 11 times more likely to die from COVID-19, it is also true that unvaccinated people are not the sole contributors to ongoing infections.
As Dr. Eric Topolo, professor of molecular medicine at Scripps Research in La Jolla, California, told the Associated Press, “It is true that the unvaccinated are the biggest driver, but we mustn’t forget that the vaccinated are part of it as well, in part because of the delta variant.”
“The pandemic clearly involves all people, not just the unvaccinated” (emphasis added).
This is further emphasized when U.S. health officials on December 1 identified the first known Omicron variant case in the U.S. as a vaccinated traveler from South Africa.
But the media campaign to dehumanize and villainize the unvaccinated is lucrative. The viral clips of anti-vaxxers shouting absurdities in rallies and city halls, for example, make for easy laughs among certain late show audiences — as such clips confirm tribal biases in a matter of seconds.
Though airing this kind of footage is a sure-fire way to increase viewership, referring to anti-vaxxers as “maniacs” and suggesting that their behavior and beliefs represent all vaccine-hesitant people is disingenuous. Despite how mainstream media portrays them, there are individuals who are wary of getting vaccinated against COVID-19 who are also perfectly rational.
To assume that all who aren’t pro-vaccination share the same logic is a hasty generalization. Of course, there are likely some correlations and similarities among them (just like there are between vaccinated and unvaccinated people), but it should be obvious that not all of them adhere to conspiracy theories involving microchips and depopulation.
Something that seemingly not enough media players are talking about is the reality that unvaccinated people have valid reasons to be hesitant. None of this is to suggest that vaccines aren’t safe and effective, but it is an attempt to rehumanize those Americans who have their rational reservations.
The Food and Drug Administration
In the 1960s, after thousands of cases of severe birth defects were traced to a drug called thalidomide, Congress charged the Food and Drug Administration (FDA) with the responsibility of ensuring that drugs were safe and effective before going on the market; a process requiring multiple trials to produce “substantial evidence.” (Click here to view the amendment in the National Archives Catalog).
Today, the FDA is “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”
Recently, the agency has come under scrutiny for its authorization and approval of COVID-19 vaccines, with some suspicious of a rushed process. The approval of Pfizer’s vaccine, now known as Comirnaty, was the fastest vaccine approval in the FDA’s more than 100-year history. As Pfizer-BioNTech filed for licensing in early May, it took a total of four months for the FDA to approve their vaccine.
Now that the FDA has approved a vaccine, the discord between the pro and anti-vax camps has increased. Of the people who remain unvaccinated despite the approval of Comirnaty and the emergency use authorization for several other COVID-19 vaccines, the Washington Post chalked up their resistance to a “willingness to shift the goalposts on what might convince them” to get vaccinated — insinuating that if approval won’t convince them nothing will.
Assumptions like these oversimplify the reasons people have for not getting vaccinated. Just after the FDA granted its approval, Pew Research reported that not only is vaccination status “strongly linked with confidence in the vaccine research and development process,” but that “Americans who are not inoculated against COVID-19 express a range of concerns about the vaccines” (emphasis added) — indicating that for many, it was never solely about FDA approval.
The report lists these concerns via the following statements along with the percentage of unvaccinated Americans who say the statements describe them “very or somewhat well.”
- “There’s too much pressure on Americans to get a COVID-19 vaccine” (88%).
- “We don’t really know yet if there are serious health risks from COVID-19 vaccines” (81%).
- “Public health officials are not telling us everything they know about COVID-19 vaccines” (80%).
- “It’s hard to make sense of all the information about COVID-19 vaccines.” (70%)
The FDA’s approval helped convince many to get vaccinated, as there was a 17 percent increase of first dose vaccinations in the U.S. post-approval. But per Pew Research’s report, said approval was never going to be the end all be all for a large percentage of unvaccinated Americans.
Before writing off those who refuse to get vaccinated despite approval as “nuts,” the FDA’s track record ought to be considered. This is not to say that the FDA doesn’t serve an important purpose, nor that it isn’t an authority on matters regarding public health and safety; however, individuals disinclined to trust the agency aren’t without reason.
Consider the FDA’s track record
Historically, the FDA has made modifications to its processes for faster product approvals. One of the earliest examples was born out of necessity as slow approval times were compounded by the AIDs crisis.
As the agency’s responsibilities expanded, approval times for potentially life-saving drugs began to lag. A 2017 scholarly journal from Harvard recounts that “the average time it took the FDA to review a new drug application swelled from 14 months in 1963 to more than 35 months by 1979.”
When these slow approval times coincided with the AIDs crisis, protests spurred the Prescription Drug User Fee Act (PDUFA) in 1992. According to the FDA, the act “authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.”
Though the kairos warranted the passing of the PDUFA, it arguably damaged the agency’s credibility because, since 1992, the FDA has been funded — at least in part — by the same pharmaceutical companies whose products the agency is charged to review and approve.
FDA funding and Big Pharma
The FDA is funded by the same pharmaceutical companies that it is regulating. According to its website, $2.7 billion of the FDA’s 2019 $5.9 budget came from industry user fees. The FDA’s site also discloses that industry user fees account for 65 percent of its “Human Drugs regulatory activities.”
In her 2018 piece, “FDA Repays Industry by Rushing Risky Drugs to Market,” ProPublica reporter Caroline Chen details how “the more that the FDA relied on industry fees to pay for drug reviews, the more it showed an inclination towards approval.”
“You don’t survive as a senior official at the FDA unless you’re pro-industry,” former FDA medical team leader Dr. Thomas Marciniak told Chen. “The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don’t like you.”
Dr. Marciniak, who retired in 2014, also told Chen that staffers know “you don’t get promoted unless you’re pro-industry.”
Chen reinforced Dr. Marciniak’s claims with additional statements from other former FDA employees explaining how the agency incentivizes teams to quickly approve drugs. “Nobody gets congratulated for turning a drug down, but you get seriously questioned,” said a former FDA employee who requested anonymity.
Chen does a deep dive into how drug approvals are often financially motivated, uncovering several instances wherein the FDA was seemingly bought out of fulfilling its primary responsibility of “protecting the public health.”
Dr. C. Michael White, Distinguished Professor and Head of the Department of Pharmacy Practice at the University of Connecticut, is also concerned that the FDA is shirking its duty to public health. He wrote an article for The Conversation earlier this year, asking “Why is the FDA funded in part by the companies it regulates?”
“The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated,” Dr. White writes. “Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.”
He goes on to observe that the FDA’s approval time has decreased over the decades, noting how in 1987 “it took 29 months from the time a new drug application was filed by the manufacturer for the FDA to decide whether to approve a medication in the U.S.,” and that the approval time has been cut down to only 10 months by 2018.
Dr. White also details how the FDA’s approval of standard new drug applications has recently increased “from 38% in 2005 to 61% in 2018.”
Finally, noting that “the COVID-19 pandemic has seen the FDA provide emergency use authorization for potential treatments in a matter of weeks, not months,” Dr. White explains that “[t]he infrastructure and capacity to review the available information so rapidly is due in large part to the funding from user fees” (emphasis added).
Acknowledging the necessity of user fees, he admits that “[s]uccesses have occurred and provided U.S. citizens with medication more quickly than before.” However, Dr. White ultimately concludes that “without careful consideration of what is being negotiated, the FDA can become weak and ineffective, unable to protect its citizens from the next thalidomide.”
The continuing debate
Debates surrounding cut corners and rushed processes with COVID-19 vaccines seem to be at a standstill. On one hand, there are qualified scientists like Dr. Namandje Bumpus from the Johns Hopkins University School of Medicine telling Reuters this year that “[t]he safety and efficacy of COVID-19 vaccines currently in use have been rigorously tested, and the trials did not skip any steps.”
On the other hand, there are academic studies like one Yale conducted in 2017 which found that “[n]early one out of every three drugs approved by the Food and Drug Administration have a new safety issue detected in the years after approval.”
And while the FDA plays a vital role “in ensuring the safety of medications and medical devices,” as Dr. White wrote, it is clearly not immune to error. And with such a significant responsibility to the general public, it should not be immune to questioning either.
Considering how the FDA’s change in funding has affected the agency over time, is it so unreasonable to question its motives or to be apprehensive at how quickly it granted approval to Pfizer’s vaccine? And should those who err on the side of caution be made to feel like deviants worthy of persecution?
Pfizer’s Pattern of Misconduct
Another reason some Americans have been slow to get vaccinated stems from the questionable reputation of Pfizer.
As Pfizer leads the way for COVID-19 vaccines in the U.S. with its FDA-approved Comirnaty vaccine, its track record should be considered as well. According to goodjobsfirst.org’s violation tracker (labeled “the most comprehensive source of data on business violations of laws and regulations in the United States” by corpwatch.org) Pfizer has accrued more than $4,660,896,333 worth of legal penalties since 2000.
The violation tracker includes a comprehensive breakdown of Pfizer’s different types of offenses as well as each penalty’s dollar amount. The corporation’s top “Primary Offense Type” is “off-label or unapproved promotion of medical products,” of which the corporation has ten offenses. The penalties for this category alone amount to $3,373,675,000.
Pfizer also has 19 “government-contracting-related offenses” and 11 “safety-related offenses” on its track record, amounting to another $214,983,098 in penalties.
Perhaps the biggest reason some Americans are hesitant to get vaccinated, even if it’s with the approved vaccine, is that Pfizer pled guilty to the “Largest Health Care Fraud Settlement in Its History” according to the U.S. Department of Justice. In 2009, the corporation had to pay “$2.3 Billion for Fraudulent Marketing.”
In the DOJ’s press release, it states that Pfizer “has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead.” Bextra was an anti-inflammatory drug that Pfizer pulled from the market back in 2005. The company committed fraud by advertising the drug for uses that were unapproved by the FDA.
“Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns,” the press release reads. To settle the case, Pfizer had to pay “the largest criminal fine ever imposed in the United States for any matter.”
Possible financial motives
It should also be noted that Pfizer may be financially motivated to sell as many vaccines as they can as soon as they can. The Health Resources and Services Administration (HRSA) is the agency that oversees compensation programs where individuals can file claims alleging injury or death from vaccination. Currently, Pfizer’s COVID-19 vaccine falls under the Countermeasures Injury Compensation Program (CICP).
The HRSA’s website states that the program is funded by “Appropriated Funds.” The Deputy Director at the HRSA’s Office of Communications, Christy Choi, explained to The Lynnwood Times that the CICP “does not have a dedicated appropriation from Congress,” and that it is “funded by Congressional appropriation to HHS [Department of Health and Human Services] and HHS transfers funds to the CICP.”
“In FY [Fiscal Year] 2022, about $5.8 million was transferred to the CICP,” Director Choi continued. “As the need for funding for COVID-19 related claims becomes clearer, additional funding may be requested.”
But, as The Lynnwood Times reported previously, eventually the COVID-19 vaccines will be moved from the CICP to the National Vaccine Injury Compensation Program (VICP). As the director of the Vaccine Injury Litigation Clinic at George Washington University Renée Gentry noted, “Once it’s no longer in emergency use and it’s recommended for children, it should go into the VICP.”
And this could be a motivation for Pfizer to quickly sell its COVID-19 vaccines in bulk; once its vaccine falls under the VICP, Pfizer will be required to pay a $0.75 excise tax for each vaccine it sells.
As Director Choi explained in an email to The Lynnwood Times:
“The Vaccine Injury Compensation Trust Fund provides funding for the National Vaccine Injury Compensation Program to compensate vaccine-related injury or death petitions for covered vaccines administered on or after October 1, 1988.
Funded by a $0.75 excise tax on vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children, the excise tax is imposed on each dose (i.e., disease that is prevented) of a vaccine. Trivalent influenza vaccine for example, is taxed $0.75 because it prevents one disease; measles-mumps-rubella vaccine, which prevents three diseases, is taxed $2.25.
These taxes are paid by the vaccine manufacturers.”
Vaccines that fall under the VICP are “recommended for routine administration to children and/or pregnant women by the Centers for Disease Control and Prevention, subject to a federal excise tax, and added to the Vaccine Injury Table by the Secretary of HHS.”
While Pfizer’s intentions are not known, it is a fact that the moment their vaccine is moved to the VICP, they will begin paying $0.75 for every dose they sell.
As of February 2021, Pfizer’s vaccines go for $19.50 per dose. According to the company’s CFO Frank A. D’Amelio, $19.50 is a very low price. During a Q4 2020 Pfizer Inc Earnings Call, D’Amelio said, “that’s not a normal price like we typically get for a vaccine, $150, $175 per dose. So pandemic pricing.”
Compared to those other prices, $19.50 does appear low (even though it’s the most expensive compared to Moderna’s $15 shot and J&J’s $10 one, according to fiercepharma.com). However, as the New York Times reported in May 2021, Pfizer’s vaccine earned $3.5 billion in revenue in only the first three months of this year.
In its July 2021 second-quarter report, Pfizer updated its first-quarter revenue assumptions for the BNT162b2 – Pfizer-BioNTech SE (BioNTech) COVID-19 – vaccine from approximately $26 billion to $33.5 billion. For its second-quarter revenue, Pfizer posted $19.0 billion of which $7.8 billion (41%) was related to COVID vaccine sales.
Clearly, the current price per COVID-19 vaccine dose is not harming their business. And when the COVID-19 vaccines are moved to the VICP, Pfizer will be losing more than a pretty penny to the excise tax. For example, if they had to pay $0.75 for each dose they sold in the first three months of 2021, they would have lost out on about $13.5 million.
Big Pharma hiring former public officials
This potential financial motivation on behalf of Pfizer is yet another reason some may be suspicious of a rushed process. It also doesn’t help that the FDA’s commissioner from 2017 to 2019, Scott Gottlieb, is now employed as Pfizer’s Director and Chair of their Regulatory and Compliance Committee and Member of its Science and Technology Committee. This isn’t to accuse Pfizer of anything suspicious, but the optics don’t look great — especially for those who were already wary of Pfizer’s vaccine given the historical felony crime the company committed in 2009.
Resisting divisive narratives
Beyond the FDA and Pfizer, there are other valid reasons as to why some have reservations regarding COVID-19 vaccines. For example, Dr. Anthony Fauci, who has more or less been the face of scientific authority during the pandemic, has recently come under fire for allegedly lying to congress about “gain-of-function” research.
Again, none of this is to suggest that the FDA is a corrupt organization or that Pfizer’s Comirnaty vaccine isn’t safe and effective, nor is this anti-vaccine propaganda. All that has been presented in this composition is to depict vaccine-hesitant Americans in a more nuanced and humanizing light and to challenge the media campaign to push the vaccinated and unvaccinated into their corners.
And now, as residents in King County must show proof of vaccination to enter businesses, the media-inspired rift between vaccine statuses is spreading from social media platforms to physical spaces.
In their New York Times bestseller, “The Coddling of the American Mind,” Greg Lukianoff and Jonathan Haidt wrote that “Both the physical and the electronic isolation from people we disagree with allow the forces of confirmation bias, groupthink, and tribalism to push us still further apart.”
Author: Bo John Brusco
