The FDA requires institutions that test drugs and biologics in children to have a pediatric plan in place, but some say<\/a> the rule \u201cis lenient to the point of being no rule at all.\u201d As Dr. Robert Frenck, director of the Cincinnati Children\u2019s Hospitals Center for Vaccine Research told TIME magazine<\/a>, \u201cThe plan can be simply \u2018We don\u2019t have a plan.\u2019\u201d<\/p>\n On Oct. 22, the FDA\u2019s Vaccines and Related Biological Products Advisory Committee convened a panel of experts to discuss coronavirus vaccines. Committee members expressed wariness<\/a> about giving the shots to children, arguing that the risks could well outweigh the benefits. Leading National Institutes of Health (NIH) researcher Dr. Luigi Notarangelo went further, frankly stating<\/a> that coronavirus vaccines \u201cshould not be considered for use\u201d in children \u201cat this point\u201d and adding that the evidence presented at the meeting had been insufficient to answer pressing questions about safety.<\/p>\n Judging by the fact that parents of 100 children<\/a> immediately volunteered to have their kids get the unapproved messenger RNA (mRNA) vaccine<\/a>, Pfizer and the Cincinnati hospital have been successful in persuading parents that, even in the face of expert concerns, there is nothing to worry about. Initially, Pfizer will test the vaccine in several thousand<\/a> 12-17-year-olds. The plan is then to broaden the pediatric test population to include younger children and infants.<\/p>\n Thanks to months of fear-inducing messaging \u2014 a form of \u201cpersuasive communication<\/a>\u201d that intentionally uses fear to \u201cmanipulate<\/a> individuals or populations\u201d into \u201cdoing things they would ordinarily resist doing\u201d \u2014 many parents are now far \u201cmore afraid of COVID<\/a> than the vaccine,\u201d making them willing to \u201ctrust the science\u201d and sign on the dotted line.<\/p>\n The altruism con<\/strong><\/p>\n Fear is only one of the tactics being used to attract the thousands of American families Pfizer needs to attain its target pediatric sample size. Many experts are also heavily playing the altruism<\/a> card, suggesting that \u201cgetting a vaccine, when it\u2019s available, is not just about you. It\u2019s about protecting your grandmother who has diabetes and Uncle Sean, who is immune-compromised.\u201d<\/p>\n The Cincinnati doctor heading up Pfizer\u2019s pediatric study has made this very case, suggesting that vaccinated children will be able to \u201cindirectly<\/a>\u201d protect their parents, grandparents, teachers and coaches.<\/p>\n The fact that Cincinnati\u2019s investigator is making such claims is both misleading and perplexing, given that Pfizer\u2019s clinical trials are designed<\/a> to assess only whether the vaccine lessens mild COVID-19<\/a> symptoms. The trials, as a growing number of observers have pointed out<\/a>, will not permit any conclusions about whether the vaccine prevents infection or interrupts transmission. The experts at the Oct. 22 VRBPAC meeting agreed<\/a> that the vaccine trials \u201chave serious design flaws.\u201d<\/p>\n Medical trade groups have chosen to ignore the FDA advisory committee\u2019s concerns about the wisdom of rushing COVID-19 vaccines into children. Instead, as the Huffington Post reported<\/a>, the American Academy of Pediatrics is \u201csounding the alarm\u201d in the opposite direction, arguing for children\u2019s \u201cimmediate\u201d inclusion in vaccine studies.<\/p>\n The media have not hesitated to add to this push, publishing thinly veiled recruitment pieces encouraging children\u2019s clinical trial involvement. For example, one editor-at-large for TIME recently gushed<\/a> that the children participating in Pfizer\u2019s study are engaging in \u201can act of public-service heroism\u201d that is the modern-day equivalent of the \u201cpolio pioneers\u201d of the 1950s.<\/p>\n Left out of the TIME article is any mention of what happened when early polio vaccines were fast-tracked: The \u201cmassive and highly publicised disaster<\/a>\u201d called the Cutter incident gave polio to thousands of children, killing 10 and leaving many others permanently disabled. Nor does TIME\u2019s revisionist portrayal of polio vaccine history discuss the severe health problems and excruciating pain<\/a> afflicting those who have suffered adverse reactions to polio vaccines, or the fact that polio vaccines are the leading cause<\/a> of polio and \u201cpolio-like\u201d illness.<\/p>\n Ignorant of this history and of the nearly 400 adverse reactions<\/a> listed in childhood vaccine package inserts, some members of the general public are also reinforcing the heroism narrative. As reported<\/a> by TIME, one of the teenage Pfizer participants has had \u201cteachers and other students in the hallway say, \u2018Hey, my gosh, that\u2019s so cool\u2019 and, \u2018You\u2019re so brave!\u2019\u201d The student\u2019s mother replies that her daughter is \u201cjust doing a little teeny-tiny thing that we believe will help lots of people.\u201d<\/p>\n Weighing the risks<\/strong><\/p>\n As the experts on the FDA\u2019s Vaccines and Related Biological Products Advisory Committee indicate<\/a>, not everyone agrees that receiving a hurriedly developed, experimental vaccine is a \u201clittle teeny-tiny thing.\u201d As the mother quoted above concedes<\/a>, \u201cthere are some people out there who don\u2019t think this is the smartest thing for us to have done.\u201d However, despite the fact that adults participating in Pfizer\u2019s Phase 3 trials have reported<\/a> experiencing high fever, pounding headaches, severe body aches, exhaustion and shivering intense enough to crack teeth, the mother\u2019s assessment of the 11-page handout provided by Pfizer (describing \u201call the ifs and whys and hows and whats\u201d) led her to conclude that her daughter would risk only minor side effects \u2014 in other words, \u201cnothing drastic or dire.\u201d<\/p>\n One wonders what these parents are being told about the never-before-approved mRNA technology<\/a> featured in Pfizer\u2019s vaccine. The proprietary mRNA platform is being supplied by Pfizer\u2019s German partner, BioNTech, a young company that, in September 2019, fortuitously signed a deal<\/a> with the Bill and Melinda Gates Foundation (worth up to $100 million) to \u201cbuild out its infectious disease infrastructure.\u201d mRNA molecules are known to be \u201cintrinsically unstable<\/a> and prone to degradation,\u201d with an inflammatory component<\/a> that risks \u201cdangerous immune reaction[s]<\/a>.\u201d<\/p>\n Pfizer<\/a> and its mRNA vaccine competitor, Moderna \u2014 which plans to start testing its vaccine in adolescents<\/a> soon \u2014 have recently grabbed headlines celebrating the apparent effectiveness of their coronavirus vaccines. However, as the New York Times noted<\/a>, both companies presented their preliminary and far-from-conclusive results in carefully crafted news releases \u2014 short on the details \u201cthat would allow outside experts to evaluate their claims\u201d \u2014 rather than in peer-reviewed scientific journals. The advocacy group Public Citizen openly criticized Pfizer\u2019s uninformative PR blitz as \u201cbad science<\/a>.\u201d<\/p>\n Experts touting these mRNA vaccines have engaged in a number of linguistic contortions to allay legitimate worries, recognizing that \u201cthe rapidity of development \u2014 an idea underscored by the name Operation Warp Speed<\/a> \u2014 [has] inadvertently aggravate[d] the public\u2019s safety concerns<\/a>.\u201d One pediatric professional, refuting the characterization of the vaccine development process as \u201crushed\u201d said<\/a>, \u201cI would say that it was intensified and that after each phase of the study it was analyzed in a quicker fashion than normally maybe so. This does not mean it was rushed, it was just worked on more aggressively.\u201d<\/p>\n A Stony Brook Children\u2019s Hospital executive, alluding to the years of fruitless research on mRNA vaccines, has likewise soothingly stated<\/a>, \u201cThe technology for this vaccine, while new, is still years old.\u201d<\/p>\n Pfizer, for its part, admits to the need for \u201cmonths and even years<\/a>\u201d of follow-up to ascertain safety meaningfully. Unfortunately, its clinical trials end after 24 months, and its active monitoring of adverse events largely focuses on the first couple of months<\/a>. As VRBPAC\u2019s consumer representative, an attorney, stated<\/a> at the FDA\u2019s late October meeting, \u201cThere could be adverse effects we don\u2019t know about, and so isn\u2019t two months a little short?\u201d<\/p>\n Moreover, long-term follow-up for conditions such as cancer and autoimmune diseases will become difficult, if not impossible, if the vaccine makers hasten to offer their vaccines to the placebo groups (thereby erasing their comparison), which Moderna<\/a> and Pfizer<\/a> executives have both suggested they will do.<\/p>\n Running down children, no matter what<\/strong><\/p>\n According to<\/a> the Centers for Disease Control and Prevention (CDC), \u201cMost children with COVID-19 have mild symptoms or have no symptoms at all.\u201d In its breakdown of risks by age groups, the public health agency rates<\/a> 5-17-year-old children\u2019s risk of COVID-19-related hospitalization as nine times lower and their risk of death as 16 times lower than for young adults aged 18-29 \u2014 who themselves are a low-risk age group.<\/p>\n In comparison, the CDC assesses the risk of death for seniors aged 75-84 or 85+ years as 220 times and 630 times higher, respectively, than for 18-29-year-olds. As of mid-November, the CDC had attributed<\/a> just 39 deaths to COVID-19 in children aged 5-14 (well under 1%<\/a> of all deaths in that age group). The CDC also acknowledges that most of the children who develop severe coronavirus illness have comorbidities<\/a> such as obesity, diabetes, asthma, immune suppression, congenital heart disease, or genetic, neurologic, or metabolic disorders.<\/p>\n Under the circumstances, it would not be surprising if many parents questioned the need to add an experimental COVID-19 vaccine to their young ones\u2019 already top-heavy vaccination schedule. It would also be understandable if parents were beginning to rethink the wisdom of flu shots. Numerous studies over the past decade, including in children, have indicated that influenza vaccination<\/a> increases the risk of subsequent acute respiratory illness, and a 2020 Pentagon study showed a 36% greater risk of coronavirus infection post-flu shot.<\/p>\n Recognizing the need to build a more solid \u201cbedrock of confidence<\/a>\u201d among parents, officials have been busy marshaling their counterarguments. All signs point toward the continued use of tactics<\/a> such as fear appeals<\/a> (including comparisons of the coronavirus to past \u201cplagues\u201d and warnings that parents will \u201cexponentially\u201d increase their children\u2019s risk of \u201ccatching the virus\u201d if they refuse the vaccine), minimization of risk concerns (even as experts admit<\/a> that \u201cany vaccine can cause an allergic reaction\u201d) and old-fashioned bribery (with the vaccine being held out as the only way to \u201crecover from the financial, emotional and medical burdens that [COVID-19] has caused\u201d).<\/p>\n The true \u201cheroes\u201d of this story, however, are likely to be the parents who recognize these tactics for the soft forms of coercion that they are, and who choose to protect their children rather than sacrifice them on the altar of a disingenuous altruism.<\/p>\n
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