Most recently, a Cincinnati, Ohio-based 12-year old girl named Maddie de Garay was hospitalized a number of times after receiving the second dose of the Pfizer-BioNTech vaccine known as BNT162b2 (Comirnaty). The adolescent actually was a participant in a clinical trial testing the mRNA-based vaccine from December 2020 to January 2021. Apparently, what triggered the Twitter action was the fact that the mother, Stephanie, commenced sharing more details about the hospitalizations. This was all captured in a press conference sponsored by Wisconsin Republican Sen. Ron Johnson, reported Gabe Kaminsky with The Federalist.
Ms. De Garay shared during the press conference that the family is both pro-family and pro-science, hence why they had their daughter and two other kids participate in the trial. Apparently, the sponsor's response — the kid's problems arise from preexisting conditions.
The Family
Apparently, this family is as patriotic and pro-science as they come. With the father working in the medical field and the mother an electrical engineer, they volunteered their children in the study involving children and adolescents in the spirit of "helping us all return to normal life." Could this family be part of some menacing, anti-vax contingent, or are they simply distraught that their daughter was afflicted by a rare serious adverse event?
The Hospitalizations
But the adverse reactions are real, clearly connected to the study, and seemingly dangerous for this 12-year old. In the press release, the mother complained of painful electrical shocks up and down the spine and neck that impacted her posture and leading her apparently to the need for a wheelchair. With severe pain in both fingers and toes, both parts of the body apparently turned white and were ice bold to the touch.
Moreover, with severe chest pain, she had a tube inserted to help her breathe. With the symptoms ongoing, Ms. De Garay shared that their daughter has now been hospitalized three times for a total of two months in the hospital. In tears, the mother asked Pfizer why hadn't these challenges been detected. Fearing that this injury could be permanent, the mother declared she was perfectly normal before participating in the clinical trial. Maddie participated in the large nationwide trial involving children/adolescents between the ages of 12 and 15.
Social Listening's Ominous Tone
A review of the chatter across social media harkens to scary times ahead — in what seemingly becomes a new kind of McCarthyism for this age. TrialSite cannot confirm if true, but there are allegations that Twitter immediately blocks any mention of Maddie's name.
Other Vantage: The Committee to Protect Health Care
A liberal-leaning group called The Committee to Protect Health Care, however, challenged this press conference, declaring it was a misinformation campaign. Apparently, a day after the press conference, a few doctors from this organization declared the event was contributing to mounting vaccine hesitancy across the country.
Emphasizing a rational risk-benefit analysis, that vaccination is key to overcoming COVID-19, a Dr. Madelaine Tully from Milwaukee, WA, declared, "Let's be clear, serious side effects of the COVID-19 vaccines are extremely rare. The chances of dying from COVID-19 is many, many times greater than the chance of serious side effects of the COVID-19 vaccine."
The Math
But is that true? Does that add up? The death rate for children involving COVID-19 is incredibly low. The American Academy of Pediatricians provides a near up-to-date count of pediatric COVID-19 cases, including mortality. As of June 24, children were 0.00%-0.24% of all COVID-19 deaths, and 8 states reported zero child deaths. In states reporting, 0.00% to 0.03% of all child COVID-19 cases resulted in death. The point here is that both sides must start using actual figures based on real underlying data, not just hurling around assumptions.
Mainstream Starts Reconsidering?
TrialSite reported recently that MedPage Today's Editor-in-Chief Martin Makary, MD, MPH, came out and declared that of course there are cases where kids should be vaccinated, however, at least for healthy kids, there is no pressing need. That the risk-benefit analysis doesn't add up to vaccine healthy kids. MedPage Today isn't some fringe group of radicals but a very mainstream online publication. The World Health Organization also came out recently declaring kids don't need to be vaccinated but they quickly updated their edict to include 12 to 15 year old, the very age range from the recently FDA emergency use authorization (EUA) on March 10, 2021.
Holistic Risk-Benefit Analysis
Many Op-Ed contributors in the TrialSite have raised concerns about vaccinating children. Granted, few studies articulate the risks associated from all sides of the equation. As TrialSite emphasized of late, a Cleveland Clinic study indicated that of all of those 4,000+ hospitalized, 99% were unvaccinated. The point from the federal government health authorities centers on the risk of not getting vaccinated. Now children face far less risk as exemplified by the American Academy of Pediatricians data.
But as TrialSite has conveyed, the overall total number of cases are dramatically dropping as the CDC reported that for March and April 2021, a total of zero deaths in an entire cohort investigated.
But Pfizer is now conducting a study for kids under 12, investigating the optimal dose for this cohort. TrialSite suggests that a comprehensive analysis be done before there are broad-based vaccinations of children under 12 with what is still an investigational product. However, there are exceptions based on risk-based analyses. For example, immuno-compromised children could fit in the more at-risk category.
Conclusion
American and other societies are facing challenging times while the pandemic appears on the wane, millions around the world are still infected and another variant-driven surge is a real possibility. There's no easy way out of this crisis as, increasingly, people appear to take sides, as a balkanized, tribal sort of fragmentation trumps a more orderly and calm discourse factoring in the real risks as opposed to benefits of vaccination, especially for low-risk cohorts such as children. Covering up the issue only serves to create more distrust and angst, which can lead to even more extreme stances.
Somewhere, somehow, soon leadership must emerge from all different vantages, based on a common, rational understanding of the actual underlying risks associated with the vaccines across various age groups.
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