Those of us critical of the one-size-fits all, coercive approach to public health that was shoed in across the West over the course of this pandemic, have spilt a good deal of ink calling out the ethical and scientific degradation of public health authorities, in particular their decision to (i) disregard wildly divergent Covid risks, (ii) recommend insufficiently tested vaccines for everyone, even infants at minimal risk from Covid, willy-nilly, and (iii) rely on coercion rather than informed consent to guarantee compliance with their directives.
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It therefore gives me special pleasure to be able to report the rare instances in which a public health authority bucks this depressing trend, and actually takes a stand in favour of well established public health principles such as the need to assess medical risk on an individualised basis, and the need to consult patients on medical decisions that affect their lives.
Florida’s Department of Health has been one of the few public authorities that has had the courage to base its pandemic recommendations on the actual balance of scientific evidence, and on an adult relationship with citizens, rather than on an infantilising, scientifically dubious narrative of disease control (to put it charitably) embraced by global elites during the pandemic. Florida, to their credit, along with Sweden, largely opted out of the global lockdown experiment, and put citizens’ liberties and health ahead of technocrats’ desire to micromanage populations based on bizarre, empirically unsupported theories of disease control.
It is not entirely unexpected, then, that Florida’s State Health Officer and Surgeon General, Dr Joseph Ladapo, is bucking an international trend of uncritically endorsing Covid vaccination and boosters for virtually all ages and population cohorts.1 Recently, Dr Ladapo has reiterated Florida’s rejection of Covid vaccines for children, and announced revised guidance on the mRNA Covid vaccines.
Florida’s Department of Health now recommends against the vaccine for males between 18 and 39 years old, based on their latest risk-benefit assessment. The new guidance is explained here. The press release can be found here.
The guidance is prefaced by a reaffirmation of a crucial principle of public health, mostly ignored by Western health authorities in 2020-21, namely individualised, patient-centred risk assessment: “Florida continues to emphasize that health care providers review all data to evaluate risks and benefits unique to each patient when determining any health care services to provide” (emphasis added).
I am neither a virologist nor a medical doctor. I am therefore not in a position to assess the strengths and weaknesses of the evidence relied on by Florida's health services to recommend against giving young men mRNA Covid vaccines. What I can say is that they have been transparent in putting their evidence and the reasoning behind their decision on the public record. Furthermore, the decision is not completely unexpected, since we have known about elevated risk of cardiac complications from the mRNA vaccines for some time; these findings do not contradict the emerging body of evidence on the mRNA vaccines.2
The most important points to underline in the revised guidance (to avoid any possible ambiguity on this important topic, I will quote verbatim) are the following:
“The Florida Department of Health…conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety. This studied mortality risk following mRNA COVID-19 vaccination. This analysis found there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination.”
“With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group. (18-39)…The State Surgeon General now recommends against the COVID-19 mRNA vaccines for males ages 18-39 years old.”
This analysis also found that “males over the age of 60 had a 10% increased risk of cardiac-related death within 28 days of mRNA vaccination.”
“Non-mRNA vaccines were not found to have these increased risks among any population.”
“The Department (of Health) continues to stand by its Guidance for Pediatric COVID-19 Vaccines issued March 2022, which recommends against use in healthy children and adolescents 5 years old to 17 years old. This now includes recommendations against COVID-19 vaccination among infants and children under 5 years old.”
While the absolute incidence of cardiac events among vaccinated people remains low, the evidence presented by the Floridian Surgeon-General suggests that the small risk of such events is not justified by a corresponding reduction of Covid-related risk of disease and death.
Regarding the emerging evidence on mRNA vaccine side-effects, it is actually quite difficult to get a good overall picture of the full extent of vaccine harms, because we largely rely on self-reported and doctor-reported side-effects, and it is generally accepted that vaccine adverse events tend to be under-reported and certainly not consistently reported.
This means that we are always dealing with imperfect data that is, of its very nature, revisable over time. If one gets clear “signals” in the data of significant harms, one must then make a prudential choice about whether those imperfectly quantified risks are compensated by the overall health benefits of the vaccine. That is a complex calculation to make, but the burden of evidence very much lies on the shoulders of those advocating a novel vaccine, especially in the case of healthy people at very low risk from Covid.
After all, to admit that this or that disease circulating in the community, in spite of one’s best efforts to treat it, carries a small risk for young and healthy people is one thing; whereas to intentionally inject a medication with serious known adverse events associated with it is something quite different.
Now, if the risk to young men from Covid-19 was very high, these increased risks of cardiac disease might be acceptable. But the risks of dying or sufferng serious or debilitating disease from Covid-19 for young men, at least those in reasonably good health, are actually very low, as can be seen by the very small percentage of people admitted to hospital with Covid, of young age and with no serious underlying health conditions. Indeed, the risks of suffering severe Covid disease, for a young man in good health, might well be even lower at this time than the risk of suffering severe disease or death as a result of the mRNA vaccination. That is why Florida’s Surgeon-General is advising young men to steer clear of these particular vaccines.
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One notable exception to this trend, at least in late 2022, is the Danish Health Authority, which is now recommending the Covid vaccines for people over 50 and people in special risk categories, a recommendation that diverges very clearly from the “vaccination for all” script still accepted by other health authorities such as the CDC.
The European Medicines Agency, for example, published a review of Pfizer’s Comirnaty mRNA vaccine on 9 December 2021, finding that “Overall, the outcome of the review confirms the risk of myocarditis and pericarditis, which is already reflected in the product information for Comirnaty….Based on the reviewed data, PRAC (Pharmacovigilance Risk Assessment Committee) has determined that the overall risk for both conditions is overall ‘very rare’, meaning that up to 1 in 10,000 vaccinated people may be affected. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males. PRAC has recommended updating the product information accordingly.” Curiously, EMA’s PRAC committee differ from Florida’s Department of Health in maintaining that the balance of risks favours vaccination, even for young men. “EMA confirms that the benefits of Comirnaty continue to outweigh its risks, given the risk of COVID-19 illness and related complications, including hospitalisation and death.” But they do not explain on that webpage the empirical basis for that risk assessment.
The Center for Disease Control and Prevention accepts that there is an elevated risk of myocarditis among young males, but concludes that the risk is outweighed by the benefits: “Data from multiple studies show a rare risk for myocarditis and/or pericarditis following receipt of mRNA COVID-19 vaccines. These rare cases of myocarditis or pericarditis have occurred most frequently in adolescent and young adult males, ages 16 years and older, within 7 days after receiving the second dose of an mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna)…The Advisory Committee on Immunization Practices (ACIP) and CDC have determined that the benefits (such as prevention of COVID-19 cases and its severe outcomes) outweigh the risks of myocarditis and pericarditis after receipt of mRNA COVID-19 vaccines.”
Well done Florida's Surgeon General!
Here's hoping the rest of the USA & the World wake up asap too,