Are Governments Ready to Embrace Flexible, Risk-based Approaches to Vaccination in Response to COVID-19?

Posted originally on TrialSite New by StaffDecember 28, 20212 Comments

Are Governments Ready to Embrace Flexible, Risk-based Approaches to Vaccination in Response to COVID-19?

Marty Makary, MD, MPH, remains one of the most prominent critically thinking public health experts during this pandemic. A staunch supporter of COVID-19 vaccination, Dr. Makary, a prominent surgeon and editor-in-chief of MedPage Today, also raised the importance of balanced, more unbiased scientific reasoning, often making declarations that haven’t been popular with the dominant government and industry-driven pandemic narrative. For example, Makary has argued that a proper risk-benefit analysis should accompany any mass COVID-19-focused pediatric vaccination drive. Now the surgeon and researcher affiliated with Johns Hopkins University shares with the world concerns about indiscriminate booster campaigns—raising the specter of possible harm associated with such a one-size-fits-all approach embraced by the current U.S. executive branch and its scientific advisors.

While the government, backed by industry and all-too-willing academician advisors (undoubtedly hopeful of more public grants and other financial benefits) continue to promote the full acceleration of mass booster programs, little to no mainstream discussion appeals to the negative side of the health-related ledger:  what are the side effects of these vaccines? What about long-term risks? Of course, little is known about long-term health impacts because these products are so new. They have only been in use in the population for about a year. Often, it can take a handful of years before the true health risks associated with medicinal products materialize. But perhaps a glimmer of awareness shines through with growing chatter about vaccination risks alongside all-encompassing benefits. 

Recently Makary shared a message from Vinay Prasad, MD, MPH, who introduces a new paper in Nature uncovering differing adverse event risk factors by vaccine product. 

Led by corresponding author Julia Hippisley-Cox from the University of Oxford, the study shares how the risks for conditions such as myocarditis and pericarditis are very real, despite the initial clinical trial results.Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

The self-controlled case series study targeting vaccinated people 16 years of age and up in England analyzed cardiovascular adverse event incidence by vaccine product, including AstraZeneca/Oxford (ChAdOx1), Pfizer-BioNTech (BNT162b2), and Moderna (mRNA-1273).

The study authors discovered that the risks for myocarditis increase under the following conditions:

∙      After the first dose of AstraZeneca and Pfizer

∙      Subsequent to the second dose of Moderna over the 1–28-day post jab period

∙      Following a SARS-CoV-2 positive test

More specifically, according to this real-world data, myocarditis risks increases by the following:

 VaccineExtra myocarditis event per/1 millionStats
AstraZeneca295% confidence interval (CI) 0, 3
Pfizer-BioNTech195% CI 0, 2
Moderna695% CI 2, 8

The authors reported these outcomes for 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. In comparison, they find an extra 40 (95% CI 38, 41) such cardiovascular events per million 28 days after preliminary test indicating risks associated with COVID-19 itself. Indicating that overall vaccination could be less risky—but that precludes important subgroup analysis.

The UK-led study extends a growing study literature investigating COVID-19 vaccine-associated adverse events. In this case, significantly so, based on an analysis of 38 million adults in England receiving both the mRNA-based vaccines as well as the AstraZeneca product (adenovirus-mediated vaccine).

The study team discovered heightened myocarditis risk in subgroups (e.g., males under 40) as well as temporal association indicating risks after both the first and second jabs within a seven-day period post-vaccination.  

The authors declared, “The excess risk was observed in men and women but was only consistently observed following both mRNA vaccines in those younger than 40 years.” The authors qualify that fewer people under 40 received the mRNA-based vaccines however other national health authorities have already acted, unbeknownst to most of the North American public. 

Vaccine Limitations

Dozens of national health authorities have established parameters for vaccination during this unprecedented mass vaccination program. TrialSite provides some examples below that rarely make it into mainstream media in places like the United States, Canada, and even England.


Due to heightened risks associated with mRNA-1273 for myocarditis and other events, numerous counties have placed either temporary or permanent restrictions on the use of this novel COVID-19 vaccine product.

TrialSite has reported how all the Scandinavian nations (Denmark, Sweden, Norway, Finland, and even Iceland) have imposed limitations on access to this vaccine. In summary, health authorities in these nations have declared that the risks of cardiovascular-related events are too high for younger people, especially young males. TrialSite notes Moderna’s share price has been on a downward trend as reported by Yahoo Finance. Could traders have known something many others don’t?


Numerous nations placed holds, some permanent, some temporary, on this vaccine as TrialSite has reported ongoing. Even Wikipedia is updated on the “Suspensions” associated with this vaccine that had so much promise (more economical, easier to distribute, etc.). 

This is not to say that this vaccine hasn’t helped in the war against COVID-19 but the health-related costs associated with the novel product are real. Numerous nations in Europe, not to mention South Africa, Canada, Indonesia, and Australia placed suspensions at one point or another due to safety concerns such as blood clotting and low blood platelets. Still authorized by Europe and other authorities, many nations however transition from a one-size-fits-all approach to a more tailored, risk-based approach to vaccination. Remember, the USA completely stopped the AstraZeneca vaccine program.

More Data from Oxford-led Follow-on Study

Back to the mRNA-based vaccines and the most recent Oxford-led study in the preprint (this means it shouldn’t be used for making definitive claims). Males under 40 years of age face a higher risk with the vaccines from Pfizer-BioNTech and Modena than actual COVID-19 infection, thus raising concern that a rigid, one-size-fits-all approach to COVID-19 vaccination should be supplanted with a more tailored, precise approach. After all, that follows the trend in the science of medicine anyway.

Dr. Prasad discussed the limitations of the former peer-reviewed (Nature) study as the exact number of vaccines were known while the actual number of SARS-CoV-2 infections wasn’t certain at all. But with known limitations, he referred to the Oxford-led authors’ updated point of view uploaded to medRxiv for further clarification.

In this update, the authors found a heightened risk of myocarditis following one to 28 days after the third booster dose of Pfizer’s BNT162b2 (IRR 2.02, 95%CI 1.40, 2.91). Not surprisingly, the risks were highest in males aged 40 and under with all vaccines with the various observations in the updated study:

Myocarditis AE events per million est. 1-28 days post first dose

Vaccine Additional event per/1 millionStats
Pfizer-BioNTech395%CI 1, 5
Moderna1295%  CI 1,17

What about additional adverse events post the second dose?

Vaccine Additional event per/1 millionStats
AstraZeneca1495%CI 8, 17
Pfizer-BioNTech1295%CI 1, 7
Moderna10195%CI 95,  104

Pfizer boost vs. COVID-19 infection

VaccineAdditional event per/1 millionStats
Pfizer1395%CI 7, 15
COVID-19 Infection795%CI  2, 11

The authors report that while the risk of myocarditis is very real for those sick with SARS-CoV-2, the risk-benefit analysis contributes to a reasonable position against vaccination of people 40 and under. But why aren’t governing health authorities discussing this science? Dr. Prasad asks publicly why health authorities aren’t and associated political representatives are re-adjusting the “risk radar?”

Medicine is nuanced as Prasad declares and in his point of view “Profit, greed, and power…not so much!!” TrialSite suggests some truth in this argument—the evidence of some forms of regulatory capture is present during this pandemic.  TrialSite has accumulated a vast trove of study results, news stories, and various analyses pointing in this direction. Moreover, the level and type of information suppression indicate some forms of collusion between government, industry, and the largest media corporations. 

Industry received considerable incentive to develop products and should be held accountable when public finances are involved. Yet they also take on enormous risks—the drug development process is complex, time-consuming, and financially risky. TrialSite suggests for those that seek reform to better understand deeper, more systemic forces are at play during the pandemic including intense investor demand for high returns.  

The pharmaceutical industry shouldn’t be unilaterally vilified but also must be held accountable as should public health authorities and government embrace the comprehensive, unfolding science—not just a subset of data or evidence to back a convenient narrative. 

TrialSite continually educates that the pharma companies operate in a system that economically and financially punishes executives and their talent for failing to shrewdly exploit financially any rich, fertile profit conditions such as COVID-19. 

On the other hand, a balance can be achieved if regulatory and executive branch agencies behave and act independently with the public interest as a goal. Hence the risks and dangers of regulatory capture. But what happens when government and industry get too cozy? Known by some as “Crony Capitalism,” this involves a move away from free-market ideals mitigated by independent and objective regulators to an intertwined dynamic, vulnerable to bias and even corrupted practices. 

The pandemic exposed system vulnerability in pandemic response, including a tendency or impulse for some Western governments and health authorities to lean toward authoritarian-centric responses while not only ensuring windfall profits for the winners at the expense of at least some public health considerations.  An example would be the ongoing imposition of PREP Act liability shields despite widespread mandates. What happened to consumer rights activism? 

Some could argue the growing polarization in places like America only worsened the situation, conflating politics with the economy and public health. However, no orthodoxy, regardless of paradigm or hypothesis, will hasten the demise of the pathogen other than an objective, science- and evidence-driven approach factoring in real-world unfolding and ongoing intelligence. Suppression of data that contradicts or raises questions about the dominant narrative only worsens social and political divides leading to new forms of crises that governments seek to manage, most of the time unsuccessfully. 

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