COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities

Authors: Kevin Bardosh University of Washington; University of Edinburgh – Edinburgh Medical School Allison Krug Artemis Biomedical Communications LLC Euzebiusz Jamrozik University of Oxford Trudo Lemmens University of Toronto – Faculty of Law Salmaan KeshavjeeHarvard University – Harvard Medical School Vinay Prasad University of California, San Francisco (UCSF) Martin A. Makary Johns Hopkins University – Department of Surgery Stefan Baral John Hopkins University Tracy Beth Høeg Florida Department of Health; Sierra Nevada Memorial HospitalDate Written: August 31, 2022

Abstract

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates. We estimate that 22,000 – 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

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https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID4206070_code5055014.pdf?abstractid=4206070&mirid=1

Big Pharma Can’t Figure Out How To Cash In On ‘Long COVID’

Authors:mmDYLAN HOUSMANHEALTHCARE REPORTER July 11, 2022

Major pharmaceutical companies are struggling to develop treatments for “long COVID” because it’s been nearly impossible to nail down what exactly the ailment actually is, according to a new report from The Wall Street Journal.

The rapid development of COVID-19 vaccines and antiviral treatments resulted in record-breaking profits for companies like Pfizer, which say they plan to continue cashing in on the pandemic and its new variants for years to come. Treating “long COVID,” however, has remained elusive, as scientists can’t even agree on what exactly the condition is or isn’t.

Head of biotechnology company Ovid Therapeutics, Jeremy Levin, told The WSJ that big pharma is eager to jump into the long COVID game, but they don’t have enough data on how to do so. “It’s not that the industry doesn’t want to get in; it’s just that the data hasn’t played out, yet,” he said. “And until you can have more clear targets, you don’t have a measurable outcome.”

The government has failed in its role to research long COVID, at least so far. The National Institutes of Health got $1.2 billion from Congress more than a year ago to study long COVID, but has yet to make much meaningful progress. Researchers may have recently discovered a reliable biomarker for long COVID, but that would only be the first step toward developing clinical trials for a treatment.

The most commonly reported symptom of long COVID is fatigue, according to The WSJ, but patients have reported a vast variety of other ailments ranging from loss of smell to anxiety to memory loss. One study found at least 203 potential symptoms of long COVID.

Global director of vaccine development at Cleveland Clinic, Ted Ross, told The WSJ that it will likely take persistent protest from patients for big pharma companies to devote more resources to the condition. But for now, they aren’t biting, for the most part. Pfizer said earlier this year it currently has no clinical trials in progress devoted to long COVID treatment.

Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials

Authors: Joseph Fraiman June 23, 2022 Louisiana State University – Lallie Kemp Regional Medical Center

Abstract

Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We leveraged the Brighton Collaboration list to evaluate serious adverse events of special interest observed in phase III randomized trials of mRNA COVID-19 vaccines.

Methods: Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines (NCT04368728 and NCT04470427), focusing analysis on potential adverse events of special interest identified by the Brighton Collaboration.

Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).

Discussion: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.

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The Bizarre Refusal to Apply Cost-Benefit Analysis to COVID Debates

Are those who oppose a ban on cars or a radical reduction in speed limits sociopaths, given the huge number of people they are knowingly consigning to death or maiming?

Authors: Glenn Greenwald 5 hr ago 285536

In virtually every realm of public policy, Americans embrace policies which they know will kill people, sometimes large numbers of people. They do so not because they are psychopaths but because they are rational: they assess that those deaths that will inevitably result from the policies they support are worth it in exchange for the benefits those policies provide. This rational cost-benefit analysis, even when not expressed in such explicit or crude terms, is foundational to public policy debates — except when it comes to COVID, where it has been bizarrely declared off-limits.

The quickest and most guaranteed way to save hundreds of thousands of lives with policy changes would be to ban the use of automobiles, or severely restrict their usage to those authorized by the state on the ground of essential need (e.g., ambulances or food-delivery vehicles), or at least lower the nationwide speed limit to 25 mph. Any of those policies would immediately prevent huge numbers of human beings from dying. Each year, according to the Center for Disease Control (CDC), “1.35 million people are killed on roadways around the world,” while “crashes are a leading cause of death in the United States for people aged 1–54.” Even with seat belts and airbags, a tragic number of life-years are lost given how many young people die or are left permanently and severely disabled by car accidents. Studies over the course of decades have demonstrated that even small reductions in speed limits save many lives, while radical reductions — supported by almost nobody — would eliminate most if not all deaths from car crashes.

Center for Disease Control, 2020

Given how many deaths and serious injuries would be prevented, why is nobody clamoring for a ban on cars, or at least severe restrictions on who can drive (essential purposes only) or how fast (25 mph)? Is it because most people are just sociopaths who do not care about the huge number of lives lost by the driving policies they support, and are perfectly happy to watch people die or be permanently maimed as long as their convenience is not impeded? Is it because they do not assign value to the lives of other people, and therefore knowingly support policies — allowing anyone above 15 years old to drive, at high speeds — that will kill many children along with adults?

That may explain the motivation scheme for a few people, but in general, the reason is much simpler and less sinister. It is because we employ a rational framework of cost-benefit analysis, whereby, when making public policy choices, we do not examine only one side of the ledger (number of people who will die if cars are permitted) but also consider the immense costs generated by policies that would prevent those deaths (massive limits on our ability to travel, vastly increased times to get from one place to another, restrictions on what we can experience in our lives, enormous financial costs from returning to the pre-automobile days). So foundational is the use of this cost-benefit analysis that it is embraced and touted by everyone from right-wing economists to the left-wing European environmental policy group CIVITAS, which defines it this way:

Social Cost Benefit Analysis [is] a decision support tool that measures and weighs various impacts of a project or policy. It compares project costs (capital and operating expenses) with a broad range of (social) impacts, e.g. travel time savings, travel costs, impacts on other modes, climate, safety, and the environment.

This framework, above all else, precludes an absolutist approach to rational policy-making. We never opt for a society-altering policy on the ground that “any lives saved make it imperative to embrace” precisely because such a primitive mindset ignores all the countervailing costs which this life-saving policy would generate (including, oftentimes, loss of life as well: banning planes, for instance, would save lives by preventing deaths from airplane crashes, but would also create its own new deaths by causing more people to drive cars).

While arguments are common about how this framework should be applied and which specific policies are ideal, the use of cost-benefit analysis as the primary formula we use is uncontroversial — at least it was until the COVID pandemic began. It is now extremely common in Western democracies for large factions of citizens to demand that any measures undertaken to prevent COVID deaths are vital, regardless of the costs imposed by those policies. Thus, this mentality insists, we must keep schools closed to avoid the contracting by children of COVID regardless of the horrific costs which eighteen months or two years of school closures impose on all children.

It is impossible to overstate the costs imposed on children of all ages from the sustained, enduring and severe disruptions to their lives justified in the name of COVID. Entire books could be written, and almost certainly will be, on the multiple levels of damage children are sustaining, some of which — particularly the longer-term ones — are unknowable (long-term harms from virtually every aspect of COVID policies — including COVID itself, the vaccines, and isolation measures, are, by definition, unknown). But what we know for certain is that the harms to children from anti-COVID measures are severe and multi-pronged. One of the best mainstream news accounts documenting those costs was a January, 2021 BBC article headlined “Covid: The devastating toll of the pandemic on children.”

The “devastating toll” referenced by the article is not the death count from COVID for children, which, even in the world of the Delta variant, remains vanishingly small. The latest CDC data reveals that the grand total of children under 18 who have died in the U.S. from COVID since the start of the pandemic sixteen months ago is 361 — in a country of 330 million people, including 74.2 million people under 18. Instead, the “devastating toll” refers to multi-layered harm to children from the various lockdowns, isolation measures, stay-at-home orders, school closures, economic suffering and various other harms that have come from policies enacted to prevent the spread of the virus:

From increasing rates of mental health problems to concerns about rising levels of abuse and neglect and the potential harm being done to the development of babies, the pandemic is threatening to have a devastating legacy on the nation’s young. . . .

The closure of schools is, of course, damaging to children’s education. But schools are not just a place for learning. They are places where kids socialize, develop emotionally and, for some, a refuge from troubled family life.

Prof Russell Viner, president of the Royal College of Pediatrics and Child Health, perhaps put it most clearly when he told MPs on the Education Select Committee earlier this month: “When we close schools we close their lives.”

For More Information: https://greenwald.substack.com/p/the-bizarre-refusal-to-apply-cost