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• Mandating Uncertainty
  Binh T. Ngo, Marc S Rendell
  Published on: 25 March 2023
• Need to consider other benefits of COVID-19 vaccine boosters in university students
  Judy Platt, Davidson H. Hamer, Marie E. Caggiano, Giang T. Nguyen and Cecilia Stuopis
  Published on: 19 December 2022
• The proportionality principle is the wrong ethical standard for vaccine mandates
  Michael Kowalik
  Published on: 6 December 2022

• Published on: 25 March 2023

  Mandating Uncertainty

  • Binh T. Ngo, Associate Professor Kec USC School of Medicine
  • Other Contributors:
    • Marc S Rendell, Medical Director

  "The will of the people shall be the basis of the authority of government".Article 21 of the United Nations' 1948 Universal Declaration of Human Rights
  The most recent feature article by Bardosh et al opposes policies requiring vaccination with SARS Cov-2 mRNA vaccines in order to matriculate at universities in the United States (1). While the exposition put forward is thorough and cogent, the article raises a much larger question dealing with forced vaccination to prevent illness in our population. Vaccination has been enormously successful in dealing with a host of human diseases (2-4). One cannot overstate the huge benefits to humanity accruing from prevention of viral diseases including smallpox, rabies, yellow fever, measles, mumps, rubella, varicella and, of course, paralytic polio. Recently developed vaccines protect against hepatitis A and B. Human papilloma virus vaccine may succeed in reducing the cancer burden in women and also in men. Typhoid, tetanus, diphtheria, pertussis, hemophilus, meningococcus, and pneumococcus vaccines have been highly successful in dealing with these bacterial pathogens (5).
  All states require children to be vaccinated against certain communicable diseases as a condition for school attendance
  That is understandable since school brings together a large number of individuals in very close proximity. Certainly colleges with the inevitable crowded living conditions in dormitories promote a 24 hour expo...

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  "The will of the people shall be the basis of the authority of government".Article 21 of the United Nations' 1948 Universal Declaration of Human Rights
  The most recent feature article by Bardosh et al opposes policies requiring vaccination with SARS Cov-2 mRNA vaccines in order to matriculate at universities in the United States (1). While the exposition put forward is thorough and cogent, the article raises a much larger question dealing with forced vaccination to prevent illness in our population. Vaccination has been enormously successful in dealing with a host of human diseases (2-4). One cannot overstate the huge benefits to humanity accruing from prevention of viral diseases including smallpox, rabies, yellow fever, measles, mumps, rubella, varicella and, of course, paralytic polio. Recently developed vaccines protect against hepatitis A and B. Human papilloma virus vaccine may succeed in reducing the cancer burden in women and also in men. Typhoid, tetanus, diphtheria, pertussis, hemophilus, meningococcus, and pneumococcus vaccines have been highly successful in dealing with these bacterial pathogens (5).
  All states require children to be vaccinated against certain communicable diseases as a condition for school attendance
  That is understandable since school brings together a large number of individuals in very close proximity. Certainly colleges with the inevitable crowded living conditions in dormitories promote a 24 hour exposure to whatever pathogens may achieve dominance in the community. The proponents of SARS-Cov-2 mRNA vaccine administration have placed the bivalent vaccine on the recommended list of childhood vaccinations, encouraging that this vaccine administration be required for children to be allowed to attend school. Such mandates are effective in compelling vaccination. The example of hepatitis A vaccination is noteworthy since it is not mandated in a significant number of states. In those states which have the longest history of compulsory hepatitis A vaccination for school attendance, the percentage of children so vaccinated is modestly higher than in those states which do not so require (6).
  Bardosh et al have provided an extensive risk benefit analysis to claim that the mandatory administration of the SARS-Cov-2 mRNA vaccine is likely to produce more harm than benefit. Although we do not dispute their analysis, we would argue that the actual ethical issue is whether the general public, consisting of the governed population of the United States, has accepted the advisability of mRNA SARS-Cov-2 immunization in the face of uncertainty and confusion. At the present time as of the end of 2022, even among the highly vulnerable senior population, ages 65 and over, only about 36% have taken the bivalent booster (7). The willingness to accept the bivalent vaccine is far less than that among parents desiring to protect their school children. Furthermore, the FDA Vaccines Division, responsible for the approval of the mRNA vaccine, recently issued a remarkably candid appraisal, authored by Marks et al, acknowledging frustration at the rapidity with which mutations of SARS-Cov-2 result in rapidly waning benefit of mRNA vaccines (8). Just 6 months before, In June, 2022 there was a strong emphasis from that same FDA Vaccines Division on accelerating the preparation of mRNA vaccines against the BA4 and BA5 variants which were projected to have dominance in the fall (9). Pfizer and Moderna produced these mRNA products only to face the current reality that as of late October the BQ1 and BQ1.1 variants had replaced BA5 as the dominant variants with rapidly waning vaccine induced immunity and protection against symptomatic disease (10,11). A recent analysis of antibody classes elicited by repeated SARS-Cov-2 mRNA vaccination showed increasing levels of IgG4 tolerogenic antibodies, perhaps furnishing a partial explanation of waning immunity (12). Furthermore, animal models of repeated SARS-Cov-2 vaccination have recently been shown to induce humoral and cellular immune tolerance in animal models (13). Marks et al now state “Continuing along the current path of the generation and administration of variant-specific vaccine boosters is inadequate as a long-term strategy for addressing COVID-19 in populations globally” (8). This major shift at the FDA certainly does not convey confidence in a plan to mandate repeated vaccination and revaccination of the young population. If we consider the list of those vaccines previously mandated for school attendance, we realize that all have had extensive testing and years of experience. If these vaccines are mandated, it is only because the test of time has led to acquiescence by the population. Furthermore, exemptions are granted to parents who are opposed to vaccinating their children. Although exemptions could result in decreased herd immunity, that is not the case because few parents choose exemption from those vaccines which have achieved the confidence of our population. The most successful Covid vaccination campaign is in the small island nation of Cuba where three separate non-mRNA recombinant protein subunit vaccines administered at all ages from 2 years and over have yielded the most favorable results in the world in terms of Omicron infection and the lowest infection related mortality. These non mRNA vaccines have impressed their population to the extent that well over 90% have demonstrated confidence in the Cuban public health program and voluntarily chosen vaccination without mandates (14). A high level report by an international group has been issued recommending engagement and consideration of the use of the Cuban Covid vaccines worldwide (15).
  In a comprehensive review of the challenges to development of effective vaccines against SARS-Cov-2 and other mucosally replicating respiratory viruses, Morens et al concluded “Durably protective vaccines against non-systemic mucosal respiratory viruses with high mortality rates have thus far eluded vaccine development efforts” (16). Marks et al now state “Simply updating the existing vaccine constructs with new variant sequences or even making trivalent or quadrivalent vaccines covering several variants is not likely to provide the depth and breadth of protection needed to interrupt viral transmission during a prolonged period” (8). They point out “However, the situation is far from hopeless because there are other approaches to future COVID-19 vaccine development currently under investigation”. We emphatically agree. In the face of uncertainty and confusion, as we attempt to protect segments of our population, we must not lose sight of the need for individuals to have the freedom to make their own educated choices. The best approach to vaccination is clearly that of education by government and the physician community so that there will be collective agreement as to benefit and absence of harm. Individuals should enjoy the dignity of choice. That policy is the venerable ideal of “consent by the governed” (17).

  REFERENCES
  1) Bardosh K, Krug A, Jamrozik E, et al. COVID-19 vaccine boosters for young adults: a risk benefit assessment and ethical analysis of mandate policies at universities. Journal of Medical Ethics Published Online First: 05 December 2022.
  2) Greenwood B. The contribution of vaccination to global health: past, present and future. Philos Trans R Soc Lond B Biol Sci. 2014 May 12;369(1645):20130433.
  3) Andre FE, Booy R, Bock HL, et al. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008 Feb;86(2):140-6.
  4) Orenstein WA, Ahmed R. Simply put: Vaccination saves lives. Proc Natl Acad Sci U S A. 2017 Apr 18;114(16):4031-4033
  5) Amanna IJ, Slifka MK. Successful Vaccines. Curr Top Microbiol Immunol. 2020;428:1-30
  6) Nelson NP, Yankey D, Singleton JA, Elam-Evans LD. Hepatitis A vaccination coverage among adolescents (13-17 years) in the United States, 2008-2016. Vaccine. 2018 Mar 14;36(12):1650-1659
  7) Baumgaertner E. As Covid Deaths Climb, Even Seniors Skip the Latest Booster https://www.nytimes.com/2022/12/21/health/covid-bivalent-booster-elderly...
  8) Marks PW, Gruppuso PA, Adashi EY. Urgent need for next-generation COVID-19 Vaccines. JAMA. Published online December 09, 2022.
  9) Marks P, Woodcock J, Califf R. COVID-19 Vaccination—Becoming part of the new normal. JAMA. 2022;327(19):1863–1864.
  10) Rubin R. COVID-19 Boosters this fall to include omicron antigen, but questions remain about its value. JAMA. 2022;328(5):412–414
  11) Rodriguez A, Weintraub K. BQ.1 and BQ.1.1 are now the dominant COVID variants. Here's what this means. https://www.usatoday.com/story/news/health/2022/11/20/new-covid-omicron-...
  12) Irrgang P, Gerling J, Kocher K, et al. Class switch towards non-inflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. Sci Immunol. 2022 Dec 22:eade2798.
  13) Gao FX, Wu RX, Shen MY, et al . Extended SARS-CoV-2 RBD booster vaccination induces humoral and cellular immune tolerance in mice. iScience. 2022 Dec 22;25(12):105479
  14) Gorry C. Vaccines and Public Trust: Containing COVID-19 in Cuba. MEDICC Rev. 2022;24(1):9-13
  15) Osterholm MT, Rabadán-Diehl C, et al. FULL TECHNICAL REPORT Insights from Cuba's COVID-19 vaccine enterprise: Report from a high level fact-finding delegation to Cuba. MEDICC Rev. 2022 Oct 31;24(3-4):72-108
  16) Morens DM, Taubenberger JK, Fauci AS. Rethinking next-generation vaccines for coronaviruses, influenzaviruses, and other respiratory viruses. Cell Host Microbe. 2023 Jan 11;31(1):146-157.
  17) Cassinelli, CW. (1959). "The 'Consent' of the Governed". Political Research Quarterly. 1959 12 (2): 391–409

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  Conflict of Interest:
  None declared.

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• Published on: 19 December 2022

  Need to consider other benefits of COVID-19 vaccine boosters in university students

  • Judy Platt, Chief Health Officer and Executive Director, Student Health Services Boston University
  • Other Contributors:
    • Davidson H. Hamer, Infectious disease specialist, consultant to Student Health Services
    • Marie E. Caggiano, Medical Director, Tufts University Health Service
    • Giang T. Nguyen, Executive Director, Harvard University Health Services
    • Cecilia Stuopis, Medical Director, MIT Medical

  We read with interest this risk-benefit and ethical analysis of the utility of SARS-CoV-2 vaccine boosters in university students. We have some major concerns about the choice of hospitalization as the primary measure of benefit. From the onset of the pandemic, healthcare providers, scientists, and public health experts in higher education have been learning from shared experiences, research, and evolving medical knowledge about the best way to safely populate college campuses with students, faculty, and staff. Hospitalizations averted is not the only marker of morbidity that is relevant to the college student population and given the rarity of severe disease requiring hospitalization in young, generally very healthy adults, hospitalization is not a good choice for a marker of COVID-19 related morbidity. We have also strived to minimize the risk of missed classes, severe illness, and need for prolonged medical leaves of absence given the potential adverse academic consequences of illness for students. Colleges and universities have been trying to balance infectious disease mitigation efforts with the need for in-person learning, social interactions, and the increased mental health challenges caused by some of these efforts that furthered the experience of isolation.

  Much has changed since early 2020 and most schools have continued to evolve their protocols and policies to reflect new information and relevant data. We are dedicated to learning and contributing to th...

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  We read with interest this risk-benefit and ethical analysis of the utility of SARS-CoV-2 vaccine boosters in university students. We have some major concerns about the choice of hospitalization as the primary measure of benefit. From the onset of the pandemic, healthcare providers, scientists, and public health experts in higher education have been learning from shared experiences, research, and evolving medical knowledge about the best way to safely populate college campuses with students, faculty, and staff. Hospitalizations averted is not the only marker of morbidity that is relevant to the college student population and given the rarity of severe disease requiring hospitalization in young, generally very healthy adults, hospitalization is not a good choice for a marker of COVID-19 related morbidity. We have also strived to minimize the risk of missed classes, severe illness, and need for prolonged medical leaves of absence given the potential adverse academic consequences of illness for students. Colleges and universities have been trying to balance infectious disease mitigation efforts with the need for in-person learning, social interactions, and the increased mental health challenges caused by some of these efforts that furthered the experience of isolation.

  Much has changed since early 2020 and most schools have continued to evolve their protocols and policies to reflect new information and relevant data. We are dedicated to learning and contributing to the continually growing literature related to COVID-19. We pay particular attention to the impact vaccination has on associated issues such as long COVID, worsening mental health, anosmia, postural orthostatic tachycardia syndrome, and other neurological sequela of infection for which data are still being gathered. We are also cautious about changing policy in reaction to a single study, although we are actively reviewing new information. As the authors allude to in their discussion of limitations, it was not possible to comprehensively address the impacts of the COVID-19 on mental health, time lost from academics, and other activities that are uniquely relevant to a college population.

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  Conflict of Interest:
  None declared.

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• Published on: 6 December 2022

  The proportionality principle is the wrong ethical standard for vaccine mandates

  • Michael Kowalik, Philosopher/Ethicist Not affiliated

  The article does not engage with the objections (published in this journal and also in response to the previous article by the same lead author) to the applicability of the ‘proportionality principle’ to ethical judgment when the considered intervention violates the right to life and discriminates on the basis of healthy, innate biological characteristics of the human race. In particular, the proportionality principle is irrelevant to coercive policies (mandates) if the associated procedure is known to kill a small percentage of people and therefore amounts to a mandated killing of a minority for the benefit of the majority. The right to life cannot be taken away in the interests of others, even if the majority would greatly benefit from the killing, without negating the very concept of human rights: if being born human is not a guarantee of the right to life, then there is no right to life. On this view, vaccination mandates can no longer be considered healthcare but democide.

  http://dx.doi.org/10.1136/medethics-2020-107026

  https://gh.bmj.com/content/7/5/e008684.responses#fundamental-values-cann...

  Conflict of Interest:
  None declared.

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