The promise and perils of the mandatory vaccination of COVID19

9/16/2021 5:06:44 PM

The promise and perils of the mandatory vaccination of COVID19
This is how the Epidemiology Team responds!

The mandatory vaccination of Covid-19 has various challenges, pros, and cons as any other issue. The Immunology Team presented their thoughts with their scale tilted towards vaccination. Here we tend to present a different and a more balanced view.

If we go through history to approve the effectiveness of vaccines, epidemics such as Smallpox are great examples. Still, the reality is that humans succeeded in eradicating just one infectious disease, aka "Smallpox," not only by vaccination but due to the unique characteristics of Smallpox, like having one host only in humans and some other epidemiological characteristics (1). For other infectious diseases, the achievements have been limited, and we can’t merely relate them to vaccination.

SARS-CoV-2, with its unique characteristics such as high virulence, zoonotic, and the mutations so far, can respond differently to vaccines compared to an infectious disease such as smallpox. (2) , therefore, cannot be fully controlled only by vaccination.

The first two qualifications for any vaccine are safety and efficacy. According to the epidemiological data, the effectiveness of vaccines is losing evidence, since the number of new cases in almost fully vaccinated societies is soaring, for instance in the USA, the UK, and Israel -the countries with the highest rates of vaccination-  witness an increase in the incidence rates after short term decreasing of new cases (graphs 1,2)(3). It is easy to link those partial rate reductions only to vaccination and relate the decline as the natural course of a propagated outbreak. In addition, many communities could control the disease and had few attributable cases and deaths without vaccination.

Another methodological and important point in this regard is that vaccine efficacy is generally reported as a relative risk reduction (RRR), the ratio of attack rates in vaccinated and not vaccinated groups. Relative risk reductions were reported as 95% for the Pfizer–BioNTech, 94% for the Moderna–NIH, 91% for the Gamaleya, 67% for the J&J, and 67% for the AstraZeneca–Oxford vaccines. However, RRR should be seen against the background risk of being infected and becoming ill with COVID-19, which varies between populations and over time. RRR considers only participants who could benefit from the vaccine. The absolute risk reduction (ARR), the difference between attack rates in with and without vaccine groups, considers the whole population and should be reported. ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1.3% for the AstraZeneca–Oxford, 1.2% for the Moderna–NIH, 1.2% for the J&J, 0.93% for the Gamaleya, and 0.84% for the Pfizer–BioNTech vaccines. 

ARR is also used to derive an estimate of vaccine effectiveness, which is the number needed to vaccinate (NNV) to prevent one more case of COVID-19 as 1/ARR.  NNVs bring a different perspective: 81 for the Moderna–NIH, 78 for the AstraZeneca– Oxford, 108 for the Gamaleya, 84 for the J&J, and 119 for the Pfizer–BioNTech vaccines. ARR (and NNV) are sensitive to background risk— the higher the risk, the higher the effectiveness. Both the numerator and denominator change, RRR does not change (66–67%), but the one-third increase in attack rates in the unvaccinated group (from 1.8% to 2.4%) translates into a one-fourth decrease in NNV (from 84 to 64)(4).

In addition, numerous factors, including genetic defects, chronic diseases, and cancers, as well as immunosuppression, interfere with vaccine effectiveness  (5).
All the above-mentioned evidence shows the ambiguity and uncertainty about the vaccines’ effectiveness (6).

Graph 1

Graph 2

The situation on the safety is somehow worse than the efficacy, specifically because it's too early to talk about medium and long term side effects, even for short term side effects there has not been sophisticated investigations performed to make a precise assessment of the causes of mortality and other complications in vaccinated groups so far, mainly due to a huge number of patients that leaves almost no time for active surveillance in health care systems. Also, keep in mind that it is the first time we are using mRNA vaccines in humans, and on such a large scale, the future perspective of this intervention is still too vague to judge. Certain doubts about the long-term immunity of Covid-19 vaccines exist; as seen in unapparent mechanisms of immunogenicity according to multiple infections in many patients, it is difficult to discuss the tradeoff between efficacy and safety of the vaccines. Obviously, being approved for emergency use, they are protected; none of these vaccine companies have to compensate for whatever complications around the world! (7).

At this point, the role of immune response for symptomatic cases and mortalities in the management of this pandemic is imperative; it is evident that most of the cases are asymptomatic, and the cause of mortality and complications are cytokine storms, not the virus. Different mortality rates in different communities despite the same coverage of vaccination, is another evidence that shows the effect of the human genome and immune response on the severity of the case, and it is not just the effect of different mutations (8) So the immunological way for controlling the disease should be immunomodulation, not just vaccination.
Forceful vaccination is also against human rights and the autonomy of individuals about their own bodies and health (9). Considering that, mandatory vaccination can be a kind of disruption of one’s autonomy.

By: Masoomeh Gholami, Shaghayegh Naderi, Ghazaleh Ghaffaripour and supervised by Dr. Alipasha Meysamie

1. Fenner F. Global eradication of smallpox. Reviews of infectious diseases. 1982;4(5):916-30.
2. Sabino EC, Buss LF, Carvalho MP, Prete CA, Crispim MA, Fraiji NA, et al. Resurgence of COVID-19 in Manaus, Brazil, despite high seroprevalence. The Lancet. 2021;397(10273):452-5.
3. Coronavirus Cases: Worldometer; 2021 [Available from:
4. Olliaro P, Torreele E, Vaillant M. COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room. The Lancet Microbe. 2021.
5. Jahanshahlu L, Rezaei N. Monoclonal antibody as a potential anti-COVID-19. Biomedicine & Pharmacotherapy. 2020;129:110337.
6. Celardo I, Pace L, Cifaldi L, Gaudio C, Barnaba V. The immune system view of the coronavirus SARS-CoV-2. Biology Direct. 2020;15(1):1-11.
7. Singh JA, Upshur RE. The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials. The Lancet Infectious Diseases. 2020.
8. Elemento O. The future of precision medicine: Towards a more predictive personalized medicine. Emerging Topics in Life Sciences. 2020;4(2):175-7.
9. Bowen RA. Ethical and organizational considerations for mandatory COVID-19 vaccination of health care workers: a clinical laboratorian's perspective. Clinica Chimica Acta; International Journal of Clinical Chemistry. 2020;510:421.


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