The lack of transparency and normalizing uncertainty

The lack of transparency and normalizing uncertainty!!

The Philosophy and Medical Ethics Team reply

The World Health Organization (WHO) announced the SARS-CoV-2 infection as a global pandemic and public health emergency. Scientists believe; to manage the COVID-19 pandemic, a protective vaccination is needed against SARS-CoV-2 infection (1). Identifying, quantifying, and weighing known and theoretical safety concerns versus possible benefits is an important component of producing any vaccine (2).

Pfizer and BioNTech stated that their investigational Covid-19 vaccine candidate avoided more than 90% of infections. The businesses aim to request emergency use authorization, which would allow the Food and Drug Administration to legally permit an unapproved medical product during a state of emergency, based on these positive statistics. This strategy, while well-intentioned, is ultimately incorrect. The globe is in the midst of a crisis, not an emergency. An emergency use authorization might possibly allow millions (or tens of millions) of people to get an unapproved and unlicensed vaccine (3).

Although the definite side effects of vaccines are not fully revealed, does it make sense to give emergency licenses to vaccines? How dangerous could it be?

Common side effects of the covid-19 vaccination listed by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) include a sore arm, fever, fatigue, and myalgia. Changes to periods and unexpected vaginal bleeding are not listed, but primary care clinicians and those working in reproductive health are increasingly approached by people who have experienced these events shortly after vaccination (4).

Moreover, despite the fact that a large number of mRNA/DNA vaccine candidates are in the preclinical and human clinical trials, no licensed vaccination for human use has been seen since 1990, when active protein was detected in a mouse model using mRNA injection; this is mostly related to safety concerns. Nevertheless, only a year after the COVID-19 vaccine development programs began, the first mRNA vaccine against SARS-CoV-2 was licensed on January 11, 2021 (5)(6).

The vaccine dilemma can also be considered from the view of potential "conflict of interest" between pharmaceutical companies and the public. Incomplete or incorrect information can influence people's decisions. In this way, social media can be a good tool for large pharmaceutical companies to increase public confidence in vaccines, as well as encourage governments to buy vaccines. Pfizer recommended booster dose injections without FDA approval through its media, But we saw that FDA denied this claim (7). Based on these reasons, it seems that these companies are trying to divert people's attention from the ambiguities and unknown definite side effects of the vaccine by promoting "the normalization of uncertainty" and focus only on results that show the effectiveness and benefits of vaccines. It^'s clear that people don't get sufficient information about the pros and cons of the covid-19 vaccine, and social media companies can completely cause it (8).

In addition to the above, the effectiveness of the vaccine can be evaluated in terms of "causality in medicine"; In other words, with what certainty it could be claimed that the decrease in the incidence and mortality rate due to corona is because of vaccination?

Because many other factors can cause this gradual decrease; Factors such as the development of health systems, better knowledge of the virus, more familiarity with pathogenicity and how the virus functions and is transmitted, etc. In addition, after the start of vaccinations around the world, we saw a temporary reduction in morbidity and mortality, but after a while, the statistics rose again (9). From all this, it can be concluded that it is not possible to say that the vaccine is the only way to stop the pandemic.

Host Factors Impact Vaccine Efficacy

Host genetic variables influence immunity to vaccinations. The humoral immune responses to viral vaccines are influenced by single nucleotide polymorphisms in genes related to human leukocyte antigen (HLA) molecules, cytokines, and cytokine receptors. Due to people's genetic differences around the world, different people's bodies respond differently to drugs, including vaccines. This means that the efficacy, side effects, and effective dose of vaccines may be different for people of different races, and the dose that is effective for one race or region may be toxic to another, or we may see various side effects of the vaccine in different regions.

So, a vaccine's effectiveness and side effects for a race cannot be generalized to another race. As a result, there is no certainty about a race's possible body responses that have not been studied for that vaccine. Because vaccines have been considered one of the main ways to stop the virus since the beginning of the pandemic, there was a great deal of urgency in approving the vaccine. This factor led to this point that limited trials for different vaccines in limited areas of the world were conducted. But in the end, we see that these vaccines are recommended and used for all people worldwide (10). A suggestion which does not seem flawless; Because the vaccine, which is effective for continents such as America and Europe, will not necessarily be effective for people in other parts of the world, such as Asia, with its high racial diversity, and may even have different side effects. As a result, it seems that the rush to grant emergency authorization to vaccines and recommend their universal injection is a factor that has rightly raised ambiguities about vaccines.

By: Elham Ranjbar, Mohammad Mohammadi, Farbod Ghobadinezhad and supervised by Dr. Hamidreza Namazi

References:

1.          Organization WH. Naming the coronavirus disease (COVID-19) and the virus that causes it. 2020. 2020.

2.          Hotez PJ, Corry DB, Bottazzi ME. COVID-19 vaccine design: the Janus face of immune enhancement. Nat Rev Immunol. 2020;20(6):347–8.

3.          Toomey J. Too Important for the Bureaucrats: Rethinking Risk and Regulatory Presumptions in Times of Crisis. Am J Law Med. 2021;47(2–3):249–63.

4.          Male V. Menstrual changes after covid-19 vaccination. British Medical Journal Publishing Group; 2021.

5.          Wolff JA, Malone RW, Williams P, Chong W, Acsadi G, Jani A, et al. Direct gene transfer into mouse muscle in vivo. Science (80- ). 1990;247(4949):1465–8.

6.          Pardi N, Hogan MJ, Porter FW, Weissman D. mRNA vaccines—a new era in vaccinology. Nat Rev Drug Discov. 2018;17(4):261–79.

7.          FDA advisers recommend COVID boosters for 65 and older, reject broad approval.

8.          DeLong G. Conflicts of interest in vaccine safety research. Account Res. 2012;19(2):65–88.

9.          Coronavirus Cases: Worldometer; 2021.

10.        Dhakal S, Klein SL. Host factors impact vaccine efficacy: implications for seasonal and universal influenza vaccine programs. J Virol. 2019;93(21):e00797-19.