The precautionary principle in the COVID-19 vaccination campaign: The complicated relationship between the scientific community, medicines regulatory agencies and citizens

Abstract

Dear Editor, COronaVIrus Disease 19 (COVID-19) pandemia and vaccination campaign showed a frail relationship between the scientific community, medical authorities, and citizens. This clearly emerged when unexpected thrombotic adverse effects have been described after the Vaxzevria vaccine administration and the European medicines regulatory agencies were forced to make a choice. As a matter of fact, some cases of unusual site venous thrombosis with thrombocytopenia occurred (mainly) in young women that received the Vaxzevria vaccine during the first half of March 2021. Suspicion on the possible causal role of vaccine immediately and concomitantly spread in the scientific community and in public opinion, supported by media concerns. As a first step, many European medicines regulatory agencies decided to stop the administration of some batches of Vaxzevria used in patients who developed the new critical syndrome. Three to four days later, the same authorities opted for a total suspension of the use of the Vaxzevria vaccine as a precautionary and temporary measure, awaiting for Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency data collection and evaluation. The administration of Vaxzevria vaccine restarted in three days, since PRAC concluded for the preponderance of vaccine benefits without a significant increased risk of overall thrombotic events, while admitting a possible correlation among (mainly) unusual site thrombosis and thrombocytopenia. Only in the following weeks several researchers better characterized this rare new vaccine-related syndrome. In particular, Greinacher and colleagues proposed to name it Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), finding many similarities with the already known Heparin-Induced Thrombocytopenia (HIT) [1]. Scientific community agreed on the definition of the syndrome, which develops from 5 to 30 days after vaccination with adenoviral vector-based vaccines and presents thrombosis mainly - but not only - in unusual sites, together with thrombocytopenia, with platelet count < 150.000/mm3. Its approximate incidence has been estimated at 1:100.000 to 1:250.000 vaccine recipients [2]. The Precautionary Principle has been critically applied by the medicines regulatory agencies. Historically, the Precautionary Principle has been defined with increasing levels of strength and progressive extension of application. In 1992 the United Nations Conference on Environment and Development produced the first international definition of the Principle, stating that “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. When there are threats of serious and irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”. Six years later, during the Wingspread Conference on the Precautionary Principle, an academic definition for the Principle was provided: it clarified that “when an activity raises threats of harms to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically” [3]. The case of the interruption and restart of the vaccination campaign is fully reflected in these definitions: the thrombotic adverse effects of the vaccine were unknown, their possible causal association with vaccination was uncertain, but they constituted nevertheless a “serious and irreversible damage” for people's health. Actually, it is impossible to deny that the consequences of the vaccine administration interruption constituted a risk with the same high priority. On the one hand, the serious risk of producing severe adverse events through drug administration may undermine the ethical Non-maleficence Principle and cause serious harm to citizens’ health. On the other hand, the rapid spread of COVID-19 pandemia needed to be urgently stopped as SARS-CoV2 had already killed millions of people around the world: vaccine was one of the most potential effective available solution in combination with testing and tracing, and the Vaxzevria vaccine constituted a large part of the available vaccines in Europe. In this case, the ethical Beneficence Principle was also applied: deciding for the vaccine suspension could cause a strong slowdown in the vaccination campaign, creating the possibility of a consistent harm to people's health [4]. At the same time, the sudden alternation of opposite decisions by medicines regulatory agencies completely disoriented citizens, to whom concerns about vaccine safety were added to the fear for the pandemic situation. Trust in authorities wavered, many people began to claim the right of receiving a different vaccine (i.e. messenger RNA base vaccines), and tension grew against health workers at vaccination centers. As a matter of fact, loss of confidence in authority has been underlined in the literature as a trouble spot in the efficacy of a decision-making process, to the point that some authors advocated collaboration with neutral third parties. For instance, experts or senior academics may help to present Institutions’ decisions to the public, and the guidance drawn up by academics and media may help journalists to be informed and to be effective part of the communication process [5]. Authorities’ possibility of accomplishing a decision-making process is strictly dependent on their role of responsibility in the society. The term “responsibility” refers to the attitude of taking charge of persons and situations: the Latin root re-spondeo encloses the idea of assurance and total dedication, while res-ponderare underlines the inclination to wisely assess situations, applying general ethical rules to concrete contexts. Thus, responsibility is based on the structural relational nature of persons and on their reciprocal dependence. In this perspective, responsibility expresses its essence of reciprocity: citizen is not a mere object of attention but become a full-dignity interlocutor [6,7]. Given this background, it seems clear how the problematic relationship between the scientific community, public authorities and citizens that emerged during the vaccination campaign has several undesirable consequences, from undermining the possibility of achieving satisfying final results to, most relevant, the betrayal of the very substantial nature of the role of authority. In this perspective, the effectiveness of institutional communication should not be evaluated only for the results it produces, such as the willingness of people to receive COVID-19 vaccine, but by considering its orientation towards relationality above all. Relationality and reciprocity should become key words in interpreting institutional decisions, as lenses through which observing authorities’ actual response to their innate call: taking responsibility for someone that never is a shapeless crowd, but always does have a face. Funding None. Declaration of Competing Interest None.