By Mario Lozano
and Andrea Gentil (**) The recent court ruling that linked the death of Melin Agustina Sartori with the application of the vaccine Sputnik V generated a strongpublic and media impact . As with any human tragedy, the first thing to do is accompany the family’s painand recognize the right of every affected person to obtain answers, investigation and justice. The loss of a 24-year-old daughter is an immeasurable pain, and the health system has an ethical and legal obligation to thoroughly investigate each serious adverse event and rprotect those who have suffered harm
. Thevaccines like any medical intervention, are not absolutely harmless. No medication is. The pharmacovigilance
It exists precisely because even broadly safe and effective treatments can, in extremely rare cases, produce serious adverse events. Recognizing this does not weaken science: on the contrary, it is part of its honesty and its control mechanisms. Active and passive surveillance systems have identified important safety signals during the pandemic, and demonstrated that medicine is capable of detecting, characterizing and responding to rare risks. However, also It is important to prevent individual cases be used forbuild an overall anti-vaccine narrative so to install political biases against certain vaccine platforms. The health evaluation must be carried out based on broad population evidence and not only on isolated cases. A court case, no matter how well founded it may be in legal terms, does not replace systematic epidemiological evaluation,
which requires comparing incidences in vaccinated versus unvaccinated populations, adjusting for multiple confounding factors.
The accumulated evidence on COVID-19 vaccines During the COVID-19 pandemic billions of doses were administered ofdifferent vaccines around the world . Thanks to it were reduced in a very significant way thehospitalizations the serious conditions and thedeaths . A multinational study that analyzed 99 million vaccinated people in eight countries confirmed that although adverse events of special interest (AESI) signals were identified for different vaccine platforms,the benefit-risk balance is clearly favorable . This research was published in the journal Vaccine
in April 2024. At the same time, international pharmacovigilance systems identifiedrare adverse effects associated with different vaccine technologies . Some adenovirus-based vaccines, such as AstraZeneca (ChAdOx1) or Johnson & Johnson (Ad26.COV2.S), showed associations with rare thrombotic events, particularly cerebral venous thrombosis and thrombocytopenia, a condition known as vaccine-induced thrombosis with thrombocytopenia (VITT) (2–4). While messenger RNA vaccines, such as Pfizer (BNT162b2) or modern
(mRNA-1273), presented other rare events, such as certain myocarditis and pericarditis, especially in young men, as demonstrated by various published studies. The existence of these adverse effects was detected precisely thanks to permanent and transparent scientific surveillance, and led to adjustments in the recommendations for use according to age groups and availability of alternatives.
What do we know specifically about Sputnik V? In that context, Various studies carried out in different countries evaluated the safety profile of Sputnik V
(Gam-COVID-Vac). The most robust studies come from the Republic of San Marino, where a national active surveillance system (ROCCA studies) was implemented that documented the safety of the vaccine in the entire vaccinated population, as detailed in papers published in eClinical Medicine in both 2021 and 2022. These trials reported that most adverse events were mild to moderate,
consistent with the expected profile of vector vaccines, and did not identify a clear population signal of thrombosis (VITT) like those seen with AstraZeneca or Janssen. However, it is important to recognize the limitations of the available evidence. Unlike AstraZeneca and Janssen, for which there are multiple large-scale population-based studies that have accurately characterized the incidence of VITT (2–4,9),for Sputnik V the evidence is more fragmentary
. There are isolated case reports and small series that describe thrombotic events and autoimmune manifestations after vaccination, published in the journals Biomedicine in 2023 and Frontiers of Immunology in 2025. But these studies lack population denominators that allow the real incidence of risk to be accurately estimated.
In Argentina, a study in people with HIV compared several vaccines, reporting the rates of adverse events in AstraZeneca, Sputnik V and Sinopharm, finding a progression of events that decreases between the first and the last mentioned, and without observing massive serious events in that cohort. Finally, analyzes of international pharmacovigilance databases have identified signs of thrombotic events associated with different vaccines, but the representation of Sputnik V in these databases is limited. In summary, The available evidence suggests that Sputnik V has an overall safety profile comparable to that of other vaccines
vectors in terms of common events, but there is no large population study that confirms or rules out a robust association with VITT. Even with more limited evidence to make accurate risk comparisons, it does not appear that the vaccine is more dangerous than others.
The risk of losing proportionality There is a significant danger when public discussion loses proportionality. If each exceptional adverse event is presented without itsepidemiological context very serious indirect damage can be generated:the deterioration of social trust in vaccines in general
. And that is not an abstract question. The decline in vaccine coverage is already favoring the return of preventable diseases such as measles, whooping cough and other infections that were controlled for decades thanks to collective immunization. And this causes many deaths that should not occur because we have the methods to prevent them. Thepublic health risk communication is complex
. It requires simultaneously conveying several issues: that rare adverse events are real and should be investigated and remedied; that these events are infrequent from a statistical point of view, compared to the population benefits of vaccination; and that the absence of zero risk does not invalidate an intervention when the benefit-risk balance is clearly favorable. When a court establishes a causal relationship between a vaccine and a serious adverse event in an individual case, it is exercising a legitimate judicial remedial function. But This judicial decision does not automatically equate to an epidemiological conclusion.
on the population risk of that vaccine. Both perspectives – individual justice and public health – are necessary and complementary, but they operate with different logics and standards of evidence.
A mature and balanced position Public health needs a mature and balanced position. This position simultaneously implies several aspects. One of them is thatIt is essential to investigate and recognize real adverse events, without minimizing or denying them
. Every serious case deserves a thorough, transparent investigation based on the best scientific standards available. Alsoit is necessary to accompany and repair those who have suffered damage
. Compensation systems for vaccine adverse events must be accessible, fair and expeditious. Affected families should not face insurmountable bureaucratic barriers to obtaining reparation. All this must be donewith an eye toward improving vaccine safety and surveillance
. Pharmacovigilance must be robust, continuous and transparent. It is essential that security data be public and accessible to the scientific community and society. The fact ofputting risks into context in an honest and understandable way is unavoidable . Communicating that an adverse event is “rare” does not mean denying it, but simply locating itin its correct epidemiological dimension
. For example, the risk of VITT with AstraZeneca was estimated to be approximately 1 case per 100,000 doses, while the risk of severe thrombosis from COVID-19 in unvaccinated people is several orders of magnitude higher. In this sense, we must avoid the risk ofconverting statistical exceptions into generalized discourses of scientific distrust . The existence of rare adverse events does not invalidate the scientific consensus on the relative effectiveness and safety of COVID-19 vaccines.
All authorized vaccines have been shown to significantly reduce mortality and severe disease. Last but not least, it is necessaryrecognize limitations of evidence when they exist
. In the case of Sputnik V, it is honest to recognize that the evidence on VITT is more limited than for other vector vaccines, not because it has been shown to be safer or more dangerous, but because there is a lack of large-scale population studies that allow precise estimates.The pandemic left many social, political and emotional wounds . It also left important lessons about howcommunicate uncertainty how to manage risks in emergency contexts, and how maintain public trust in science
without falling into uncritical defense or denialism. The case of Melín Agustina Sartori reminds us that behind the statistics there are people, families and specific lives. His death deserves to be rigorously investigated, and his family deserves justice and reparation. At the same time,That individual case cannot be used to discredit a public health intervention that has saved millions of lives around the world.
.
Defending vaccination does not mean denying adverse effects. And acknowledging adverse effects should not become a tool to erode one of the most effective public health interventions in modern history. Both statements can and must be true simultaneously. Public health is built on evidence, transparency, empathy and proportionality. In a context of increasing polarization,maintaining that balanced position is more necessary than ever
.
*Mario Lozano, Molecular virologist, Professor at the National University of Quilmes and researcher at CONICET.
**Andrea Gentil, scientific journalist, Medicine and Science Editor of News Magazine.
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