Report says that no children died because of Covid-19 vaccines in Brazil. It is true?

O secretário municipal de Saúde do Rio, Daniel Soranz aplica a primeira dose da vacina contra Covid-19 em crianças, no Rio de Janeiro

The Municipal Secretary of Health of Rio, Daniel Soranz applies the first dose of the vaccine against Covid-
in children, in Rio de Janeiro| Photo: Tomaz Silva/Agência Brasil

The Ministry of Health published a report on the day

of April indicating that there were no deaths of children related to the application of vaccines against Covid-19 at the Brazil. The report, called epidemiological bulletin, deals with the state of the pandemic in Brazil and the world, and also brings an investigation of adverse events of vaccination against the disease. Four vaccines were applied in Brazil, and in children, among which the document reports zero deaths, inoculation was performed with the Pfizer mRNA vaccine and the attenuated virus vaccine Coronavac.

Worldwide, six million two hundred thousand deaths from Covid- are recorded, but two independent analyzes converge to the mark of 12 millions of deaths considering the excess mortality of the pandemic and the sanitary measures to contain it. In Brazil, there were more than 23 million cases and 660 a thousand officially registered deaths.

The ministerial report reports adverse events by dose rather than by person, with a total of 45 thousand adverse events in more than 169 millions of doses administered. Of these adverse events, 12 one thousand were classified as serious (with hospitalization and/or risk of death), and others 3806 were deaths. Among young people under 05, the Ministry of Health reports 1,45 serious adverse event per million doses, and 1,26 death per million doses.

It is important to consider the difference between

adverse event and

side effect

of vaccines. While the first term refers to any negative event concomitant or subsequent to inoculation, the second term has established a plausible causal relationship with the dose, hence the term “effect” rather than “event”. An adverse event is an initial indication that may be spurious, and, once confirmed, it is called a side effect. In the case of the Pfizer vaccine, studies such as the one by the American health plan Kaiser Permanente have established sufficient evidence that inflammation of the heart and its lining is a side effect that occurs mainly in young men at a rate of up to 14 every 100 thousand inoculated.

Analysis of serious events and deaths

In the general population, serious adverse events and deaths are classified by the Ministry as coincidental or inconsistent in terms of a proportion of 26% and 36%, respectively. That is, most deaths reported as adverse events from vaccination would not be the result of vaccination. The report accepts a causal relationship with the vaccine, in accordance with the literature, in 5.5% of the 12 a thousand serious events and 0.3% of the almost 4 thousand deaths. Are 12 deaths, all due to thrombosis with thrombocytopenia (blood clotting problem), involving the AstraZeneca and Janssen vaccines, which share the same manufacturing method (viral vector).

The number rounded up to 4,000 deaths is exactly the same reported by the Minister of Health Marcelo Queiroga. Applying two different sources in the scientific literature, the

Gazeta do Povo

showed that this number may not be far from reality.

Among minors, were observed 45 deaths, 20 of which occurred after inoculation with a dose of Pfizer vaccine. The other two were after the application of Coronavac. Of these deaths, 19 were classified as coincidental and inconsistent, thus having a causal relationship ruled out. Two deaths were excluded due to conflicting data. One of them was cardiac inflammation (myocarditis). The authors explain that they ruled out a causal relationship between this death and the vaccine because of the period: myorcarditis appeared more than 12 days after vaccination. For these reasons, the bulletin concludes that there is no adverse event with a fatal outcome among children and adolescents whose cause was a vaccine for covid in the country.

This causality analysis methodology is objectionable. Although in fact the literature indicates an onset of myocarditis less than a week after inoculation, this does not mean that a later onset is impossible. Discarding deaths for this reason may be premature. The bulletin’s attitude recalls the apparent haste of the São Paulo State Health Department, which carried out a lightning investigation of a case of post-vaccination cardiac arrest in a girl from Lençóis Paulista. Sought at the time by 10163559Gazeta do Povo , the secretariat gave evasive answers to specific questions based on the cardiologist’s opinion.

In addition, the scientific literature on Covid-19 and vaccines for the disease is in the process of expanding, it’s all new and quite controversial in detail. Dependent on this literature to speculate on causal mechanisms without direct patient-to-patient examination, the Ministry of Health can replicate blind spots that still exist in it. As a recent detailed study that established a causal relationship between a virus and multiple sclerosis shows, doing causality analysis is more complicated than analyzing population epidemiological data.

Anecdotes can become truths

Science does not have the same speed as direct observation. Reports that something may have happened with a certain causal relationship are called “anecdotal evidence”. The belief of observers can be confirmed or disconfirmed, and this will almost always take time when dealing with phenomena with multiple causes that oblige scientists to take into account the cases taken together. The clinical eye observation of medical professionals can help to increase the rigor of “anecdotal evidence”.

In the case of a specific patient with a post-vaccination adverse event where there is a true causal relationship with the vaccine due to a rare problem, healthcare professionals are likely to observe a causal relationship and correctly believe it very before any confirmation by the survey. This was the case with the clotting problems seen with the AstraZeneca and Janssen vaccines, which started out as “anecdotal evidence” and then even had a confirmed mechanism of action. Among the deaths listed as adverse events after vaccination with the Pfizer vaccine in the epidemiological bulletin, one of the most common reports pending scientific confirmation is “sudden death”. It matches the most common allegations on social media, many of which are censored.

Therefore, although mistakes are made with the direct observation of individual cases, there are also successes, and it is reckless for social networks to engage in the suppression of these reports with the excuse that they are a deterrent to vaccination for other people who could benefit from it . Inaccurate information must be corrected with more accurate information, not with new arbitrary and politically biased limits on freedom of expression.

In a study published in the Lancet in March, funded by the Israeli Ministry of Health and Pfizer, physician Eric Haas and his collaborators calculated that without the country’s national vaccination campaign with mRNA triple the number of people would have been hospitalized and killed by covid in Israel. Although this vaccine is not very efficient in preventing contagion and transmission, it is efficient in preventing deaths. However, in a major investigation of the state of New York, it showed in children the effectiveness of only 05% in the case of the ômicron variant. It is below the minimum effectiveness threshold required by Anvisa. It is still under debate whether vaccination against Covid-14 of healthy children without comorbidities is even necessary, especially considering how many of them have already acquired natural immunity.

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