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Adverse vaccine reactions: lack of data and debate fuels concern among parents

The vaccination of children and young people with vaccines for Covid-19, especially the Pfizer vaccine ( Comirnaty), based on new mRNA technology, remains a source of contention. The main reason has to do with the fact that it is applied to millions of people with emergency authorization, for a long time, and not a full approval. This fact fuels mistrust and, to make matters worse, the disregard of authorities with whom it presents legitimate inquiries only increases the confusion between notoriously false cases that circulate on social networks and others, more consistent, in which there are indications that there may actually be some causal relationship. between death and inoculation of the vaccine.

Pfizer’s vaccine won this approval in September 2021, while another of the same technology, Spikevax , by Moderna, was only authorized, now, in 31 January, in the United States. Alarmed by reports of adverse effects of inoculation, many parents have resisted the idea of ​​vaccinating their children, and some are looking for the Coronavac alternative, as it is based on traditional immunization technology.

One of the cases of death after application of the Covid vaccine was that of Bruno Graf, aged 28 years old, immunized with a dose of AstraZeneca. There are alleged cases of children, such as that of Kauã Bandeira e Silva, 12 years old, from Mossoró, who would have died eight days after inoculation. Despite these reports, the National Health Surveillance Agency (Anvisa) has declared to the press that there are no confirmed cases of infant deaths as a result of the vaccine.

Indignation

Tired of what they consider governments’ slowness or failure to deal with reports of adverse events, some citizens took their own initiative to gather, expose and investigate these occurrences. This is the case of the website No More Silence (“Chega de Silêncio”). In it, the organizers state: “we are not anti-vaccine or conspiracy theorists (…), we are pro-informed choice, pro-consent, pro-science and emphatically anti-coercion”. The website lists 17 cases of Brazilians allegedly victims of adverse effects from these vaccines, including deaths such as the one in Kauã. There is no way to prove if they are all true.

Lists of adverse cases circulate even on Facebook, which maintains partnerships with verification agencies to restrict this type of information. With a little rigor in analyzing the reports, it is possible to quickly notice that, in fact, there are false cases exposed, many of them notoriously motivated by anti-vaccine activism. There are also those who confuse care with evidence and prudence in claims of causal relationship – common in medicine and science – with insensitivity or neglect.

The case of Lençóis Paulista

On the last day 19, a ten-year-old child from the city of Lençóis Paulista (SP) was hospitalized in Botucatu with a cardiac condition that developed after vaccination for Covid-19. The girl passed out 12 hours after inoculation with the pediatric version of the Pfizer vaccine and went into cardiac arrest. Desperate, the father came to believe that he had lost his daughter. Fortunately, doctors were successful in resuscitating her.

In response to the case, the city suspended vaccination of children aged five to 83 years for a week, to observe the 29 children who had been inoculated with this vaccine in the place. Ministers Marcelo Queiroga, of Health, and Damares Alves, of Human Rights, visited the family.

The report by Gazeta do Povo

spoke to the girl’s mother, who asked not to have her name released. On the day 24 of January, his daughter underwent surgery to correct a sequel left by the stop. “She never showed anything unusual, she always did dance, swimming, wrestling at school. She was active,” says the mother, giving a list of three asthma medications her daughter has already taken. Regarding her daughter having a congenital heart problem, she says that there is no consensus among the doctors involved: “some say yes, others say no. I do not understand. They don’t want to say anything.”

The doctors’ doubts reported by the mother contradict the conclusion of a lightning investigation carried out by ten specialists coordinated by the Epidemiological Surveillance Center of the São Paulo State Health Department. The experts claimed that the girl already had a “rare congenital disease” and that “there is no causal relationship between vaccination and the clinical picture presented”. The committee saw the need to reaffirm the safety and efficacy of immunizers approved by Anvisa.

For cardiologist and electrophysiologist Ellen Guimarães, the conclusion of the investigative group that dealt with the case of Lençois Paulista was hasty: “ you can’t hit the hammer in 24 hours and say that the event has no other ‘influence’”, he says.

According to the doctor, there are congenital syndromes, such as Wolff-Parkinson-White (WPW), in which the risk of cardiac arrest and sudden death exists, although it is very small, up to 0.3%. Therefore, in cases like this, the probabilities indicate that an external interference, such as the vaccine, could act as a trigger for cardiac arrest.

The cardiologist exemplifies that in the autopsy of victims of sudden death with WPW , half of them have myocarditis as a possible trigger of cardiac arrest. Therefore, she believes that vaccinal myocarditis cannot be ruled out and only a rigorous investigation – not a “lightning bolt” – could clarify what happened.

The São Paulo State Health Department was contacted. to comment on the inconsistencies between the mother’s report and the investigative team’s statements. The report also presented the cardiologist’s inquiries, but the secretariat chose not to answer specific questions and only repeated what was said to the press earlier, reaffirming the inexistence of a causal relationship between the vaccine and cardiac arrest.

Accuracy in statistics

Due to cases of inflammation of the heart and its lining associated with the mRNA vaccine, critics of childhood immunization have concluded that the Pfizer vaccine may have been this external interference in cases such as Lençóis Paulista.

The most reliable estimates indicate that the overall risk of inflammation in the heart and its lining after taking the vaccine is two people in 100 thousand, but increases to ten in 100 thousand in young people between 16 and 29 years, reaching the highest expression among male adolescents: 14 in 100 thousand. This inflammation usually goes away in less than a week. However, it is acute soon after inoculation, manifesting itself in a few days or, in some cases, hours. Therefore, there are elements that coincide with the case of the girl from Lençóis Paulista, but there are also less consistent elements, such as her gender. COVID itself 17, suggest different studies, causes more myocarditis than vaccination.

The Comirnaty package insert, available on the Pfizer website, has the age limit of five years in the recommendations, indicating a diluted pediatric dose. The document mentions the cases of pericarditis and myocarditis, acknowledging that young men are the most affected, but states that they are “very rare” and “mild” events. Furthermore, it recognizes that the duration of protection conferred by the vaccine is unknown and that, “as with any vaccine, it is possible that (…) it does not protect all individuals”.

In Bulletin Epidemiological report published in November, the Ministry of Health reports that the number of adverse vaccine events reported curiously dropped in the first twelve weeks of vaccination (p. 82) . For every 100,000 doses administered, the reported death rate is 1.5 for AstraZeneca, 3.7 for Coronavac, 0.3 for Pfizer, and 0.5 for Janssen (p. 83). The champion of total adverse events is AstraZeneca, with 92 cases in 100 thousand doses, and, according to these data the safest would be Pfizer, with 24 for 100 a thousand doses .

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