Cardiologist Teresa Gomes Mota has taken to print to ask why ““parents are being coerced into submitting their children to an experimental vaccine precisely when a new variant has entered Portugal about which little is known”.
Observador, the online news website carrying her article, has sent the text out to all its subscribers ahead of next month’s vaccination drive to ensure the youngest school-age children receive current mRNA vaccines against Covid-19.
This is the kind of expert opinion on decisions made by the Vaccine Technical Commission that the media, up till now, almost never gives centre-stage.
As such it is a rare Christmas gift, which shouldn’t be watered down, or ‘put into other words’.
Following on from warnings by columnists like Henrique Raposo (Expresso click here) this new dose of plain-speak somehow carries even more ‘weight’, as it has been written by a medical specialist who will have taken the Hippocratic oath: “First do no harm”.
Here it is:
“On the day in which the Portuguese mainland started vaccinating its children from the ages of 5 – 11 for a disease which rarely affects them and does not kill them, health authorities publicly recognised that a new variant of SARS-CoV-2 with apparent South African origin, of which little is known, is about to become the most prevalent in the population.
“As such, all the debatable scenarios and simulations made by the Vaccine Technical Commission for Covid-19 (CTVC) to effect a risk/ benefit analysis of vaccination in this age group fell to the ground, because the basis of models, like the effectiveness of vaccines, incidence and pathogenicity (cases of the disease and hospital admissions) passed to the Omicron variant. Indeed, the European Centre for the Control of Diseases (ECDC) warned on December 1, 2021: “The emergence of new variants of concern will introduce new uncertainties, for which it will be necessary to re-evaluate the potential impact of vaccinating children.”
“For a start, many unknowns are added to the balance of risks. According to data from the manufacturer, adverse effects from vaccination in the short-term, albeit very frequent, are mild. But even though they may be rare, serious adverse effects like anaphylactic shock, myocarditis and syncope (medical term for fainting), which are potentially fatal, can occur.
“Nothing is known about the medium- and long-term risks of this vaccination with drugs that trick children’s bodies into making genetically-modified viral proteins (modified nucleoside mRNA vaccine).
“Contrary to what has been repeatedly reported by national authorities and widely disseminated by the media, vaccines for Covid-19 are not approved in Portugal. They simply have conditional use authorisation, ratified by the European Commission following a recommendation by EMA – the European Medicines Agency, given the situation of emergency caused by the pandemic.
“If there was no emergency, these medications would have to conclude pre-clinical and clinical trials and prove their safety and efficacy – which up till now has not happened before their introduction into the market.
“But in Portugal certainly, Covid-19 is not configured as a situation of emergency for children. Covid-19 is an illness that barely affects them; serious cases are rare and mortality practically non-existent (five deaths since the start of the pandemic, the majority involving comorbidities).
“So what can INFARMED (the medications authority in Portugal) do in situations when conditional authorisation is conceded by a centralised procedure of the European Union for a drug that does not fit the specifics of its country? It can simply not authorise. In this case, it can simply not authorise vaccines against Covid-19 for pediatric age groups. Conditional authorisation means there is not sufficient data on efficacy and safety, and beyond other conditions, there has to exist a situation of emergency in order to allow its use. But for the children of Portugal, with regard to Covid-19, there is no situation of emergency.
“If Infarmed had used its authority, and complied with the Law, protecting the children of Portugal, it could have avoided this sad circus that has been left to political decisions which are not in the higher interest of children. It could have conditioned the technical decisions taken by the general health directorate (DGS).
“Let’s go back to July 21, 2021 when the prime minister opened the State of the Nation debate announcing that the first priority of the government would be vaccinating children from the ages of 12-15. This was a declaration made before there was an opinion from the DGS. We should also remember that various scientific groups and the Vaccine Technical Commission itself (CTVC) gave an opinion against vaccinating healthy 12-15 year olds. On the same day (of this opinion) the composition of this commission was altered. And on August 10, director general of health Graça Freitas justified the change in the recommendation for the universal vaccination of adolescents from 12 -15 on the basis of two documents, one of which remains secret. Vaccinations began on August 16.
“Now, with the vaccination of 5-11 year olds, we have a sense of déjà vu: on November 25 the prime minister announced the purchase of 762,000 pediatric vaccines, before any recommendation from the DGS. The CTVC, an advisory body of the DGS, this time did not choose to request opinions from scientific entities that had previously given negative opinions on the vaccination of teenagers. Instead it invited them to introduce (other) specialists in pediatrics and child health to integrate the group. In this group of 12 experts, five occupied positions within the DGS itself. Yet in spite of all this, the group did not recommend the vaccination of healthy children because “it could be prudent to wait for more scientific evidence before taking a final decision over the universal vaccination of this age group”.
“Nonetheless, on December 7, the final opinion of the CTVC was in favour of vaccination, and the DGS decided to recommend the universal vaccination of children from the ages of 5-11, but hid the contents of the final opinion from the public. Civil society reacted, demanding the presentation of technical and scientific arguments, to which Graça Freitas countered that these were internal documents that would not be made public. In the end, a resumé of the information relating to the CTVC decision was published.
“The minister of health Marta Temido was called to parliament on December 9, and MPs from various parties demanded the full disclosure of documentation that supported the decision to vaccinate minors aged from 5-11 in the name of transparency and the right to know administrative documents of the State.
“On December 10, in a press conference given by Graça Freitas and (under) secretary of state for health Lacerda Sales, on the timetable for the vaccination against Covid-19 for children aged 5-11, these documents were finally published on the DGS site, as it was announced that the vaccination of children would begin on December 18.
“Days from the start of a mass-vaccination of children, there was simply no time for independent experts, scientific societies, colleges of speciality of professional orders, pediatricians, GPs or other health professionals to engage in any form of serious discussion or technical validation of the decision. Yet it is important that this evaluation could have been made, given that so many parents sought the opinion of their medical assistants.
“For those who did analyse the documentation, it was clear there was fragility in the estimation of the number of cases and hospitalisations that could be avoided in four months thanks to mass inoculations (with an estimated 85% adherence) of a vaccine the efficacy of which had only been tested for two months in the face of a respiratory virus open to mutations, with a new variant already coming into Portugal.
“Even more worrying, data analysis of the safety of vaccines recently administered to Portuguese adolescents (12-15 year olds), was not included in the (DGS) opinion, which could raise the question: was this yet more recklessness due to the haste to vaccinate in a period previously decided by the government, or was this data also secret? And what about the Pharmacovigilance report for November, which should already have been published by this time by Infarmed, but which was delayed? It needs to be pointed out that the Report for October (September 26-October 31) where adverse reactions from the vaccination of adolescents already appeared showed a worrying increase in global notifications per 1000 doses of vaccines administered. The level of serious adverse reactions was five times higher, the level of adverse reactions eight times higher. It is urgent that these are clarified.
“In addition, the bioethical opinion made public, given by an advisory member of the CTVC, is weak due to the exclusion of the Right of Autonomy of children, the absence of any mention of necessity and on the basis that in the terms of Informed Consent this is a genetically modified biological vaccine for which efficacy and safety are not proven.
“Will Justice help in the reposition of the Law and the Truth in the higher interests of Portuguese children? While courts receive various requests for cases, powered by citizens and concerned with the illegality of measures affecting children (like the demand for digital vaccination certificates, tests, use of masks, measures of isolation etc.) here is the result of one recent court action: on August 23, a Class Action requesting a national embargo on Covid-19 vaccines with conditional authorisation for the under-18s entered the Administrative Court of Lisbon. It was an urgent request, given the imminence of vaccination of adolescents, which was dismissed outright five days later, allegedly for lack of legitimacy.
“An urgent appeal was lodged with the Central Administrative Court of the South, which only three months later issued a ruling, rendering the matter extinct “due to the supervening uselessness of the dispute” given that all children aged 12-17 had been vaccinated, “with the exception of those who did not adhere to the initiative”. Surprisingly, the ruling came on the eve of the start of the vaccination of 5-11 year olds, when its admission would have been of maximum pertinence.
“Faced with the politicising of health, with the connivance of Infarmed and the sloth and obstacles of the courts, parents are left with the heavy responsibility of vaccinating their children for Covid-19, or not. They know that if they don’t, their children will be discriminated against, as the DGS has already announced this by promising to relieve measures of prophylactic isolation for the vaccinated.
“Parents are asking themselves why are they being coerced into submitting their children to a biological, genetic vaccine, in an experimental phase, for a disease that does not pose them danger, which does not prevent transmission, and precisely when a new variant is entering Portugal about which little is known? What is the goal? What is the rush?
“These questions are difficult to answer, so, when in doubt, it is better to respect the cautionary principle of “Primum non nocere” (First do no harm) and not vaccinate, in this way exercising citizenship in fighting for children’s rights.
“From South Africa, now in focus due to variants, we should remember the words of their iconic leader, a tireless warrior for human rights and against all types of discrimination.
“There can be no keener revelation of a society’s soul than the way in which it treats its children. (Nelson Mandela)”
TERSEA GOMES MOTA is one of the numerous Portuguese professionals who has consistently spoken out against the need for vaccinations for Covid-19 in children. She works out of the Hospital da Luz group in Lisbon. Back in June, she and over 30 colleagues published an Open Letter which received scant attention in the press. The contents of that letter can be found in a text we carried online (click here)