A group of 27 medical experts – including pediatricians – is urging Portugal’s health service to suspend the country’s child vaccinations programme.
In an Open Letter they explain that Infarmed (the country’s medications authority) has already been notified of more than 100 possible adverse reactions “including collapses, myocarditis/ pericarditis and death in children and young people” since the start of mass inoculations among the under-18s.
The letter (so far not carried in its entirety by any news source) shows its signatories are principally concerned with the vaccination of children aged from 5 to 11, which is ‘ongoing during a peak of the pandemic in circumstances that were never tested in clinical trials’.
“Vaccinating children previously infected by SARS-CoV-2, or their infection after being vaccinated, could in a short period of time lead to an increase in cases of myocarditis, to harmful effects on the immune system and other adverse reactions, potentially serious, possible even lethal, risks”, they warn.
The letter has been spearheaded by pediatrician Jorge Amil, president of the General Medical Council’s College of Pediatrics.
Explain reports, Jorge Amil “appeals to health authorities to reappreciate the decision to continue vaccinating healthy children against Covid-19, analysing the risk-benefit relationship in the face of the new reality determined by Omicron”.
In a peak of infections of the current dimension – today’s number of new cases set another ‘record’ – “it could be prudent to reassess whether to proceed with vaccination; whether in addition to being effective, it will be safe. There is nothing wrong with doing continued reassessment”.
Prudence has always been the approach favoured by pediatricians (click here).
Only last month, intensive care pediatric specialist Francisco Abecasis warned of the potential pitfalls of vaccinating perfectly healthy children, pointing out that the vaccines are not even focused on the variant currently circulating (click here).
But now there is new data (we are not given much in the way of details; the data is simply referred to as existing), prompting yet another attempt by specialists to call for a halt, or at least a ‘precautionary suspension’ of the programme, while reanalysis can go ahead.
Concerns are primarily for ‘healthy children’, the signatories stress. This has nothing to do with an appeal to halt vaccinations for children with comorbidities.
Jorge Amil also referred to the fact that even with the 300,000-odd vaccinations that have gone forwards in children under the age of 11 – as well as the hundreds of thousands that were administered to older age groups – dissemination of infection has been “enormous”.
In other words, much as Francisco Abecasis inferred last month, these vaccines are not stopping transmission, and in an age group that rarely suffers any consequence of SARS-CoV-2 infection, it might be better all round to change tack, or at least take a breath.
“If the objectives that were proposed and promised have not been attained, maybe it makes sense to review the safety of the vaccine, the efficiency of vaccination, once again and re-equation the decision”, says Jorge Amil.
None of the stories circulating at the moment mention the lack of uptake by parents of these vaccines, but it is accepted now that less than half the universe of 5-11 year olds were put forwards by their parents for inoculations.
The process began just before Christmas (December 18-19), with the dates for second jabs set between February 5 and March 13.
For the time being, there has been no health authority response to the Open Letter, which we will carry in full once it becomes freely available (see below).
To date, national media has referred only to one possible incidence of ‘serious adverse reaction’ to vaccination, in which a completely healthy child died days after receiving his first shot (click here). The Open Letter suggests there have been others (see below):
English text of the Open Letter:
Suspension of vaccine against SARS-CoV-2 in children and teenagers
Since August 2021 a controversial vaccination campaign of children and teenagers has been underway in Portugal, currently directed at children over the age of five. This Open Letter is in respect of the situation of healthy children and does not seek to make any extrapolation for adults or children with comorbidities who run an increased risk from Covid-19.
Within the European Union, in the face of an emergency situation, authorisation for the use of medicines that do not have complete safety and efficacy studies, such as these vaccines, can be granted conditionally, when various requirements are met, including a risk-favourable benefit (Regulation (EC) nº 507/2006 of the commission of March 29, 2006).,
In Portugal, even the first condition has not been verified for children, as there is no emergency situation with regard to Covid-19. In most cases, infection in children and teenagers is asymptomatic, or with mild symptoms; hospitalisations are very rare, and mortality tends to be zero in healthy children in our country. For this reason, there has been contestation to the current campaign using vaccines with conditional authorisation, which means there is not sufficient data on efficacy and safety, particularly in the medium and long term.
Many of the reasons invoked by health authorities for this campaign have proved to be too fragile and not backed up, particularly in the current panorama. Let’s look at the main arguments: existing vaccines would be effective and safe in children; there would be a favourable risk-benefit relationship for the health of children; vaccination would contribute to the reduction in community transmission – and there would be good adhesion by the population to the process.
Since November 2021, with the dissemination of the new Omicron variant, highly transmissible but less aggressive than previous variants (particularly Delta), the epidemiological situation in Portugal and the world has changed substantially, especially since it was confirmed there was vaccine leakage – that is, a clear drop in effectiveness of the vaccines in preventing infection in adults and children. The much-desired “group immunity” promised by health authorities as a banner for vaccination also for children and teenagers, paradoxically translated in the last month along to the infection of one million people.
The good news is that this variant is less pathogenic. It has a lower affinity for the lower respiratory airways; in other words, it prefers the nose and throat instead of the bonchi and lungs, causing less pneumonia, fewer hospitalisations, less lethality.
Faced with this new reality determined by the appearance of the Omicron variant which has become dominant and for which the vaccines are considered inefficient, the risk-benefit analysis for the use of these vaccines for Covid-19, most particularly in children, should be redone, as confirmed by the ECDC (European Centre for the Control of Diseases) on December 1, 2021.
This analysis has still not been presented by Portuguese health authorities, nor by the vaccine manufacturers. For this same reason, an imperative for precautionary suspension of vaccination in children and teenagers is identified, until the need, benefit and safety is proved.
Most worrying is that the vaccination of 5-11 year olds is going forwards during full pandemic peak, circumstances that were not tested in clinical trials of these vaccines. The vaccination of children previously infected by SARS-CoV-2, or their infection after being vaccinated could translate, in a short period of time, to an increase in the incidence of cases of myocarditis, deleterious effects on the immune system, or other potentially serious adverse reactions and potentially lethal risks.
INFARMED has already been informed of more than a hundreds possible serious adverse reactions, including syncope (collapses), myocarditis/ pericarditis and death in children and teens. In other words, it is admissible to assume that there exists a toxicity in the vaccines that can be verified in the short term, while adverse consequences in the medium and long term are ignored due to an unnecessary medical act of trying to immunise those who were already immunised by an infection that is often asymptomatic.
In conclusion, given the appearance of the Omicron variant in Portugal, and for all the clinical safety reasons presented, the signatories warn of the imperative to:
- Immediately suspend the vaccination campaign against Covid-19 in children and teenagers without comorbidities, as well as the conditional authorisation for the marketing of vaccines in pediatric age
- Investigate the sudden deaths and syncopes of young adults, adolescents and children that occurred in Portugal after the initiation of the vaccination campaigns in these age groups
The signatories,
Health professionals and citizens who honour and defend leges artis and the ethics of medicine, and who, in this condition, publicly raise their voices in defence of the health of the Portuguese people, and particularly children and young people
(by alphabetical order)
Francisco Abecasis – Pediatric doctor
Sofia Almeida – Pediatric doctor
Helena Alves – Specialist in Immuno-hemotherapy
Jorge Amil – Pediatric doctor
Paula Azeredo – Pediatric doctor
Cristina Camilo – Pediatric doctor
Henrique Delgado Carreira – Graduated assistant in general and family medicine
Fernando Chaves – Pediatric doctor
João Melo Coelho – Senior graduate assistant in general and family medicine
Horácio Costa – Specialist in reconstructive plastic surgery
Professor Miguel Félix – Pediatric doctor
Pedro Ferreira – Pharmacist
Elsa Fragoso – Specialist in pneumology and intensive medicine
Pedro Girão – Specialist in Anesthesiology
Jacinto Gonçalves – Specialist in Cardiology and Internal Medicine;
Professor (retired) Juan Gonçalves – Pediatric doctor
Marta Loureiro – Pediatric doctor
António Pedro Machado – Specialist in internal medicine
Tiago Marques – Specialist in Infecciology
Isabel Saraiva de Melo – Pediatric doctor
Teresa Gomes Mota – Specialist in Cardiology
José Almeida Nunes – Specialist in Internal Medicine
Joana Rios – Pediatric doctor
Ana Tavares – Pediatric doctor
Jorge Torgal – doctor and professor in Public Health
Erica Torres – Pediatric doctor
Marisa Vieira – Médica Pediatra
For the original text in Portuguese:
Suspensão da vacinação contra a SARS-CoV-2 em crianças e jovens
Desde agosto de 2021 que está em curso em Portugal uma controversa campanha de vacinação contra a COVID-19 em crianças e jovens, atualmente dirigida às crianças a partir dos 5 anos de idade. Esta Carta Aberta diz respeito à situação das crianças saudáveis e não se pretende qualquer extrapolação para adultos ou crianças com comorbilidades que acarre- tem risco acrescido de COVID-19.
No espaço da União Europeia, perante uma situação de emergência, a autorização de utilização de medicamentos que não tenham os estudos de segurança e eficácia completos, como estas vacinas, pode ser atribuída de forma condicional, quando se verifiquem diversos requisitos, incluindo uma relação risco-benefício favorável. (Regulamento (CE) N.º 507/2006 DA COMISSÃO de 29 de março de 2006).
Em Portugal ainda não se verificou para as crianças nem sequer a primeira condição, dado que não existe situação de emergência no que à COVID-19 diz respeito. A infeção de crianças e jovens é assintomática ou com sintomas ligeiros na maioria dos casos; os internamentos são muito raros, e a mortalidade tendencialmente nula em crianças saudáveis no nosso país. Por essa razão, no meio médico tem surgido contestação à atual campanha com vacinas com autorização de utilização condicional, o que significa não terem suficientes dados de eficácia e segurança, nomeadamente a médio e longo prazo.
Muitos das razões invocadas pelas autoridades de saúde para esta campanha têm vindo a comprovar-se demasiado frá- geis e não sustentadas, sobretudo no panorama atual. Vejamos os principais argumentos: as vacinas existentes seriam eficazes e seguras nas crianças; existiria uma relação risco-benefício favorável para a saúde das crianças; a vacinação iria contribuir para a diminuição da transmissão comunitária da infeção; e haveria uma boa adesão da população ao processo.
Desde novembro de 2021, com a disseminação da nova variante Ómicron, altamente transmissível mas menos agressiva que as anteriores, nomeadamente a variante Delta, a situação epidemiológica em Portugal e no mundo alterou-se substan- cialmente, tanto mais que se confirmou haver escape vacinal, ou seja, há uma evidente quebra da eficácia das vacinas na prevenção da infeção em adultos e crianças. A tão almejada “imunidade de grupo” prometida pelas autoridades de saúde como uma bandeira da vacinação também para as crianças e jovens, paradoxalmente, traduziu-se, só no último mês, na infeção de um milhão de pessoas.
A boa notícia é que esta variante é menos patogénica, tem uma menor afinidade para as vias aéreas respiratórias inferio- res, ou, dito de outra forma, prefere o nariz e a garganta em lugar dos brônquios e pulmões, causando menos pneumonias, menos internamentos, menor letalidade.
Perante esta nova realidade, determinada pelo aparecimento da variante Ómicron que se tornou dominante e para a qual as atuais vacinas são consideradas ineficazes, deveriam ser refeitas as análises da relação risco-benefício da utiliza- ção das vacinas para a COVID-19, muito particularmente em crianças, conforme recomendado pelo Centro Europeu de Controlo de Doenças em 1 de dezembro de 2021.
Esta análise ainda não foi apresentada pelas autoridades de saúde portuguesas, nem pelos fabricantes de vacinas. Também por este motivo se identifica um imperativo da suspensão cautelar da vacinação em crianças e jovens, até que se comprove a sua necessidade, benefício e segurança.
O mais preocupante é que está a decorrer a vacinação das crianças dos 5 aos 11 anos em pleno pico pandémico, circuns- tâncias que não foram testadas nos ensaios clínicos de vacinas contra a COVID-19. A vacinação de crianças previamen- te infetadas por SARS-CoV-2, ou a sua infeção depois de vacinadas, num curto intervalo temporal, pode vir a traduzir--se num aumento da incidência de casos de miocardites, efeitos deletérios no sistema imunitário ou outras reações ad- versas, riscos potencialmente graves e eventualmente letais.
Já foram notificadas ao INFARMED mais de uma centena de possíveis reações adversas graves, incluindo síncopes (co- lapsos), miocardites/pericardites e morte, em crianças e jovens. Ou seja, é admissível assumir que existe uma toxicidade das vacinas que se verifica a curto prazo e ainda se ignoram as consequências adversas a médio e a longo prazo, devidas a um desnecessário ato médico de tentar imunizar quem já estava imunizado por uma infecção muitas vezes assin- tomática.
Em conclusão, face ao aparecimento da variante Ómicron em Portugal e pelas razões de segurança clínica apresentadas, os signatários advertem do imperativo de:
- Suspensão imediata da campanha de vacinação contra a COVID-19 em crianças e jovens sem comorbilidades e da autorização condicional de introdução no mercado de vacinas em idade pediátrica
- Investigação das mortes súbitas e síncopes em adultos jovens, adolescentes e crianças ocorridas em Portugal depois de iniciadas as campanhas de vacinação nestes grupos etários.
Os signatários,
profissionais de saúde e cidadãos que honram e defendem a leges artis e a ética da medicina e que, nessa condi- ção, erguem a sua voz publicamente na defesa da saúde dos portugueses e muito particularmente das crianças e jovens:
(por ordem alfabética)
Francisco Abecasis – Médico Pediatra Sofia Almeida – Médica Pediatra
Helena Alves – Especialista em Imuno-Hemoterapia
Jorge Amil – Médico Pediatra
Paula Azeredo – Médica Pediatra Cristina Camilo – Médica Pediatra
Henrique Delgado Carreira – Assistente Graduado de Medicina Geral e Familiar
Fernando Chaves – Médico Pediatra
João Melo Coelho – Assistente Graduado Senior de Medicina Geral e Familiar
Horácio Costa – Especialista em Cirurgia Plástica Reconstrutiva e Estética;
Professor Catedrático Miguel Félix – Médico Pediatra
Pedro Ferreira – Farmacêutico
Elsa Fragoso – Especialista em Pneumologia e em Medicina Intensiva
Pedro Girão – Especialista em Anestesiologia
Jacinto Gonçalves – Especialista em Cardiologia e Medicina Interna;
Professor Jubilado Juan Gonçalves – Médico Pediatra
Marta Loureiro – Médica Pediatra
António Pedro Machado – Especialista em Medicina Interna
Tiago Marques – Especialista de Infecciologia
Isabel Saraiva de Melo – Médica Pediatra
Teresa Gomes Mota – Especialista em Cardiologia
José Almeida Nunes – Especialista em Medicina Interna
Joana Rios – Médica Pediatra
Ana Tavares – Médica Pediatra
Jorge Torgal – Médico, Professor Catedrático de Saúde Pública
Erica Torres – Médica Pediatra
Marisa Vieira – Médica Pediatra
