Here is a mechanical English translation of the Full TEXT of the Above Motion by the Opposition Party, Fratelli d’Italia
For the original Italian, click the image above.

Act No. 1-00388

Posted on June 16, 2021, in session No. 337

Sponsored by Senators: ZAFFINI , CIRIANI , CALANDRINI , BALBONI , BARBARO , DE BERTOLDI , DE CARLO , FAZZOLARI , IANNONE , LA PIETRA , PETRENGA , RAUTI , RUSPANDINI

The Senate,

WHEREAS:

in Italy the phase of the vaccination campaign that provides for the vaccination also of the “over 16” was recently launched, while in recent days the green light arrived from the EMA and AIFA agencies for the vaccination also of people in the age group between 12 and 15 years, for which the so-called open days for the administration of the Comirnaty vaccine (Pfizer/Biontech) have already been scheduled and started;

in Germany, the Standing Committee on Vaccinations (Stiko) of the “Robert Koch Institut” does not recommend the administration of Pfizer to very young people and even, in the official recommendations disseminated on the website of the Robert Koch Institut, which is the equivalent of the Italian Institute of Health, states that “The use of Comirnaty in children and adolescents aged 12 to 17 years without previous diseases is currently generally not recommended” and that “for this age group, vaccination is therefore possible only after medical advice and if the child or adolescent or guardians accept the individual risks.”

in Israel and the United States vaccination with COVID-19 mRNA vaccines for the very young 12-16 years of age and over 16 years of age began some time ago, and it is recent news that in Israel 275 myocarditis have been reported in young people between 16 and 30 years of age;

to this evidence was added the concern aroused by the latest vigilance report of the CDC, the Centers for Disease Control and Prevention in the USA, according to which, after the vaccinations with Pfizer and Moderna, in subjects between 16 and 24 years old were found myocarditis in higher numbers than expected;

on May 20, 2021 an open letter appeared on the HART (Health advisory & recovery team) website, signed by a group of British doctors, addressed to the MHRA (Medicines & healthcare products regulatory agency), the equivalent of the Italian AIFA;

the contents of the appeal raise serious doubts, both from the ethical and scientific point of view, with respect to the choice of administering vaccines to “under 18”;

it is considered appropriate to report some significant passages of the letter, the content of which is still fully viewable on the website of HART: the petitioners state that “it is irresponsible, unethical, and indeed unnecessary to include children under 18 in the national launch of the COVID-19 vaccine,” and it is made clear that clinical trials in children pose enormous ethical dilemmas because of the unknown risks, adding that one would have to wait until the end of the current phase 3 studies and several more years to receive all safety data in adults in order to rule out or quantify all potential adverse effects;

specifically, it states that “All phase 3 studies of COVID-19 vaccines are ongoing and are not expected to conclude until late 2022/early 2023. The vaccines are, therefore, currently experimental with limited short-term adult safety data unavailable (…). Completely new mRNA vaccine technology that has never previously been approved for use in humans (…). Potential late-onset effects may take months or years to manifest. The limited trials in children undertaken to date are totally underpowered to rule out uncommon but serious side effects. Children have a life ahead of them and their immunological and neurological systems are still developing, making them potentially more vulnerable to adverse effects than adults. A number of specific concerns have already been raised, including autoimmune diseases and possible effects on the placenta and fertility. A recently published article raised the possibility that COVID-19 mRNA vaccines may trigger prion-based neurodegenerative diseases. All potential risks, known and unknown, must be balanced against the risks of COVID-19 itself, so a very different risk/benefit ratio will apply to children than to adults.”

On protection from COVID in children it adds that “Healthy children are at almost no risk from COVID-19, with a risk of death of just 1 in 2.5 million. No previously healthy children younger than 15 years of age died during the pandemic in the United Kingdom, and hospitalizations or intensive care admissions are extremely rare and most children have no or very mild symptoms. Although Long-Covid has been cited as a reason to vaccinate children, there is little hard data. (…) The inflammatory condition, PIMS, was listed as a potential adverse effect in the Oxford AstraZeneca Children’s Study. Naturally acquired immunity will give a? wider and longer-lasting immunity than vaccination. In fact, many children will already be immune while individual high-risk children may already receive the vaccination.”

the physicians also specify that the potential benefits are clear for the elderly and vulnerable, however, for children, the balance between benefit and risk would be very different and that we need to “ensure that there is no repeat of past tragedies that have occurred especially when vaccines are brought to market,” citing the example of the swine flu vaccine, Pandemrix (2010), which resulted in over a thousand cases of narcolepsy (a devastating brain injury), and Dengvaxia, the new Dengue vaccine, which resulted in the deaths of 19 children due to a possible “ADE effect” (“antibody-dependent enhancement”) before the vaccine was withdrawn;

the appeal concludes with the observation that “There is important wisdom in the Hippocratic oath that states, ‘First do no harm.’ All medical interventions carry a risk of harm, so we have a duty to act with caution and proportionality. This is especially true when considering mass intervention in a healthy population, in which situation there must be strong evidence of benefits far outweighing harms. The current available evidence clearly shows that the calculation of risk versus benefit does not support the hasty and experimental administration of COVID-19 vaccines to children, who have virtually no COVID-19 risk, but face known and unknown risks from vaccines. The Declaration of the Rights of the Child states that ‘the child, because of his physical and mental immaturity, needs special safeguards and care, including adequate legal protection.’ As adults, we have a duty to protect children from unnecessary and foreseeable harm. We conclude that it is irresponsible, unethical, and indeed unnecessary to include children under the age of 18 in the national launch of the COVID-19 vaccine.”

with reference to the ethical aspects of the issue raised, it is considered necessary and not postponeable the intervention of the Ethics Committee;

to this end, it seems useful to recall that, pursuant to Article 10 of the Decree of the Minister of Health of October 24, 2014, approving the Statute of the Istituto Superiore di Sanità, the Ethics Committee “operates as a guiding and evaluating body from the ethical point of view for research and experiments , in accordance with the regulations in force,” and that, pursuant to the Decree of the Minister of Health of February 8, 2013, setting forth the criteria for the composition and functioning of ethics committees, they are responsible for ensuring the protection of the rights, safety and well-being of persons undergoing trials and for providing public assurance of such protection;

the Ethics Committee has an advisory function to ISS in relation to ethical issues related to scientific, welfare, educational and administrative activities, in order to protect and promote ethical values and respect for the person;

the epidemiological reports available so far show that there is little evidence of secondary infection from children to others in the transmission pathways of COVID-19 and therefore vaccination of children cannot be justified if it is to provide direct protection despite the minimal burden of disease or to help stop transmission if children do not constitute a substantial reservoir for transmission;

a meta-analysis published in Clinical Infectious Disease on December 6, 2020 (“A meta-analysis on the role of children in severe acute respiratory syndrome coronavirus 2 in household transmission clusters”) documented that children would be significantly uninfectious;

the authors observed 90,000 children in all North Carolina schools during the pandemic and could not demonstrate a single case of transmission of the virus from children to teachers;

if for other infections that can be prevented by the vaccine, such as meningococcal disease, the immunization of children has not only prevented infections in children, but has also conferred indirect benefits, decreasing the disease in the elderly, because of its effect on reducing carriage and blocking transmission, for COVID-19 it could be the opposite case, with adults having to be vaccinated to confer protection to young children;

with reference to the lack of data on adverse effects in children under 18, it is useful to highlight that in the summary of the technical characteristics of Comirnaty, published by AIFA, in the paragraph “Efficacy and immunogenicity in adolescents aged 12 to 15 years”, it is noted that the participants analyzed in study 2 were just 1,005, incredibly small number to assess, with due certainty, the relationship between benefits and risks in the face of an authorization for mass vaccination of the age group in question;

always in the same section of the technical data sheet, is perplexing the provision according to which “This medicinal product has been authorized with procedure ‘subject to conditions’. This means that further data on this medicinal product must be provided. The European Medicines Agency will review new information on this medicinal product at least annually and the summary of product characteristics (SPC) will be updated as necessary.”

the numerous cases of myocarditis reported in countries where vaccination of the under 18s is well advanced, together with the small number of subjects in the 12-15 age bracket analysed in study 2 on Comirnaty, do not appear compatible with the provision of “at least annual analysis of data on the vaccine” as a condition for its administration;

as is well known, the strengthening of systems for monitoring reports of suspected adverse reactions (ADRs – adverse drug reactions) is a very important source of information for pharmacovigilance activities, as it allows early detection of potential warning signs related to the use of medicines, so as to make them safer, to the benefit of all patients;

it is no longer postponeable the creation of a pharmacovigilance mechanism specifically for adverse effects related to the administration of COVID-19 vaccines, a monitoring network that is able to monitor in real time and in a sustained and systematic way, providing disaggregated and public data, the adverse effects of vaccinations to allow scientists a proper assessment of risks and benefits and the Ethics Committee a proper evaluation from the ethical point of view of the administration of vaccines to “under 18”;

the current reports made by AIFA are a useful piece, but not sufficient with respect to the need to adapt the current system of pharmacovigilance to the new health reality dominated by COVID-19, a reality in which a vigilance still calibrated, for timing and mode, on the monitoring of adverse effects of influenza vaccines, seems totally inadequate to intercept in an organic, systematic and complete adverse effects related to the administration of vaccines COVID-19;

the Decree of the Minister of Health of April 30, 2015 reiterated the obligation to promptly report suspected adverse reactions from drugs and vaccines, but in Italy there are no vigilance systems dedicated to COVID-19 vaccines;

based on European pharmacovigilance regulations (in particular, Implementing Regulation (EU) No 520/2012 of June 19, 2012, on the performance of pharmacovigilance activities provided for in Regulation (EC) No. 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council), medicinal products containing new active substances, not present in medicinal products authorized in Europe on January 1, 2011, should be subject to additional monitoring, in particular products whose authorization is conditional on or authorized under exceptional circumstances, as in the case of authorized coronavirus vaccines. In these cases, the regulations also provide for the possibility of requiring companies holding MAs to conduct additional studies on the safety or efficacy of the drug;

in England the MHRA has dedicated a dynamic surveillance system in the administration of COVID-19 vaccines, through a dedicated site, the “Coronavirus yellow card”, launched in May 2020 specifically for drugs and medical devices and for vaccines used for COVID-19;

the information collected in this database is composed of reports that can be made by anyone: patients, manufacturers and healthcare professionals. These reports are categorized and statistically processed at the national level, as well as in a European system managed by the EMA and in a worldwide system managed by the WHO;

Italy does not yet have a pharmacovigilance system dedicated to COVID-19 and implementable, which would allow such categorization and statistical processing of data at the national level and in a European system managed by the EMA or in a worldwide system managed by the WHO,

commits the Government:

1) to urgently activate the Ethics Committee of the Istituto Superiore di Sanità to assess the benefits and risks of the administration of COVID-19 vaccines to the under 18s;

2) to suspend the mass vaccination of under 18, unless there are specific indications for individual cases, until the scientific community has sufficient data to resolve the doubts related to adverse events made known, for example, by the CDC and the Israeli surveillance system;

3) to strengthen the pharmacovigilance network with a system dedicated to COVID-19 and implementable, which allows a categorization and statistical processing of data at the national level and within a European system managed by the EMA, as well as in a global system managed by WHO, as done for example by England.