the rules are changing, the Academy of Medicine wants to go further

the rules are changing the Academy of Medicine wants to

VACCINATION OF CHILDREN AND TEENAGERS. How to accelerate the vaccination of children? The government has “simplified things” on parental consent. “We know the reluctance, but vaccination is worth it,” said the executive’s Mr. vaccine.

[Mis à jour le 26 janvier 2022 à 13h49] The government is not satisfied with the current progress in the vaccination of children in France. The executive, at the request of the Council of State, had requested that the agreement of both parents be necessary for the vaccination of children under 12 years of age. The ministry of the Ministry of Health is backtracking: the agreement of a single parent is enough. “We are simplifying things,” the ministry said on Tuesday, January 26, in a press briefing.

This development aims not to “dramatize vaccination”, which is considered by the Ministry of Health to be safe, in a context of intense circulation of Covid-19 in schools, as Alain Fischer said on LCI January 20. “We know the reluctance, they exist, but vaccination is worth it,” he added.

Thursday, January 20, Prime Minister Jean Castex announced that the vaccination of the youngest was to “progress”, opening the booster vaccination for 12-17 year olds. It is on the basis of volunteering that this vaccination can be decided by parents, without obligation and without a health or vaccination pass being set up for children under 12 years of age.

Opinions favorable to the vaccination of children

In order to reassure parents, the entire executive recalled having waited for the opinions of several scientific and health authorities, that of the National Ethics Advisory Committee (CCNE)), to that of the High Authority for Health, passing through that of Orientation council for the vaccine strategy (COSV), before opening the vaccination to children. A way to remind that this vaccine is safe – what the aforementioned authorities have hammered home on many occasions. Another reassuring fact: the fact that France has awaited the results in real life from countries that have already opened up vaccination to children (in particular the United States). Without the obligation to vaccinate and the establishment of a health pass, there is no doubt that a period of time will still be necessary before managing to convince the parents.

The reason for this expansion of vaccination? For all the scientists consulted, the benefit/risk ratio of childhood vaccination proves to be “favourable” on an individual level, even in healthy children. The HAS also believes that the vaccination of children “could potentially reduce the impact of subsequent waves by reducing the circulation of the virus in the general population”, and points out that it is useful to prioritize the vaccination of middle school students, ages under 12 years.

The Academy of Medicine wants vaccination sessions at school

The Academy of Medicine wants to go even further. In a press release, the body writes: “In order to prevent the individual and collective risks linked to the unpredictable evolution of the pandemic, the academies recommend to hasten the vaccination of children aged 5 to 11 against Covid-19 to reach good vaccination coverage as quickly as possible: by increasing the vaccination offer, i.e. the number of centers offering vaccination for children (currently 300 against 1,500 for adults); by diversifying the people authorized to vaccinate children; by reducing the administrative obstacles that limit children’s access to vaccination; by promoting vaccination appointments for school children; by organizing vaccination sessions at school, by mobile teams , in consultation with school medicine; in “going towards ” children with comorbidities and not vaccinated to convince parents of the need to vaccinate them in the face of the risk of serious forms; by using all the means of information and communication devoted to health education in order to convince and reassure reluctant parents.

No, the vaccination of children under 12 is only carried out on a voluntary basis and with the explicit agreement, via form and signature, of one of the parents. A parent must also be present during the administration of the vaccine dose. It is also possible to request a serological test to find out if the child has already contracted Covid-19, given the fact that asymptomatic forms are numerous in 5-11 year olds.

There is currently no question of introducing a health pass for 5-11 year olds. The opinion of the National Consultative Ethics Committee (CCNE), dated December 16, insists that “this vaccination of children must be a proposal and not an obligation, and must not be included in a health pass”.

[Cette section de l’article n’a pas été actualisée depuis le 22 décembre] According to safety data extracted from the phase 3 study of the Pfizer vaccine, cited by the United States Food and Drug Administration (FDA) and by the Vaccine Strategy Guidance Council (COSV) on December 6, the coronavirus vaccine is “safe and well tolerated” by children. In a sample of 2,268 children aged 5 to 11 years (included in a double-blind study, 2 vaccinated for 1 placebo), “the most frequent adverse effects consisted of pain and an inflammatory reaction at the puncture site, headache, chills or fever” but “no complications were reported, including no case of myocarditis”, could we read. The document specified, however, that the size of this study proved “too small to be able to detect adverse and severe effects whose frequency would be of the order of 1/1000 or less” and considered “necessary to collect more data on possible adverse effects from real-life data from countries that have already started vaccination of children aged 5 to 11 years. Data that has since begun to deliver results.

L’opinion of the National Consultative Ethics Committee (CCNE), published for its part in mid-December, indicated that “the ‘real life’ safety data, in other words statistics on the adverse effects actually observed after the injection of the vaccine in the countries which have already started the vaccination, prove to be “reassuring after a complete vaccination schedule”. All this while asking, in France, “pharmacoepidemiological monitoring in the age group of 5 to 11 years” by the State services with “a vision of medium to long term”.

L’opinion of the High Authority for Health (HAS) published on December 20 came to detail a significant number of these data on the adverse effects of the vaccine on children. Recalling the analysis of clinical safety data, it also looked at international pharmacovigilance data relating to more than 7 million vaccinations in children under 12 in the United States (more than 2 million two-dose complete vaccines) and approximately 107,500 carried out in Israel. Two countries that started vaccinating children in November. Overall, more than 10 million children aged 0 to 14 worldwide show conclusions “still limited but reassuring”, indicates the HAS. Of these millions of vaccinated children, it reports a total of “3233 adverse events” according to North American databases, “of which the majority of them (97%) were not serious”. For the remaining 3%, there are 2 deaths occurring “in children who had a heavy medical history” and “14 cases of myocarditis”, one of the most feared adverse effects.

“About thirty adverse events, all serious”, are also reported from all over the world to the European database (Eudravigilance) following “a vaccination with the Pfizer vaccine between November 16 and December 12, 2021”, specifies the HAS which lists “3 neurological effects, 2 myocarditis, 1 anaphylactic reaction, 1 respiratory arrest and 1 death”. Concerning this death which occurred in the United States, “the evaluation of the association between BNT162b2 (the Pfizer vaccine – Editor’s note) and the circumstances leading to the reported fatal outcome is impossible”, specifies the document.

In Europe, Denmark and Austria have already taken the step of vaccinating children. In Germany, where opponents of vaccination remain mobilized, several regions, including the capital Berlin and Bavaria, launched on Wednesday, December 15. Hungary has also launched its campaign for 5-11 year olds, like Greece or Spain, one of the good pupils of vaccination in Europe. Other European countries, such as Italy, Poland, the Baltic countries or even Slovakia, the Czech Republic, Portugal and Switzerland have started or will start their campaign in the coming days.

Outside Europe, Canada and the United States or even Israel also authorized the vaccination of children very early this fall. China, Chile, Argentina, Venezuela and Colombia vaccinate children from 3 years old, Cuba and Nicaragua from 2 years old.

Children are vaccinated in France with a third of a dose of Pfizer vaccine, usually reserved for adults (10 micrograms, against 30 for adults). “The bottles, which will contain ten doses, will have an orange cap to differentiate them from adult doses (with a purple cap) and avoid any error”, specifies The world of December 15.

Pfizer was the first vaccine to be approved by the authorities. The US Food and Drug Administration (FDA) review board found in mid-October that the Pfizer-BioNTech vaccines had more benefits than risks for this age group. Pfizer presented the FDA with the results of a clinical trial that demonstrated a 90.7% efficacy of the vaccine in preventing symptomatic forms of the disease in 5 to 11 year olds. Results repeated in France in a Opinion of the Vaccine Strategy Guidance Council December 6. The Moderna vaccine, for its part, is still in phase III of its clinical trial, but the first results are promising and an application for authorization has been made.

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