On May 20, 2022, HAS published a preliminary recommendation for a vaccine strategy against the virus monkeypox (Monkey pox). Subsequently contacted by the Director-General of Health in order to provide details of the interactive vaccination strategy for two population groups: first-time recipients and children. To do this, in its opinion of June 16, 2022, HAS took into account the definition of cases and contacts at risk according to Public Health France (SPF), the opinion of the National Agency for the Safety of Medicines and Health Products (ANSM) [Lien de l’avis] On the vaccination of persons already vaccinated against smallpox in childhood and the use of the smallpox vaccine from 3e Children’s Generation, WHO recommendations dated June 14, 2022 as well as numerous studies and clinical trials.
One dose for first vaccinated and at-risk contact cases, three for immunocompromised
Preventive vaccination against human smallpox was mandatory in France until the 1980s (1979 for primary vaccination, 1984 for boosters). To establish, with or without a document justifying vaccination, evidence of prior smallpox vaccination, the HAS retains an indelible waffle scarcharacteristic in people vaccinated with the 1 . vaccineDr or 2e generation.
While many of the studies referenced in the HAS opinion have demonstrated a persistence of the immune response in individuals vaccinated against human smallpox in childhood, three clinical trials have also shown that administration of a dose of Imvanex® In a person who previously received a primary vaccination with another type of smallpox vaccine confers a reinforcing effect, even far removed from this primary vaccination.
Therefore, HAS recommends giving a single dose of Imvanex vaccine® For people at risk who have received the smallpox vaccine 1Dr generation before 1980.
In the particular case where those at risk are immunocompromised patients, previous vaccination with another smallpox vaccine does not modify the initially recommended vaccination schedule in this group, i.e. 3 doses of Imvanex®.
Post-exposure vaccination of minors should be considered on a case-by-case basis
The number of cases of the virus monkeypox She’s progressing fast in France but it’s not about the kids at the moment. While the smallpox vaccine has long been applied to infants and young children who had first and second generation vaccinations prior to smallpox eradication, the Imvanex vaccine® Adults only allowed.
To express its opinion, the association analyzed the available studies. Several of them, conducted in African countries, have shown that children are more likely to develop severe forms of the disease and that the mortality rate is also higher in this population. During the epidemic that struck the United States in 2003, out of 35 laboratory-confirmed cases (of 71 reported cases), 11 were children aged 6 to 18 years, of whom 2 developed severe disease.
Moreover, despite the Imvanex vaccine® Currently licensed for adults only, many studies on other vaccines use the same platform as Imvanex® (The Ankara virus modification – MVA) at doses higher than those recommended for Imvanex®Show good tolerance in children over 4 months of age. In addition, no adverse effects were reported after vaccinations – including those for children and infants – during the UK outbreak in 2018 and 2019.
HAS has also relied on the opinion of ANSM which Indicates that immunogenicity data are insufficient to allow a full decision on the benefit/risk balance About giving smallpox vaccinations from 3e generation in the children’s society. However, ANSM considers that safety data History obtained with vaccinations from 1Dr Generation (vaccine used from 1 year of age) plus available safety data on the “MVA platform” used as a vector for immunization against other pathogens (Ebola virus, malaria, tuberculosis) Support the use of vaccines from 3e generation, after assessing each child on a case-by-case basis, as part of a post-exposure reactive vaccination.
Based on these various elements, it has:
- It is suggested that cross-contact vaccination of at-risk children (as defined by the sun protection factor) could be considered to protect exposed and possibly more susceptible children to severe forms of the disease, particularly the most fragile and immunocompromised. However, in the absence of clinical data on the safety of third generation vaccines (indirect reassuring safety data are nonetheless available), the HAS recommends that vaccination of persons under 18 years of age be considered on a case-by-case basis, by professionals. Only and after a rigorous assessment of the benefits and risks to the minor concerned, within the framework of a joint medical decision, and with the consent of the parents (or legal guardian of the child), and if applicable, the adolescent.
- It is recommended that clinical trials be expedited in the pediatric population to evaluate the efficacy and safety of third-generation smallpox vaccines with a view to extending indication in the pediatric population by EMA.
HAS will adapt this initial recommendation as soon as data from clinical trials in the pediatric population becomes available. Based on new epidemiological and clinical data. He stresses the importance of soon obtaining more accurate data on human-to-human transmission of cases currently identified, epidemic surveillance data and additional real-life data regarding the efficacy and tolerability of the smallpox vaccine.e generation, administered before exposure and after exposure to the virus monkeypoxon the prevention of acute forms and transmission of the disease in different subpopulations, as well as data on the efficacy and tolerability of a booster dose in people vaccinated against smallpox in childhood.
finally, Cases identified in France concerning men who have sex with one or more men (MSM), she has Insists on me necessity To inform them of the risks of transmission during physical contact close or intimate. It also remembers the importance To comply with transmission prevention measures virus monkeypox Both for the general public and for nursing staffAs recommended by the Supreme Council of Public Health in 24 . opinion last May.
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