the OJ specifies the conditions of vaccination

Thursday 07th November 2024 11:52 AM

Résumé

A decree published in Official Journal of October 23, 2024 defines the conditions for vaccination against Mpox and more particularly:

people who can be vaccinated with Mpox defined in the recommendations of the High Authority for Health (HAS) and the High Council for Public Health (HCSP);
vaccines to use:
- IMVANEX suspension injectable,
- JYNNEOS suspension injectable en flacon.
purchase, importation (for JYNNEOS), storage and distribution (free) under the responsibility of Public Health France (SPF);
the places of vaccine administration: all health establishments, free information, screening and diagnosis centers (Cegidd), authorized establishments and organizations, as well as community pharmacies designated by the regional vaccination agency health ;
health professionals authorized by derogation to prescribe and/or administer vaccines under certain conditions: retired nurses and doctors, nursing or medical students, pharmacy technicians;
the fixed remuneration fixed by derogation for several categories of health professionals.

Between 1^is January and October 29, 2024, 195 cases of Mpox were reported to SPF and only clade II Monkeypox viruses were detected by the Orthopoxvirus CNR.

Un order published in Official Journal from October 23, 2024 [1] repeals the decree of July 2022 relating to vaccination against Mpox (formerly monkeypox) and updates the terms of this vaccination.

Who is affected by this vaccination?

Can be vaccinated “people at risk of exposure” to the virus and/or having had “an identified risk contact” defined in the recommendations of the High Authority for Health (HAS) [2] and the High Council for Public Health (HCSP) [3] (cf. Boxes 1 and 2).

The two vaccine strategies recommended in 2022 (for prevention and post-exposure), which were renewed by the HAS at the beginning of September 2024, are therefore still relevant (cf. our article of September 5, 2024). The only modification introduced at the beginning of September 2024 concerned people vaccinated during the 2022 campaign who must receive a booster dose.

A map of centers operational staff, in charge of this vaccination campaign in the territory, is regularly updated. The objective is to vaccinate the target population by the end of 2024.

**Box 1 – Preventive vaccination**
Preventive vaccination is recommended in: people at high risk of exposure [2] : men who have sex with men (MSM) and trans people reporting multiple sexual partners, people in prostitution, professionals in sexual meeting places, whatever the status of these places, partners or people sharing the same living space as the people mentioned above; THE healthcare professionals at risk of exposure (including laboratory staff); travelers [3] : having sexual practices at risk of Mpox regardless of destination (see above); going to an area of active circulation of Mpox clade 1 (a and/or b) in particular: caregivers and humanitarian workers, people originating from active traffic areas visiting their loved ones (or for other reasons) and at risk of exposure (highly promiscuous stay, sharing bedding, sexual relations, etc.), immunocompromised people: advise them against travel because of the risk of serious illness or even death and vaccinate them if travel is continued. Travel in such an active traffic area is not recommended among the children and pregnant/breastfeeding women car : there is a risk of maternal-fetal and perinatal transmission, children are at risk of severe forms, and severe forms are possible in newborns, the vaccine does not have marketing authorization (AMM) in these populations (to be considered on a case-by-case basis); All travelers must apply barrier measures: avoid any contact with a living or dead wild animal such as rodent or primate, do not ingest bush meat, avoid gatherings at risk of mucocutaneous contact, stay away from subjects with skin lesions compatible with Mpox.

Box 2 – Reactive vaccination

Reactive vaccination is aimed (ideally within 4 days of the first risky contact and at the latest within 14 days):

to people who have had risky contact;
to immunocompromised people who have had close contact with a contact person at risk.

A contact is considered at risk when there has been (without effective protection):

prolonged contact (without notion of duration) with broken skin or body fluids of an infected person ;
contact with utensils, surfaces and fabrics touched by the person.

Sexual intercourse is still considered “unsafe” with or without condom.

What vaccines?

Two so-called “third generation” vaccines produced by the Danish firm Bavarian Nordic can be used (cf. our article of June 2, 2022):

These live vaccines are derived from the highly attenuated viral strain, modified vaccinia Ankara virus of Bavarian Nordic (MVA-BN). They have the advantage of being non-replicative (that is to say they cannot multiply in the human organism).

These two vaccines are very similar in terms of effectiveness and safety profile.

Who provides the vaccines?

Public health France (SFP) and/or the army health service are responsible for purchasing, importing (for JYNNEOS), storing vaccines and making them available for free.

In addition, SFP ensures the delivery vaccines in different locations where they can be administered that’s to say :

pharmacies for indoor use which have the possibility of supplying:
- THE health facilities,
- free information, screening and diagnosis centers (A mouthful),
- THE establishments et organisms empowered.
THE pharmacies d’officine volunteers and designated by the director general of the regional health agency according to different criteria.

An exemption for certain health professionals

An exemption authorizes the following healthcare professionals to prescribe and/or administer vaccines:

retired doctors are authorized to prescribe and administer them;
retired nurses are authorized to administer them on medical prescription and to prescribe them if they have followed the training required during their activity;
nursing students who have validated their 1^re year of training, students of 2^e cycle of medical studies, students of 2^e et 3^e years of 1^is cycle of medical studies in the presence of a doctor or nurse;
pharmacy technicians provided they have received appropriate training and under the supervision of a pharmacist.

Furthermore, the decree specifies that: “ Health establishments which provide vaccination against the monkeypox virus and which use the participation of these professionals for this campaign will be able to benefit from fixed compensation paid by Health Insurance. ».

Remuneration per hour, per half-day of activity or per act

Doctors, nurses, students…

Health professionals who participate in this vaccination campaign “ in a collective setting outside the usual conditions of exercise or outside their service obligation » are paid according to an hourly rate (cf. Tableau 1) or half-day (cf. Tableau 2).

**Table 1 – Fixed price per hour**
	Between 8 a.m. and 8 p.m.	Between 8 p.m. and 11 p.m. or between 6 a.m. and 8 a.m.	Between 11 p.m. and 6 a.m. or Sunday/public holiday
Nursing students	12 euros	18 euros	24 euros
Students in 2^e cycle of medicine and retired nurses	24 euros	36 euros	48 euros
Students in 3^e medical cycle and retired doctors	50 euros	75 euros	100 euros

**Table 2 – Half-day rates**
	Intervention less than 4 hours excluding weekends – hourly rate	Intervention less than 4 hours Saturday afternoon/Sunday/public holiday-time package	Half day of 4 hours minimum excluding weekends	Half day of 4 hours minimum Saturday afternoon/Sunday/public holiday
Liberal doctors or in a health center	80 euros	105 euros	320 euros	420 euros
Liberal state-certified nurses	42 euros	54 euros	162 euros	216 euros

…and community pharmacists

Pharmacists working in duly designated pharmacies can invoice an amount of 9.61 euros for the prescription and administration of one of the two vaccines, an amount fully covered by health insurance.

Traceability and pharmacovigilance

Finally, vaccine traceability is ensured by the pharmaceutical establishment of the National Public Health Agency. The National Agency for the Safety of Medicines and Health Products (ANSM) is responsible for implementing reinforced pharmacovigilance.

Key figures of the epidemic between January and the end of October 2024

As of October 29, 2024195 cases of Mpox have been declared to SPF since 1^is January 2024, including 5 over the last 7 days [4] :

almost half of the cases (n=93; 48%) said they did not know if they had had risky contact with a case of Mpox in the 3 weeks preceding the first symptoms;
44% of infected people (n=85) resided in the Île-de-France region;
only clade II Monkeypox viruses were detected by the Orthopoxvirus CNR;
these are only adults including 188 men and 7 women.