Ordering and delivering
At the beginning of March 2021, three
COVID-19 vaccines are available in Belgium: Comirnaty®
(Pfizer/BioNtech), Moderna® and AstraZeneca® vaccines.
The
vaccination schedule for these three vaccines
consists of two doses (only one dose is not recommended by the
Belgian Superior health council), administered with a recommended
interval of 21 days (that can be extended to maximum 35 days if needed)
for Comirnaty®, 28 days for Moderna®,
or 12 weeks for AstraZeneca®.
The vaccine of Pfizer/BioNtech
(Comirnaty®) is delivered by the firm in hospital hubs. Hospital hubs
were designed by the Federal Agency for Medicines and health Products
(FAMHP) and must be equipped
with Ultra temperature (ULT) freezers. Maximum quantities that can
be delivered (quotas) in each hub is defined by the Federal State,
according the number of vaccines available. These quotas are
communicated by the FAMHP. Other vaccines (Moderna®
and AstraZeneca®) are delivered by the firms in a central HUB of
Medista, a highly specialized medical supply chain company that operates
in a strictly controlled environment. Medista was designated by the
FAMHP to receive and store vaccines as
well as the equipment required for vaccination (syringes, needles,
dry ice, etc.).
Under the supervision of the FAMHP, Medista is
also responsible for distributing the vaccines to centres that have
vaccine storage facilities, i.e. from
the hubs to hospitals, collective care institutions (including
nursing homes and homes for the elderly), and vaccination centres.
Based
on the number of vaccines available, the federal state communicates to
each federated entity their maximum
quota of vaccines. Each federated entity is then responsible for
distributing this quota between hospitals, collective care institutions
and vaccination centres.
The national vaccination plan
The Belgian vaccination strategy
consists of three phases:
● Phase 1a (few vaccines and
stocks, multi-dose vials, complex storage conditions of frozen
vaccines): centralised administration of vaccines to high-priority
target groups, according to the following sequence:
○ Residents and
staff (including volunteers) in nursing homes and homes for the elderly
followed by collective care institutions.
○ Health care professionals working in hospitals and health care and support professionals working in ambulatory
care.
○ Other hospital professionals and health professionals working in other health services such as in preventive programmes.
● Phase 1b (wider range of vaccines and stocks, multi-dose vials, less complex storage conditions): centralised
administration of vaccination extended to:
○ People aged 65 years
and over, either indistinctly or by descending age categories depending
on the availability of vaccines (decision managed by the federated
entities).
○ People aged 45-64 years
old with a well-known risk factor, later extended to 18-64 years for some co-morbidities.
○ People occupying a critical function within an essential social or economic profession (criteria not yet defined).
○ Pregnant women, as signalled
by the professionals in charge of pregnancy follow-up
● Phase
2 (very wide range of vaccines and stocks, both multi-dose and single
dose vials, simple storage in the fridge): vaccination generalised to
all adults (18 years and over), including
low-risk groups, via both centralised and decentralised channels.
The vaccination prioritisation is done on the basis of age. Also, people
living in community based establishements (e.g. prisons) are
prioritized.
The timeline is currently as follows:
• Residents
of nursing homes and staff of nursing homes : Starting January 2021
(with a pilot phase that started on 28 December2020)
• Hospital health care professionals: starting end of January 2021
• First line health care professionals: starting February 2021
• Collective health care facilities and other hospital personnel starting February 2021
• Over 65 years of age: starting March 2021
• 18/45-64 years old with comorbidities : starting March 2021
• People with critical functions in essential sectors: starting April 2021
• General population: starting
June 2021
Also from April 2021, Belgians that are willing to get vaccinated, but do not fulfil the phase’s vaccination criteria, can access an online platform (Qvax for Wallonia and Flanders, Bruvax for the Brussels region) to sign up to receive leftover vaccine doses from vaccination centres. Priority in this system is given to older people.
Invitation process
Vaccination
is done on a voluntary basis and is free. Belgian federated entities
are responsible for initiating the vaccination process in respect with
this national vaccination plan.
A
computerized centralized booking system is in place since February 15th
2021. The sending of invitations is initiated from the booking
application, which creates a vaccination code. An activated vaccination
code that has not yet resulted in the registration
of one or more vaccination moments remains valid until 31 December
2021.
Individual invitations can be sent by post, text message
and/or email. The invitation includes a link toward the booking
application and a phone number for people unable to use the online
booking application, as well as general and organizational
information. People are also invited to contact their GPs,
pharmacists, or a call centre managed by the federated entities in case
of questions. People have then the option to confirm, refuse or move
their appointment, either online via the centralized
booking system or by phone. The appointment for the second dose is
made at the same time.
The selection of individuals and the
procurement of contact information is done using different sources, such
as the national register (e.g. for people
aged 65 years and over), sickness funds data (e.g. for people with
risked co-morbidities) or the Common Base Registry for HealthCare Actor
(CoBRHA) (e.g. for health care workers).
Responsibility to sign up to the Qvax or Bruvax platforms (see the section on vaccination timeline) is on the citizen’s own initiative.
Vaccines administration
The
vaccination effort
in phases 1a and 1b is centralized. Vaccines are delivered in
hospitals for hospital staff, in collective care facilities (e.g. in
nursing homes and homes for older people) for both residents and staff
(including volunteer), and in vaccination centres
for other people. People tasked to administer the vaccine are those
allowed to do so under Belgian law, this may include besides health care
providers also trainees, students, pensioners, volunteers, and other
profiles. These people are allowed to
provide vaccination following the law of 6th November 2020 (see also
section 2.2). This law allowed, in the context of the COVID-19
pandemic, people without valid professional titles to perform nursing
acts (including vaccine administration) under
strict conditions, including having had prior training. This
training is to be provided by a nurse or doctor, both in relation to the
nursing activities performed and to health protection measures
necessary to perform these nursing activities. The
training must be adapted according to the knowledge and skills of
people following them. The nursing activities must then be carried out
under the supervision of the nurse coordinator, who must be accessible.
This does not require the physical presence
of the nurse coordinator.
Supplies to address adverse events
during vaccination are provided by the place where the vaccination is
done (vaccination centres, hospitals, collective care facilities).
To
speed up vaccination, an
increase in the number of vaccination centres is planned. The
number/brand of vaccines available will also be increased (e.g. with the
Johnson & Johnson vaccine). Moreover, when logistical obstacles
will be reduced (i.e. very wide range of vaccines
and stocks, both multi-dose and single dose vials, simple storage in
the fridge), vaccination will probably also be allowed in GPs office or
other decentralized centres (discussions ongoing).
Federated
entities also plan to provide for
"mobile actors" capable of reaching populations that are not able to
go to a vaccination centre on their own (see below: access).
In May 2022, some pilot tests for vaccination in pharmacy were launched.
Vaccination financing, coverage and access
The
financing of vaccination is shared between federated
entities and the federal state/compulsory health insurance. The
operation of large-scale vaccination centres involves the mobilization
of many people with different backgrounds. These may include trainees,
students, pensioners, health care providers
and other volunteers, these people may be contracted in the
following forms:
● on a volunteer basis;
● via an employment contract (e.g. ordinary or student work);
● via a provision of their employer (who therefore continues to pay the
person);
● via self-employed workers.
Anyone aged 18 and
over with a social security identification number (SIN) has access to
the vaccine free of charge (no cost-sharing). This includes all persons
residing in Belgium (the NISS corresponds
to the national register number) or persons not residing in Belgium
but having close and stable relations with Belgium, such as cross-border
workers (these persons are identified by a BIS number). Some of these
persons do not yet have a BIS number
(e.g. because they had not yet needed one). In this case, the
vaccinating doctor or a social secretariat can create a BIS number
directly (but only if the patient presents a valid identity document
with predefined minimum identification data).
The vaccination of
people who do not meet these criteria (homeless people, undocumented
migrants, etc.) is currently under discussion. Federated entities also
plan to provide for "mobile actors" capable of reaching populations that
are not
able to go to a vaccination centre on their own. Two populations are
particularly targeted:
● people who are bedridden and cannot move or be moved in acceptable conditions (home vaccination);
●
people in precarious situations that
prevent them from going to vaccination centers for various reasons
(vaccination directly with these people in the field or in collective
facilities such as day/night shelters for homeless people).
Vaccination surveillance
A
single
software package, Vaccinnet+, is used to record all vaccinated
people and allow all required activities related to surveillance and
pharmaco-vigilance. People in charge of the vaccination are responsible
for the uploading of data on vaccinated individuals
on Vaccinnet, including information about the received vaccine
(brand, lot number, date of vaccination, etc).
Sciensano is
charged with the vaccine surveillance plan. In order to achieve post
authorization monitoring and surveillance, COVID-19
testing data are coupled with the COVID-19 vaccine registry
Vaccinnet, in addition to other national datasets.
The surveillance plan includes:
•
National vaccine uptake and coverage: by vaccine brand, age, gender,
geographical
region, target group (Health Care Worker, >65y, 18/45-64y and
co-morbidities, nursing-home residents), and by socio-economic
indicators.
• Identification of breakthrough cases: i.e. Covid-19
confirmed cases occurring in fully vaccinated
individuals. Primary objective: Incidence rates of break-through
cases: by vaccine-brand, by age, gender, target group, by time since
vaccination, by severity. Secondary objective: Conservation of samples
of breakthrough cases for ulterior whole genome
sequencing (identification of mutations).
• Vaccine
effectiveness: the primary objective is to measure pandemic COVID-19
vaccine-effectiveness (CVE) against laboratory confirmed SARS-CoV-2 in
patients of all ages, by vaccine-brand. The secondary
objective is to estimate pandemic CVE against laboratory confirmed
SARS-CoV-2: by target group (Health Care Worker, >65y, 18/45-64y and
co-morbidities), by age-group, by gender, by risk-group (ex by specific
co-morbidities), by time since vaccination
and regularly over calendar time, by vaccine-dose (one vs two dose)
if applicable, and by specific genetic variant, if feasible and
documented.
• Vaccine safety in support of the FAMHP. The FAMHP regularly publish pharmaco-vigilance data
on adverse reactions, both for the public and health professionals.
Vaccination of health care professionals
In May 2022, the compulsory vaccination of health care professionals against COVID-19 is under discussion within the Parliament and has raised extensive discussions between the current political majority and the opposition. The proposal currently supported by the political majority is to impose compulsory vaccination on all health care professionals, but to allow for flexible entry into force, decided by the Council of Ministers, depending on the pandemic situation. This decision should be supported by scientific opinions, in particular from the Vaccination Taskforce and the Superior Health Council.