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A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
Superior Health
  Council

A BOOSTER DOSE OF mRNA COVID-19
VACCINATION FOR HEALTHCARE WORKERS

NOVEMBER 2021
SHC № 9679
          Lorem ipsum

 HCW
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
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Federal Public Service Health, Food Chain Safety
and Environment

Superior Health Council
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Tel.: 02/524 97 97
E-mail: info.hgr-css@health.fgov.be

All rights reserved.
Please cite this document as follows:
Superior Health Council. A booster dose of mRNA COVID-19
vaccination for healthcare workers. Brussels: SHC; 2021.
Report 9679.

Public advisory reports as well as booklets may be consulted
in full on the Superior Health Council website:
www.css-hgr.be

This publication cannot be sold.
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
ADVISORY REPORT OF THE SUPERIOR HEALTH COUNCIL no. 9679

           A booster dose of mRNA COVID-19 vaccination for healthcare workers

      In this scientific advisory report, which offers guidance to public health policy-makers,
    the Superior Health Council of Belgium provides recommendations on vaccination against
                                   COVID-19 for healthcare workers.

                This version was validated by the members of the NITAG and the Board on
                                              27 October 2021
                   This version will be validated by the College on 03 November 20211

      I     INTRODUCTION AND ISSUE

On September 30 2021, the Superior Health Council (SHC) received a request for advice from
the Task Force ‘Operationalisation vaccination strategy COVID-19’ on the need of booster
dose of COVID-19 vaccination for individuals working in the healthcare sector.

A third dose for immunocompromised patients to complete primary vaccination against
COVID-19 and a booster dose for elderly (≥ 65 years) and individuals living in care facilities
such as nursing homes has been already implemented in Belgium (SHC 9650).

      II    RECOMMENDATION

Vaccinating as many people as possible around the world is essential in managing this
pandemic. Within the COVAX project, Belgium is collaborating to fair and equitable access to
COVID-19 vaccines for every country in the world.

The SHC emphasizes the importance of primary vaccination against COVID-19 of the
general population; the SHC also recommends to make vaccination of workers in the health
care sector mandatory (SHC 9671, 2021). The term "people working in the healthcare sector"
includes all the socio-professional categories listed in the advisory report SHC 9597-9611 of
September 2020. Furthermore, the SHC would like to remind on the advisory report on
vaccination against seasonal influenza (SHC 9625) and simultaneous vaccination (SHC
9675).

1
  The Council reserves the right to make minor typographical amendments to this document at any time. On the other hand,
amendments that alter its content are automatically included in an erratum. In this case, a new version of the advisory report is
issued.

     Superior Health Council
     www.shc-belgium.be                                          −1−
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
Based on currently available data,

          - Healthcare workers are at the same risk of both symptomatic and severe infections
          and are no more prone to symptomatic or severe infections than the general population
          with the same vaccination status.
          - Healthcare workers were vaccinated early in the COVID-19 primary vaccination
          program: therefore they could have decreased immunity against viral colonization
          and/or asymptomatic/pauci symptomatic infection.
          - Healthcare workers present a risk of transmitting infections especially to vulnerable
          patients because in healthcare structures masks are systematically worn during care
          by healthcare workers but not always by patients in their rooms during care. In this
          context, the SHC reminds the importance of barrier measures and hand hygiene during
          care (SHC 9344, 2018) and reminds the procedure from RAG2 that any healthcare
          worker found to be PCR positive should be removed from the healthcare system
          whether symptomatic or not (except in certain circumstances, cfr RAG report 26 oct
          2020).
          - Even when vaccinated, the risk of confirmed infection by SARS-CoV-2 exists.
          However, a recent publication in a large population (Israël) showed that this risk
          decreases by a factor 11 after 15 days following the administration of a booster dose
          (Bar-on et al., 2021).
          - Healthcare workers will be confronted in the autumn/winter season with the
          management of pandemic SARS-CoV-2 patients but also other infectious respiratory
          diseases (such as seasonal influenza or RSV). By decreasing the risk of infection with
          SARS-CoV-2, a booster dose might help to ensure the sustainability of the healthcare
          system. A booster dose has been shown in preliminary data from Israël to be effective
          in reducing symptoms.
          - The safety data for a booster dose are similar to those for the first and second doses
          of the vaccine.

Within this overall context, the SHC recommends that a booster dose of a mRNA
vaccine against COVID-19 should be given to all healthcare workers over 18 years of
age at least 4-6 months after the primary vaccination against COVID-19 essentially to
ensure the sustainability of the healthcare system and to reduce the risk of nosocomial
infections.

Keywords

          Keywords          Sleutelwoorden          Mots clés        Schlüsselwörter
          Prevention        Preventie               Prévention       Verhütung
          Booster           Booster                 Rappel (dose)    Booster
          COVID-19          COVID-19                COVID-19         COVID-19
          Vaccination       Vaccinatie              Vaccination      Impfung
          Healthcare        Gezondheidswerkers      Travailleurs     Mitarbeiter   des
          Workers                                   du secteur de    Gesundheitswesens
                                                    soins       de
                                                    santé

2   RAG: Risk Assessment Group

     Superior Health Council
     www.shc-belgium.be                           −2−
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
III METHODOLOGY

After analysing the request, the Board and Chair of the area Vaccination identified the
necessary fields of expertise. An ad hoc working group was then set up which included experts
in hospital hygiene, microbiology, infectiology, epidemiology, vaccinology and general
medicine. The experts of this working group provided a general and an ad hoc declaration of
interests and the Committee on Deontology assessed the potential risk of conflicts of interest.

This advisory report is based on a review of the scientific literature published in both scientific
journals and reports from national and international organisations competent in this field (peer-
reviewed), as well as on the opinion of the experts.

Once the advisory report was endorsed by the working group and by the standing working
group Vaccination (NITAG), it was ultimately validated by the members of the Board of the
SHC.

   IV ELABORATION AND ARGUMENTATION

List of abbreviations used

CDC            Centers for Disease Control and Prevention
CEPI           Coalition for Epidemic Preparedness Innovations
ECDC           European Center for Disease Prevention and Control
HCW            Healthcare workers
NITAG          National Immunization Technical Advisory Group
RAG            Risk Assessment Group
SHC            Superior Health Council
VoC            Variants of Concern
WHO            World Health Organization

   1    WHO – statement on the administration of booster doses

On October 4 2021, the WHO published a statement on the administration of booster doses.

“The current primary goal of immunization in the COVID-19 pandemic remains to protect
against hospitalization, severe disease and death. Hence, booster doses may only be needed
if there is evidence of insufficient protection against these disease outcomes over time.

The degree of waning of immunity and need for booster doses of vaccine may differ between
vaccine products, target populations, circulating SARS-CoV-2 virus, in particular variants of
concern (VoC), and intensity of exposure.

In a period of continued global vaccine supply shortage equity considerations at country,
regional and global level remain an essential consideration to assure vaccination of high
priority groups in every country. Improving coverage of the primary vaccination series should
be prioritized over booster vaccination”. (WHO, Oct 2021)

Within the COVAX project, Belgium is collaborating to guarantee fair and equitable access for
every country in the world. By the end of October 2021 around 3 million doses of COVID-19
vaccines will be donated by Belgium (https://observablehq.com/@tf-vaccination/belvax).

  Superior Health Council
  www.shc-belgium.be                              −3−
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and
the World Health Organization (WHO), alongside key delivery partner UNICEF.

Within the framework of the coordinated European approach 'Team Europe', Belgium gave
priority to the donation of COVID-19 vaccines to the countries of the Western Balkans, the
Eastern Neighbourhood and Southern Europe, as well as to Africa.

    2   Vaccination against covid-19 for Healthcare workers

    2.1 Four different COVID-19 vaccines used for healthcare workers in Belgium

The four vaccines used against COVID-19 in Belgium became available successively, with
the Comirnaty® vaccine (Pfizer/BioNtech) first (28 December 2020), followed by the Spikevax
vaccine Moderna® (11 January 2021), the Vaxzevria® vaccine (AstraZenecaOxford) (12
February 2021), and finally the COVID-19 Janssen® vaccine (Johnson & Johnson) (28 April
2021). Caregivers were among the first to be vaccinated, with the majority receiving the first
available vaccine, Comirnaty® (61.5%), followed by Vaxzevria® (29.7%). Only a small
proportion of caregivers received the COVID-19 Vaccine Moderna® (8.5 %) or the COVID-19
Janssen® (0.3 %) (Catteau et al., Sciensano 2021).

Figure 1: Percentage of different brands of COVID-19 vaccines used for the first dose among healthcare providers
in Belgium (Sciensano, Catteau et al. 2021)

   Superior Health Council
   www.shc-belgium.be                                   −4−
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
Figure 2. Percentage of different brands of COVID-19 vaccines used for the first dose among health care providers
by professional category (Sciensano, Catteau et al. 2021)

    2.2 Vaccine effectiveness

The report of ECDC, published on September 1 2021, gives an update of the evidence on
vaccine effectiveness: https://www.ecdc.europa.eu/sites/default/files/documents/Interim-
public-health-considerations-for-the-provision-of-additional-COVID-19-vaccine-doses.pdf

A (preprint) study by Andrews et al. in the UK showed limited waning in vaccine
effectiveness against hospitalisation and death more than 20 weeks post-vaccination with
Vaxzevria® or Comirnaty®. There was greater waning in protection against hospitalisation
among the oldest age group, except in the 20+ weeks period with Vaxzevria®, though there
was limited data in the 40-64 years group for this period and confidence intervals overlapped
(Andrews et al., 2021).

A (preprint) study by Goldberg et al. from Israel indicated a strong waning in vaccine
effectiveness in all age groups after six months (Goldberg et al. 2021).

    2.3 Studies on booster vaccination against Covid-19

The booster dose increases vaccine efficacy in cases of infection and severe forms. For
example, the effectiveness data observed in real life concerning a booster dose of Comirnaty®
vaccine administered first to people aged 60 years or more who were vaccinated with two
doses at least five months previously show a reduction in the risk of infection with Covid-19.
These results show 11.3 times fewer cases of infection and 19.5 times fewer cases of severe
disease among those who received a booster dose than among those who did not (Bar-on et
al., 2021).

   Superior Health Council
   www.shc-belgium.be                                    −5−
A BOOSTER DOSE OF mRNA COVID-19 VACCINATION FOR HEALTHCARE WORKERS NOVEMBER 2021 SHC 9679 - Superior Health Council
Table. Primary outcome of confirmed infection and severe illness after booster vaccination in Israël (Bar-on et al.,
2021)

The administration of a booster dose would also reduce the viral load and therefore probably
the contagiousness of people who develop an SARS-CoV-2 infection.

Falsey et al. administered a third dose of the Pfizer mRNA vaccine 7.9 to 8.8 months after
dose 2 to 11 participants 18 to 55 years of age and to 12 participants 65 to 85 years of age.
Neutralizing responses were determined after 2 and 3 doses of the mRNA vaccine. They found
that 1 month after dose 3, neutralization GMTs against wild-type virus increased to more than
5 times as high (in 18-to-55-year-olds) and to more than 7 times as high (in 65-to-85-year-
olds) as the GMTs 1 month after dose 2.
Neutralization GMTs against the beta variant increased more after dose 3 than did GMTs
against wild-type virus, to more than 15 times as high (in younger adults) and more than 20
times as high (in older adults) as those after dose 2 (figure below).

   Superior Health Council
   www.shc-belgium.be                                     −6−
Figure. Neutralizing responses after two and three doses of BNT162b2 (Falsey et al. 2021)

Corbett et al. studied the immune response in nonhuman primates that received primary
vaccination series. Following boost, animals had increased neutralizing antibody responses
across all VOC3, which was sustained for at least 8 weeks post-boost. Nine weeks following
boost, animals were challenged with the SARS-CoV-2 β variant. Viral replication was low to
undetectable in bronchoalveolar lavages and significantly reduced in nasal swabs in all
boosted animals suggesting booster vaccinations may be required to sustain immunity and
protection (Corbett et al., 2021).

      2.4 Safety of booster vaccination

Booster dose in Israel has a safety profile similar to the other doses. Data were presented at
the Vaccines and Related Biological Products Advisory Committee (VRBRAC) of October 14-
15, 2021: https://www.fda.gov/media/153086/download (figures here below)

3
    VOC: variant of concern

     Superior Health Council
     www.shc-belgium.be                                 −7−
Superior Health Council
www.shc-belgium.be        −8−
2.5 Breakthrough infections for healthcare workers

Sciensano presented at the ad hoc meeting of Friday October 22 2021 its preliminary report
on protection offered by COVID-19 vaccines to healthcare workers in Belgium (Sciensano,
non-published data, van Loenhout et al., 2021).

These data showed that the probability of developing a breakthrough infection for healthcare
workers is not higher than for non-healthcare workers until at least 6 months after being fully
immunized.

Figure: Probability of breakthrough infection over time by healthcare worker status. From the 1st of February 2021
to 3th of October 2021; Belgium. No HCW = no healthcare worker, HCW = healthcare worker (Sciensano, 22 Oct
2021)

There was also no larger probability of infection observed for healthcare workers with an
assumed higher risk of exposure than for those with a moderate or low risk of exposure in
Belgium.

A recent study in Qatar showed that a history of contact with a confirmed case and presence
of symptoms were independently associated with higher risk for breakthrough SARS-CoV-2
infection after vaccination. This study also showed a very low rate of breakthrough infections
in healthcare workers (Alishaq et al., Oct 15 2021).

    2.6 Transmission of SARS-CoV-2

Limiting the transmission of the SARS-CoV-2 virus and protecting the most vulnerable remains
essential. It is therefore necessary to reinforce the vaccination protection of the populations
most exposed to the virus and likely to transmit the disease to people in contact with them, in
particular if they are at risk of developing a severe form of COVID-19 or dying from it. However,
despite the precautions taken (PPE), a significant number of SARS-CoV-2 infections are still
observed in institutions.

The Oxford University published in pre-print a study conducted by Eyre et al. showing that
vaccination reduces transmission of Delta, but less than the Alpha variant. The impact of
vaccination decreased over time. The authors conclude that booster vaccination may help
controlling transmission together with preventing infections (pre-print, Eyre et al., 2021).

Studies from several countries found significantly reduced likelihood of transmission to
household contacts from people infected with SARS-CoV-2 who were previously vaccinated
for COVID-19 (de Gier et al, 2021; Harris et al., 2021; Layan et al., 2021; Prunas et al., 2021;
Salo et al., 2021; Shah et al., 2021).

   Superior Health Council
   www.shc-belgium.be                                    −9−
Braeye et al. found significant protection against infection after a high-risk contact by a full
schedule of any of the vaccines currently administered in Belgium. Significant effects on
onward transmission in case of breakthrough infections were shown for mRNA-vaccines
(Braeye et al., 2021).

These data suggest that transmission risk is (substantially) reduced in vaccinated people and
that vaccinated people who become infected could be infectious for a shorter period of time
than unvaccinated people.

      2.7 Countries recommending a booster dose for HCW

Several countries started vaccinating their HCW such as the USA (CDC), France (HAS), UK
(JCVI) and Germany (STIKO).

      3   Recommendation

Vaccinating as many people as possible around the world is essential in managing this
pandemic. Within the COVAX project, Belgium is collaborating to fair and equitable access to
COVID-19 vaccines for every country in the world.

The SHC emphasizes the importance of primary vaccination against COVID-19 of the
general population; the SHC also recommends to make vaccination of workers in the health
care sector mandatory (SHC 9671, 2021). The term "people working in the healthcare sector"
includes all the socio-professional categories listed in the advisory report SHC 9597-9611 of
September 2020. Furthermore, the SHC would like to remind on the advisory report on
vaccination against seasonal influenza (SHC 9625) and simultaneous vaccination (SHC
9675).

Based on currently available data,

          - Healthcare workers are at the same risk of both symptomatic and severe infections
          and are no more prone to symptomatic or severe infections than the general population
          with the same vaccination status.
          - Healthcare workers were vaccinated early in the COVID-19 primary vaccination
          program: therefore they could have decreased immunity against viral colonization
          and/or asymptomatic/pauci symptomatic infection.
          - Healthcare workers present a risk of transmitting infections especially to vulnerable
          patients because in healthcare structures masks are systematically worn during care
          by healthcare workers but not always by patients in their rooms during care. In this
          context, the SHC reminds the importance of barrier measures and hand hygiene during
          care (SHC 9344, 2018) and reminds the procedure from RAG4 that any healthcare
          worker found to be PCR positive should be removed from the healthcare system
          whether symptomatic or not (except in certain circumstances, cfr RAG report 26 oct
          2020).
          - Even when vaccinated, the risk of confirmed infection by SARS-CoV-2 exists.
          However, a recent publication in a large population (Israël) showed that this risk
          decreases by a factor 11 after 15 days following the administration of a booster dose
          (Bar-on et al., 2021).
          - Healthcare workers will be confronted in the autumn/winter season with the
          management of pandemic SARS-CoV-2 patients but also other infectious respiratory
          diseases (such as seasonal influenza or RSV). By decreasing the risk of infection with
          SARS-CoV-2, a booster dose might help to ensure the sustainability of the healthcare

4   RAG: Risk Assessment Group

     Superior Health Council
     www.shc-belgium.be                           − 10 −
system. A booster dose has been shown in preliminary data from Israël to be effective
      in reducing symptoms.
      - The safety data for a booster dose are similar to those for the first and second doses
      of the vaccine.

Within this overall context, the SHC recommends that a booster dose of a mRNA
vaccine against COVID-19 should be given to all healthcare workers over 18 years of
age at least 4-6 months after the primary vaccination against COVID-19 essentially to
ensure the sustainability of the healthcare system and to reduce the risk of nosocomial
infections.

  Superior Health Council
  www.shc-belgium.be                          − 11 −
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    2021;https://www.medrxiv.org/content/10.1101/2021.07.13.21260393v1

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-   RAG. Health staff with covid-19 infection. 26 October 2020. https://covid-
    19.sciensano.be/sites/default/files/Covid19/20201026_Advice_RAG_COVID%2B%20
    health%20workers.pdf
-   RKI: https://www.rki.de/DE/Content/Kommissionen/STIKO/Empfehlungen/PM_2021-
    10-07.html
    https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/Ausgaben/43_21.pdf?__bl
    ob=publicationFile
-   Salo J, Hagg M, Kortelainen M, et al. The indirect effect of mRNA-based Covid-19
    vaccination       on      unvaccinated         household     members.       medRxiv.
    2021;https://www.medrxiv.org/content/10.1101/2021.05.27.21257896v2.
-   Shah A, Gribben C, Bishop J, et al. Effect of vaccination on transmission of COVID-
    19: an observational study in healthcare workers and their households. medRxiv.
    2021;https://www.medrxiv.org/content/10.1101/2021.03.11.21253275v1
-   Smriti Mallapaty. Nature 05 October 2021. COVID vaccines cut the risk of transmitting
    Delta — but not for long. doi: https://doi.org/10.1038/d41586-021-02689-y
-   WHO. Interim statement on booster doses for COVID-19 vaccination. Oct 4,2021.
    https://www.who.int/news/item/04-10-2021-interim-statement-on-booster-doses-for-
    covid-19-vaccination

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VI COMPOSITION OF THE WORKING GROUP

The composition of the Committee and that of the Board as well as the list of experts appointed
by Royal Decree are available on the following website: About us.

All experts joined the working group in a private capacity. Their general declarations of
interests as well as those of the members of the Committee and the Board can be viewed on
the SHC website (site: conflicts of interest).

An ad hoc meeting was organised on Friday October 22, 2021. Based on the discussions and
conclusions of this meeting, this advisory report was drafted and send for approval to the
standing working group Vaccination (NITAG) by email on Wednesday October 27, 2021. The
following experts participated at the ad hoc meeting and/or approval of the report. The
standing and ad hoc working group were chaired by Yves VAN LAETHEM; the scientific
secretariat were Veerle MERTENS, Fabrice PETERS and Muriel BALTES.

  BEUTELS Philippe    Health Economics                                 UAntwerpen
  BLUMENTAL Sophie    Infectiology                                     HUDERF
  BYL Baudouin        Hospital Hygiene, Epidemiology                   CHU Erasme, ULB
  CALLENS Steven      Infectiology, Internal medicine                  UZ Gent
  CHATZIS Olga        Pediatrics, Vaccinology                          UCL
  CORNELISSEN Laura   Epidemiology,                Obstetrics,         Sciensano
                      Gynaecology
  DAELEMANS Siel      Infectiology, Vaccinology, Travel clinic         UZBrussel
  DE LOOF Geert       General medicine                                 BCFI
  DE SCHEERDER Marie- Internal medicine, Infectiology, Travel          UZ Gent
  Angélique           clinic, HIV
  DESMET Stefanie     Microbiology                                     UZ Leuven
  DOGNE Jean- Michel  Farmacovigilance                                 UNamur, EMA
  FLAMAING Johan      Geriatrics                                       KU Leuven
  FRERE Julie         Pediatrics, Infectiology                         CHU Liège
  GERARD Michèle      Hospital Hygiene, Infectiology                   CHU St Pierre, ULB
  LEROUX-ROELS Isabel Vaccinology, Infection prevention,               UZ Gent
                      Microbiology
  MANIEWSKI Ula       Infectiology,     Tropical    infectious         ITG-IMT
                      diseases, Vaccinology
  MALFROOT Anne       Pediatrics, Infectiology                         UZ Brussel
  PELEMAN Renaat      Infectiology, Vaccinology                        UZ Gent
  ROBERFROID          Epidemiology                                     KCE, UNamur
  Dominique
  SCHELSTRAETE Petra Pediatrics, Pneumology, Vaccinology               UGent
  SCHOEVAERDTS        Geriatrics                                       UCLouvain
  Didier
  SIMON Anne          Microbiology, Hospital hygiene                   Jolimont
  SOENTJENS Patrick   Internal medicine, Tropical infectious           ITG - Defensie
                      diseases
  SWENNEN Béatrice    Epidemiology, Vaccinology                        ULB
  THEETEN Heidi       Vaccinology                                      UAntwerpen

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TILMANNE Anne             Pediatrics, Infectiology                CHU TIVOLI
  TUERLINCKX David          Pediatrics, Vaccinology                 CHU UCL Namur
  VAN DAMME Pierre          Epidemiology, Vaccinology               UAntwerpen
  VAN     DER LINDEN        Pediatrics, Infectiology                UCLouvain
  Dimitri
  VAN KERSSCHAEVER          General Medicine                        Domus Medica
  Greet
  VAN LAETHEM Yves          Infectiology,  Vaccinology,  Travel CHU Saint-Pierre, ULB
                            medicine, HIV
  VAN LOENHOUT Joris        Epidemiology, Infectiology          Sciensano
  VANDEN DRIESSCHE          Pediatrics, Immunology, Pneumology UZA
  Koen
  VERHAEGEN Jan             Microbiology, Bacteriology             UZ Leuven
  WAETERLOOS                Quality of vaccines and blood products Sciensano
  Geneviève
  WYNDHAM-THOMAS            Epidemiology, Infectiology              Sciensano
  Chloé

The following experts or administrations were heard but did not take part in endorsing the
advisory report.

  CARRILLO                                                          ONE
  SANTISTEVE Paloma
  DAEMS Joël                                                        RIZIV-INAMI

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