10.14639/0392-100X-N2131
text/xml
1827-675X
2131
en
Valérie Pourcher
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
guidelines
Peripheral facial palsy following COVID-19 vaccination: a practical approach to use the clinical situation as a guide
Text.Serial.Journal
https://www.actaitalica.it/
42
Letters to the Editor-in-Chief
2022-06-30
2022-04-20
2022-07-26
2022-07-26
300-303
1
Valérie Pourcher
2022/06/30
10.14639/0392-100X-N2131
300
Sorbonne University, Department of Infectious Diseases and Tropical Medicine, Pitié- Salpêtrière University Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP), Paris, France; INSERM, Institut Pierre Louis d’Épidémiologie et de Santé Publique, Paris, France. N. Weiss and V. Pourcher contributed equally to this work.
1827-675X
guidelines
en
303
Peripheral facial palsy following COVID-19 vaccination: a practical approach to use the clinical situation as a guide
https://www.actaitalica.it/article/download/2131/838
42
ACTA OTORHINOLARYNGOLOGICA ITALICA 2022;42:300-303; doi: 10.14639/0392-100X-N2131




Letter to the Editor


Peripheral facial palsy following COVID-19
vaccination: a practical approach to use the clinical
situation as a guide
Paralisi facciale periferica dopo vaccinazione per COVID-19:
una guida per un approccio pratico alla problematica clinica
Claire Foirest1, Kévin Bihan2, Frédéric Tankéré1, Helga Junot3, Sophie Demeret4, Rabab Debs 5, Elisabeth Maillart6,
Christine Lebrun-Frenay7, Augustin Vigouroux1, Maxime Caudron1, Etienne Canouï8, Georges Lamas1,
Nicolas Weiss4,9,10,11*, Valérie Pourcher12,13 *
1
  ENT Department, Pitié-Salpêtrière University Hospital, Assistance Publique des
Hôpitaux de Paris (AP-HP), Paris, France; 2 Centre Régional de Pharmacovigilance,
Service de Pharmacologie, Hôpitaux Universitaires La Pitié Salpêtrière-Charles
Foix, AP-HP, Paris, France; 3 Pharmacy, Pitié Salpetrière Univ. Hospital, Assistance
Publique des Hôpitaux de Paris (AP-HP), Paris, France; 4 Sorbonne Université, AP-
HP. Sorbonne Université, Hôpital de la Pitié-Salpêtrière, Département de Neurologie,
Unité de Médecine Intensive Réanimation à orientation neurologique, Paris, France;
5
  Departement of Neurophysiology, Pitié-Salpêtrière University Hospital, Assistance
Publique des Hôpitaux de Paris (APHP) Paris, France; 6 Neurology Departement,
Pitié-Salpêtrière University Hospital, Assistance Publique des Hôpitaux de Paris
(APHP) Paris, France; 7 CRCSEP CHU de Nice. UR2CA URRIS. Université Côte
d’Azur, Nice, France; 8 : Antimicrobial Stewardship Team GH Paris Centre,
Cochin Hospital, APHP, Paris, France; 9 Brain Liver Pitié-Salpêtrière (BLIPS) Study
Group; 10 INSERM UMR_S 938, Centre de Recherche Saint-Antoine, Maladies
métaboliques, biliaires et fibro-inflammatoire du foie; 11 Institute of Cardiometabolism
and Nutrition (ICAN), Paris, France & Groupe de Recherche Clinique en REanimation          Received: April 20, 2022
et Soins intensifs du Patient en Insuffisance Respiratoire aiguE (GRC-RESPIRE)             Accepted: May 16, 2022
Sorbonne Université; 12 Sorbonne University, Department of Infectious Diseases
and Tropical Medicine, Pitié- Salpêtrière University Hospital, Assistance Publique         Correspondence
des Hôpitaux de Paris (AP-HP), Paris, France; 13 INSERM, Institut Pierre Louis             Claire Foirest
d’Épidémiologie et de Santé Publique, Paris, France                                        ENT Department, Pitié-Salpêtrière University
*
  N. Weiss and V. Pourcher contributed equally to this work.                               Hospital, Assistance Publique des Hôpitaux de Paris
                                                                                           (AP-HP), 47-83, boulevard de l’Hôpital, 75013
                                                                                           Paris, France
                                                                                           Tel. + 33 142163111. Fax +33 142163128
KEY WORDS: COVID-19 vaccination, peripheral facial palsy, pharmacovigilance data,          E-mail: claire.foirest@aphp.fr
adverse effect, guidelines
PAROLE CHIAVE: vaccinazione anti COVID-19, paralisi facciale periferica,                     How to cite this article: Foirest C, Bihan K,
farmacovigilanza, effetti avversi, linee guida                                               Tankéré F, et al. Peripheral facial palsy following
                                                                                             COVID-19 vaccination: a practical approach to
                                                                                             use the clinical situation as a guide. Acta Otorhi-
                                                                                             nolaryngol Ital 2022;42:300-303. https://doi.
Dear Editor,                                                                                 org/10.14639/0392-100X-N2131
in the face of the various phases of the COVID-19 epidemic, governments
                                                                                           © Società Italiana di Otorinolaringoiatria
have called for a massive vaccination of the population. As soon as randomised             e Chirurgia Cervico-Facciale
Phase 3 clinical trials were set up to test the efficacy of mRNA vaccines in
protecting against COVID-19, the occurrence of peripheral facial palsy (PFP)                              OPEN ACCESS
was reported with a higher incidence than that observed in the placebo group 1,            This is an open access article distributed in accordance with
and confirmed worldwide in larger populations. However, it should be noted                 the CC-BY-NC-ND (Creative Commons Attribution-Non-
                                                                                           Commercial-NoDerivatives 4.0 International) license. The
that the incidence remains low, and seems comparable to that of PFP follow-                article can be used by giving appropriate credit and mentio-
                                                                                           ning the license, but only for non-commercial purposes and
ing administration of other vaccines such as anti-influenza 2. The two types of            only in the original version. For further information: https://
vaccines [messenger RNA (mRNA) vaccines and viral vector vaccines] seem                    creativecommons.org/licenses/by-nc-nd/4.0/deed.en




300
                                                                                Peripheral facial palsy following COVID-19 vaccination




to promote herpetic viral reactivation 3 with a risk of PFP.    adenovirus vector vaccine (Vaxzevria®, Oxford-AstraZen-
To date, research in the worldwide pharmacovigilance da-        eca) for short, low-dose corticosteroid therapy (< 30 mg
tabase has found more than 19,000 reported cases (includ-       prednisone) 5. Another study showed a trend towards lower
ing nearly 1,100 in France) of PFP following vaccination        immunogenicity of BNT162b2 for patients on low-dose
against COVID-19, with the following breakdown: 85%             steroids for an extended period 6. Consequently, in the
with mRNA vaccines and 15% with viral vector vaccines.          case of high-dose corticosteroid therapy prescribed close
In this context, from June 2021 to January 2022, we man-        to vaccination (< 15 days), it seems legitimate to ensure
aged 41 cases of PFP following expansion of the COV-            a good vaccine response, as suggested by the French rec-
ID-19 vaccination to the general population in June 2021.       ommendations of the “Conseil d’Orientation pour la Stra-
We received numerous calls for advice by our colleagues         tégie Vaccinale” (COSV) dated 19 November 2021. Thus,
at other sites. We are also solicited daily by patients them-   quantitative IgG anti-Spike serology monitoring would be
selves, who are worried about the risk of recurrence of PFP     recommended after 15 days of the booster. If the antibody
described in the prescribing information of the different       level is > 260 BAU/mL, the protection conferred by vacci-
vaccines.                                                       nation is considered sufficient. Serological follow-up may
To provide an answer to these patients and our colleagues,      be suggested if immunosuppression persists.
and in the absence of definitive scientific data, we have lo-
cally gathered a group of experts from different specialties    Attitude towards COVID-19 vaccine
(ENT, infectiology, neurology, pharmacovigilance, phar-
                                                                and boosters
macy, virology) in order to give advice on a case-by-case
basis and have established local guidelines according to the    Given the severity of the pandemic and the risks associ-
different situations that may arise. Our proposals as an ex-    ated with COVID-19, we agree that the development of
pert group are summarised below.                                PFP following SARS-Cov2 vaccination should not always
                                                                contraindicate subsequent booster vaccinations. Our prac-
                                                                tical approach for the vaccination in the case of PFP after
Initial management of PFP
                                                                vaccination against COVID-19 is summarised in Table I.
Any acute or subacute (< 72 hours) onset PFP following pri-     After discussion and review of scientific data, we consider
mary vaccination against COVID-19 or following a booster        that in cases of mild post-vaccine PFP (grades II, III, IV
vaccination should be reported to pharmacovigilance as          according to the House and Brackmann classification 7),
soon as possible (after informing the patient). As this is a    where the prognosis for recovery is favourable 8, the ini-
diagnosis of exclusion, a standardised clinical examination     tially planned vaccination schedule should be maintained.
and complementary explorations should be systematically         Clinical examination should be systematically performed
performed according to French ENT guidelines 4. Any PFP         before the next vaccine dose to assess the degree of recov-
that occurs after COVID-19 vaccination should be treated        ery.
as soon as possible in the same way as idiopathic PFP ac-       In cases of severe PFP following vaccination against COV-
cording to the French ENT guidelines 4 (high-dose corti-        ID-19 (grades V and VI 4) with poor prognostic factors
costeroid, 1 to 2 mg/kg/day depending on severity) for 8 to     for recovery 8, and in the absence of early recovery (< 3
10 days and antiviral treatment with valaciclovir (3 g/day      months) of symptoms, it is proposed that further doses be
for 7 days).                                                    deferred. In this case, the patient should be discussed at a
                                                                dedicated multidisciplinary consultation meeting (MCM)
High-dose corticosteroid therapy on vaccine                     to assess the benefit-risk balance as best as possible accord-
                                                                ing to the individual case, context and degree of recovery
response                                                        from PFP (clinical re-evaluation every two months).
The French High Council of Public Health, in its 2014 re-       A severe PFP without favourable evolution at 6 months,
port, contraindicates live vaccines when the doses used are     whether it occurs in a post-vaccine context or not, should
considered immunosuppressive (10 mg prednisone equiva-          be the subject of a new clinical and MRI imaging assess-
lent per day for more than 2 weeks or bolus corticosteroids     ment.
(≥ 500mg/day). Regarding vaccination against COVID-19,          Data from the literature suggest an overall increased risk of
data on long-term corticosteroid therapy shows a decreased      PFP after COVID-19 vaccination 1. However, the beneficial
vaccine response for the BNT162b2 COVID-19 mRNA                 and protective effects of the COVID-19 vaccine far out-
vaccine (Comirnaty®, BioNTech-Pfizer). One study identi-        weigh the risk of this generally self-limiting adverse event.
fied a decrease in immunogenicity of ChAdOx1 nCoV-19            Thus, despite severe PFP without recovery at 3 months, a



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C. Foirest et al.




Table I. Practical approach for vaccination in case of PFP following vaccination against COVID-19.
                                                                Recommended vaccination                                            Authorised vaccines
 History of PFP other than vaccine                                                  Yes                                                           All
 PFP grade II, III, IV* post-vaccine                                                Yes                             All, including those suspected of being responsible for
                                                                                                                                               the PFP
 PFP grade V, VI* post-vaccination with rapid clinical                              Yes                                           Propose to continue the vaccine
 recovery                                                                                                            regimen with another modality (mRNA or viral vector)
 PFP grade V, VI* post-vaccine without recovery                               Suspended;                                      If the benefit-risk balance is in favour
 or with severe after-effects                                  Assessment of the benefit-risk balance                  of a booster vaccination, continue the vaccination
                                                             according to the patient’s comorbidities and                    schedule with another type of vaccine;
                                                             context; Regular re-evaluation according to           If no, suspend booster for 6 months and then reassess
                                                                           clinical evolution;
                                                                    Decision to be made in MCM
 History of post-vaccination PFP, patient requesting                              Yes,                             Propose to continue the vaccine scheme with another
 a complete vaccination scheme, regardless of the             Exhaustive information given to the patient                     modality (mRNA or viral vector)
 severity of the PFP
* Following House and Brackmann grading scale 7; PFP: peripheral facial palsy; MCM: Multidisciplinary Consultation Meeting.



patient requesting vaccination may be vaccinated later de-                                 COVID-19 vaccine should protect against the risk of post-
pending on the disease progression after being informed of                                 COVID PFP.
the benefits and risks.                                                                    In conclusion, the risk of PFP after vaccination against
In the case of PFP in a post-vaccination context, the pa-                                  COVID-19 is low and seems comparable to that of PFP
tient might be offered to change the type of vaccine for the                               following the administration of other vaccines such as anti-
subsequent injections if it is adapted to the general context                              influenza vaccines. Herein, we propose a practical transdis-
of the patient and national recommendations. If an mRNA                                    ciplinary approach for management of PFP in the context
vaccination was used, a booster with another vaccine, either                               of a recent vaccination against SARS-CoV-2. Further stud-
the other mRNA vaccine or an inactivated SARS-CoV-2                                        ies are needed to evaluate the impact of a booster vaccine
vaccine, may be preferred.                                                                 on the facial nerve.

What to offer in case of prior history of PFP                                              Conflict of interest statement
                                                                                           The authors declare no conflict of interest.
before COVID-19 pandemic?
From a clinical, patient-oriented perspective, none of the                                 Funding
studies published so far provide definitive evidence to in-                                This research did not receive any specific grant from fund-
form the choice of a specific vaccine in individuals world-                                ing agencies in the public, commercial, or not-for-profit
wide with a history of PFP (idiopathic or not) 9. While                                    sectors.
waiting for conclusive evidence on vaccine-associated fa-
cial palsy, one certainty remains: the benefit of getting vac-                             Authors’ contributions
cinated outweighs any possible risk.                                                       CF, KB, EC, VF and NW collected the information, and
In the case of a history of PFP other than vaccination                                     wrote the Letter. CF, FT, AV, MC and GL provided the
against COVID-19, and regardless of the degree of recov-                                   ENT expertise and reviewed the article. KB, HJ provided
ery, there is no contraindication to vaccination, irrespective                             the pharmacological expertise and reviewed the article. SD,
of the specialty used. According to the current recommen-                                  RD, EM, CLF and NW provided the neurological expertise
dations, the COVID- 19 vaccination scheme must then be                                     and reviewed the article. EC and VP provided the infec-
completed. The risk of recurrence of idiopathic PFP, out-                                  tious diseases expertise and reviewed the article.
side of a vaccine context, is about 6.5% 4. Further studies
are needed to determine whether this risk is higher in vac-
cinated patients with a history of PFP prior to vaccination
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