Appropriateness for SARS-CoV-2 vaccination for otolaryngologist and head and neck surgeons in case of pregnancy, breastfeeding, or childbearing potential: Yo-IFOS and CEORL-HNS joint clinical consensus statement.
Saibene, Alberto Maria; Allevi, Fabiana; Ayad, Tarecket al.
2021 • In European Archives of Oto-Rhino-Laryngology, 278 (10), p. 4091-4099
[en] PURPOSE: SARS-CoV-2 vaccines are a key step in fighting the pandemic. Nevertheless, their rapid development did not allow for testing among specific population subgroups such as pregnant and breastfeeding women, or elaborating specific guidelines for healthcare personnel working in high infection risk specialties, such as otolaryngology (ORL). This clinical consensus statement (CCS) aims to offer guidance for SARS-CoV-2 vaccination to this high-risk population based on the best evidence available. METHODS: A multidisciplinary international panel of 33 specialists judged statements through a two-round modified Delphi method survey. Statements were designed to encompass the following topics: risk of SARS-Cov-2 infection and use of protective equipment in ORL; SARS-Cov-2 infection and vaccines and respective risks for the mother/child dyad; and counseling for SARS-CoV-2 vaccination in pregnant, breastfeeding, or fertile healthcare workers (PBFHW). All ORL PBFHW were considered as the target audience. RESULTS: Of the 13 statements, 7 reached consensus or strong consensus, 2 reached no consensus, and 2 reached near-consensus. According to the statements with strong consensus otorhinolaryngologists-head and neck surgeons who are pregnant, breastfeeding, or with childbearing potential should have the opportunity to receive SARS-Cov-2 vaccination. Moreover, personal protective equipment (PPE) should still be used even after the vaccination. CONCLUSION: Until prospective evaluations on these topics are available, ORL-HNS must be considered a high infection risk specialty. While the use of PPE remains pivotal, ORL PBFHW should be allowed access to SARS-CoV-2 vaccination provided they receive up-to-date information.
Saibene, Alberto Maria; ORCID: 0000-0003-1457-6871 ; Otolaryngology Unit, ASST Santi Paolo E Carlo, Department of Health Sciences, ; Young Otolaryngologists-International Federation of Otorhinolaryngological
Allevi, Fabiana; ORCID: 0000-0002-5012-4031 ; Maxillofacial Surgery Unit, ASST Santi Paolo E Carlo, Department of Health
Ayad, Tareck; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Division of Otolaryngology-Head and Neck Surgery, Centre Hospitalier de
Baudoin, Tomislav; Department of Otorhinolaryngology and Head and Neck Surgery, University Clinical ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS),
Bernal-Sprekelsen, Manuel; ORCID: 0000-0001-8191-9833 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Rhinology and Skull Base Unit, Department of Otorhinolaryngology, Hospital
Briganti, Giovanni ; Université de Mons - UMONS > Faculté de Médecine et de Pharmacie > Service de Neurosciences ; ORCID: 0000-0002-4038-3363 ; Richard J McNally Laboratory, Harvard University, Cambridge, MA, USA.
Carrie, Sean; ORCID: 0000-0003-1722-1814 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Freeman Hospital, Newcastle, UK.
Cayé-Thomasen, Per; ORCID: 0000-0002-6837-694X ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of Oto-Rhino-Laryngology, Head and Neck Surgery, and Audiology,
Dauby, Nicolas; ORCID: 0000-0002-7697-6849 ; Department of Infectious Diseases, CHU Saint-Pierre, Université Libre de ; School of Public Health, Université Libre de Bruxelles (ULB), Brussels, Belgium. ; Institute for Medical Immunology, Brussels, Belgium.
Fenton, John; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of ORL-HNS, University of Limerick Medical School, Limerick, Ireland.
Golusiński, Wojciech; ORCID: 0000-0002-6075-3464 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of Head and Neck Surgery, Poznan University of Medical Sciences, The
Klimek, Ludger; ORCID: 0000-0002-2455-0192 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Center for Rhinology and Allergology, Wiesbaden, Germany.
Leclerc, Andrée-Anne; ORCID: 0000-0003-2398-8018 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Division of Otolaryngology and Head and Neck Surgery, University of Montréal,
Longtin, Yves; Department of Medicine, Jewish General Hospital, Montreal, Canada.
Mannelli, Giuditta; ORCID: 0000-0001-7079-3964 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Head and Neck Oncology and Robotic Surgery, Azienda Ospedaliero Universitaria
Mayo-Yáñez, Miguel; ORCID: 0000-0002-1829-6597 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario ; Clinical Research in Medicine, International Center for Doctorate and Advanced
Meço, Cem; ORCID: 0000-0001-8372-8045 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of ORL-HNS, Ankara University Medical School, Ankara, Turkey. ; Department of ORL-HNS, Salzburg Paracelsus Medical University, Salzburg, Austria.
Metwaly, Osama; ORCID: 0000-0002-4470-7329 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Kasr Alainy School of Medicine, Cairo University, Giza, Egypt.
Mouawad, François; ORCID: 0000-0001-6307-2907 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Lille,
Niemczyk, Kazimierz; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of Otorhinolaryngology, Head and Neck Surgery, Medical University of
Pedersen, Ulrik; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; University Clinic of ORL-HNS, Aarhus University Hospital, Aarhus, Denmark.
Piersiala, Krzysztof; ORCID: 0000-0003-3844-5999 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska
Plzak, Jan; ORCID: 0000-0003-3710-4455 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of
Remacle, Marc; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of ORL-Head & Neck Surgery, Centre Hospitalier du Luxembourg,
Rommel, Nathalie; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of Gastroenterology, Neurosciences, Experimental ORL,
Saleh, Hesham; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Department of Otolaryngology, Charing Cross and Royal Brompton Hospitals,
Szpecht, Dawid; ORCID: 0000-0002-7966-3768 ; Department of Neonatology, Poznan University of Medical Sciences, Poznan, Poland.
Tedla, Miroslav; ORCID: 0000-0002-3471-7195 ; Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), ; Medical Faculty, Comenius University, Bratislava, Slovakia.
Tincati, Camilla; ORCID: 0000-0002-3083-2962 ; Infectious Disease Unit, ASST Santi Paolo E Carlo, Department of Health Sciences,
Tucciarone, Manuel; ORCID: 0000-0001-6463-1459 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Department of Otorhinolaryngology and Head and Neck Surgery, Jerez University
Zelenik, Karol; ORCID: 0000-0003-1349-9958 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital
Lechien, Jerome R; ORCID: 0000-0002-0845-0845 ; Young Otolaryngologists-International Federation of Otorhinolaryngological ; Department of Otolaryngology-Head and Neck Surgery, Foch Hospital, Paris Saclay
Appropriateness for SARS-CoV-2 vaccination for otolaryngologist and head and neck surgeons in case of pregnancy, breastfeeding, or childbearing potential: Yo-IFOS and CEORL-HNS joint clinical consensus statement.
Woolf SH, Chapman DA, Lee JH (2021) COVID-19 as the leading cause of death in the United States. JAMA 325:123–124 DOI: 10.1001/jama.2021.5199
Saibene AM, Allevi F, Biglioli F, Felisati G (2020) Role and management of a head and neck department during the COVID-19 outbreak in Lombardy. Otolaryngol Head Neck Surg 162:795–796 DOI: 10.1177/0194599820917914
Chou R, Dana T, Buckley DI et al (2020) Epidemiology of and risk factors for coronavirus infection in health care workers: a living rapid review. Ann Intern Med 173:120–136 DOI: 10.7326/M20-1632
Magill JC, Unadkat S, Bullock E et al (2021) Rhinology in the COVID-19 era: our experience from a rhinology tertiary referral hospital and implications for future practice. ClinOtolaryngol 46:96–100
Zou L, Ruan F, Huang M et al (2020) SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med 382:1177–1179 DOI: 10.1056/NEJMc2001737
Parilli-Troconis D, Baptista P, Marcano-Lozada M et al (2020) COVID-19 infection and its influence in otorhinolaryngology-head and neck surgery. Int Arch Otorhinolaryngol 24:e527–e534 DOI: 10.1055/s-0040-1715586
Szilagyi PG, Thomas K, Shah MD et al (2020) National trends in the US public’s likelihood of getting a COVID-19 vaccine—April 1 to December 8, 2020. JAMA. 10.1001/jama.2020.26419 DOI: 10.1001/jama.2020.26419
Verger P, Scronias D, Dauby N et al (2021) Attitudes of healthcare workers towards COVID-19 vaccination: a survey in France and French-speaking parts of Belgium and Canada, 2020. Euro Surveill 26:2002047 DOI: 10.2807/1560-7917.ES.2021.26.3.2002047
Dashraath P, Nielsen-Saines K, Madhi SA, Baud D (2020) COVID-19 vaccines and neglected pregnancy. Lancet 396:e22 DOI: 10.1016/S0140-6736(20)31822-5
Li T (2020) Diagnosis and clinical management of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection: an operational recommendation of Peking Union Medical College Hospital (V2.0). Emerg Microbes Infect 9:582–585 DOI: 10.1080/22221751.2020.1735265
Allotey J, Stallings E, Bonet M et al (2020) Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ 370:m3320 DOI: 10.1136/bmj.m3320
Maykin MM, Heuser C, Feltovich H, with the Society for Maternal-Fetal Medicine Health Policy Advocacy Committee (2021) Pregnant people deserve the protection offered by SARS-CoV-2 vaccines. Vaccine 39:171–172 DOI: 10.1016/j.vaccine.2020.12.007
Rosenfeld RM, Nnacheta LC, Corrigan MD (2015) Clinical consensus statement development manual. Otolaryngol Head Neck Surg 153:S1–S14 DOI: 10.1177/0194599815601394
Remuzzi A, Remuzzi G (2020) COVID-19 and Italy: what next? The Lancet 395:1225–1228 DOI: 10.1016/S0140-6736(20)30627-9
Lu D, Wang H, Yu R et al (2020) Integrated infection control strategy to minimize nosocomial infection of coronavirus disease 2019 among ENT healthcare workers. J Hosp Infect 104:454–455 DOI: 10.1016/j.jhin.2020.02.018
Martin-Villares C, Bernal-Sprekelsen M, Molina-Ramirez CP et al (2021) Risk of contagion of SARS-CoV-2 among otorhinolaryngologists in Spain during the “Two waves.” Eur Arch Otorhinolaryngol. 10.1007/s00405-020-06582-8 DOI: 10.1007/s00405-020-06582-8
Cheng X, Liu J, Li N et al (2020) Otolaryngology providers must be alert for patients with mild and asymptomatic COVID-19. Otolaryngol Head Neck Surg 162:809–810 DOI: 10.1177/0194599820920649
Thamboo A, Lea J, Sommer DD et al (2020) Clinical evidence based review and recommendations of aerosol generating medical procedures in otolaryngology—head and neck surgery during the COVID-19 pandemic. J Otolaryngol Head Neck Surg 49:28 DOI: 10.1186/s40463-020-00425-6
Mick P, Murphy R (2020) Aerosol-generating otolaryngology procedures and the need for enhanced PPE during the COVID-19 pandemic: a literature review. J Otolaryngol Head Neck Surg 49:29 DOI: 10.1186/s40463-020-00424-7
Bertossi D, Mohsahebi A, Philipp-Dormston WG et al (2020) Safety guidelines for nonsurgical facial procedures during COVID-19 outbreak. J CosmetDermatol 19:1829–1837
Sowerby LJ, Stephenson K, Dickie A et al (2020) International registry of otolaryngologist-head and neck surgeons with COVID-19. Int Forum Allergy Rhinol 10:1201–1208 DOI: 10.1002/alr.22677
Radulesco T, Lechien JR, Sowerby LJ et al (2020) Sinus and anterior skull base surgery during the COVID-19 pandemic: systematic review, synthesis and YO-IFOS position. Eur Arch Otorhinolaryngol. 10.1007/s00405-020-06236-9 DOI: 10.1007/s00405-020-06236-9
Sharma A, Bhardwaj R (2020) COVID-19 and ENT surgery: a brief review of essential precautions and triage. Eur Arch Otorhinolaryngol. 10.1007/s00405-020-06207-0 DOI: 10.1007/s00405-020-06207-0
Leboulanger N, Sagardoy T, Akkari M et al (2020) COVID-19 and ENT Pediatric otolaryngology during the COVID-19 pandemic. Guidelines of the French Association of Pediatric Otorhinolaryngology (AFOP) and French Society of Otorhinolaryngology (SFORL). Eur Ann Otorhinolaryngol Head Neck Dis 137:177–181 DOI: 10.1016/j.anorl.2020.04.010
Unadkat SN, Andrews PJ, Bertossi D et al (2020) Recovery of elective facial plastic surgery in the post-coronavirus disease 2019 Era: recommendations from the European Academy of Facial Plastic Surgery Task Force. Facial PlastSurgAesthet Med 22:233–237 DOI: 10.1089/fpsam.2020.0258
Park JS, El-Sayed IH, Young VN, Pletcher SD (2020) Development of clinical care guidelines for faculty and residents in the era of COVID-19. Head Neck 42:1403–1408 DOI: 10.1002/hed.26225
Diriba K, Awulachew E, Getu E (2020) The effect of coronavirus infection (SARS-CoV-2, MERS-CoV, and SARS-CoV) during pregnancy and the possibility of vertical maternal-fetal transmission: a systematic review and meta-analysis. Eur J Med Res 25:39 DOI: 10.1186/s40001-020-00439-w
do Amaral WN, de Moraes CL, Rodrigues APDS et al (2020) Maternal coronavirus infections and neonates born to mothers with SARS-CoV-2: a systematic review. Healthcare. 10.3390/healthcare8040511 DOI: 10.3390/healthcare8040511
Rodrigues C, Baía I, Domingues R, Barros H (2020) Pregnancy and breastfeeding during COVID-19 pandemic: a systematic review of published pregnancy cases. Front Public Health 8:558144 DOI: 10.3389/fpubh.2020.558144
Moyer CA, Compton SD, Kaselitz E, Muzik M (2020) Pregnancy-related anxiety during COVID-19: a nationwide survey of 2740 pregnant women. Arch WomensMent Health 23:757–765 DOI: 10.1007/s00737-020-01073-5
Yan H, Ding Y, Guo W (2020) Mental health of pregnant and postpartum women during the coronavirus disease 2019 pandemic: a systematic review and meta-analysis. Front Psychol 11:617001 DOI: 10.3389/fpsyg.2020.617001
Dancause KN, Laplante DP, Oremus C et al (2011) Disaster-related prenatal maternal stress influences birth outcomes: project Ice Storm. Early Hum Dev 87:813–820 DOI: 10.1016/j.earlhumdev.2011.06.007
Centeno-Tablante E, Medina-Rivera M, Finkelstein JL et al (2021) Transmission of SARS-CoV-2 through breast milk and breastfeeding: a living systematic review. Ann N Y AcadSci 1484:32–54 DOI: 10.1111/nyas.14477
Dimopoulou D, Triantafyllidou P, Daskalaki A et al (2020) Breastfeeding during the novel coronavirus (COVID-19) pandemic: guidelines and challenges. J MaternFetal Neonatal Med. 10.1080/14767058.2020.1838481 DOI: 10.1080/14767058.2020.1838481
Pavlidis P, Eddy K, Phung L et al (2020) Clinical guidelines for caring for women with COVID-19 during pregnancy, childbirth and the immediate postpartum period. Women Birth. 10.1016/j.wombi.2020.10.015 DOI: 10.1016/j.wombi.2020.10.015
Chen H, Guo J, Wang C et al (2020) Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet 395(10226):809–815 DOI: 10.1016/S0140-6736(20)30360-3
Jaffe E, Lyerly AD, Goldfarb IT (2020) Pregnant women’s perceptions of risks and benefits when considering participation in vaccine trials. Vaccine 38:6922–6929 DOI: 10.1016/j.vaccine.2020.08.059
Whitehead CL, Walker SP (2020) Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet 395:e92 DOI: 10.1016/S0140-6736(20)31029-1
Rasmussen SA, Kelley CF, Horton JP, Jamieson DJ (2020) Coronavirus disease 2019 (COVID-19) vaccines and pregnancy: what obstetricians need to know. ObstetGynecol. 10.1097/AOG.0000000000004290 DOI: 10.1097/AOG.0000000000004290
[No authors listed] COVID-19 vaccines. (2020) In: Drugs and Lactation Database (LactMed). National Library of Medicine (US)
COVID-19 Vaccines and pregnancy: conversation guide for clinicians. Vaccines and pregnancy conversation guide for clinicians. https://www.acog.org/en/COVID-19/COVID-19. Accessed 9 Feb 2021
CDC (2021) Vaccination considerations for people who are pregnant or breastfeeding. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html. Accessed 8 Feb 2021
Vaccinating Pregnant and Lactating Patients Against COVID-19. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19. Accessed 8 Feb 2021
ACOG and SMFM Joint Statement on WHO recommendations regarding COVID-19 vaccines and pregnant individuals. https://s3.amazonaws.com/cdn.smfm.org/media/2726/WHO_Response.pdf. Accessed 8 Feb 2021
Updated advice on COVID-19 vaccination in pregnancy and women who are breastfeeding. https://www.rcog.org.uk/en/news/updated-advice-on-covid-19-vaccination-in-pregnancy-and-women-who-are-breastfeeding/. Accessed 8 Feb 2021
Krubiner CB, Faden RR, Karron RA et al (2021) Pregnant women & vaccines against emerging epidemic threats: ethics guidance for preparedness, research, and response. Vaccine 39:85–120 DOI: 10.1016/j.vaccine.2019.01.011
PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF-07302048) VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE BRIEFING DOCUMENT. https://www.fda.gov/media/144246/download. Accessed 3 Jan 2021
FDA Briefing Document. Moderna COVID-19 vaccine https://www.fda.gov/media/144434/download. Accessed 3 Jan 2021
Tomljenovic M, Petrovic G, Antoljak N, Hansen L (2021) Vaccination attitudes, beliefs and behaviours among primary health care workers in northern Croatia. Vaccine 39:738–745 DOI: 10.1016/j.vaccine.2020.11.049
Marchant A, Sadarangani M, Garand M et al (2017) Maternal immunisation: collaborating with mother nature. Lancet Infect Dis 17:e197–e208 DOI: 10.1016/S1473-3099(17)30229-3
Bleier BS, Ramanathan M, Lane AP (2021) COVID-19 vaccines may not prevent nasal SARS-CoV-2 infection and asymptomatic transmission. Otolaryngol Head Neck Surg 164:305–307 DOI: 10.1177/0194599820982633