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Eur Arch Otorhinolaryngol. 2021 Oct;278(10):4091-4099. doi: 10.1007/s00405-021-06794-6. Epub 2021 Apr 15.

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.

European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery

Alberto Maria Saibene, Fabiana Allevi, Tareck Ayad, Tomislav Baudoin, Manuel Bernal-Sprekelsen, Giovanni Briganti, Sean Carrie, Per Cayé-Thomasen, Sara Dahman Saidi, Nicolas Dauby, John Fenton, Wojciech Golusiński, Ludger Klimek, Andrée-Anne Leclerc, Yves Longtin, Giuditta Mannelli, Miguel Mayo-Yáñez, Cem Meço, Osama Metwaly, François Mouawad, Kazimierz Niemczyk, Ulrik Pedersen, Krzysztof Piersiala, Jan Plzak, Marc Remacle, Nathalie Rommel, Hesham Saleh, Dawid Szpecht, Miroslav Tedla, Camilla Tincati, Manuel Tucciarone, Karol Zelenik, Jerome R Lechien

Affiliations

  1. Otolaryngology Unit, ASST Santi Paolo E Carlo, Department of Health Sciences, Università Degli Studi Di Milano, Via Antonio di Rudinì, 8, 20142, Milan, Italy. [email protected].
  2. Young Otolaryngologists-International Federation of Otorhinolaryngological Societies (Yo-IFOS), Paris, France. [email protected].
  3. Maxillofacial Surgery Unit, ASST Santi Paolo E Carlo, Department of Health Sciences, Università Degli Studi Di Milano, Milan, Italy.
  4. Young Otolaryngologists-International Federation of Otorhinolaryngological Societies (Yo-IFOS), Paris, France.
  5. Division of Otolaryngology-Head and Neck Surgery, Centre Hospitalier de L'Université de Montréal, Montreal, QC, Canada.
  6. Department of Otorhinolaryngology and Head and Neck Surgery, University Clinical Hospital Centre Sestre Milosrdnice, Zagreb University School of Medicine, Zagreb, Croatia.
  7. Confederation of European Otorhinolaryngology-Head and Neck Surgery (CEORL-HNS), Vienna, Austria.
  8. Rhinology and Skull Base Unit, Department of Otorhinolaryngology, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.
  9. Richard J McNally Laboratory, Harvard University, Cambridge, MA, USA.
  10. Freeman Hospital, Newcastle, UK.
  11. Department of Oto-Rhino-Laryngology, Head and Neck Surgery, and Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
  12. Private Practice, Ganshoren, Belgium.
  13. Department of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium.
  14. School of Public Health, Université Libre de Bruxelles (ULB), Brussels, Belgium.
  15. Institute for Medical Immunology, Brussels, Belgium.
  16. Department of ORL-HNS, University of Limerick Medical School, Limerick, Ireland.
  17. Department of Head and Neck Surgery, Poznan University of Medical Sciences, The Greater Poland Cancer Centre, Poznan, Poland.
  18. Center for Rhinology and Allergology, Wiesbaden, Germany.
  19. Division of Otolaryngology and Head and Neck Surgery, University of Montréal, Montreal, Canada.
  20. Department of Medicine, Jewish General Hospital, Montreal, Canada.
  21. Head and Neck Oncology and Robotic Surgery, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy.
  22. Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Galicia, Spain.
  23. Clinical Research in Medicine, International Center for Doctorate and Advanced Studies (CIEDUS), Universidade de Santiago de Compostela (USC), Santiago de Compostela, Galicia, Spain.
  24. Department of ORL-HNS, Ankara University Medical School, Ankara, Turkey.
  25. Department of ORL-HNS, Salzburg Paracelsus Medical University, Salzburg, Austria.
  26. Kasr Alainy School of Medicine, Cairo University, Giza, Egypt.
  27. Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Lille, Université de Lille 2, Lille, France.
  28. Department of Otorhinolaryngology, Head and Neck Surgery, Medical University of Warsaw, Warsaw, Poland.
  29. University Clinic of ORL-HNS, Aarhus University Hospital, Aarhus, Denmark.
  30. Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.
  31. Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic.
  32. Department of ORL-Head & Neck Surgery, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg.
  33. Department of Gastroenterology, Neurosciences, Experimental ORL, Neurogastroenterology & Motility, Deglutology-University Hospitals Leuven, University of Leuven, Leuven, Belgium.
  34. Department of Otolaryngology, Charing Cross and Royal Brompton Hospitals, Imperial College, London, UK.
  35. Department of Neonatology, Poznan University of Medical Sciences, Poznan, Poland.
  36. Medical Faculty, Comenius University, Bratislava, Slovakia.
  37. Infectious Disease Unit, ASST Santi Paolo E Carlo, Department of Health Sciences, Università Degli Studi Di Milano, Milan, Italy.
  38. Department of Otorhinolaryngology and Head and Neck Surgery, Jerez University Hospital, Jerez de la Frontera, Spain.
  39. Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
  40. Department of Otolaryngology-Head and Neck Surgery, Foch Hospital, Paris Saclay University, Saint-Aubin, France.

PMID: 33855628 PMCID: PMC8046580 DOI: 10.1007/s00405-021-06794-6

Abstract

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.

© 2021. The Author(s).

Keywords: Breastfeeding; Coronavirus infections; Covid-19; Health planning guidelines; Healthcare workers; Pregnancy; Vaccine

References

  1. Woolf SH, Chapman DA, Lee JH (2021) COVID-19 as the leading cause of death in the United States. JAMA 325:123–124 - PubMed
  2. 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 - PubMed
  3. 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 - PubMed
  4. 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 - PubMed
  5. 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 - PubMed
  6. 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 - PubMed
  7. 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. https://doi.org/10.1001/jama.2020.26419 - PubMed
  8. 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 - PubMed
  9. Dashraath P, Nielsen-Saines K, Madhi SA, Baud D (2020) COVID-19 vaccines and neglected pregnancy. Lancet 396:e22 - PubMed
  10. 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 - PubMed
  11. 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 - PubMed
  12. 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 - PubMed
  13. Rosenfeld RM, Nnacheta LC, Corrigan MD (2015) Clinical consensus statement development manual. Otolaryngol Head Neck Surg 153:S1–S14 - PubMed
  14. Remuzzi A, Remuzzi G (2020) COVID-19 and Italy: what next? The Lancet 395:1225–1228 - PubMed
  15. 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 - PubMed
  16. 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. https://doi.org/10.1007/s00405-020-06582-8 - PubMed
  17. 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 - PubMed
  18. 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 - PubMed
  19. 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 - PubMed
  20. 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 - PubMed
  21. 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 - PubMed
  22. 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. https://doi.org/10.1007/s00405-020-06236-9 - PubMed
  23. Sharma A, Bhardwaj R (2020) COVID-19 and ENT surgery: a brief review of essential precautions and triage. Eur Arch Otorhinolaryngol. https://doi.org/10.1007/s00405-020-06207-0 - PubMed
  24. 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 - PubMed
  25. 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 - PubMed
  26. 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 - PubMed
  27. 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 - PubMed
  28. 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. https://doi.org/10.3390/healthcare8040511 - PubMed
  29. 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 - PubMed
  30. 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 - PubMed
  31. 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 - PubMed
  32. 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 - PubMed
  33. 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 - PubMed
  34. Dimopoulou D, Triantafyllidou P, Daskalaki A et al (2020) Breastfeeding during the novel coronavirus (COVID-19) pandemic: guidelines and challenges. J MaternFetal Neonatal Med. https://doi.org/10.1080/14767058.2020.1838481 - PubMed
  35. 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. https://doi.org/10.1016/j.wombi.2020.10.015 - PubMed
  36. 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 - PubMed
  37. 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 - PubMed
  38. Whitehead CL, Walker SP (2020) Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet 395:e92 - PubMed
  39. Rasmussen SA, Kelley CF, Horton JP, Jamieson DJ (2020) Coronavirus disease 2019 (COVID-19) vaccines and pregnancy: what obstetricians need to know. ObstetGynecol. https://doi.org/10.1097/AOG.0000000000004290 - PubMed
  40. [No authors listed] COVID-19 vaccines. (2020) In: Drugs and Lactation Database (LactMed). National Library of Medicine (US) - PubMed
  41. 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 - PubMed
  42. 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 - PubMed
  43. 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 - PubMed
  44. 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 - PubMed
  45. 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 - PubMed
  46. 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 - PubMed
  47. 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 - PubMed
  48. FDA Briefing Document. Moderna COVID-19 vaccine https://www.fda.gov/media/144434/download . Accessed 3 Jan 2021 - PubMed
  49. 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 - PubMed
  50. Marchant A, Sadarangani M, Garand M et al (2017) Maternal immunisation: collaborating with mother nature. Lancet Infect Dis 17:e197–e208 - PubMed
  51. 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 - PubMed

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