A multidisciplinary group of experts involved in research on the COVID-19 pandemic and with significant experience in the management of the disease contributed to this CCS. There was a positive general attitude towards the opportunity for vaccines for SARS-CoV-2 vaccination in ORL-HNS PBFHW. Nevertheless, the response from the panel mirrored a mixed attitude. In the present paper, a consensus was reached for more than half of the statements. This represents a more than satisfactory result, given the strict criteria required by the modified Delphi method as proposed by Rosenfeld et al. [13].
As no study has yet to be able to delve into the role of SARS-CoV-2 vaccines for ORL-HNS specialists, this CCS fills out a gap in the current literature on the subject. The main result of this CCS is recognizing the risk of infection for ORL-HNS specialists and the importance of vaccination for pregnant colleagues. Moreover, the opportunity for vaccination for breastfeeding ORL-HNS reached only a near consensus, albeit with an extremely high score. Last, the panel felt as evidence was not sufficient to build a consensus towards colleagues with childbearing potential. Nevertheless, it is worth reiterating that, above anything else, adhering to the SARS-CoV-2 vaccination campaign should always represent an option and not an obligation for any pregnant, breastfeeding, or childbearing age woman. On the other hand, having access to information to make this free choice also a conscious choice is mandatory. This aspect is highlighted when comparing the results of statements 6 and 7 (“all pregnant otolaryngologists and head and neck surgeons [...] should be given the opportunity to receive the SARS-CoV2 vaccine rapidly” vs. “All pregnant otolaryngologists and head and neck surgeons [...] may be encouraged to receive the SARS-CoV2 vaccine rapidly” ). While allowing the opportunity for vaccination reached a strong consensus, the encouragement for vaccination failed to reach any consensus among experts.
This CCS reflects the simple, yet not predictable, rationale briefly presented in the introduction. Such reasoning is based on the data collected from the available literature in the systematic review. Such data will be briefly covered in this article to maximize its informative content.
1) In the context of a high rate of SARS-CoV-2 infection in healthcare workers[14], ORL-HNS have a higher risk of SARS-CoV-2 infection [15, 16]. Such risk can be reduced by awareness [17], prevention measures, and the adequate use of personal protective equipment [18–20]. This is demonstrated by the high price paid by these specialists in terms of infections and victims during the pandemic [21]. It has to be noted though that despite recommendations for introduction of routine testing of patients for SARS-CoV-2, not all emergency or outpatient clinic settings allow for it [22]. Last, we are not able to postpone elective surgeries ad libitum as initially proposed [23–25]. Somehow, ORL-HNS staff must be trained to better respond to potential infection and leaves among colleagues [26]. In that way, the vaccine may represent a powerful tool for ensuring that our specialties may meet the demands of the general population. This general framework was positively accepted by the whole CCS, as mirrored by scores of statements 1, 2, 11, and 12.
2) SARS-CoV-2 represents a risk for pregnancy with indirect negative effects on the newborns [27]. SARS-CoV-2 infection during pregnancy has been diffusely associated with preterm delivery, with fetal growth restriction and with more severe forms of COVID-19 illness for mothers [11]. Consequently, a non-negligible percentage of newborns required Intensive Care Unit Admission [28, 29]. Furthermore, the infection risk was associated with a heavier psychological burden for mothers [30–32]. SARS-CoV-2 vertical transmission is infrequent but is ascertained in several cases. Furthermore, the presence of a viral load in the placenta and milk has been demonstrated [28]. This latter feature though has not been linked to horizontal infective risk, as the secreted virus is being considered an infection incompetent [33]. Breastfeeding is therefore recommended even in case of maternal infection. This has been shown as one of the few points of convergence of pregnancy management guidelines worldwide [34, 35]. Mask use and careful disinfection of hand and breast remain a staple of babies’ protection from environmental infection during breastfeeding. The separation between mother and newborn is usually not recommended [34]. Nevertheless, the evidence gathered nevertheless felt not enough univocal and strong. Consequently, we failed to reach a consensus on the related items (3 and 13, the latter though reaching near-consensus with a good score). For what concerns item 3, which addresses a pivotal aspect of the relationship between COVID-19 and motherhood, the three remaining outliers from the second Delphi round scored the statement 5. Two outliers didn’t support their choice with any comment. The third panelist stated that pregnancy could act as a kind of protection against COVID-19. It has to be noted that this hypothesis was consistent with early reports from China [36], reports which were later denied by data from larger cohorts.
3) The vaccines for SARS-CoV-2 may not represent a risk for the mother-baby dyad during pregnancy and breastfeeding. No specific trials have been conducted yet in these two populations, despite a sound request by the scientific community [9, 37, 38]. Nevertheless, the characteristics of this new mRNA vaccine appear safe in pregnant and breastfeeding women from a biological perspective [39, 40]. mRNA vaccines are indeed not live virus vaccines, nor do they use an adjuvant to enhance vaccine efficacy. These vaccines do not enter the nucleus and do not alter DNA in vaccine recipients, as demonstrated in animal models [39, 41]. In that way, it seems impossible that mRNA vaccines might cause any genetic changes, as mRNA lasts only 24-36h in the cell before degradation. These assumptions led several agencies and societies to suggest offering the vaccines for SARS-CoV-2 to pregnant and breastfeeding women [42–45]. This position has been supported not only from a merely scientific standpoint but also from an ethical perspective, as reported by the PREVENT working group [46]. It has to be noted that every recommendation for SARS-CoV-2 vaccination during pregnancy suggests considering the risk of viral infection and complications against the unassessed safety profile of the vaccine. Furthermore, among the 15 pregnancy cases who received approved vaccines for SARS-CoV-2 [47, 48] there were no complications. The general lack of evidence and the novelty of the vaccines turned into the most diverse response from the panel. The inadequacy of scientific evidence on the vaccine and the need for informing PBFHW on risks and benefits were recognized by the CCS (statements 4 and 5). The scientific context was deemed adequate to support the opportunity for pregnant ORL-HNS vaccination with strong consensus but not sufficient to fully support the opportunity for breastfeeding ORL-HNS vaccination. Unfortunately, the motivation for the near-consensus about statement 8 (which had two outliers scoring 5), were not disclosed by the panelists. Furthermore, the panel judged presently available information not adequate to support postponing the vaccination in inactive breastfeeding ORL-HNS. Analogously, they did not suggest temporary contraception after vaccination in non-pregnant and non-breastfeeding colleagues with childbearing potential.
This CCS acquires a specific role if we frame it in the complex picture of public reaction to vaccines for SARS-CoV-2, a topic that has shifted from scientific debate to media sensation no differently than for any news related to COVID-19, from infection rates to containment measures and potential therapies. Despite that the vaccines for SARS-CoV-2 development represent a long-awaited scientific breakthrough, the expected response rate to the call to vaccination is variable, even among healthcare professionals [7, 8]. This is not only due to a rising serpentine diffidence towards vaccines, unbacked by scientific data [49], but also to the technical novelty of these vaccines, the first one being based on the inoculation of synthetized viral mRNA.
Still, there are other aspects to take into account when evaluating the relationship between SARS-CoV-2 infection and human fertility. Such topics have not been covered in this CCS as they concern the vaccine issue only marginally and there is little pertinent scientific information is available. First, we currently don’t have any conclusive data on the role of SARS-Cov-2 infection and human fertility. Another important issue is the unexplored role of this pathogen in maternal immunization. Beyond maternal protection, maternal immunization against SARS-CoV-2 might contribute to the protection of the neonate in the postnatal period, as already demonstrated with other vaccines such as pertussis [50]. Lastly, we have no data on the duration of the immunization related to vaccines and on the risk of asymptomatic infection and shedding risk. [51]. Therefore, the use of personal protection devices remains strongly recommended for all healthcare workers.
Last, it is helpful to recall that this study, albeit structured with the utmost scientific rigor and based on all available evidence, still represents an opinion paper on a rapidly evolving topic. While we confirm our commitment to providing information and guidance to all ORL-HNS PBFHW, we cannot underestimate the role of future prospective evaluations on these topics which we hope will be soon available for scrutiny from the scientific community.