Background: Vaccinations against Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) are intended to induce an immune response in the sense of protection against infection/disease. Allergen-specific immunotherapy (AIT) is also thought to induce a (different) immune response in the sense of tolerance to allergens. There is uncertainty among patients and physicians regarding the use of vaccination and AIT in temporal relation, which this position paper aims to clarify. The four vaccines currently approved in Germany for vaccination against SARS-CoV-2 are described and possible immunological interactions with AIT are highlighted, as well as practical recommendations for action. Methods: Based on the current internationally published literature, this position paper provides specific recommendations for action regarding the use of AIT in temporal relation to a SARS-CoV-2 vaccination. Results: The present recommendations for action relate to the following conditions for which AIT is used i) allergic rhinitis, ii) allergic bronchial asthma, iii) insect venom allergy, iiii) food allergy (peanut). Conclusions: If vaccination is imminent, initiation of subcutaneous (SCIT), sublingual (SLIT), or oral (OIT) AIT should be delayed until 1 week after the 2nd vaccination date. Thus, there should generally be an interval of approximately 1 week between SCIT and COVID-19 vaccination. For the continuation of an ongoing AIT, we recommend an interval of 1 week before and after vaccination for SCIT. For SLIT and OIT, we recommend taking them up to the day before vaccination and taking a break from SLIT and OIT for 2 – 7 days after vaccination.

Background: After the beginning and during the worldwide pandemic caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), patients with allergic and atopic diseases have felt and still feel insecure Currently, four vaccines against SARS-CoV-2 have been approved by the Paul Ehrlich Institute in Germany, and vaccination campaigns have been started nationwide In this respect, it is of utmost importance to give recommendations on possible immunological interactions and potential risks of immunomodulatory substances (monoclonal antibodies, biologicals) during concurrent vaccination with the approved vaccines Methods: This position paper provides specific recommendations on the use of immunomodulatory drugs in the context of concurrent SARS-CoV-2 vaccinations based on current literature Results: The recommendations are covering the following conditions in which biologicals are indicated and approved: i) chronic inflammatory skin diseases (atopic dermatitis, chronic spontaneous urticaria), ii) bronchial asthma, and iii) chronic rhinosinusitis with nasal polyps (CRSwNP) Patients with atopic dermatitis or chronic spontaneous urticaria are not at increased risk for allergic reactions after COVID-19 vaccination Nevertheless, vaccination may result in transient eczema exacerbation due to general immune stimulation Vaccination in patients receiving systemic therapy with biologicals can be performed Patients with severe asthma and concomitant treatment with biologicals also do not have an increased risk of allergic reaction following COVID-19 vaccination which is recommended in these patients Patients with CRSwNP are also not known to be at increased risk for allergic vaccine reactions, and continuation or initiation of a treatment with biologicals is also recommended with concurrent COVID-19 vaccination In general, COVID-19 vaccination should be given within the interval between two applications of the respective biological, that is, with a time-lag of at least 1 week after the previous or at least 1 week before the next biological treatment planned Conclusion: Biologicals for the treatment of atopic dermatitis, chronic spontaneous urticaria, bronchial asthma, and CRSwNP should be continued during the current COVID-19 vaccination campaigns However, the intervals of biological treatment may need to be slightly adjusted (DGAKI/AeDA recommendations as of March 22, 2021) © 2021 Dustri-Verlag Dr Karl Feistle

Severe allergic reactions to vaccines are very rare Single severe reactions have occurred worldwide after vaccination with the new mRNA-based COVID-19 vaccines PEG2000 is discussed as a possible trigger We provide guidance on risk assessment regarding COVID-19 vaccination in patients with allergic diseases and suggest a standardized, resource-oriented diagnostic and therapeutic procedure Reports of severe allergic reactions in the context of COVID-19 vaccination can be made via www anaphylaxie net using an online questionnaire

Mit den Biologika stehen zunehmend mehr Therapeutika zur Verfugung, die zielgerichtet bestimmte Schaltstellen im Pathomechanismus immunologisch dominierter Erkrankungen adressieren Damit steht mehr die individuelle Krankheitsauspragung des einzelnen Patienten im Fokus der Diagnostik und Therapie (Prazisionsmedizin) Bezuglich der unterschiedlichen Phanotypen atopischer Erkrankungen war das schwere Asthma die erste Entitat, fur die Biologika zugelassen wurde, gefolgt von Urtikaria, und schlieslich der atopischen Dermatitis und der chronischen Rhinosinusitis mit nasalen Polypen Die Erfahrungen in der Therapie des schweren Asthma bronchiale machten deutlich, dass die Intensitat des Ansprechens auf eine Biologikatherapie entscheidend von der Qualitat der klinischen und immunologischen Phanotypisierung der Patienten abhangt, wobei diese Unterscheidung z T schwierig sein kann und sich verschiedene Phanotypen durchaus uberlagern konnen Das gilt auch fur unterschiedliche Erkrankungen des atopischen Formenkreises, da Patienten in jeweils entsprechend unterschiedlicher Auspragung unter mehreren atopischen Krankheiten gleichzeitig leiden konnen Es bilden sich bereits Biologika heraus, die eine geeignete Therapie fur das allergische Asthma bronchiale, das haufig gemeinsam mit einer schweren Neurodermitis auftritt, sowie die chronische Rhinosinusitis mit nasalen Polypen darstellen konnen In der Praxis stellt sich dennoch zunehmend die Frage nach moglichen Biologika-Kombinationen zur Therapie komplexer Krankheitsbilder einzelner Patienten Dabei gilt es, das Nebenwirkungsprofil zu beachten, zu denen auch Hypersensitivitatsreaktionen gehoren, deren diagnostisches und logistisches Management eine sichere und effiziente Therapie der Grunderkrankung zum Ziel haben muss Erhohte Aufmerksamkeit gilt auch fur eine Biologikatherapie bei Schwangerschaften und geplanten (planbaren) Impfungen sowie bestehenden Infektionen, wie zum Beispiel die SARS-CoV-2-Infektion Vor dem Start einer Biologikatherapie sollten der Immunstatus in Bezug auf chronische Virusund bakterielle Infektionen gepruft und gegebenenfalls vor Therapieeinleitung der Impfstatus aufgefrischt bzw fehlende Impfungen nachgeholt werden Derzeit liegen verlassliche Daten zum Effekt von Biologika auf die immunologische Situation der SARS-CoV-2-Infektion und COVID-19 nicht vor Daher ist die Erforschung und Entwicklung geeigneter Diagnostikverfahren zur Erfassung immunologisch bedingter Nebenwirkungen sowie der Erfassung potenzieller Therapie-Responder und -Non-Responder von groser BedeutungAlternate abstract:With the advent of biologicals, more and more therapeutics are available that specifically address specific switch points in the pathomechanism of immunologically dominated diseases Thus, the focus of diagnostics and therapy (precision medicine) is more on the individual disease characteristics of the individual patient Regarding the different phenotypes of atopic diseases, severe asthma was the first entity for which biologicals were approved, followed by urticaria, and finally atopic dermatitis and chronic rhinosinusitis with nasal polyps Experience in the treatment of severe bronchial asthma has shown that the intensity of the response to biological therapy depends on the quality of clinical and immunological phenotyping of the patients This also applies to different diseases of the atopic form, as patients can suffer from several atopic diseases at the same time, each with different characteristics Biologics are already emerging that may represent a suitable therapy for allergic bronchial asthma, which often occurs together with severe neurodermatitis, and chronic rhinosinusitis with nasal polyps In practice, however, the question of possible combinations of biologicals for the therapy of complex clinical pictures of individual patients is increasingly arising In doing so, the side effect profile must be taken into account, including hypersensitivity reactions, whose diagnostic and logistical management must aim at a safe and e ficient therapy of the underlying disease Increased attention must also be paid to biological therapy in pregnancy and planned (predictable) vaccinations as well as existing infections, such as SARS-CoV-2 infection Before starting a biological therapy, the immune status should be checked with regard to chronic viral and bacterial infections and, if necessary, the vaccination status should be refreshed or missing vaccinations should be made up for before starting therapy Currently, reliable data on the effect of biologicals on the immunological situation of SARS-CoV-2 infection and COVID-19 are not available Therefore, research and development of suitable diagnostic methods for detection of immunologically caused side effects as well as detection of potential therapy responders and non-responders is of great importance

textabstractThe high prevalence of allergic diseases warrants for sufcient health care provisions available to patients with allergic diseases. Allergy care should be delivered by well-trained specialists. However, the current status of allergy care is not well documented. For this reason a survey among European and a few non-European countries was launched by the National Allergy Society Committee from the European Academy of Allergy and Clinical Immunology and the Union Europeenne des Medecins Specialistes section and board of Allergology. The survey shows that in the vast majority of countries allergy care services are available. However, a substantial heterogeneity is reported regarding recognition of the full specialty, the number of practicing specialists or subspecialists, and training aspects. Growth but also decline of specialty and subspecialties is reported. In addition, the survey gives insight in strengths, weaknesses, opportunities and threats in this feld. It appears that the recognition of the full specialty determines strength as well as weakness. Aging of specialists combined with a decline in the number of trainees form a major threat. Opportunities are seen in creating awareness for allergy, focus on attracting young physicians. The conclusion is that harmonization of allergy services across Europe is needed. Investment in young doctors, creating new opportunities and lobbying for the full specialty is required

In 2006 to 2017, a number of randomized, double-blind, placebo-controlled trials on the use of monoclonal antibodies in chronic rhinosinusitis with nasal polyps were published. They were the first to demonstrate that these innovative therapies are in principle effective in the treatment of nasal polyps. The target proteins, interleukin (IL)-4, IL-5, and IL-13 as well as immunoglobulin (Ig) E had been identified as key proteins in previous basic studies. The studies are characterized by small numbers of cases, but have paved the way for phase 3 studies, which are currently underway and which could lead to the market introduction of the first drug with this indication as early as next year. They already provide some hints of the effects to be expected from biologics; however, phase 3 studies with more patients and a more homogeneous patient population will be crucial for indications, patient selection, and stop rules for each of these biologics. For those patients with severe polyposis whose disease could previously not be controlled by pharmacotherapy and/or surgery, there will undoubtedly be new therapeutic options that will put an end to the risks and shortcomings of previous therapies.

Allergen immunotherapy (AIT) is a proven therapeutic option for the treatment of allergic rhinitis and/or asthma. Many guidelines or national practice guidelines have been produced but the evidence- based method varies, many are complex and none propose care pathways. This paper reviews care pathways for AIT using strict criteria and provides simple recommendations that can be used by all stakeholders including health professionals. The decision to prescribe AIT for the patient should be individualized and based on the relevance of the allergens, the persistence of symptoms despite appropriate medications according to guidelines as well as on the availability of good-quality and efficacious extracts. Allergen extracts cannot be regarded as generics. Immunotherapy is selected by specialists for stratified patients. There are no currently available validated biomarkers that can predict AIT success. In adolescents and adults, AIT should be reserved for patients with moderate/severe rhinitis or for those with moderate asthma who, despite appropriate pharmacotherapy and adherence, continue to exhibit exacerbations that appear to be related to allergen exposure, except in some specific cases. Immunotherapy may be even more advantageous in patients with multimorbidity. In children, AIT may prevent asthma onset in patients with rhinitis. mHealth tools are promising for the stratification and follow up of patients.