| 1. For patients with autoimmune disorders |
| 1.1. Autoimmune inflammatory rheumatic diseases |
| 1 |
Curtis, J.R. |
Vaccinate AIIRD patients with stable, low‐activity disease, and those receiving immunomodulatory treatments, with either vaccine available to them (suggest the 2nd dose of the same vaccine) Vaccinate AIIRD patients with life‐threatening disease, only after controlling their disease Consider patients with SLE receiving cytotoxic therapy and higher‐dose glucocorticoids, or patients receiving RTX therapy as high risk AIIRD patients and advised to get vaccinated
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AIIRD patients are at a higher risk for incident viral infections hospitalization due to COVID‐ 19 compared to the general population |
Withhold MTX and JAK inhibitors 1 week after each vaccine dose, for those with controlled disease Withhold ABT SC both 1 week prior to and 1 week after only the 1st dose of vaccination Schedule ABT IV infusion 4 weeks only before the 1st vaccination, and postpone the subsequent ABT infusion by 1 week (5 week interval in total) (no adjustments needed for 2nd vaccine dose) Schedule CP administration 1 week after each vaccine dose Delay RTX 2–4 weeks after 2nd vaccine dose if disease activity allows
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Prophylaxis with Acetaminophen or NSAIDs to prevent post‐vaccination symptoms is not recommended |
| 2 |
Park, J.K. |
Suggest patients with AIIRD and their family members to receive a COVID‐19 vaccine Administer the vaccination, ideally when the patient's AIIRD is in a quiescent state, and before beginning immunosuppressive therapy Continue DMARDs during vaccination; and to improve vaccine efficacy, adjust the timing of RTX, MTX, and ABT administration Consider immediate, severe allergic reaction to a previous COVID‐19 vaccine or its components, the only contraindication to COVID‐19 vaccination
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Patients with AIIRD are immunocompromised due to underlying immune dysfunction and concomitant immunosuppressive treatment |
Continue DMARDs during vaccination since withholding DMARDs can increase disease activity, which is associated with worse COVID‐19 infection severity and outcomes Temporarily discontinue MTX for 1–2 weeks after each dose Start the next cycle of RTX 4 weeks after the 2nd vaccine dose Schedule ABT 1 week after the 1st vaccine dose and continue after the 2nd vaccine dose Schedule CP IV 1 week after each vaccine dose Withhold JAK inhibitors 1 week after each vaccine dose
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Monitor patients for at least 15 min after being vaccinated for signs of anaphylaxis Patients should continue general public health measures against COVID‐19, such as wearing masks, hand hygiene, and social distancing, even after vaccination
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| 3 |
Moutsopoulos, H.M.
Moutsopoulos
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Delay initiation of immunosuppressive therapy until vaccination is completed Vaccinate patients on monthly IV pulse CP/methyl prednisone therapy either prior to therapeutic scheme or 1 month after the completion of 6 months pulse therapy Perform immunization after the anti‐cytokine drug therapy has reached baseline sera levels Vaccinate reluctant patients without withholding their immunoregulatory/immunosuppressive therapy Check antibody titers against SARS‐CoV‐2, 2–4 weeks after the final vaccination dose and at 3 and 6 months thereafter, in all of the mentioned cases
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Serum antibodies against PF‐4 in patients with SLE and APS display an association with thrombotic events |
Hold anti‐metabolites, calcineurin and JAK inhibitors for 10 days before and 10 days after each vaccine dose Decrease Prednisone dosage (of >0.5 mg/kg body weight or an equivalent synthetic steroid dose) to <10 mg/daily for 10 days before and after each vaccine dose Vaccinate patients on RTX therapy either 1 month prior to initiation of the therapeutic scheme or 6–8 months after the RTX infusion Continue anti‐cytokine therapies, AZA and calcineurin inhibitor therapy in patients Temporarily hold MTX and JAK inhibitors only after and not prior to administration of each vaccine dose
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| 4 |
Tam, L.S. |
For rheumatic and musculoskeletal diseases (RMD) (including SLE):
Vaccinate RMD patients with normal or altered immunocompetence as soon as it becomes available to them based on current country, regional and/or international guidelines Initiate immunosuppressive therapies in patients with newly diagnosed RMD at least 2 weeks after the completion of COVID‐19 vaccination (with 2nd dose administered after minimum interval), if disease activity allows
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To allow an adequate immune response to the vaccine and also to minimize the delay in the administration
of immunosuppressive therapy
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NM |
| 5 |
Santosa, A. |
For connective tissue disorders, Psoriatic arthritis, SLE, Immune mediated inflammatory myositis, Sjogren's syndrome, Systemic sclerosis:
Making individualized decisions is suggested If possible, administer the vaccine when the disease is quiescent Continue immunomodulatory drugs, other than RTX, alongside COVID‐19 vaccination Vaccinate household contacts
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B cell depleting therapy with RTX is associated with significant reduction in immunogenicity. |
Administer the vaccine a minimum of 6 months after the last dose, and/or 4 weeks prior to the next dose of RTX Do not delay vaccination in patients on or planned for RTX, with an ideal interval of vaccination 4–8 weeks after the last dose of RTX or 2 weeks prior to a planned dose of RTX, if possible
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NM |
| 6 |
Bechman, K. |
For immunosuppressed patients with rheumatic disorders
If immunosuppressive treatment has not been started, administer the 1st dose at least 2 weeks prior to initiation of the therapy course and administer 2nd dose before starting the treatment with a minimum interval of 3–4 weeks after 1st dose If patients are already on immune modulation, vaccinate at least 6 months after administration and 4 weeks before the next course of B cell–depleting therapy No universal decision on DMARD interruption has been made yet
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To have a more adequate immune response |
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NM |
| 1.1.1 Psoriasis |
| 7 |
Gelfand, J.M. |
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Comorbidities leading to more severe COVID‐19 are more frequent among patients with psoriasis |
|
NM |
| 8 |
Mease, P. J. |
Consensus opinion from rheumatologists, dermatologists, infectious disease specialists, and patient research partners:
Data does not suggest that having psoriatic diseases or being under treatment significantly increases the risk of COVID infection, or a more severe disease course The telehealth experience for patients with psoriatic diseases has been a success overall
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Concerns of more severe outcomes of COVID‐19 among those with psoriatic diseases |
Before getting the chance to vaccinate, treatment should continue without concerns of a more severe COVID course. |
NM |
| 1.2. Hidradenitis Suppurativa (HS) |
| 9 |
Giamarellos‐Bourboulis, E.J. |
Vaccinate HS patients without specific contraindications Consider HS patients with metabolic diseases as a priority group to get vaccinated Patients treated with biologics should not be given vaccines containing living microorganisms Serological confirmation of adequate immune response is still not recommended as routine practice Treatment of HS with ADA and antibiotics seems not to increase the chance of contraction or a more severe course of COVID‐19
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Metabolic diseases, which are more common in HS, may induce an increased risk of a severe course of COVID‐19 and possible fatalities.
Biological drugs reduce the hyperactivity of the immune system which might result in suboptimal immunization.
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Treatment with ADA should not be interrupted especially in moderate‐to‐severe HS, and patients can be vaccinated with non‐living virus vaccines, but ADA may be suspended around the vaccination periodat the discretion of the responsible physician, who knows the patient's clinical situation best
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Initiation of HS treatment with therapies other than ADA and antibiotics should be carefully evaluated at an individual level Recommend self‐protection with masks, even after vaccination
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| 1.3. Patients with pemphigus on RTX |
| 10 |
Waldman, R. A. |
Individuals who have not initiated RTX therapy:
Individuals who are actively receiving RTX:
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Concerns of the effect of RTX on immune response after vaccination |
Before getting the change to vaccinate, encourage careful use of anti‐CD20 (RTX) therapy for skin diseases. When vaccines are available, consider vaccination 12–20 weeks after the completion of a treatment cycle, or extending RTX dosing intervals Extending RTX dosing intervals to enhance the immune response after vaccination should be weighed against the risk of disease recurrence.
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Although vaccine response may be attenuated, and may have lower rates in RTX recipients, it can be quantified with titers, which may then be helpful for further decisions to revaccinate patients.
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| 1.4. Inflammatory bowel diseases |
| 11 |
Siegel, C. A. |
Patients with IBD should be vaccinated against COVID as soon as possible. Patients with IBD are at the same risk of COVID as the general population. Patients with IBD, whether or not receiving immune‐modifying therapies, can safely receive all non‐live vaccinations for any vaccine‐preventable illness. If on immune they should not receive live virus vaccines. Do not defer vaccination for a patient with IBD receiving immune‐modifying therapies. Inform patients that they will mount an immune response to vaccination, however, vaccine efficacy may be blunted when receiving systemic corticosteroids.
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Concerns of inefficient immunization |
Patients with IBD receiving Infliximab infusions can receive non‐live vaccinations: with no reduction in efficacy and safety of vaccination. Patients can be vaccinated during induction or maintenance of biologic therapies irrespective of timing within their treatment cycle.
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NM |
| 2. For patients with allergic or atopic disorders |
| 2.1. Atopic dermatitis |
| 12 |
Pfaar, O. |
Vaccination is possible at any time No increased risk of allergic reactions, only short‐term aggravation of eczema is possible after vaccination Suggest vaccination of patients receiving systemic therapy with CYSP, MTX, Systemic Steroids and/or CYSP, AZA, or Baricitinib at any time, but a temporary interruption of treatment or a reduced dosage of the medication is recommended
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General immune stimulation in AD, and immune suppression under drugs |
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Apply topical anti‐inflammatory locally, using both steroids and calcineurin inhibitors |
| 13 |
Ring |
Vaccinate according to their local or national vaccination plan Suggest to do a diagnostic work‐up for allergy prior to vaccination in patients with a history of anaphylaxis to drugs in general or vaccinations, and in patients with systemic mastocytosis or idiopathic anaphylaxis
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The protein or the vector, one possible elicitor of anaphylaxis could be other ingredients such as PEG, present both in the BNT162b1 and the mRNA‐1273 vaccines |
NM |
NM |
| 14 |
Thyssen, J.P. |
AD is not a contraindication to vaccination
recommend a case‐by‐case approach considering the specific drug and vaccine product recommend to strictly follow guidelines and decisions issued by the local and national health authorities in each country Suggest at least 3 weeks between the two COVID‐19 vaccine doses
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AD worsening is unlikely after vaccination, as the vaccination response is mainly skewed toward T helper cell 1.
The risk of AD flares and loss of AD control increases if the systemic AD therapy is withheld or reduced in dose for longer than 3 weeks.
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Most clinicians pause these therapies as follows:
JAK‐inhibitors and CYSP from the vaccination day until 1 week after MTX and AZA until 2 weeks after vaccination (to possibly improve chances or appropriate vaccination response) -
suggest using the lowest dose possible:
2.5 mg/kg/day CYSP,1 mg/kg/day AZA and 7.5 mg/week MTX
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NM |
| 2.2. Mastocytosis |
| 15 |
Bonadonna, P. |
Mastocytosis alone is not a contraindication to vaccines but some patients have a high risk of anaphylaxis:
Uncontrolled MC‐mediator induced symptoms (intense flushing, episodes of hypotension, other uncontrolled symptoms from cardiovascular, respiratory, gastrointestinal, neurological systems): first treat symptoms accordingly, and vaccination should be delayed until treatment and proper control of symptoms Unstable mastocytosis and severe uncontrolled MCAS symptoms should first be treated until the symptoms are well controlled before receiving vaccination. known or suspected allergy to PEG or polysorbate 80/20 previous anaphylaxis to vaccination Brighton consensus anaphylactic reaction grade 1 and 2 to the 1st dose of COVID ‐19 vaccine
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NM |
Continue anti‐mediator‐based treatment, like omalizumab, during the time of vaccination |
Allergy evaluation prior to vaccination Skin test to PEG and polysorbate 80/20 and vaccine H1‐antihistamines 30 to 60 min before vaccination (also consider corticosteroids, H2‐antihistamines, and montelukast) Supervision for 60 min after vaccination
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| 16 |
Stingeni, L. |
For cutaneous and systemic mastocytosis in general, the following criteria are suggested as contraindications for vaccination:
Severe anaphylaxis on 1st administration of SARS‐cov‐2 vaccine History of severe immediate reactions (urticaria‐angioedema syndrome, anaphylaxis) and/or delayed reactions (maculo‐papular eruptions, severe adverse drug reactions) to drugs containing PEG, polysorbate 80/20, and tromethamine Documented immediate and/or delayed allergy to PEG, polysorbate 80/20, and tromethamine
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Excipients with known sensitizing potential in COVID‐19 vaccines:
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NM |
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| 2.3. Urticaria |
| 12 |
Pfaar, O. |
For chronic spontaneous urticaria:
Vaccination is possible at any time No increased risk of allergic reactions; but vaccination may result in transient aggravation Patients on systemic steroids and/or CYSP can be vaccinated at any timeHowever, if applicable, adequate immunological response to vaccination should be verified by serum antibody levels
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Effect of vaccination may be reduced by systemic immunosuppression |
Vaccination is recommended between two injections of biologics with 1 week interval between vaccination and the treatment; however, vaccination can be done at any time under Omalizumab |
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| 13 |
Ring, J. |
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Systemic allergic reactions to vaccines are rare, and are due to hypersensitivity to components of the formulation of the vaccine |
For patients with urticaria, acute flare of eczema, and other allergic diseases, do not delay vaccination, but they should be actively treated for their disease
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Consider anti‐allergic medication such as combined histamine H1 and H2 receptor antagonists + oral glucocorticoids prior to vaccination Observe for 30 min after vaccination In the case of anaphylaxis: main acute treatment includes IM Epinephrine
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| 2.4. Allergic diseases (general) |
| 17 |
Klimek, L. |
Consider common allergies due to medications, food, inhalants, venoms and latex as general public Consider patients with history of allergy to oral medications or family history of severe allergic reaction as general public Vaccinate in a healthcare setting with appropriate equipment Do not vaccinate if a patient has a history of severe reaction to the 1st dose or to the vaccine's component (PEG) Recommend to use non‐live vaccines in chronic rhinosinusitis with nasal polyps or AD patients whom are under immunomodulator medications
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No evidence of immunosuppressive effects in dupilumab and omalizumab |
Defer vaccination for 90 days after receiving convalescent plasma or monoclonal antibody treatment for COVID‐19 Administer any other vaccines with a minimum interval of 14 days before and after mRNA COVID‐19 vaccines No need to hold allergen immunotherapy and biologics Do not administer SC immunotherapy injections or biologics on the same day as mRNA vaccine No need to adjust the dose for sublingual forms of immunotherapy
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Monitor patients with history of severe allergic reaction for 30 min and others for 15 min |
| 18 |
Peter, J. |
Consider following conditions as contraindications to vaccinationin allergic or immune‐based diseases:
Patients with inborn errors of immunity, malignancies (hematological cancers with immunoparesis), hematopoietic stem cell and solid organ transplant Patients with a prior anaphylactic reaction to either the 1st dose of COVID‐19 vaccine or an ingredient in the vaccine formulation, like PEG
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Increased risk for severe COVID‐19 disease is considered in contraindicated conditions.
The majority of drug‐ or vaccine‐induced anaphylactic reactions occur within the first 30 min following vaccination.
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Suggest a case‐by‐case risk assessment |
Observe patients with prior anaphylaxis or severe allergic disorders for 30 min after vaccination Suggest an allergy assessment and review by a specialist in patients with prior vaccine‐associated anaphylaxis suggest vaccination in a fully equipped setting with experienced staff to manage
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| 19 |
Murphy, K.R. |
Known history of a severe allergic reaction to any component of the vaccine (e.g., polysorbate, PEG) is a contraindication for vaccination In case of immediate allergic reaction of any severity happening within 4 h of receiving the 1st dose, do not vaccinate with 2nd dose State that there is an experimental option for vaccine administration in patients with higher risk for developing serious or fatal COVID‐19 infections and who have previously experienced a suspected or confirmed severe allergic reaction to a COVID‐19 vaccine (explained in the adjustment column)
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Adjuvants and other excipients/components in the vaccine are generally responsible for allergic reactions |
The graded vaccine administration protocol as an experimental protocol: administer 0.05 ml of 1:10 dilution, and 10%, 20%, 30%, and 40% of the full dose in ascending order, in alternate arms at 15‐min intervals, followed by a minimum 30‐min observation period |
Screen patients by asking several questions to determine the possible risk for an allergic reaction to the mRNA COVID‐19 vaccines Observe patients with a history of systemic reactions to food, drugs, or venoms for 30 min, others for 15 min
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| 20 |
Kleine‐Tebbe, J. |
For atopic and/or eosinophilic airway diseases with type 2 inflammation:
Consider a 1–2 week interval between vaccination and allergen immunotherapy injections, on manufacturer's recommendations Continue sublingual immunotherapy as usual
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NM |
Do not interrupt biologics such as Benralizumab, Dupilumab, Mepolizumab, Omalizumab, Reslizumab; continue as planned Schedule vaccination approximately midway through the treatment interval
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NM |
| 21 |
Tanno, L.K. |
Consider following conditions as contraindication for COVID‐19 vaccination:
Vaccinate with precaution in following conditions:
Possible Mast Cell Activation Syndrome (MCAS)/mastocytosis History of immediate allergic reaction to multiple drug classes, with the trigger unidentified History of “immediate allergy” or anaphylaxis to a vaccine or a parenteral biological therapy, an injected corticosteroid, colonoscopy preparation, or laxatives History of idiopathic anaphylaxis, latex allergy or topical disinfectant allergy, bradykinin related angioedema or inhibitor angiotensin agent induced anaphylaxis
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Concerns of allergies |
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Observe patients for 15–30 min In local reactions: use local treatment and carry on In systemic mild reaction (like acute urticaria): treat accordingly, take precise clinical history, and refer immediately to the allergist/immunologist (count them as contraindicated patients for 2nd injection until allergy work up) In anaphylaxis: measure tryptasemia between 30 min to 2 h after the onset of reaction, then >24 h after the onset of reaction, to exclude other diagnosis like mast cell activation
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| 22 |
Untersmayr, E. |
Recommendation clearly speaks in favor of COVID‐19 vaccination In times of vaccine shortage, high‐risk patients as well as patients under immunosuppressive therapy should be prioritized. Although further detailed assessment of the protective effect of vaccination is warranted, especially for patients receiving immunomodulatory or immunosuppressive therapy, vaccination is expected to be beneficial. Patients should be clearly informed that vaccination reactions are to be expected.
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Concerns of vaccination among patients under immunomodulatory and immunosuppressive therapy or those with immunodeficiencies |
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Prophylactic paracetamol (in not contraindicated), about 6 h after vaccination can attenuate reactions to vaccination. If necessary, paracetamol can be continued every 6 h for 24 to 48 h.
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| 2.5. Precautions for anaphylaxis |
| 23 |
Turner, P.J. |
Recommend special precaution for following conditions:
history of immediate allergic reaction like anaphylaxis to multiple different drug classes, with the trigger unidentified (which may indicate PEG allergy) history of anaphylaxis to a vaccination or parenteral monoclonal antibody preparation Mast cell disease (systematic mastocytosis)
Vaccination contraindications:
In these cases, vaccination should be proceeded as normal: Local (non‐systemic) reaction to prior vaccination, stable asthma on biologics, hypersensitivity to NSAIDs, prior history of allergy to an identified food, venom or a defined group of medication
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Adjuvants and other excipients/components in the vaccine are generally responsible for allergic reactions |
NM |
Assessment of possible risk of PEG‐allergy, and referral to allergist‐immunologist 30 min observation after vaccine injection No pretreatment with antihistamine, as it may mask initial symptoms of a reaction Consider obtaining venous access prior to skin testing with PEGs Recommend a blood sample for evaluation of mast cell tryptase to diagnose vaccine‐associated anaphylaxis after a reaction
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| 24 |
Kim, M. A. |
Those excluded from or candidates for a delayin vaccination:
Past history of COVID‐19 infection: vaccinate at least 4 weeks after recovery
In asymptomatic cases: vaccinate 4 weeks after first PCR test
Patient on systemic steroids for more than 2 weeks:
vaccinate at least 4 weeks after stopping systemic steroids If patients cannot stop steroids due to underlying diseases, vaccinate based on the risk‐to‐benefit ratio.
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Concerns of vaccination after a COVID infection or in special groups |
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| 25 |
Klimek, L. |
Contra‐indications to vaccination:
Immediate‐ or late‐type allergy, or anaphylaxis to one or more ingredients of the vaccine or to substances that are cross‐reactive to them Patients with an anaphylactic reaction to the first dose of vaccine Previous anaphylaxis of unclear cause Known mastocytosis or anaphylaxis to different drugs or other vaccines
No allergy sufferer should be excluded from COVID‐19 vaccination without sufficient reason, except those with contra‐indications or high‐risk groups.
High risk patients should undergo an “allergological evaluation” prior to COVID vaccination.
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Concerns of allergies in vaccination |
Provide an interval of 7 days between allergologically relevant biologics and vaccination |
Monitor patients with allergies or those who belong to a defined risk groups for 30 min after vaccination.
Vaccinators and vaccination staff must be prepared and have the appropriate expertisefor the recognition and treatment of anaphylaxis and severe allergic reactions and vaccination sites must have a minimum equipment of drugs and instruments.
In case of (supposed) allergic reactions to vaccination, an allergological work‐up in a specialized center is indicated.
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| 26 |
Klimek, L. |
Regularly inform patients about possible severe allergic/anaphylactic reactions Ask patients about such incidents in the past, including allergic reactions to additives, in particular PEG and cross‐reactive PEG analogues In suspected cases, perform an allergological clarification (skin prick test, laboratory diagnostics) and consult an allergist More precise definitions of the type, cause, and severity of severe allergic reactions are needed not over‐exclude people from vaccination and possibly damage the achievement of herd immunity
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Concerns of allergies in vaccination |
NM |
Vaccination personnel must always be prepared for the possibility and treatment of severe allergic/anaphylactic reactions and anaphylaxis |
| 27 |
Worm, M. |
A recommended set of questions for the assessment of the “allergological riskpotential” for COVID‐19 vaccination should be asked, finding details on
Previous (possibly repeated) severe allergic reactions to medications, vaccines, or PEG‐macrogol or polysorbate‐containing drugs (e.g., macrogol or cold medications) (Repeated) severe general reactions during medical procedures such as colonoscopies or operations under general anesthesia Severe general reaction to an unknown trigger Known mastocytosis in patients with previous severe immediate drug reactions or anaphylaxis to an unknown trigger For the second dose: possible a = severe general reaction after the first dose
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Concerns of allergies prior to vaccination |
NM |
NM |
| 3. For dermatology patients on immunosuppressive, immunomodulatory or biologic therapies |
| 28 |
Ferretti, F. |
Consider patients with systemic comorbidities related to immune‐mediated chronic skin diseases, such as cardiovascular diseases, diabetes and obesity, and those under treatment with conventional therapy or biologics as a priority group to get vaccinated A case‐by‐case approach to any therapeutic decision is recommended, but it is suggested to withdraw or delay immunosuppressant drugs or biologics in case of COVID‐19 diagnosis up to infection recovery, except for patients on systemic corticosteroids therapy
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Due to high risk of severe COVID‐19 or hospitalization |
Taper systemic corticosteroids to ≤20 mg/day of prednisone or equivalent to administer live vaccines Withhold MTX and JAK inhibitors 1 week after each vaccine dose For patients with an autoimmune bullous disease treated with RTX; if RTX is not started, patient needs to be vaccinated ≥4 weeks prior to RTX infusion, otherwise they need to be vaccinated 12–20 weeks after completion of a cycle of therapy
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NM |
| 29 |
Gresham, L.M. |
Advise to check antibody titers after vaccination, and use additional vaccinations if needed, to boost the level of protective antibodies Consider nonviral or inactivated SARS‐CoV‐2 vaccine subtypes before, during, or after receiving systemic immunosuppressant, immune‐targeting therapy and biologic therapy without significant modification of ongoing treatments
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Concerns of immune therapies |
NM |
Consider anti‐IL‐17 biologics, anti‐IL‐12/23 biologics, Omalizumab, MTX and JAK inhibitors as safe therapies during the COVID‐19 pandemic
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| 30 |
Wang, C. |
Consider atopic dermatitis, immune‐bullous disorders, vasculitis and cutaneous drug eruptions as high‐risk patients and advise to get vaccinated if immunomodulator or biologic therapy have not been started, vaccinate prior to initiation of the therapy course Advise to administer vaccines other than those against COVID at least 7 days either before or after the completion of the two‐dose COVID‐19 vaccine regimen
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To maximize vaccine response and decrease the frequency of local and systemic reactions |
if patient is already on a biologic or immunomodulatory agent:
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NM |
| 31 |
Hauptman, M. |
For patients on biologic therapies (including patients with psoriasis):
Administer an inactivated vaccine if it is a possible option Consider discontinuation of biologics prior to receiving an inactivated vaccine in patients who prioritize high titer immunity over potential skin flare Discontinue the biologic therapy, if only live attenuated vaccines are available
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Concerns of immune therapies |
NM |
NM |
| 32 |
Chakravarthy, K. |
There is no evidence that patients receiving epiduralsteroid therapy for pain management are more at risk of adverse reactions to COVID vaccination There is no evidence that bolus steroids in theepidural space will impact the immune response to vaccination
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Concerns of those receiving steroids |
There is no need to defer neuraxial steroid injections
when indicated in the context of COVID‐19 vaccination
There is no specific guidance suggesting withholding NSAIDs or other anti‐inflammatories before vaccination
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NM |
| 4. Precautions for vaccine‐induced thrombotic thrombocytopenia |
| 33 |
Elalamy, I. |
Rapidly vaccinate those under 60 years of age with comorbidities (like cancer, CVD, kidney or liver impairment, immunosuppressant use, obesity, DM) and patients on long‐term anticoagulant treatment for APS or other reasons IM injection should be done correctly at the appropriate lower site of deltoid muscle and not intravascularly Minimal systemic signs, low‐grade fever, or muscular pain are expected in varying degrees for each individual and should decrease in 48 to 72 h Check for extensive ecchymotic or purpuric local reaction that is particularly painful In case of thrombocytopenia (PLT < 120 G/L): investigate for HIT by screening for heparin‐PF4 antibodies Do not take these steps for everyone systematically: management of vaccination with thromboprophylaxis (LMWH or direct oral anticoagulant or aspirin, screening for thrombophilia before vaccination, measuring of anti‐PF4 antibodies after vaccination, monitoring of D‐dimer changes before and after vaccination, venous ultrasound before and after vaccination; use a case‐by‐case basis Do not contraindicate vaccination in case of history of thrombosis, autoimmune disease, history of HIT (but mRNA vaccines are preferable), history of allergy (except for allergy after 1st dose of any vaccine), immune thrombocytopenia
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on a Principle of Precaution |
Recommended labs after physical exam:CBC with PLT count, D‐dimers (>1000 ng/mL), and schistocytes to rule out a hypercoagulable state with PLT consumption (PLT < 120 G/L) or DIC with a decrease in fibrinogen (<2 g/L), and other tests depending on the clinical state Use imaging to detect thrombosis in various sites (venous ultrasound, MRI, CTA) Patients presenting more than 4 days (4–28 days) after the vaccination with symptoms suggestive of thrombosis and thrombocytopenia should be admitted with a low threshold so an immediate and thorough work‐up is possible Symptoms include: intense and persistent headaches, dizziness, visual disorders, impaired speech, acute pain or worsening muscular pain, edema of a limb suggestive of phlebitis, significant changes in a limb temperature (heat or cold), difficulty breathing, sudden heart rate acceleration, unusual bleeding signs, especially petechiae)
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In the event of major thrombotic events, infuse immunoglobulins (1 g/kg) + antithrombotics for 48 h Steroids and plasma exchange are also options to reduce the autoantibodies inhibitors of Bruton's tyrosine kinase (like Ibrutinib), can be another potential option in treatment of VITT Implement an effective non‐heparin antithrombotic treatment without delay: By injectable anticoagulant (Fondaparinux, Danaparoid, Argatroban), and depending on the clinical evolution, switching to direct oral anticoagulant (dabigatran, rivaroxaban, apixaban) can be an option In case of flu‐like symptoms, it is advisable for the patient to drink lots of fluids and take Paracetamol
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| 34 |
Oldenburg, J. |
The positive effects of vaccination with ChAdOx1 nCoV‐19 outweigh the negative effects, so its administration is welcome to be resumed in Germany. Considering the immunogenesis of thrombosis in intracranial veins or other atypical locations, patientswith a history of thrombosis and/or known thrombophilia do not have a higher risk for this specific and very rare complication with ChAdOx1 nCoV‐19. Flu‐like symptoms (joint and muscle pain or headache) persisting for 1 to 2 days after vaccination are a common side effect and not a cause for concern If side effects persist or recur more than 3 days after vaccination (dizziness, headache, visual disturbances, nausea, vomiting, shortness of breath, acute pain in chest, abdomen, or extremities), further medical diagnostics should be carried out to clarify a thrombosis Anticoagulation is necessary to treat the thrombosis. While heparins are contraindicated in (autoimmune) HIT, IV anticoagulation with heparins is likely possible in confirmed VIPIT. Diagnostics for HIT/VIPIT should be ordered before administering IVIG, since high‐dose IVIGs may lead to false‐negative test results. There is no indication for routine thromboprophylaxis with anticoagulants or antiplatelet agents following vaccination with ChAdOx1 nCoV‐19. Regardless of (autoimmune) HIT/VIPIT test results, alternative causes of thrombocytopenia and/or thrombosis must be considered and further clarified, including: thrombotic microangiopathies ITTP or atypical HUS, APS, paroxysmal nocturnal hemoglobinuria, and underlying hematological malignancies
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Concerns of thromboses after ChAdOx1 nCoV‐19 |
Labs: CBC with PLT count, blood smear, D‐dimers, further imaging in indicated (cranial MRI, ultrasound, chest and abdomen CT).
In the case of thrombocytopenia and/or evidence of thrombosis (regardless of previous exposure to heparin): antibodies against the PF4/heparin complex In case of a negative screening test: an HIT‐like cause of thrombosis/thrombocytopenia can be ruled out. In case of a positive screening test for PF4/heparin antibodies: order classical HIPA assayor SRA, as a functional confirmatory test; if positive: establishment of the diagnosis of autoimmune HIT (in the absence of previous heparin exposure) if negative: order a modified HIPA assay; if positive: establishes the diagnosis of VIPIT Patients receiving oral anticoagulation (e.g., for AF, VTE): continue treatment during and after vaccination. Patients with no indication for oral anticoagulation at significant risk of VTE: thromboprophylaxis over several days may be indicated individually, in case of severe flu‐like symptoms with fever and immobilization
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Until (autoimmune) HIT is ruled out: anticoagulation with heparins should be avoided, alternated to danaparoid, argatroban, direct oral anticoagulants, and possibly fondaparinux (with very specific considerations) The authors of this guidance document advise against the use of LMWH or fondaparinux for thromboprophylaxis, as it cannot be safely ruled out that these IV anticoagulants foster the production of platelet‐activating antibodies. As an off‐label alternative, general measures (exercise, fluid replacement, compression stockings) + prophylactic doses of direct oral anticoagulants (rivaroxaban 10 mg once daily or apixaban 2.5 mg BD), maybe be considered. In case of confirmed (autoimmune) HIT/VIPIT and critical thromboses such as sinus/cerebral or splanchnic vein thrombosis: high dose IVIG is very likely to interrupt the prothrombotic pathomechanism.
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| 5. For delayed reactions to hyaluronic acid soft tissue fillers |
| 35 |
Gotkin, R. H. |
Collected data does not support the concern for a higher risk of adverse reactions following soft tissue filler injections associated with COVID vaccination, compared to other previously described triggers or the default of adverse reactions following soft tissue filler injections |
Concerns of reactions to fillers |
NM |
NM |
| 36 |
Rice, S. M. |
Emerging reports of delayed‐type hypersensitivity reactions (DTRs) to facial fillers after COVID vaccination may cause patients to become confused by potential side effects and possibly postpone vaccination as a result. Vaccination must be encouraged and patients should be informed about the temporary and treatable nature of these side effects. Do not discourage patients with a history of treatment with dermal fillers from vaccination
A time frame should be suggested:
longer than 2 weeks between vaccination and filler procedures, dental procedures or for with recent infections, potentially longer windows for those with risk factors such as prior sensitivity to dermal fillers, autoimmune disorders, or those on immunomodulatory medications
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Concerns of DTRs to fillers |
Dilution of fillers with saline or lidocaine or use of non‐HA fillers around the time of vaccination may also be suggested to minimize the risk of DTRs |
In case of facial swelling lasting longer than 48 h: treat with antihistamines, steroids, and/or hyaluronidase, with resolution both alone or in combination, without altering the vaccine efficacy
ACE‐Is(lisinopril) have been recommended (not strongly) for the treatment of facial edema following COVID‐19 vaccination
In case of symptoms after first vaccine dose, manage the side effects, reassure the patient and advise them to obtain their second dose, with pretreatment considerations (including antihistamines), and instruct them to present to the emergency department if a more severe reaction is suspected
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Rice, S. M. |
Pre‐vaccine counseling in cosmetic patients seeking fillers:
Patients with allergies, history of injection site reactions, or urticaria may benefit from antihistamines and topical medications. COVID‐19 vaccine–related planning (procedures could be planned with a time window to minimize the risk of reactions), along with screening for dental procedures and the herpes simplex virus Cutaneous implications of both COVID‐19 infection and vaccination may become part of standard medical counseling prior to aesthetic procedures Patients seeking filler injection may be counseled regarding vaccine options not associated with adverse reactions; especially for patients with risk factors discussed
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Concerns of DTRs to fillers |
In cases of facial swelling: short courses of oral steroids (<2 weeks) can achieve resolution, and do not appear to alter vaccine effectivity In case of residual or prolonged edema: hyaluronidase Consider a 4 –8 week window between filler injections and vaccination for the general population, and potentially longer for those with risk factors: autoimmune or immunologic disorders, chemotherapy or immunomodulatory medications, history of sensitivity to dermal fillers (more pronounced and delayed swelling than expected for a given filler)
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Inform patients to contact their physicians for treatment if facial swelling or nodules develop, or present to the emergency room in case of more serious reactions. Fillers containing HA and polymethylmethacrylate may be more likely to cause reactions, so other filler options (e.g., calcium hydroxyapatite, polylactic acid, or laser resurfacing) may be prioritized, especially during the months surrounding vaccination Dilution of filler is another reasonable consideration, for both polylactic acid and HA with saline, sterile water, or lidocaine can decrease the risk of adverse reactions and DTRs
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