最新消息NEWS

COVID-19 vaccination guidance for people with bleeding disorders

出血性疾病患者的COVID-19疫苗接種指南

World Federation of Hemophilia - December 22, 2020 (google翻譯 / 血友病協會 譯)


Guidance from the World Federation of Hemophilia (WFH), European Association for Haemophilia and Allied Disorders (EAHAD), European Haemophilia Consortium (EHC), and U.S. National Hemophilia Foundation (NHF).
指南出自於世界血友病聯盟（WFH），歐洲血友病和相關疾病協會（EAHAD），歐洲血友病協會（EHC）和美國國家血友病基金會（NHF）。

It is important that hemophilia treatment centres, in close collaboration with patient organizations, take action to inform people with bleeding disorders about the COVID-19 vaccines and contribute to an effective vaccination program.
血友病治療中心應與患者組織密切合作非常重要，採取行動使出血性疾病患者了解COVID-19疫苗，並為有效的疫苗接種計劃做出貢獻。



1.   People with bleeding disorders are not at greater risk of contracting COVID-19 or developing a severe form of the disease, so they are not considered a priority group for vaccination.
1.  患有出血性疾病的人患上COVID-19或發展為嚴重疾病的風險不大，因此他們非接種疫苗的優先人群。


2.  The vaccine should be administered intramuscularly. The smallest gauge needle available (25-27 gauge) should be used, if possible. Some vaccines must be administered using the accompanying needle–syringe combination, and so the use of an alternative needle may not be possible or desirable. Pressure should be applied to the site for at least 10 minutes post-injection to reduce bleeding and swelling. Additionally, self-inspection/palpation of the injection area several minutes and 2-4 hours later is recommended to ensure that there is no delayed hematoma. Discomfort in the arm felt for 1-2 days after injection should not be alarming unless it worsens and is accompanied by swelling. Any adverse events (e.g., hematoma, allergic reaction) should be reported to a hemophilia treatment centre.
2.  疫苗應肌肉注射。如果可以，應使用最小的針規（25-27規）。某些疫苗必須使用隨附的針頭-注射器組合，因此可能無法使用替代針頭。注射後應至少對該部位  施加壓力10分鐘，以減少出血和腫脹。除此之外，建議在數分鐘和2到4小時後對注射區域進行自我檢查/觸診，以確保沒有延遲的血腫。注射後1至2天若感覺到的手臂不適感是正常現象，除非它加劇並伴隨腫脹。若有嚴重不適症狀（例如血腫，過敏反應）應報告給血友病治療中心。


3.  Patients should contact their physician immediately or go to the nearest hospital emergency room right away if they experience an allergic reaction (fever, warmth, redness, itchy skin rash, shortness of breath, or swelling of the face or tongue) as it can be life-threatening. Patients with a history of allergic reactions to extended half-life clotting factor concentrates containing polyethylene glycol (PEG) should discuss vaccine choice with their physician because some vaccines contain PEG as an excipient.
3.  如果患者出現過敏反應（發燒，發熱，發紅，皮膚紅腫，呼吸急促或面部或舌頭腫脹）且會威脅到生命，則應立即聯繫醫生或立即去最近的醫院急診室。對含有聚乙二醇（PEG）的半衰期延長的凝血因子濃縮物有過敏反應史的患者，應與醫師討論疫苗的選擇，因為某些疫苗含有PEG做為增量劑。


4.  Many individuals with bleeding disorders may not have ready access to hemostatic therapies prior to vaccination. In these cases, make efforts to access other clotting factors if possible. Alternatively, follow the instructions above making sure the smallest possible needle is used and maintain pressure for more than 10 minutes.
4.  許多患有出血性疾病的人在接種疫苗之前可能無法立即使用止血療法。在這些情況下，請盡可能嘗試獲取其他凝血因子。或者按照上面的說明進行操作，確保使用了最小的針頭，並保持壓力超過10分鐘。


5.  For patients with severe/moderate hemophilia, the injection should be given after a factor VIII (FVIII) or factor IX (FIX) injection. For patients with a basal FVIII or FIX level above 10%, no hemostatic precautions are required.
5.  對於重度/中度血友病患者，應在注射因子VIII（FVIII）或因子IX（FIX）之後再注射疫苗。對於基礎FVIII或FIX水平高於10％的患者，則無需採取止血措施。


6.  Patients on emicizumab (with or without an inhibitor) can be vaccinated by intramuscular injection at any time without hemostatic precautions and without receiving a dose of FVIII.
6.  接受雙特異性抗體（有或沒有抑製劑）的患者可隨時通過肌肉注射進行疫苗接種，而無需採取止血措施，也無需接受一定劑量的FVIII。


7.  Patients with Type 1 or 2 Willebrand disease (VWD), depending on their baseline von Willebrand factor (VWF) ristocetin cofactor (RiCof) activity levels, should use therapies (i.e., DDAVP if available, tranexamic acid), in consultation with their hemophilia treatment centre. Patients with Type 3 VWD should be given a VWF-containing injection.
7.  患有第1型或第2型類血友病（VWD）的患者，根據其基線類血友病因子（VWF）Ristocetin輔因子活性測定等級 (RiCof)，應與血友病治療中心協商後使用療法。第3型類血友病患者應接受含VWF的注射。


8.  All rare bleeding disorder patients (including those with thrombocytopenia and/or platelet function disorders) should be vaccinated. Patients on anticoagulants should have prothrombin time testing performed within 72 hours prior to injection to determine international normalized ratio (INR); if results are stable and within the therapeutic range, they can be vaccinated intramuscularly.
8.  所有罕見的出血性疾病患者（包括血小板減少或血小板功能異常的患者）都應接種疫苗。接受抗凝劑治療的患者應在注射前72小時內進行凝血酶原時間測試，以確定國際標準化比率（INR）；如果結果穩定且在治療範圍內，則可以肌肉注射。


9.  There are no specific contraindications to vaccination related to complications of hemophilia and other bleeding disorders or their therapies. Immune tolerance, treatment of hepatitis C and HIV, and other conditions do not contraindicate vaccination.
9.  沒有針對與血友病並發症和其他出血性疾病或其療法有關的疫苗接種的特定禁忌症。免疫耐受、慢性C型肝炎和愛滋病和其他條件並不禁止接種疫苗。


10.  Vaccination is not contraindicated for patients on immunosuppressive agents (cortisone, other immunosuppressive drugs).
10.  對於使用免疫抑製劑（可體松，其他免疫抑製劑）的患者，在疫苗的接種上是沒有禁忌的，可以接種的。


11.  Potential contraindications should be discussed individually with the physician because recommendations vary in different jurisdictions due to lack of data in special populations (e.g., pregnant or breastfeeding women).
11.  潛在的禁忌症應與醫師單獨討論，因為由於特殊人群（例如孕婦或餵養母乳的婦女）缺乏數據，不同地區的建議會有所不同。


12.  The U.K. Medicines and Healthcare Products Regulatory Agency and the U.S. Centers for Disease Control and Prevention have advised caution in using the Pfizer/BioNTech vaccine in people with a history of significant allergic reactions. Specific recommendations for people with a history of allergic/anaphylactoid reactions can be found in the advisory published by each agency.
12.  英國藥品和保健產品監管局和美國疾病控制與預防中心已建議對有嚴重過敏反應史的人使用輝瑞/ BioNTech疫苗。每個機構發布的諮詢中都可以找到針對具有過敏/類全身型過敏性反應史的人的具體建議。


13.  For patients in a clinical study, vaccination should be reported to the study investigators.
13.  對於進行臨床試驗的患者，應向研究調查人員報告疫苗接種情況。


(Information will be updated on the WFH, EAHAD, EHC, and NHF websites as needed.)
(資訊將會在WFH、 EAHAD、EHC和NHF的網站上視需要而更新)

 

Resources:

COVID-19 vaccination guidance for people with bleeding disorders [PDF]

COVID-19 WFH Announcements and Statements

Specific Risks of COVID-19 to the Bleeding Disorders Community

COVID-19: Practical Recommendations for People with Hemophilia

Practical guidance for the in‐hospital management of PWH published in Haemophilia