[Posted 04/14/2021]
Updated Janssen COVID-19 Vaccine Frequently Asked Questions
Why are the FDA and CDC recommending a pause in the use of the Janssen COVID-19 Vaccine?
The FDA and CDC are reviewing data involving six cases reported to the Vaccine Adverse Event Reporting System (VAERS) of a low level of platelets in the blood in combination with a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST) in individuals who had received the Janssen COVID-19 Vaccine. One individual died. All cases occurred in females ranging in age from 18 through 48 years. In some of the reported cases of CVST, blood clots also involved large veins in the abdomen.
Out of an abundance of caution, the FDA and CDC are recommending a pause in the use of the Janssen COVID-19 Vaccine while the FDA and CDC, including through its Advisory Committee on Immunization Practices investigate these reports of serious adverse events. This is important, in part, to help ensure that health care providers are aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required for CVST with low levels of platelets.
The safety monitoring program that is in place to monitor COVID-19 vaccines is working, as we were able to detect the reports of these very rare, serious adverse events early and take action to assess them. The FDA and CDC will continue to fully investigate all reports to determine if a causal relationship exists.
If I received the Janssen COVID-19 Vaccine, am I at risk for these adverse events?
If you received the vaccine a month or more ago, the risk of these events appears to be extremely low. In all six cases, the symptoms occurred 6 to 13 days after vaccination.
You should contact your health care provider immediately if you are experiencing any of the following symptoms:
• shortness of breath
• chest pain
• leg swelling
• persistent abdominal pain
• neurological symptoms (including severe or persistent headaches or blurred vision)
• a diffuse rash on the skin consisting of pinpoint like spots (petechiae).
These symptoms are distinct from the commonly reported side effects that people may experience in the first few days following vaccination, which can include headache, fatigue, muscle aches and nausea. Most of these side effects are mild to moderate in severity and last 1-2 days.
What should health care providers look for in evaluating Janssen COVID-19 Vaccine recipients for these rare events?
Healthcare providers should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia in individuals vaccinated with Janssen COVID-19 Vaccine. In the management of cases of thromboembolism with thrombocytopenia following Janssen COVID-19 Vaccine, heparin and its derivatives should be avoided, and health care providers should consider consulting a hematologist.
Additional information for clinicians is available in CDC's Health Alert Network notice, “Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine.”
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/bXNbQo
為什麼美國FDA和CDC建議暫停使用Janssen COVID-19疫苗？
美國FDA和CDC正在審查疫苗不良事件報告系統（Vaccine Adverse Event Reporting System, VAERS）所通報的六例因施打Janssen COVID-19疫苗後出現血小板低下合併罕見嚴重的血栓，稱為腦靜脈竇血栓（cerebral venous sinus thrombosis, CVST）的案例。其中一名個案死亡。所有案例均發生在18至48歲女性。某些CVST案例中，腹腔大靜脈也出現血栓。在調查此嚴重藥品不良反應時，美國FDA和CDC為慎重起見，建議先暫停施打Janssen COVID-19疫苗。CVST的血小板低下，需獨特的治療方法，醫療專業人員應了解施打此疫苗可能發生這些不良事件，並確保能提供適當鑑別診斷和妥適的治療計畫。
美國FDA認為能夠及早發現這類非常罕見的嚴重不良事件的報告，並採取行動進行評估，顯示COVID-19疫苗的安全監控系統正在發揮作用。美國FDA和CDC將持續進行全面調查，以確定此不良反應與疫苗是否存在因果關係。
如果我施打Janssen COVID-19疫苗，是否有發生這些不良事件的風險？
在六個案例報告中，其症狀大約於接種疫苗後6到13天發生。若接種疫苗的時間已超過一個月以上，發生此不良反應的風險則非常低。
若出現以下症狀，請立即與醫療專業人員聯繫：
• 呼吸急促
• 胸痛
• 腿部腫脹
• 持續性腹痛
• 神經相關症狀（包括嚴重或持續性頭痛或視力模糊）
• 皮膚上的發散性皮疹，包括細小斑點（紫斑瘀點）。
這些症狀與一般人在接種疫苗後前幾天可能會出現的常見副作用不同，後者可能包括頭痛、疲勞、肌肉酸痛和噁心。大多數為輕度至中度，持續1-2天。
醫療專業人員應如何評估接種Janssen COVID-19疫苗者之罕見不良反應？
對於接種Janssen COVID-19疫苗者，醫療專業人員應注意血栓栓塞和/或血小板減少的徵兆和症狀。在治療接種Janssen COVID-19疫苗後所出現的血小板減少性血栓栓塞案例時，應避免使用肝素(heparin)及其衍生物，並考慮照會血液科醫師。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/bXNbQo
資料來源：美國FDA之藥物 安全警訊
資料提供：台大醫院藥劑部
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