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Jan 14 (Reuters) - A safety panel of the European drug regulator on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca's (AZN.L) COVID-19 vaccine.

The European Medicines Agency's (EMA) safety committee also recommended a similar warning be included for Johnson & Johnson's (JNJ.N) one-shot vaccine in October, and reiterated the decision on Friday.

Transverse myelitis is an inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, sensory symptoms or problems with bladder or bowel function.

"There is currently no confirmed mechanism that has been verified by which a COVID-19 vaccine could cause the very rare event transverse myelitis," an AstraZeneca spokesperson said.

The EMA's committee, after reviewing data, concluded there was a reasonable possibility of a causal relationship between the two vaccines and transverse myelitis.

However, it added the benefit-risk profile of both vaccines remains unchanged.

The regulatory agency did not provide any information on how many such cases were reported after the vaccination was given but said transverse myelitis has been added as an adverse reaction of unknown frequency to the product information.

AstraZeneca's vaccine has faced several setbacks, including production delays and probes by regulators following rare cases of severe side effects such as blood clots with low platelets, which led to several countries restricting or stopping its use.

Transverse myelitis was also at the heart of trial halts in the early stages of development for both AstraZeneca and J&J's shots, which are based on similar technology.

EMA also recommended updating the product information for AstraZeneca's vaccine regarding rare blood clotting with a low platelet count following the first shot, to say fewer such side effects were observed after the second dose.

Among 1,809 cases of the condition called thrombosis with thrombocytopenia syndrome reported worldwide, it said 1,643 were reported after the first dose and 166 after the second.

1 月 14 日（路透社）- 歐洲藥物監管機構的一個安全小組週五建議添加一種罕見的脊髓炎症，稱為橫貫性脊髓炎，作為阿斯利康 (AZN.L) 的 COVID-19 疫苗的副作用。

歐洲藥品管理局 (EMA) 安全委員會也在 10 月份建議強生公司 (JNJ.N) 的一次性疫苗包含類似的警告，並在周五重申了這一決定。

橫貫性脊髓炎是脊髓一側或兩側的炎症，可導致手臂或腿部無力、感覺症狀或膀胱或腸道功能問題。

阿斯利康（AstraZeneca）的一位發言人說：“目前尚無已證實的機制證實 COVID-19 疫苗可能導致非常罕見的橫貫性脊髓炎事件。”

EMA 委員會在審查數據後得出結論，這兩種疫苗與橫貫性脊髓炎之間存在因果關係的合理可能性。

然而，它補充說，這兩種疫苗的收益-風險狀況保持不變。

監管機構沒有提供關於接種疫苗後報告了多少此類病例的任何信息，但表示橫貫性脊髓炎已作為未知頻率的不良反應添加到產品信息中。

阿斯利康（AstraZeneca）的疫苗面臨數次挫折，包括生產延遲和監管機構在罕見的嚴重副作用病例（例如血小板低的血栓導致幾個國家限製或停止使用）後進行調查。

橫貫性脊髓炎也是阿斯利康（AstraZeneca）和強生（J&J）基於類似技術的疫苗開發早期試驗停止的核心。

EMA 還建議更新阿斯利康 (AstraZeneca) 疫苗的產品信息，即第一次注射後血小板計數低的罕見凝血，表示在第二次注射後觀察到的此類副作用較少。

在全球報告的 1,809 例稱為血栓形成伴血小板減少綜合徵的病例中，第一劑後報告了 1,643 例，第二劑後報告了 166 例。