以色列認為輝瑞疫苗與心肌炎病例之間可能存在聯繫

Recently Yahoo News on-line reported the following:

Israel sees probable link between Pfizer vaccine and myocarditis cases

Tue., June 1, 2021, 3:34 p.m.

By Jeffrey Heller

JERUSALEM (Reuters) - Israel's Health Ministry said on Tuesday it had found the small number of heart inflammation cases observed mainly in young men who received Pfizer's COVID-19 vaccine in Israel were likely linked to their vaccination.

Pfizer said in a statement that it was aware of the Israeli observations of myocarditis and said no causal link to its vaccine had been established.

It said adverse events are thoroughly reviewed and Pfizer meets regularly with the Vaccine Safety Department of the Israeli Ministry of Health to review data.

In Israel, 275 cases of myocarditis were reported between December 2020 and May 2021 among more than 5 million vaccinated people, the ministry said in disclosing the findings of a study it commissioned to examine the matter.

Most patients who experienced heart inflammation spent no more than four days in the hospital and 95% of the cases were classified as mild, according to the study, which the ministry said was conducted by three teams of experts.

The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30," it said in a statement. According to the findings, such a link was observed more among men aged 16 to 19 than in other age groups.

A U.S. Centers for Disease Control and Prevention (CDC) advisory group last month recommended further study of the possibility of a link between myocarditis and mRNA vaccines, which include those from Pfizer and Moderna Inc.

In a May 24 meeting, the CDC advisory group said that the data from the Vaccine Adverse Event Reporting System (VAERS) - which relies on individuals to report results - showed a higher-than-expected number of observed myocarditis or pericarditis cases in 16– to 24-year-olds.

However, the group also said data from another database -Vaccine Safety Datalink (VSD) - did not show that rates of myocarditis or pericarditis after COVID-19 vaccination differed from expectations. The VSD has data from nine healthcare organizations and can be used to compare vaccinated populations to unvaccinated ones.

Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said that parents should still vaccinate their kids because of the known risks of COVID-19, including multi-system inflammatory syndrome.

"This issue of a transient myocarditis associated with a vaccine is at the moment a theoretical and unproven risk," Offit said. "So I think that in the world of trying to weigh relative risks, the disease is a greater risk."

The European Medicines Agency (EMA) said last week that heart inflammation after receiving the Pfizer vaccine had been no cause for concern as such incidents were similar rate to those in the general population. It added at the time that young men were particularly prone to the condition.

Israel had held off making its 12- to 15-year-old population eligible for the vaccines, pending the Health Ministry report. In parallel to publishing those findings, a ministry committee approved vaccinating the adolescents, a senior official said.

"The committee gave the green light for vaccinating 12- to 15-year-olds, and this will be possible as of next week," Nachman Ash, Israel's pandemic-response coordinator, told Radio 103 FM. "The efficacy of the vaccine outweighs the risk."

Israel has been a world leader in its vaccination rollout.

With COVID-19 infections down to just a handful a day and total active cases at just 340 across the country, the economy has fully opened, though restrictions remain on incoming tourism.

About 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing and the need for special green vaccination passes to enter certain restaurants and venues were scrapped.

Translation

耶路撒冷（路透社）——以色列衛生部周二表示，發現主要在以色列接受輝瑞 (Pfizer) 的 COVID-19 疫苗的年輕男性中, 觀察到的少數心臟炎症病例可能與他們的疫苗接種有關。

輝瑞在一份聲明中表示，它了解以色列對心肌炎的觀察，並表示尚未確定與其疫苗的因果關係。

輝瑞表示會徹底審查不良事件，並定期與以色列衛生部疫苗安全部門會面以審查數據。

色列衛生部在披露其委託調查此事的一項研究結果時說，在以色列在2020 年 12 月至 2021 年 5 月期間，超過 500 萬接種疫苗的人, 報告了 275 例心肌炎病例。

衛生部表示，這項研究是由三個專家小組進行的。根據這研究，大多數患有心臟炎症的患者在醫院住院時間不超過四天，95% 的病例被歸類為輕度。

該研究在一份聲明中說，他們究發現“接受第二劑（輝瑞）疫苗與 16 至 30 歲男性出現心肌炎之間可能存在聯繫”。根據調查結果，觀察到這樣的關聯 在16 至 19 歲的男性比其他年齡組別多。

美國疾病控制和預防中心 (CDC) 諮詢小組上個月建議進一步研究心肌炎和 mRNA 疫苗之間存在聯繫的可能性，其中包括輝瑞和 莫德納 (Moderna Inc. ) 的疫苗。

在 5 月 24 日的一次會議上，CDC 諮詢小組表示，來自疫苗不良事件報告系統 (VAERS) 的數據- 該系統依賴於個人報告結果 - 顯示在 16 至 24 歲羣組中觀察到的心肌炎或心包炎病例數目高於預期。

然而，該組織還表示，來自另一個數據庫 - 疫苗安全數據鏈 (VSD) 的數據, 並未顯示 COVID-19 疫苗接種後心肌炎或心包炎的發生率與預期不同。 VSD 擁有來自九個醫療保健組織的數據，可用於比較接種疫苗的人群與未接種疫苗的人群。

費城兒童醫院疫苗教育中心主任 Paul Offit 博士說，父母仍應為孩子接種疫苗, 因為已知到 COVID-19 的風險，包括多系統炎症綜合徵，。

Paul Offit 說: “在與疫苗相關的短暫性的心肌炎的這個問題, 目前是一個理論和未經證實的風險” 。 又說 : “所以我認為，在試圖權衡相對風險的世界裡，病毒的風險更大。”

歐洲藥品管理局 (EMA) 上週表示，無需擔心接受輝瑞疫苗後的心臟炎症，因為此類事件發生率與一般人群相似。它當時補充說年輕人特別容易遇上這種狀況。

以色列已推遲使其 12 至 15 歲的人口夠資格接種疫苗, 以便等待衛生部報告。一位高級官員說，在公佈這些調查結果的同時，一個部門委員會批准為年青人接種疫苗。

以色列大流行應對協調員 Nachman Ash 告訴 Radio 103 FM說:“委員會批准為 12 至 15 歲的兒童接種疫苗，這將在下周成為可能” 。又說: “疫苗的功效大於風險。”

以色列在疫苗接種方面一直處於世界領先地位。

隨著 COVID-19 感染減少到每天少數，全國活躍病例總數僅為 340宗，經濟已經全面開放，但對入境旅遊的限制仍然存在。

大約 55% 的以色列人口已經接種了疫苗。在週二，以色列取消了對社交距離的限制, 以及取消進入某些餐館和場所需要特殊的綠色疫苗接種通行證。

              So, Israel's Health Ministry finds out that a small number of heart inflammation cases have happened in the young people who have received Pfizer's COVID-19 vaccine. They suspect that this could be linked to their vaccination. Even with this observation, most health professionals still insist that the benefit of the vaccine outweighs its risk. I appreciate the transparency of the Israel government in handling this case.