CDC 和 FDA 確定了針對 65 歲及以上人群的初步 COVID-19 疫苗安全信號 CDC/FDA Taimocracy翻譯 20230113

【縛雞之論】英文拷到 G / D 找中文翻譯
標題是：CDC 和 FDA 確定了針對 65 歲及以上人群的初步 COVID-19 疫苗安全信號
即便是引用中央社，這種較為嚴謹的新聞媒體，都要非常小心。
藥界的水很深，2021年我們已經親眼見過。也導致2022選舉執政黨大敗。

人命關天，新藥或新疫苗上市，主管機關是FDA。FDA要求要經過 三階段實驗 才發給藥證。
美國給新冠疫苗，是同意 2.5階段（第三階段做到期中報告）合格後 ，就搶時間先給「緊急使用授權」（EUA），然後第三階段繼續做完。做完第三階段，換「正式藥證」上市，EUA作廢。然後，藥廠繼續做第四階段 （就是追蹤臨床表現的統計分析，母體數會高達數千萬、數億～）。現在美國的疫苗，全數是「正式藥證」後。
中央社所報導CDC新聞，就是CDC對於三種疫苗上市後的第四階段追蹤的統計分析。可以看出CDC公告中出現：醫療保險和醫療補助服務中心數據庫、退伍軍人事務部數據庫、CDC不良事件通報數據庫、輝瑞-BioNTech 的全球安全數據庫、他國數據庫等的統計。都是從醫院出來的臨床資料，都是第四階段的統計分析。
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順便講一下，台灣國產疫苗給的EUA，台灣FDA同意 1.5階段 （稱為，擴大第二階段、不同實驗的比對橋接）後就發給，這是投機取巧的行為。
在前兩個月，要給那隻國產疫苗EUA的會議中，我們不知道公司提出什麼實驗合格，反正台灣疾管署（不是台灣FDA）做了第四階段的統計分析 ，認為OK，所以，公司滿足一年前的EUA的附帶條件。過關！
這是跳躍： 第三階段EUA還沒合法，就搶先過第四階段。
---------問題是：美國CDC的公告是說，雖有數據，卻未出現意義的報告，但將會提交專家會議討論。好，這樣就知道，為何中央社的報導很奇怪了。
假使是紐約時報、華盛頓郵報等美國媒體報導，有「不具名的官員說」，或有可能。但在台灣的中央社，報導「美國不具名的官員」怎樣說，怎樣都不具有說服力（現地訪問，很不可能）。
而且王必勝的FB，在CDC未下結論或警告之前，也跟下去評論。事理未明之前，如此做也是操之過及。為何如此？
遑論，先前還有「某次世代疫苗」該買不該買的新聞爭議。所以說，要小心。原始出處可能在這裡（and/or else where）

CDC & FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older    CDC/FDA 20230113　Taimocracy翻譯

Transparency and vaccine safety are top priorities for the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). U.S. government agencies use multiple, complementary safety monitoring systems to help detect possible safety signals for vaccines and other medical countermeasures as early as possible and to facilitate further investigation, as appropriate. Often these safety systems detect signals that could be due to factors other than the vaccine itself. 透明度和疫苗安全性是美國疾病控制與預防中心 (CDC) 和美國食品藥品監督管理局 (FDA) 的首要任務。美國政府機構使用多種互補的安全監測系統來幫助儘早發現疫苗和其他醫療對策的可能安全信號，並酌情促進進一步調查。這些安全系統通常會檢測到可能由疫苗本身以外的因素引起的信號。

All signals require further investigation and confirmation from formal epidemiologic studies. When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance. 所有信號都需要通過正式的流行病學研究進一步調查和確認。當一個系統檢測到信號時，將檢查其他安全監測系統，以驗證該信號是否代表對疫苗的實際關注，或者是否可以確定它與臨床無關。

Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination. 隨著更新的（雙價）COVID-19 疫苗的可用性和使用，CDC 的疫苗安全數據鏈 (VSD)（一種近乎實時的監測系統）符合統計標準，以促使進一步調查是否存在缺血性中風的安全問題接種輝瑞-BioNTech COVID-19 雙價疫苗的 65 歲及以上人群。對 VSD 中信號的快速反應調查提出了一個問題，即接種輝瑞-BioNTech COVID-19 雙價疫苗的 65 歲及以上人群是否在接種疫苗後的 21 天內比接種疫苗後的第 22 天更有可能發生缺血性中風 -42 接種疫苗後。

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal: Moderna COVID-19 雙價疫苗尚未確定該初步信號。可能還有其他混雜因素導致 VSD 中確定的信號值得進一步調查。此外，重要的是要注意，迄今為止，還沒有其他安全系統顯示出類似的信號，而且隨後的多項分析也沒有驗證這個信號：

• A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke使用醫療保險和醫療補助服務中心數據庫對更新的（雙價）疫苗（來自輝瑞生物技術公司和 Moderna）進行的一項大型研究表明，缺血性中風的風險沒有增加
• A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine使用退伍軍人事務部數據庫的初步研究並未表明更新（二價）疫苗後缺血性中風的風險增加
• The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine由 CDC 和 FDA 管理的疫苗不良事件報告系統 (VAERS) 未發現在更新（二價）疫苗後缺血性中風的報告有所增加
• Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine輝瑞-BioNTech 的全球安全數據庫未顯示更新的（二價）疫苗會導致缺血性中風的信號
• Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines其他國家尚未觀察到更新的（二價）疫苗會增加缺血性中風的風險

Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. 儘管目前的全部數據表明 VSD 中的信號不太可能代表真正的臨床風險，但我們認為與公眾分享這些信息很重要，就像我們過去所做的那樣，當我們的一項安全監測時系統檢測到一個信號。 CDC 和 FDA 將繼續評估來自這些和其他疫苗安全系統的額外數據。這些數據和其他分析將在即將於 1 月 26 日舉行的 FDA 疫苗和相關生物製品諮詢委員會會議上進行討論。

No change in vaccination practice is recommended. CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries: 不建議改變疫苗接種做法。 CDC 繼續建議所有 6 個月及以上的人及時接種 COVID-19 疫苗；這包括目前有資格接種更新的（二價）疫苗的個人。及時接種疫苗是我們減少 COVID-19 死亡、住院和嚴重疾病的最有效工具，正如現在在美國和其他國家/地區進行的多項研究所證明的那樣：

• Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine. 數據顯示，與之前接種過疫苗但尚未接種更新疫苗的人相比，更新的 COVID-19 疫苗可將因 COVID-19 住院的風險降低近 3 倍。
• Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated. 數據顯示，與未接種疫苗的人相比，更新後的 COVID-19 疫苗還可將死於 COVID-19 的風險降低近 19 倍。
• Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine. 來自美國以外的其他初步數據表明，與未接種雙價疫苗的人相比，雙價疫苗可預防 80% 以上的嚴重疾病和死亡。

Overall safety data for the bivalent COVID-19 vaccines are available here. 此處提供了二價 COVID-19 疫苗的總體安全數據。

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here. 再一次，不建議對 COVID-19 疫苗接種實踐進行任何更改，可在此處找到。