<p>作者：Jaimy Lee</p>
<p>FDA 的高級監管官 Vinay Prasad 並未在內部備忘錄中詳細説明導致該結論的數據</p>
<p>輝瑞和 BioNTech 開發了 COVID-19 疫苗 Comirnaty。</p>
<p>週一早上，Moderna 和 BioNTech 的股票下跌，可能是由於 FDA 官員的備忘錄指出 COVID-19 mRNA 疫苗與 10 名兒童的心肌炎死亡之間的關聯。</p>
<p>對這一關聯的擔憂，特別是與青少年男孩和年輕男性相關，成為反對在兒童中接種基於 mRNA 的 COVID 疫苗的主要論點。</p>
<p>據報道，食品藥品監督管理局生物製品評估與研究中心的負責人 Vinay Prasad 上週向員工發出了一份備忘錄，稱監管機構計劃承認 10 名兒童在接種疫苗後死亡。（該備忘錄被媒體廣泛報道，並由生物技術記者 Adam Feuerstein 公開分享。）</p>
<p>FDA 尚未公開備忘錄中引用的內部研究，儘管 Prasad 表示這些數據來自疫苗不良事件報告系統，該系統收集公眾、醫療專業人員和製造商的 adverse events 報告。</p>
<p>在疫情期間，Prasad 因反對疫苗強制接種和對 COVID-19 疫苗心肌炎風險的擔憂而獲得了在線關注。</p>
<p>其他研究發現，COVID-19 感染導致心肌炎的風險高於接種疫苗。</p>
<p>醫學期刊上發表的研究表明，接種 COVID-19 mRNA 疫苗後發生心肌炎的情況很少，儘管在接種第二劑後的第一週內，男孩發生的可能性更高。根據 2023 年在《JAMA Pediatrics》上發表的信件，心肌炎通常會自行緩解，作者為領先的疫苗研究者、費城兒童醫院疫苗教育中心主任 Paul Offit。</p>
<p>輝瑞（PFE）在九月份分享的全球數據也顯示，心肌炎是罕見的，但在接種 mRNA COVID-19 疫苗的初始系列第二劑後的兩週內，年輕男性中最為常見。該製藥公司表示，數據顯示，接種加強針後的心肌炎發生率低於前兩針。</p>
<p>輝瑞和 BioNTech 開發了 COVID-19 疫苗 Comirnaty。</p>
<p>週一，Moderna 的股票（MRNA）下跌約 6%，而 BioNTech 的股票（BNTX）下跌 4%。這兩家公司開發並現在銷售 COVID-19 的 mRNA 疫苗。Dynavax（DVAX）剛與 Vaxart（VXRT）達成協議，開發其實驗性 COVID-19 疫苗，股價下跌 5%。另一家疫苗生物技術公司 Vaxcyte（PCVX）的股票也下跌了 6%。</p>
<p>這並不是 Prasad 第一次對 mRNA COVID-19 疫苗進行影響變更。今年 6 月，FDA 將心肌炎和心包炎的風險添加到了 Comirnaty 和 Moderna 的 SpikeVax 中。</p>
<p>“我們對備忘錄的解讀是，CBER 將把努力集中在新批准的 COVID-19 疫苗上，特別是針對 12 至 24 歲男性人羣，因為該人羣的心肌炎風險最高，” William Blair 的分析師告訴投資者。</p>
<p>華爾街現在正在考慮 Prasad 的備忘錄如何影響不僅在 mRNA 技術和 COVID-19 疫苗方面工作的製藥公司，該備忘錄還提到流感和肺炎疫苗。FDA 官員還呼籲在疫苗的臨牀試驗中採用不同的終點。</p>
<p>根據美國疾病控制與預防中心的數據，截至 11 月 21 日，美國 5.8% 的兒童和 13.8% 的成年人在本呼吸道疾病季節接種了 COVID-19 疫苗。</p>
<p>-Jaimy Lee</p>
<p>此內容由 MarketWatch 創建，MarketWatch 由道瓊斯公司運營。MarketWatch 與道瓊斯新聞通訊和《華爾街日報》獨立出版。</p>
<p>（完）道瓊斯新聞通訊</p>
<p>12-01-25 1235ET</p>

BNTX

MRNA

<p>疫苗股票，包括 Moderna 和 BioNTech，在一位 FDA 官員的備忘錄將 COVID-19 mRNA 疫苗與 10 名兒童的心肌炎死亡事件聯繫起來後下跌。該備忘錄未公開詳細內容，引發了對心肌炎的擔憂，特別是在年輕男性中。Moderna 股價下跌 6%，BioNTech 下跌 4%，Dynavax 下跌 5%，Vaxcyte 下跌 6%。FDA 計劃將新疫苗的重點放在 12 至 24 歲年齡組。備忘錄還提到了流感和肺炎疫苗，影響了更廣泛的製藥公司戰略</p>

<p>By Jaimy Lee</p>
<div class="lb-trans"><p>作者：Jaimy Lee</p>
</div><p>Vinay Prasad, a top regulator at the FDA, did not detail the data in the internal memo that led to the conclusion</p>
<div class="lb-trans"><p>FDA 的高級監管官 Vinay Prasad 並未在內部備忘錄中詳細説明導致該結論的數據</p>
</div><p>Pfizer and BioNTech developed the COVID-19 vaccine Comirnaty.</p>
<div class="lb-trans"><p>輝瑞和 BioNTech 開發了 COVID-19 疫苗 Comirnaty。</p>
</div><p>Shares of Moderna and BioNTech were down on Monday morning, likely in response to a FDA official's memo outlining a link between COVID-19 mRNA vaccines and myocarditis deaths in 10 children.</p>
<div class="lb-trans"><p>週一早上，Moderna 和 BioNTech 的股票下跌，可能是由於 FDA 官員的備忘錄指出 COVID-19 mRNA 疫苗與 10 名兒童的心肌炎死亡之間的關聯。</p>
</div><p>Concern about that link, particularly relating to teenage boys and young men, has been a key argument against administering mRNA-based COVID vaccines in children.</p>
<div class="lb-trans"><p>對這一關聯的擔憂，特別是與青少年男孩和年輕男性相關，成為反對在兒童中接種基於 mRNA 的 COVID 疫苗的主要論點。</p>
</div><p>Vinay Prasad, the head of the Food and Drug Administration's Center for Biologics Evaluation and Research, reportedly issued a memo to staff last week that said the regulator plans to acknowledge that 10 children died after getting the vaccine. (The memo was widely reported by media outlets and shared publicly by Adam Feuerstein, a biotechnology journalist.)</p>
<div class="lb-trans"><p>據報道，食品藥品監督管理局生物製品評估與研究中心的負責人 Vinay Prasad 上週向員工發出了一份備忘錄，稱監管機構計劃承認 10 名兒童在接種疫苗後死亡。（該備忘錄被媒體廣泛報道，並由生物技術記者 Adam Feuerstein 公開分享。）</p>
</div><p>The FDA has not publicly shared the internal research cited in the memo, although Prasad said it comes from the Vaccine Adverse Event Reporting System, which gathers reports of adverse events from the public, healthcare professionals and manufacturers.</p>
<div class="lb-trans"><p>FDA 尚未公開備忘錄中引用的內部研究，儘管 Prasad 表示這些數據來自疫苗不良事件報告系統，該系統收集公眾、醫療專業人員和製造商的 adverse events 報告。</p>
</div><p>During the pandemic, Prasad gained an online following for his opposition to vaccine mandates and concern about myocarditis risk from the COVID-19 vaccines.</p>
<div class="lb-trans"><p>在疫情期間，Prasad 因反對疫苗強制接種和對 COVID-19 疫苗心肌炎風險的擔憂而獲得了在線關注。</p>
</div><p>Other studies have found that the risk of myocarditis from a COVID-19 infection is higher than from vaccination.</p>
<div class="lb-trans"><p>其他研究發現，COVID-19 感染導致心肌炎的風險高於接種疫苗。</p>
</div><p>Research published in medical journals indicates that myocarditis after a COVID-19 mRNA vaccine is rare, although it is more likely to occur in boys within the first week of receiving the second dose. The condition often resolves on its own, according to a letter published in JAMA Pediatrics in 2023 by Paul Offit, a leading vaccine researcher and director of the Vaccine Education Center at Children's Hospital of Philadelphia.</p>
<div class="lb-trans"><p>醫學期刊上發表的研究表明，接種 COVID-19 mRNA 疫苗後發生心肌炎的情況很少，儘管在接種第二劑後的第一週內，男孩發生的可能性更高。根據 2023 年在《JAMA Pediatrics》上發表的信件，心肌炎通常會自行緩解，作者為領先的疫苗研究者、費城兒童醫院疫苗教育中心主任 Paul Offit。</p>
</div><p>Pfizer (PFE) in September shared global data that also show myocarditis is rare but is most common in young men within two weeks of a second dose of the primary series of mRNA COVID-19 shots. The drugmaker said data show that the condition is less common after a booster than after the first two shots.</p>
<div class="lb-trans"><p>輝瑞（PFE）在九月份分享的全球數據也顯示，心肌炎是罕見的，但在接種 mRNA COVID-19 疫苗的初始系列第二劑後的兩週內，年輕男性中最為常見。該製藥公司表示，數據顯示，接種加強針後的心肌炎發生率低於前兩針。</p>
</div><p>Pfizer and BioNTech developed the COVID-19 vaccine Comirnaty.</p>
<div class="lb-trans"><p>輝瑞和 BioNTech 開發了 COVID-19 疫苗 Comirnaty。</p>
</div><p>Moderna shares (MRNA) were down about 6% Monday, while BioNTech's stock (BNTX) fell 4%. Both companies developed and now market mRNA vaccines for COVID-19. Dynavax (DVAX), which just made a deal with Vaxart (VXRT) for its experimental COVID-19 vaccine, saw its shares drop 5%. The stock of another vaccine biotech called Vaxcyte (PCVX) was also down 6%.</p>
<div class="lb-trans"><p>週一，Moderna 的股票（MRNA）下跌約 6%，而 BioNTech 的股票（BNTX）下跌 4%。這兩家公司開發並現在銷售 COVID-19 的 mRNA 疫苗。Dynavax（DVAX）剛與 Vaxart（VXRT）達成協議，開發其實驗性 COVID-19 疫苗，股價下跌 5%。另一家疫苗生物技術公司 Vaxcyte（PCVX）的股票也下跌了 6%。</p>
</div><p>This is not the first time Prasad has made changes affecting the mRNA COVID-19 vaccines. In June, the FDA added the risks of myocarditis and pericarditis to Comirnaty and SpikeVax, Moderna's shot.</p>
<div class="lb-trans"><p>這並不是 Prasad 第一次對 mRNA COVID-19 疫苗進行影響變更。今年 6 月，FDA 將心肌炎和心包炎的風險添加到了 Comirnaty 和 Moderna 的 SpikeVax 中。</p>
</div><p>&#34;Our interpretation of the memo is that CBER will focus its efforts on the younger 12- to 24-year-old male population for newly approved COVID-19 vaccines where the myocarditis risk is highest,&#34; William Blair analysts told investors.</p>
<div class="lb-trans"><p>“我們對備忘錄的解讀是，CBER 將把努力集中在新批准的 COVID-19 疫苗上，特別是針對 12 至 24 歲男性人羣，因為該人羣的心肌炎風險最高，” William Blair 的分析師告訴投資者。</p>
</div><p>Wall Street is now considering how Prasad's memo, which also reportedly mentions vaccines for flu and pneumonia, may affect drugmakers that aren't just working on mRNA technology and COVID-19 vaccines. The FDA official also called for different endpoints in clinical trials for vaccines.</p>
<div class="lb-trans"><p>華爾街現在正在考慮 Prasad 的備忘錄如何影響不僅在 mRNA 技術和 COVID-19 疫苗方面工作的製藥公司，該備忘錄還提到流感和肺炎疫苗。FDA 官員還呼籲在疫苗的臨牀試驗中採用不同的終點。</p>
</div><p>As of Nov. 21, 5.8% of children and 13.8% of adults in the U.S. have received a COVID-19 vaccine during this respiratory-disease season, according to the Centers for Disease Control and Prevention.</p>
<div class="lb-trans"><p>根據美國疾病控制與預防中心的數據，截至 11 月 21 日，美國 5.8% 的兒童和 13.8% 的成年人在本呼吸道疾病季節接種了 COVID-19 疫苗。</p>
</div><p>-Jaimy Lee</p>
<div class="lb-trans"><p>-Jaimy Lee</p>
</div><p>This content was created by MarketWatch, which is operated by Dow Jones &amp; Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.</p>
<div class="lb-trans"><p>此內容由 MarketWatch 創建，MarketWatch 由道瓊斯公司運營。MarketWatch 與道瓊斯新聞通訊和《華爾街日報》獨立出版。</p>
</div><p>(END) Dow Jones Newswires</p>
<div class="lb-trans"><p>（完）道瓊斯新聞通訊</p>
</div><p>12-01-25 1235ET</p>
<div class="lb-trans"><p>12-01-25 1235ET</p>
</div>

疫苗股價下跌，因 FDA 官員指出 COVID-19 疫苗與年輕男性罕見心臟病之間存在關聯