The Vaccines and Related Biological Products Advisory Committee has unanimously recommended the approval of mFlusiva, an mRNA influenza vaccine created by Moderna for adults aged 50 and older.

疫苗及相關生物製品諮詢委員會一致建議批准 mFlusiva，這是一款由 Moderna 為 50 歲及以上成年人研發的 mRNA 流感疫苗。

This recommendation comes after a large clinical trial with 40,000 participants, which showed that the vaccine was 27% more effective than standard flu shots. The committee suggested two different approval paths: full approval for people aged 50 to 64, and a faster, 'accelerated' path for those 65 and older, provided that more studies are done after the vaccine reaches the market. This decision follows a disagreement with the FDA, which had previously rejected the application because the trial did not compare the new vaccine to the high-dose shots usually given to elderly patients. However, Moderna argued that the FDA had previously agreed to the trial design and provided extra data to show the vaccine worked similarly to high-dose options.

此建議是在一項有 40,000 人參與的大型臨床試驗後提出的，結果顯示該疫苗比標準流感疫苗有效 27%。委員會建議了兩種不同的批准路徑：50 至 64 歲人士可獲得完全批准，而 65 歲及以上人士則可透過較快的「加速」路徑批准，前提是疫苗上市後須進行更多研究。此決定是在與 FDA 產生分歧後做出的，FDA 此前因試驗未將新疫苗與通常提供給高齡患者的高劑量疫苗進行比較而拒絕了申請。然而，Moderna 主張 FDA 此前已同意該試驗設計，並提供了額外數據證明該疫苗的效果與高劑量方案相似。

From a technical side, the mRNA platform is much faster to produce than traditional egg-based vaccines. While traditional methods take about six months, mRNA vaccines can be ready in two to three months. Consequently, this allows scientists to match the vaccine more accurately to the current flu strains. Despite these benefits, the political situation is difficult. Health Secretary Robert F. Kennedy Jr. has expressed doubts about mRNA technology and has already cancelled around $500 million in research funding. Furthermore, the FDA currently lacks permanent leaders in its vaccine division and commissioner's office, meaning temporary officials must make the final decision.

從技術層面來看，mRNA 平台的生產速度遠快於傳統的雞蛋疫苗。傳統方法約需六個月，而 mRNA 疫苗在兩到三個月內即可準備就緒。因此，這使得科學家能更準確地使疫苗對應當前的流感病毒株。儘管有這些優勢，但政治局勢十分困難。衛生部長 Robert F. Kennedy Jr. 對 mRNA 技術表示懷疑，並已取消了約 5 億美元的研究資金。此外，FDA 的疫苗部門和局長辦公室目前缺乏常任領導人，這意味著最終決定必須由臨時官員做出。

Although the advisory panel supports the vaccine, it will not be available until it receives formal FDA approval and a recommendation from the CDC, which is currently delayed by a court case.

雖然諮詢小組支持該疫苗，但在獲得 FDA 正式批准及 CDC 建議之前，該疫苗將無法上市，而目前正因一起法院訴訟而延遲。