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Moderna Seeks FDA Approval For Updated COVID-19 Shot For Kids, But Scrambles Supply Challenges

Moderna Seeks FDA Approval For Updated COVID-19 Shot For Kids, But Scrambles Supply Challenges

Moderna尋求美國食品和藥物管理局批准更新後的新冠肺炎兒童疫苗，但面臨供應挑戰
Benzinga Real-time News ·  2022/09/26 07:26
  • Last week, Moderna Inc (NASDAQ:MRNA) said it asked the FDA to authorize the use of its updated booster shot in children ages 6 to 17. The company expects to complete a request for the use of the booster in children six months through 5 years later this year.
  • But federal officials have advised state officials that there is a limited supply of updated booster shots for Moderna.
  • Vaccine sites have either canceled or stopped scheduling new appointments for people seeking a Moderna booster shot.
  • Hence, the vaccine providers are offering the new COVID-19 booster shot only from Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX).
  • A Moderna spokesman said the company anticipates resolving constraint issues in the coming days, WSJ reported.
  • "We are working closely with the U.S. government to deliver significant amounts of updated, bivalent booster doses as we continue to see high demand in certain areas of the country," the report quoted the spokesman.
  • A manufacturing-quality problem at a contract manufacturer caused a shortage of Moderna's new booster shot.
  • FDA inspection found several potential violations of drug-manufacturing standards at Catalent Inc's (NYSE:CTLT) plant this August.
  • The inspectors said Catalent didn't properly investigate findings of visible particles in certain products.
  • Moderna said booster shot supply could improve within days after the FDA cleared the release of about 10 million doses that had been held up over the production issue.
  • The company still expects to deliver 70 million doses of its updated booster shot by the end of this year.
  • Price Action: MRNA shares are trading lower by 1.08% at $122.30 in the premarket on Monday.
  • 上週,Moderna納斯達克表示，它請求美國食品和藥物管理局授權對6至17歲的兒童使用最新的強化疫苗。該公司預計將於今年晚些時候完成對6個月至5歲兒童使用強化疫苗的請求。
  • 但聯邦官員已建議州政府官員，新浪Moderna的最新強化注射供應有限。
  • 疫苗網站已經取消或停止為尋求Moderna強化注射的人安排新的預約。
  • 因此，疫苗供應商只提供來自以下地點的新新冠肺炎強化疫苗輝瑞(紐約證券交易所股票代碼：PFE)和BioNTech SE(納斯達克：bntx)。
  • 據《華爾街日報》報道，新浪Moderna的一位發言人説，公司預計將在未來幾天解決相關限制問題。
  • 報道援引這位發言人的話説：“我們正在與美國政府密切合作，提供大量最新的二價強化疫苗，因為我們看到美國某些地區的需求仍然很高。”
  • 一家代工廠的製造質量問題導致Moderna的新增強劑短缺。
  • FDA的檢查發現了幾個潛在的違反藥品製造標準的情況Catalent Inc.的(紐約證券交易所股票代碼：CTLT)將於今年8月開工。
  • 檢查人員説，Catalent沒有正確調查某些產品中可見顆粒的發現。
  • Moderna表示，在美國食品和藥物管理局批准了因生產問題而被擱置的約1,000萬劑疫苗的釋放後，加強疫苗的供應可能會在幾天內改善。
  • 該公司仍預計在今年年底前交付7000萬劑最新的強化疫苗。
  • 價格行動：在週一的盤前交易中，mrna股價下跌1.08%，至122.30美元。
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