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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寻求美国食品和药物管理局批准更新后的新冠肺炎儿童疫苗，但面临供应挑战
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.
  • 上周,Moderna纳斯达克表示，它请求美国食品和药物管理局授权对6至17岁的儿童使用最新的强化疫苗。该公司预计将于今年晚些时候完成对6个月至5岁儿童使用强化疫苗的请求。
  • 但联邦官员已建议州政府官员，新浪Moderna的最新强化注射供应有限。
  • 疫苗网站已经取消或停止为寻求Moderna强化注射的人安排新的预约。
  • 因此，疫苗供应商只提供来自以下地点的新新冠肺炎强化疫苗辉瑞(纽约证券交易所股票代码：PFE)和BioNTech SE(纳斯达克：bntx)。
  • 据《华尔街日报》报道，新浪Moderna的一位发言人说，公司预计将在未来几天解决相关限制问题。
  • 报道援引这位发言人的话说：“我们正在与美国政府密切合作，提供大量最新的二价强化疫苗，因为我们看到美国某些地区的需求仍然很高。”
  • 一家代工厂的制造质量问题导致Moderna的新增强剂短缺。
  • FDA的检查发现了几个潜在的违反药品制造标准的情况Catalent Inc.的(纽约证券交易所股票代码：CTLT)将于今年8月开工。
  • 检查人员说，Catalent没有正确调查某些产品中可见颗粒的发现。
  • Moderna表示，在美国食品和药物管理局批准了因生产问题而被搁置的约1,000万剂疫苗的释放后，加强疫苗的供应可能会在几天内改善。
  • 该公司仍预计在今年年底前交付7000万剂最新的强化疫苗。
  • 价格行动：在周一的盘前交易中，mrna股价下跌1.08%，至122.30美元。
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