Moderna: COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to ≤ 6 Years successfully meets its primary endpoint
Moderna has announced interim data from the Phase 2/3 KidCOVE COVID-19 vaccine study ahead of its submission to global regulatory bodies.
Approximately 4,200 children aged 2 to <6 years and 2,500 children aged 6 months to <2 years were recruited across the U.S. and Canada with participants receiving 2 doses of 25 μg, 28 days apart (a lower dose compared with older age groups).
Moderna reports immunogenicity consistent with that seen in adults (18-25 years) receiving doses of 100mcg with a vaccine efficacy of 43.7% in those aged 6 months to <2 years and 37.5% in those aged 2 to <6 years. Omicron was the predominant COVID-19 strain circulating during this trial.
Adverse events following vaccination were reported as mild or moderate and more frequently associated with dose two. No deaths, myocarditis, pericarditis, or cases of multisystem inflammatory syndrome in children (MIS-C) were reported. Independent safety monitoring will continue for 12 months following the second dose.
To read the press release in full, please click on the link below:
COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to ≤ 6 Years successfully meets its primary endpoint
COVID-19 疫苗的临床建议 - 更新的加强建议
澳大利亚免疫技术咨询小组 (ATAGI) 提供了关于使用加强剂量的 COVID-19 疫苗的最新建议：
- 建议 18 岁及以上的个人接受单次加强剂量的任一 mRNA 疫苗（辉瑞公司 或者 现代), 初级疫苗接种完成后 3 个月。
- 建议 16-17 岁的个人在完成主要课程后 3 个月接受单剂 Comirnaty（辉瑞）作为他们的助推器。其他 COVID-19 疫苗品牌未注册用作该年龄段的加强剂量。
- 同时 Nuvaxovid (Novavax) 未在 TGA 注册用作加强剂量，ATAGI 建议在存在 mRNA 疫苗禁忌症的情况下，可将其用作 18 岁或以上个人的加强剂。支持使用 Nuvaxovid 作为加强剂量的安全性和有效性数据有限，但没有理论上的担忧。
- Vaxzevria（阿斯利康） 不再推荐用作加强剂量。已经接受 Vaxzevria（阿斯利康）作为加强剂的个人不需要重复服用替代品牌的加强剂。
有关 ATAGI 关于使用加强剂量的 COVID-19 疫苗的建议的更多信息，请参阅以下链接：
ATAGI 关于使用加强剂量的 COVID-19 疫苗的建议
The Conversation: The Moderna vaccine is now available for 6 to 11 year olds. Here’s what parents need to know
The Moderna COVID-19 vaccine is now approved for use in children aged 6 to 11 years. With just under half of Australian primary-school-age children having received their first COVID vaccine dose, the approval of Moderna’s COVID vaccine provides parents with an additional opportunity to protect their children against severe disease.
Following the KidCOVE clinical trial, this article explores the ongoing safety and efficacy as well as the considerations and administrative recommendations for the use of Moderna’s COVID-19 vaccine in the 6 to 11 years cohort.
To read the full article, follow the link below.