FDA Panel Convenes To Discuss Requirement Of Moderna Vaccine Booster Shots

FDA小组召开会议讨论现代疫苗强化注射的需求

2021-10-21 18:30:14 RTTNews

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The U.S Food and Drug Administration panel is holding an important meeting on Thursday to discuss and vote on whether permission should be given for the use of booster shots of Moderna's Covid Vaccine for certain adults. The meeting is the first one of a two-day Vaccine and Related Biological Products Advisory Committee, which will also discuss and vote on booster shots of the Johnson & Johnson vaccines. There will be discussions on the topics of mix-and-match vaccines as well. On Thursday, the FDA panel will discuss the Moderna vaccine and on Friday, they will debate on the topic of J&J booster shots. On its part, Moderna is asking for approval of a 50-microgram booster dose, which is half the 100-microgram doses, used in the main first two doses. Moderna recommends that the booster dose be administered six months after the second dose, and only for people of certain age groups like people age 65 and older; people ages 18 to 64 who risk getting severe Covid-19; and people between 18-64 years, who can be exposed to severe Covid-19 symptoms due to their job profile or other settings. Moderna's demand for the booster shot is similar to the one for Pfizer's mRNA vaccine. The third dose of the Moderna vaccine and Pfizer vaccine have already been approved for certain category of people with lesser immunity. Last month, the FDA approved the emergency use of a booster dose of the Pfizer-BioNTech's COVID-19 vaccine for people over 65 years of age, healthcare workers, and others at high risk of severe COVID-19. The company had claimed that although its vaccine was effective in preventing Covid-19 in early months, the vaccine lost its efficacy over a period. Meanwhile, a recent study by the Centers for Disease Control and Prevention has found that the Moderna vaccine holds out better than Pfizer. In documents made public on Tuesday, there is no mention about the fact that Moderna's vaccine needs a booster to prevent severe COVID or hospitalization. Instead, the documents highlighted the need for preventing infection and mild to moderate disease. The vaccine maker said that the mean antibody level of participants in its study was 1.8 times higher after the booster than it was after the second shot. In other information, the company said that the booster raised neutralizing antibodies at least four times in 87.9 percent people compared to after the second dose, thus missing the FDA requirement of 88.4 percent by a small percentage. For comments and feedback contact: editorial@rttnews.com
美国食品药品监督管理局小组将于周四举行一次重要会议,讨论并投票决定是否应该允许对某些成年人使用莫德纳的Covid疫苗的强化注射。 这次会议是为期两天的疫苗和相关生物制品咨询委员会的第一次会议,该委员会还将讨论并投票表决强生疫苗的加强注射。还将讨论混合和匹配疫苗的话题。周四,美国食品和药物管理局小组将讨论现代疫苗,周五,他们将就J&J强化注射的话题进行辩论。 就莫德纳而言,它要求批准50微克的强化剂量,这是主要的前两剂中使用的100微克剂量的一半。莫德纳建议在第二剂后六个月服用强化剂,并且只适用于特定年龄组的人,如65岁及以上的人;18至64岁有患严重新冠肺炎病风险的人;18-64岁之间的人,由于他们的工作概况或其他环境,他们可能会暴露在严重的新冠肺炎症状中。 莫德纳对强化疫苗的需求类似于辉瑞的基因疫苗。第三剂莫德纳疫苗和辉瑞疫苗已经被批准用于某些免疫力较低的人群。 上个月,美国食品和药物管理局批准为65岁以上的人、医护人员和其他患有严重新冠肺炎病的高风险人群紧急使用辉瑞-生物技术公司的新冠肺炎疫苗。该公司声称,尽管其疫苗在最初几个月对预防新冠肺炎有效,但疫苗在一段时间内失去了效力。 与此同时,疾病控制和预防中心最近的一项研究发现,现代疫苗比辉瑞更有效。 在周二公开的文件中,没有提到莫德纳的疫苗需要助推器来防止严重的COVID或住院。相反,这些文件强调了预防感染和轻中度疾病的必要性。 疫苗制造商表示,其研究中参与者的平均抗体水平在注射助推器后比第二次注射后高1.8倍。在其他信息中,该公司表示,与第二剂相比,该增强剂在87.9%的人中至少提高了四倍中和抗体,从而在很小程度上低于美国食品和药物管理局88.4%的要求。 如需评论和反馈,请联系:editorial@rttnews.com

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