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[生活] Moderna研发的rsv mrna疫苗临床试验翻车: 疫苗组感染率重症率均更高

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发表于 2024-12-14 12:17 | 显示全部楼层 |阅读模式
本帖最后由 气旋 于 2024-12-14 12:24 编辑

感染率: 疫苗组12.5%, 对照组5%;

重症率: 疫苗组26.35%, 对照组8.3%.

可能又是ADE导致的, 不过好消息是没像60年前的疫苗一样导致接种者死亡.
In September 2024, Moderna announced that the clinical trial of its mRNA vaccine for respiratory syncytial virus (RSV) in children aged 5–24 months was abruptly halted.

The clinical trial, conducted in the UK and other countries, ended after alarming data suggested that the vaccine might not just fail to prevent severe RSV disease, but could potentially worsen it.

Until now, the data was kept secret.

This week, the Food and Drug Administration (FDA) disclosed that vaccinated children in the trial experienced higher rates of severe RSV compared to those in the placebo group.

The data was striking: 12.5% of vaccinated children developed severe or very severe RSV disease, compared to just 5% in the placebo group.

Moreover, among those who developed symptomatic RSV, 26.3% of vaccinated participants progressed to severe illness, sharply contrasting with the 8.3% in the placebo group.

The FDA, which granted the vaccine Fast Track designation in 2021, said the data has “uncertain implications for the ongoing and future pediatric development of other non-live attenuated RSV vaccines.”

顺便请教下, 这种针对婴幼儿的临床一期实验是从哪找的志愿者啊? 你说成年人缺钱去当实验对象, 愿打愿挨很合理; 这才出生的去做实验, 是爹妈缺钱?  按新闻里的说法, 实验是在带英做的, 之前搞新冠攻毒实验的也是带英吧?
这路子比美帝还野?

此外, 按文中说法, 该疫苗的失败可能对整个mrna疫苗路线造成严重影响.   mrna新冠疫苗没有经过严格验证就大规模上市已经影响很坏了, 这下又要给疫苗阴谋论提供素材了.

For parents, the idea that a vaccine could worsen the disease it is meant to prevent, is profoundly unsettling. For scientists, it calls into question the long-term reliability of mRNA as a platform for combating diverse diseases.

The stakes are high—not only for the future of RSV vaccines but for the reputation of mRNA technology as a whole.

Moderna’s mRNA vaccine against RSV takes a tumble | Canberra Daily
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发表于 2024-12-14 12:19 | 显示全部楼层
这不是疫苗 是带路的吧?
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发表于 2024-12-14 12:29 | 显示全部楼层
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发表于 2024-12-14 12:44 来自手机 | 显示全部楼层
三期临床本来就需招募志愿者的啊。

现在武汉这里的RSV疫苗三期也在招募,父母有意愿的都可以报名。
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 楼主| 发表于 2024-12-14 13:23 来自手机 | 显示全部楼层
Wiksy 发表于 2024-12-14 12:44
三期临床本来就需招募志愿者的啊。

现在武汉这里的RSV疫苗三期也在招募,父母有意愿的都可以报名。 ...

这是一期实验, 之前只有动物模型, 没有人类数据的。 得多心大的父母让自家小孩参与
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发表于 2024-12-14 13:30 来自手机 | 显示全部楼层
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 楼主| 发表于 2024-12-14 13:55 来自手机 | 显示全部楼层
讨逆修会 发表于 2024-12-14 13:30
这病毒我记得一直不都是小卡拉米吗,怎么还需要研制疫苗了

—— 来自 鹅球 v3.1.88.3-alpha ...

时代变了啊。现在连鼻病毒这种一般只能造成普通感冒的玩意,都能让人ICU了
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发表于 2024-12-14 14:33 | 显示全部楼层
讨逆修会 发表于 2024-12-14 13:30
这病毒我记得一直不都是小卡拉米吗,怎么还需要研制疫苗了

—— 来自 鹅球 v3.1.88.3-alpha ...

冠哥把全人类免疫-5%

关注下小红书你可以看到各种妈妈抱怨小孩呼吸道疾病一年不重样
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发表于 2024-12-14 14:43 来自手机 | 显示全部楼层
d2loader 发表于 2024-12-14 14:33
冠哥把全人类免疫-5%

关注下小红书你可以看到各种妈妈抱怨小孩呼吸道疾病一年不重样 ...

这实验里疫苗组的六例重症/危重症,其中两例就是和新冠的共感染
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发表于 2024-12-14 14:56 | 显示全部楼层
本帖最后由 wszweill 于 2024-12-14 02:05 编辑
The document, released ahead of a meeting tomorrow of the FDA's Vaccine and Related Biologic Products Advisory Committee (VRBPAC), revealed that a phase 1 trial evaluating the safety, tolerability, and immunogenicity of two Moderna RSV vaccine candidates (mRNA-1365 and mRNA-1345) in infants aged 5 months to 8 months was paused in July after five cases of severe to very severe lower RSV respiratory tract infection (LRTI) were reported in infants who received a 15-microgram (μg) dose of mRNA-1345 (3 cases) or a 15-μg dose of mRNA-1365 (2 cases), compared with 1 case in the placebo group. Five of the 6 infants required hospitalization, with 1 needing mechanical ventilation.

"The observed imbalance in severe/very severe cases of RSV LRTI in the mRNA-1345 and mRNA-1365 vaccine development program among 5-month to <8-month-old recipients of mRNA-1345 (15 μg) and mRNA-1365 (15 μg) has uncertain implications for the ongoing and future pediatric development of other non-live attenuated RSV vaccines," the FDA said.

Moderna was made aware of the safety signal and paused further enrollment on July 17 and notified the FDA of the study-wide pause on July 19, according to the document. The FDA then put a clinical hold on the trial. On September 12, Moderna announced that the RSV program for seronegative children—those without detectable RSV antibodies—younger than 2 years old was listed under discontinued programs.

The trial also found that vaccine immune responses in infants who received mRNA-1345 and had previously been exposed to the monoclonal antibody nirsevimab=》单克隆抗体疫苗 were blunted compared with those who had not received nirsevimab, suggesting a possible interaction.

这报道读起来怎么细思极恐的。这几个月大婴儿咋同时打了单抗和疫苗测试,按比例来总共可能也就一百上下的小样本,不会是专业户吧(

几个月大的婴儿还太小了。成年人可以快速清除外源mRNA,婴儿自己的免疫系统本身就在 发育中。mRNA真感染了大量其他组织,被免疫系统gank了也不好说。
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发表于 2024-12-14 15:40 来自手机 | 显示全部楼层
怕不是用的乌克兰人
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发表于 2024-12-14 17:19 来自手机 | 显示全部楼层
气旋 发表于 2024-12-14 13:23
这是一期实验, 之前只有动物模型, 没有人类数据的。 得多心大的父母让自家小孩参与 ...

不明真相的穷人。
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发表于 2024-12-14 17:58 | 显示全部楼层
气旋 发表于 2024-12-14 13:23
这是一期实验, 之前只有动物模型, 没有人类数据的。 得多心大的父母让自家小孩参与 ...

有人生孩子只是为了拿补贴,试药能拿更多钱何乐而不为
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发表于 2024-12-14 18:47 | 显示全部楼层
润人一大收入来源就是试药啊,有营养补贴你看那些润家长会不会让孩子去试,没在怕的
还有大把的不是润人但是一样没钱的底层家长,你说他让孩子感染,他不拿这个钱可能就饿死了
类似的项目可以去了解一下人源白蛋白和其他人源血液成分制品是怎么来的,就是高级版卖血
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发表于 2024-12-14 22:39 来自手机 | 显示全部楼层
学名叫VAERD效应
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