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[医药资讯] 辉瑞向FDA提交了5-11岁儿童注射疫苗的数据 [复制链接]

石头底下

铜靴族

发表于 2021-9-21 08:52 来自手机 |显示全部楼层

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本帖最后由石头底下于 2021-9-21 09:16 编辑

一共有2，268个小孩参与了实验，人数少了点，尤其是其中只有一半注射了疫苗。

https://www.pfizer.com/news/pres ... ive-topline-results

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石头底下

铜靴族

发表于 2021-9-21 08:57 来自手机 |显示全部楼层

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Antibody titers were as high as adults

The fact that the peak antibody titers are equal between the kids 5 to 11 years old and young adults indicates the COVID vaccine will be protective in the kids.

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铜靴族

发表于 2021-9-21 08:58 来自手机 |显示全部楼层

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"Favorable safety profile" with the 10 microgram dose used

Pfizer used a dose of 10 in the kids instead if the 30 used in adults. That was a reasonable decision, and they see fewer side effects with the lower kid dose (fevers, chills, etc). Other doses were tested early on.

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铜靴族

发表于 2021-9-21 08:59 来自手机 |显示全部楼层

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"The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said pediatric studies should be large enough to rule out any higher risk to young children."

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铜靴族

发表于 2021-9-21 09:01 来自手机 |显示全部楼层

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Filed with the FDA

It looks like they are filing this with the FDA ASAP, with the hope of having FDA EUA authorization before the end of October.
The antibody data are clear evidence the vaccine will work in the kids.

The FDA will have to make a judgement call on the safety data relative to “rule out any higher risk”, but one can expect the FDA to make a judgement relatively quickly.