Pharmaceutical company Moderna informed the Food and Drug Administration that a "statistically significant" number of rats whose mothers received the company's mRNA COVID-19 vaccine were born with skeletal deformities, according to data from the Department of Health and Human Services that a watchdog group obtained. 制药公司 Moderna 通知美国食品和药物管理局，根据卫生与公共服务部的数据，其母亲接种了该公司的 mRNA COVID-19 疫苗的大鼠中有“具有统计学意义”的数量出生时骨骼畸形。 Judicial Watch announced on Tuesday that HHS had handed over 699 pages of records pertaining to data Moderna sent the FDA. Said handover followed a Freedom of Information Act lawsuit the group filed to obtain the records after the relevant agencies failed to respond to the initial FOIA request.
司法观察周二宣布，HHS 已经移交了 699 页与 Moderna 向 FDA 发送的数据有关的记录。上述移交是在相关机构未能回应最初的 FOIA 请求后，该组织提起信息自由法诉讼以获取记录之后进行的。
A "nonclinical overview" included in the records the group obtained noted that "mRNA-1273 [Moderna vaccine]-related variations in skeletal examination included statistically significant increases in the number of F1 rats with 1 or more wavy ribs and 1 or more rib nodules. Wavy ribs appeared in 6 fetuses and 4 litters with a fetal prevalence of 4.03% and a litter prevalence of 18.2%. Rib nodules appeared in 5 of those 6 fetuses." 该小组获得的记录中包含的“非临床概述”指出，“骨骼检查中与 mRNA-1273 [现代疫苗] 相关的变异包括具有 1 个或更多波浪肋骨和 1 个或更多肋骨结节的 F1 大鼠数量的统计显着增加波状肋骨出现在6胎4胎中，胎儿患病率为4.03%，胎仔患病率为18.2%，6胎中有5胎出现肋骨结节。 "Skeletal variations are structural changes that do not impact development or function of a developing embryo, are considered reversible, and often correlate with maternal toxicity and/or lack of other indicators of developmental toxicity (Carney and Kimmel 2007)," it continued. "Maternal toxicity in the form of clinical observations was observed for 5 days following the last dose (GD 13), correlating with the most sensitive period for rib development in rats (GDs 14 to 17)." “骨骼变异是不影响发育或发育中胚胎功能的结构变化，被认为是可逆的，并且通常与母体毒性和/或缺乏其他发育毒性指标相关（Carney 和 Kimmel 2007），”它继续说道。 “在最后一次给药后的 5 天内（GD 13）观察到以临床观察形式出现的母体毒性，与大鼠肋骨发育最敏感的时期（GD 14 至 17）相关。” "Furthermore, there were no other indicators of mRNA-1273-related developmental toxicity observed, including delayed ossification; therefore, these common skeletal variations were not considered adverse," the records read. “此外，没有观察到其他与 mRNA-1273 相关的发育毒性指标，包括骨化延迟；因此，这些常见的骨骼变异不被认为是不利的，”记录中写道。
The watchdog then contrasted the overview's dismissal of the abnormalities as non "adverse" with a separate article espousing that a comparable abnormality "may give rise to a different and more severe outcome." 然后，监管机构将概述中将异常视为非“不利”的观点与另一篇文章进行了对比，该文章支持类似的异常“可能会导致不同且更严重的结果”。 An advisory committee for the FDA voted in June to recommend that children as young as 6 months old receive the Moderna COVID-19 vaccine. FDA 的一个咨询委员会在 6 月投票建议年仅 6 个月大的儿童接种 Moderna COVID-19 疫苗 The Moderna vaccine received full FDA approval on Jan. 31 of this year. It was previously available under an emergency use authorization. Moderna 疫苗于今年 1 月 31 日获得了 FDA 的全面批准。它以前是根据紧急使用授权提供的。
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