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Mostrando entradas con la etiqueta Vaccines. Mostrar todas las entradas
Mostrando entradas con la etiqueta Vaccines. Mostrar todas las entradas

15 de junio de 2022

炸了!FDA败诉!辉瑞被迫公开疫苗数据!副作用足足9页!全网惊呆…

 

炸了!FDA败诉!辉瑞被迫公开疫苗数据!副作用足足9页!全网惊呆…

US168资讯网 2022-03-04 19:17

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自从疫苗全面推广接种以后,就陆续有各种副作用被曝出,常见的包括发烧、注射肌肉酸疼,此外还有不少人患上心肌炎,皮炎,以及出现其他较为罕见的症状。




但昨天,一则最新消息让很多人震惊!


辉瑞疫苗被迫公布了真实疫苗数据,其中,一份有关“辉瑞疫苗不良反应”的9页报告,瞬间在Twitter上炸锅!


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事情的经过是这样的:


3月1日,美国食药监局FDA在官司中败诉,法院要求FDA今年夏天之前要完成辉瑞新冠疫苗32.9万页完整审评文件的公开现在, FDA已经发布了首批文件。


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不过没有对文件提供任何形式的解读或整理。目前其网站上总共公布了150份文件,可供自由下载。


不过,说到这起案件的过程,却是一波三折。


将FDA告上法庭的是透明度公共卫生和医疗专业人员组织(PHMPT),这是一个非盈利组织,于去年9月首次在美国得克萨斯州北部地区法院向美国食品和药物管理局(FDA)提起诉讼。质疑FDA决定扣留与辉瑞和BioNTech对2019年新冠疫苗的相关数据


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去年11月,PHMPT组织就要求FDA完整披露疫苗评审数据,但FDA并没有给出回应。


随后,PHMPT组织将FDA告上了法院。


FDA向联邦法官申请,每个月只披露500页相关文件。也就是说,全部披露32.9万页的资料,需要足足55年,到2076年!


PHMPT组织当时就怒了:到了2076年,很多制造、批准和接种疫苗的人早就离开这个世界了。


原告方认为,FDA违反了美国联邦法律规定,即“一旦获得许可,生物产品在使用许可审批过程中的数据和信息可立即公开披露”,这与FDA对新冠疫苗审批前后“完全透明”的承诺背道而驰。


注:

PHMPT组织是由美国知名大学的数十位学者、教授和公共健康专业人士组成,他们声称在辉瑞向FDA提交用以申请新冠疫苗获批的全部文件公开之前,独立科学家们不能进行适当的分析,无法确保数百万美国人或自愿或被雇主要求接种的关键疫苗一定安全有效。


这场官司在本周迎来了重大进展,3月1日,FDA在德州地区法院败诉了,从当天开始,必须陆续发布大量辉瑞疫苗“安全有效”相关的审查文件。


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在众多的文件里,最让人震惊的,莫过于关于辉瑞疫苗不良反应的报告,足足有9页之多,很多网友瞬间就炸了!


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目前披露的文件中列出了1000多种不良反应,很多都是头一次看到,包括:


筋膜炎、眼部肿胀、面瘫、斑秃、过敏休克、妊娠过敏反应综合征、急性心肌病、急性呼吸衰竭、注射部位血管炎、癫痫、血栓、心律失常、关节炎、哮喘、支气管痉挛、心脏骤停、心力衰竭、胸部不适、窒息、急性皮肤红斑狼疮、急性脑脊髓炎、急性肾损伤、急性黄斑外层视网膜病变、再生障碍性贫血、慢性自身免疫性肾小球肾炎、慢性皮肤红斑狼疮、慢性自发性荨麻疹、溶血性贫血、结肠炎、皮炎、糖尿病、栓塞性脑梗塞、内分泌失调、新生儿重症肌无力、脊髓炎、非感染性卵巢炎、甲状腺炎、溃疡性直肠炎、眼部瘙痒症、生殖器疱疹、舌咽神经麻痹、出血性血管炎、宫颈炎、狼疮性膀胱炎、狼疮性脑炎、多发性硬化症等等。


详情连接:http://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf


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根据相关的报道,在发布出的文件中,被标记为优先审查请求的文件包含了100多页匿名安全性相关数据表,其他一些文件还包括未识别参与者的性别、年龄和 BMI 表;一些典型的药品或疫苗申请文件;一份文件显示辉瑞向FDA支付近290万美元的标准使用者付费费用;快速通道认定信(通常不会公布);疫苗的非临床保密摘要;未随机接受疫苗试验的匿名受试者清单等。


据报道,目前尚不清楚这些被披露的文件是否会为疫苗的安全性或有效性提供新的研究结果。但代表非盈利组织方面表示,“我们的工作是获取这些文件,真实的情况要交给科学家和其他专业人员来分析。”


此事一经公开,立即在Twitter上引起网友们的激烈讨论:


“在辉瑞试验研究的46,000参与者中,有42,000人有不良反应,1200人死亡。FDA的规定是,在接受一种实验性试验药物后30天内只要有一个人死亡就会结束试验。但这却从未发生过,我们需要问为什么。”

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“法国正取消强制疫苗,想知道这是否与辉瑞公布数据有关。报告显示,有1229名健康的人死于疫苗。”

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“长达9页的副作用,他们竟然想隐藏75年。”

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“数以百万计的人们会因疫苗生病或死亡,没人能知道之后几年会发生什么事情。”

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“接种疫苗后出现的副作用” ↓

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“在接种疫苗一周后,我的大腿出现了收缩性肌肉痛,已经持续了一个多月了......”

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不过另外一方面,也有人表示,所有疫苗都可能存在副作用,辉瑞已经将实际数据公布出来,“那它就是‘最安全’的疫苗” ↓

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综合:医谷、华尔街见闻、北美观察家、加国无忧等

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22 de diciembre de 2021

House Republicans Ask Biden When Legal Immunity for Vaccine Manufacturers Will End

 

House Republicans Ask Biden When Legal Immunity for Vaccine Manufacturers Will End

Rep. Michael Cloud (R-Texas) speaks at a press conference in El Paso, Texas on March 15, 2021. (Justin Hamel/AFP via Getty Images)
By Zachary Stieber
December 21, 2021 Updated: December 21, 2021

A group of House Republicans has asked President Joe Biden about the legal immunity granted to COVID-19 vaccine manufacturers, expressing concern about the immunity combined with the administration’s vaccine mandates.

Rep. Michael Cloud (R-Texas) and 15 colleagues told Biden in a Dec. 20 letter that the mandates raise “many concerns as to the ethics of the federal government requiring a vaccine which receives special liability protections normally afforded to developing drugs, financially benefiting the vaccine manufacturers.”

During the Trump administration, then-Health Security Alex Azar invoked the Public Readiness and Emergency Preparedness (PREP) Act and declared vaccine makers immune from claims except for those alleging “willful misconduct.”

The invocation has been extended multiple times and is currently set to stay in place until October 2024.

People who suffer adverse reactions from a COVID-19 vaccine can seek compensation from a program known as CICP, but program administrators have been slow to analyze claims. The first payout was just announced last week.

Cloud and the other congressmembers said they see the combination of mandates and legal protection for Pfizer, Moderna, and Johnson & Johnson unjust.

“It is utterly unjust to the American people to not only use the coercive arm of the government to force vaccines upon them, but to then provide little legal recourse for damages should they be adversely affected. It is our belief that in the face of such mandates, the American people should be entitled to greater legal recourse to recoup damages brought on by the federal government,” they wrote.

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House Republicans Ask Biden When Legal Immunity for Vaccine Manufacturers Will End

“Trying to unconstitutionally mandate an experimental vaccine on Americans without allowing them legal recourse if they are adversely affected is one of the most egregiously tyrannical abuses of power in America’s history,” Cloud added in an emailed statement to The Epoch Times. “Giving full-blown legal immunity to vaccine manufacturers while mandating the public to use their product is absurd. If the Biden administration continues to pursue forced injections, then vaccine manufacturers must have their legal immunity revoked, allowing Americans to take legal action if they experience harmful side effects.”

Epoch Times Photo
A nurse fills up syringes for patients as they receive their COVID-19 booster vaccination during a Pfizer-BioNTech vaccination clinic in Southfield, Mich., on Sept. 29, 2021. (Emily Elconin/Reuters)

Pfizer, Moderna, Johnson & Johnson, the Department of Health and Human Services, and the White House did not respond to requests for comment.

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Federal Officials Should Lift Liability Protection From COVID-19 Shots: Former HHS Official

Millions of Americans have experienced side effects after getting a COVID-19 vaccine, according to reports submitted to the Vaccine Adverse Event Reporting System.

One of the most severe side effects, blood clotting with low blood platelet levels, has been seen more frequently after people get Johnson & Johnson’s shot. About 15 percent of cases have led to death. That prompted the Centers for Disease Control and Prevention (CDC) last week to recommend people get one of the other vaccines.

The Pfizer and Moderna shots have been linked to post-vaccination heart inflammation, but health officials have said they have not been able to confirm that the condition has resulted in any deaths.

The Food and Drug Administration and the CDC say the benefits of all three vaccines cleared for use in the United States outweigh the risks. The benefits are primarily the reduction of hospitalizations following contraction of the CCP (Chinese Communist Party) virus, which causes COVID-19.

The Biden administration was asked whether there are plans to rescind the current PREP Act declaration, given regulators approved Pfizer’s vaccine in August.

It was also asked what criteria must be satisfied to rescind the declaration before its expiration date and how the criteria are decided upon.

Zachary Stieber

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