参议员要求 FDA 就新冠疫苗和儿童的安全信号做出答复
Senator Demands Answers From FDA On Safety Signal For COVID Vaccines And Children

原始链接: https://www.zerohedge.com/medical/senator-demands-answers-fda-safety-signal-covid-vaccines-and-children

美国参议员罗恩·约翰逊 (Ron Johnson) 呼吁美国食品药品监督管理局 (FDA) 和美国疾病控制与预防中心 (CDC) 公布有关给 1 岁以下儿童接种 COVID-19 疫苗的潜在安全问题的记录 五个。 约翰逊参议员在呼吁中强调了 FDA 最近发表的一篇研究论文,该论文确定了该年龄组在接种 COVID-19 疫苗后出现“癫痫和抽搐的信号”。 虽然一些著名的公共卫生机构声称疫苗的整体功效超过了固有的危险,但这份特别报告引发了围绕决策过程的质疑,从而导致针对婴儿和幼儿的疫苗(特别是来自 Moderna 和辉瑞的疫苗)获得批准。 此前,当局对此前疫苗试验的处理方式提出了批评,认为没有足够的临床试验证据来支持大规模管理。 透明度活动人士认为,公开和坦诚将提高民众的信心,他们对官方的信心目前可能因部门内的不实报道或掩盖行为而动摇。 然而,FDA 和 CDC 拒绝了参议员约翰逊和其他人多次尝试获取基础材料进行审查。 FDA 的一名代表声称,“现有数据继续表明 [COVID-19 疫苗] 的益处大于风险”,然而,尽管经过多次询问,但两个组织都没有澄清这些统计数据是如何实现的。 批评者认为,这种遗漏导致了疾病疫苗接种决策的不确定性,加剧了父母对其婴儿后代的长期影响的怀疑。 总体而言,提高透明度的呼声反映出政治人物和公众对提高健康相关行业诚信度的日益关注,特别是考虑到根据更广泛的社会发展坚持科学严谨、实证分析和问责原则的压力越来越大 与疫苗接种有关。

相关文章

原文

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. agencies that clear and recommend vaccines should disclose when they learned that COVID-19 vaccines may cause seizures and convulsions in children, a U.S. senator says.

Sen. Ron Johnson (R-Wis.) urged the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) to disclose the information after both agencies refused to do so to The Epoch Times.

In a preprint paper published on Oct. 15, FDA researchers said they detected a safety signal for seizures/convulsions in children aged 2 to 5 following COVID-19 vaccination.

The paper covered data from no later than April.

About a month before the paper was released, the FDA authorized new shots from Moderna and Pfizer for children as young as 6 months of age. The CDC then announced it was recommending the shots for virtually all Americans, despite little data supporting such a recommendation. Neither agency mentioned the signal of seizures and convulsions.

"When was FDA and CDC first made aware of the findings of the FDA-funded study eventually published as a preprint on October 15, 2023? Provide the names and titles of the individuals who were initially made aware of the study’s findings," Mr. Johnson asked the heads of the FDA and CDC on Oct. 25.

In their paper, the FDA researchers said that the signal should be investigated further "in a robust epidemiological study."

Mr. Johnson asked whether the FDA is pursuing such a study, and for any other steps the FDA and CDC have taken in response to the signal being found.

Sen. Ron Johnson (R-Wis.) speaks during an interview for American Thought Leaders in Washington on May 15, 2023. (Madalina Vasiliu/The Epoch Times)

Mr. Johnson said the new information could change the promoted view that the benefits of the vaccines outweigh the risks. The CDC and FDA said that was the case for nearly all Americans, but many other countries, such as Denmark, have limited COVID-19 vaccination to select groups in light of waning vaccine effectiveness and the high levels of prior infection in the population.

The FDA has refused so far to say when its officials first learned of the signal.

“The FDA is confident in the safety, effectiveness and quality of the COVID-19 vaccines. The available data continue to demonstrate that the benefits of these vaccines outweigh their risks," a spokeswoman told The Epoch Times in an email, ignoring a question about when the signal was first detected.

The CDC did not respond to a request on when it was first informed of the signal.

Pfizer and Moderna have also not responded to queries.

Transparency advocates said the lack of transparency undermines public trust in the health agencies.

"Trust is lost in public health policy recommendations when health officials either refuse or are slow to make information available that can help people weigh the risks for themselves when considering their own current health and medical history," Barbara Loe Fisher, founder and co-president of the National Vaccine Information Center, told The Epoch Times via email.

Mr. Johnson, the ranking member of the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations, has perhaps been the member of Congress most focused on COVID-19 vaccine safety, repeatedly asking federal officials for information that has been withheld or reported in the media.

Mr. Johnson, for instance, asked the FDA for results of data mining done on adverse event reports after The Epoch Times obtained the results from similar mining that showed federal officials detected hundreds of signals for the Pfizer and Moderna shots.

The FDA in September refused to provide Mr. Johnson with the requested data, claiming it could not do so because of ongoing litigation over the information.

Pfizer and Moderna bivalent COVID-19 vaccines are readied for use at a clinic in Richmond, Va., on Nov. 17, 2022. (Steve Helber/AP Photo)

Mr. Johnson has sent 60 letters to federal agencies to try to get answers, but has received little in return.

"Federal health agencies must be transparent and provide all the information they have so that patients can benefit from informed consent. To date, they have failed to do so," Mr. Johnson told The Epoch Times in an email. "It is well past time for them to divulge what they know.”

Mr. Johnson told the leaders of the FDA, the CDC, and the U.S. Department of Health and Human Services that they "have a duty to provide the American people with complete and transparent data regarding the safety and effectiveness of the COVID-19 'vaccines'" and that it is "completely unacceptable" that they've refused to be transparent.

"The fact that the vast majority of my questions and information requests remain unanswered or outstanding," he wrote, "only heightens my level of suspicion."

联系我们 contact @ memedata.com