{"id":76195,"date":"2021-07-28T18:05:49","date_gmt":"2021-07-28T22:05:49","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=76195"},"modified":"2021-07-28T18:05:49","modified_gmt":"2021-07-28T22:05:49","slug":"who-has-the-right-to-submit-their-children-to-these-extremely-dangerous-covid-vaccine-clinical-trials","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=76195","title":{"rendered":"Who has the right to submit their children to these extremely dangerous Covid ‘vaccine’ clinical trials?!"},"content":{"rendered":"

At FDA Urging, Pfizer and Moderna to Include Thousands More Children in Clinical Trials<\/strong><\/h1>\n

Citing concerns about the risk of heart inflammation associated with the vaccines, the U.S. Food and Drug Administration asked Pfizer and Moderna to expand the number of children in their clinical trials.<\/em><\/h3>\n

<\/p>\n

By Children’s Health Defense Team<\/p>\n

\"\"<\/p>\n

Pfizer and Moderna will increase the number of children in their COVID vaccine clinical trials prior to seeking\u00a0Emergency Use Authorization<\/a>\u00a0(EUA), after the U.S. Food and Drug Administration (FDA)\u00a0told the vaccine makers<\/a>\u00a0the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects.<\/p>\n

The rare side effects cited by the FDA include\u00a0myocarditis<\/a>, an inflammation of the heart muscle, and\u00a0pericarditis<\/a>, inflammation of the lining around the heart, multiple people familiar with the trials told\u00a0The New York Times<\/a>.<\/p>\n

Moderna\u2019s<\/a>\u00a0shot is authorized for emergency use in people 18 and up, and\u00a0Pfizer\u2019s<\/a>\u00a0vaccine is authorized for children as young as 12. No COVID vaccines have yet received EUA approval for children younger than 12.<\/p>\n

Expanding the pediatric trials means thousands more children as young as 6 months old may soon be recruited and enrolled in COVID vaccine trials.<\/p>\n

According to the Times, the FDA asked the companies to include 3,000 children in the 5- to 11-year-old group, the group for whom results were expected first.<\/p>\n

One person, granted anonymity by the Times to speak freely, described that figure as double the original number of study participants.<\/p>\n

Tell Schools\/Universities\u00a0No Vaccine Mandates<\/span>\u00a0for Children\/Young Adults!<\/a><\/span><\/div>\n

Moderna researchers had intended to test the vaccine in about 7,000 children, with some as young as 6 months,\u00a0according to ABC News<\/a>, but the company told the news outlet today in an email they never decided on how many kids would be added to the trial.<\/p>\n

Pfizer began testing its vaccine in children ages 5 to 11 on June 8, with those younger than 5 being included as of June 21. The study will involve up to 4,500 subjects from the U.S., Finland, Poland and Spain,\u00a0according to the Wall Street Journal<\/a>, which also reported the company declined to say whether the recent request from the FDA will change the timing of any authorization submissions.<\/p>\n

Last month, Pfizer and Moderna\u00a0said<\/a>\u00a0their vaccines for children 5 through 11 could be ready as early as September. Pfizer, which is on a faster timetable than Moderna, may be able to meet the FDA\u2019s expectations on a bigger trial size and still file a request for expanded EUA by the end of September, the Times reported.<\/p>\n

A federal official, who\u00a0spoke to the Washington Post<\/a>\u00a0on the condition of anonymity because they were not authorized to speak publicly, predicted authorization of a COVID vaccine for children 5 through 11 might come by late October or early November.<\/p>\n

The government is not expecting it will be a big problem to enroll more children because so many parents are eager to get their children vaccinated, the official said.<\/p>\n

Heart inflammation in teens raises red flag<\/strong><\/p>\n

Moderna spokesman Ray Jordan told the Post the goal is \u201cto enroll a larger safety database which increases the likelihood of detecting rarer events.\u201d<\/p>\n

According\u00a0The Washington Post<\/a>:<\/p>\n

\u201cThe FDA wants to be particularly careful about the possibility of children developing myocarditis, or heart inflammation, after receiving a coronavirus vaccine. Adolescents who receive the vaccines are more likely to develop myocarditis than adults \u2014 though the risk remains small \u2014 and officials want to increase the chances that the trials will indicate whether there is increased incidence of heart inflammation in children.\u201d<\/p>\n

The Centers for Disease Control and Prevention in June\u00a0acknowledged<\/a>\u00a01,200 cases of heart inflammation in 16- to 24-year-olds, and said\u00a0mRNA COVID vaccines<\/a>\u00a0should carry a warning statement. The FDA followed by\u00a0adding<\/a>\u00a0the warning.<\/p>\n

According to the\u00a0latest data<\/a>\u00a0available, the CDC\u2019s\u00a0Vaccine Adverse Event Reporting System<\/a>\u00a0has received\u00a0383 reports<\/a>\u00a0of myocarditis and pericarditis in vaccine recipients between the ages of 12 and 17 years old, with\u00a0379 cases<\/a>\u00a0attributed to Pfizer\u2019s vaccine.<\/p>\n

For all age groups during the same period,\u00a01,848 cases<\/a>\u00a0of myocarditis and pericarditis were reported to VAERS, with\u00a01,176 cases<\/a>\u00a0attributed to Pfizer,\u00a0606 cases<\/a>\u00a0to Moderna and\u00a062 cases<\/a>\u00a0to J&J\u2019s COVID vaccine.<\/p>\n