To Urge FDA, Pfizer and Moderna to Join Thousands of Children in Clinical Trials • Protecting Children’s Health

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Pfizer and Moderna increase children in their COVID vaccine clinical trial before search Emergency Use Permit (EUA), after the U.S. Food and Drug Administration (FDA) told the makers of the vaccine the size and scope of their child studies, as first thought, were insufficient to detect rare effects.

The remarkable side effects cited by the FDA are accompanying myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, many people are familiar with the tests spoken The New York Times.

Moderns authorized is used for emergency use by persons 18 and older, and Pfizer’s The vaccine is allowed for children as young as 12. No COVID vaccines have yet received EUA approval for children under 12.

The increase in child trials means thousands more children as young as 6 years of age can easily be recruited and enrolled in COVID vaccine trials.

According to the Times, the FDA has asked companies to include 3,000 children in the 5 to 11 age group, the group for when results are expected.

One person, who was allowed by the Times to remain anonymous to speak for free, described the number as double the original number of study participants.

Moderna researchers plan to test the vaccine on nearly 7,000 children, some as young as 6 months, agreed with ABC News, but the company told the news outlet today in an email that they have never decided how many children will be added to the test.

Pfizer began testing its vaccines on children ages 5 to 11 on June 8, with children under 5 included until June 21. The study will include up to 4,500 subjects. from the US, Finland, Poland and Spain, according to the Wall Street Journal, which also reported that the company declined to say whether the new request from the FDA would change the timing of any authorization submissions.

Last month, Pfizer and Moderna SAYS their vaccines for children 5 to 11 will be ready in September. Pfizer, which is on a faster schedule than Moderna, could meet FDA expectations in a larger trial and will still file a request for an expanded EUA by the end of September, the Times reported.

A federal official, who spoke to the Washington Post on condition of anonymity because they are not allowed to speak in public, the predicted approval of a COVID vaccine for children 5 to 11 may come in late October or early November.

The government did not expect enrollment of many children to be a big problem because many parents are excited to have their children vaccinated, according to the official.

Inflammation of the heart in teenagers raises the red flag

Moderna spokesman Ray Jordan told the Post that the goal is to “enroll in a more comprehensive security database that increases the likelihood of detecting more events.”

ACCORDING The Washington Post:

“The FDA wants to be careful about the possibility that children will develop myocarditis, or inflammation of the heart, after receiving a coronavirus vaccine. Teenagers who receive vaccines are more likely to have myocarditis disease than adults. – even if the risk is small – and officials want to increase the chance of being shown on tests if there is an increased incidence of heart inflammation in children.

The Centers for Disease Prevention and Prevention in June recognized 1,200 cases of heart inflammation in 16 to 24-year-olds, and said mRNA COVID vaccine must carry a warning statement. The FDA followed increasing the warning.

Agreed to most recent data available, the CDC’s Adverse Vaccine Reporting System RECEIVES 383 reports of myocarditis and pericarditis in vaccine recipients between the ages of 12 and 17 years, with 379 cases dedicated to Pfizer’s vaccine.

For all age groups at the same time, 1,848 cases of myocarditis and pericarditis have been reported in VAERS, with 1,176 cases dedicated to Pfizer, 606 cases in Moderna and 62 cases on the COVID vaccine by J&J.

The data shows reports received between Dec. 14, 2020 and July 16, 2021. The FDA first allowed Pfizer’s vaccine is for about 12 to 15 -year -olds in May this year.

Despite known cases and FDA warnings, the CDC says the benefits of the vaccine outweigh the risks.

Doctors stress the bad advice of rushing to vaccinate children

The authors of a op-ed published last month in The BMJ arguing that even if one thinks the vaccine provides protection against severe COVID, given the “shortest incidence in children,” a much higher number should be vaccinated to prevent a serious case.

Meanwhile, many children who are at very low risk for serious illness are placed at vaccine risks, both knowingly and unknowingly, they say.

They wrote:

“In clinical trials undergoing approval Pfizer-BioNTechVaccine mRNA in children aged 12 to 15, of nearly 1000 children who received placebo, 16 tested positive for COVID-19, compared with none in the fully vaccinated group.

“Because of this small incident, the fact that COVID-19 is usually asymptomatic or mild in children, and the high rate of adverse events of those vaccinated (e.g. in the Pfizer trial 12-15 years of age, 3 in 4 children were tired and had a headache, almost half had a cold and muscle aches, and about 1 in 4 to 5 had a fever and joint pain), a comparison of The adjusted quality life years in the trial preferred the placebo group. ”

Doctors for COVID Ethics, an EU -based international alliance you are hundreds to concerned doctors and scientists, said COVID vaccines not only “unnecessary and ineffective,” but “also dangerous for children and adolescents.”

Three of the groups signed by the signers – Dr. Michael Palmer (Canada), Dr. Sucharit Bhakdi, (Germany) and Stefan Hockertz, Ph.D. (Germany) – compiled in a strong document expert evidence highlighting the high risk of Pfizer vaccine harm in adults and adolescents.

In a open letter of EU Medicines and Healthcare Products, more than 40 doctors, physicians and scientists in the UK say children are more vulnerable to potentially long-term effect of COVID vaccines.

Vaccinating children for COVID is “irresponsible, unethical and unnecessary,” they said.

The letter warns against vaccinating people under 18 because evidence shows that the virus is about to appear. no risk in healthy children. the risk of death from COVID of healthy children one in 1.25 million, the authors write.

COVID vaccines, however, are associated with strokes due to cerebral venous thromboses in people under 40 – a FINDING which “led to the suspension of Oxford-AstraZeneca testing children, ”according to the authors.

The doctors wrote:

“Children have a first life ahead of them, and their cognitive and neurological systems are still in development, making them even more vulnerable. adverse effects than adults. ”

Agreed to latest available data for 12- to 17-year-olds, between Dec. 14, 2020 and July 16, 2021, VAERS received a total 14,494 reports of adverse events related to COVID vaccines, including 871 is taken seriously and 17 died.

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