Senator Demands Answers From FDA on Safety Signal for COVID Vaccines and Children

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U.S. Food and Drug Administration researchers found a signal for seizures/convulsions.

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.

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.

By Zachary Stieber

Read Full Article on TheEpochTimes.com

Sen. Johnson Presses HHS, FDA, CDC, and NIH for Information on COVID-19 Vaccine Adverse Events

WASHINGTON – On Wednesday, U.S. Sen. Ron Johnson (R-Wis.), ranking member of the Permanent Subcommittee on Investigations, sent a letter to the top U.S. health officials at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH) calling for transparency and complete responses to the senator’s numerous requests on the COVID-19 vaccines and other aspects of the pandemic. This correspondence marks the senator’s 60th public letter to U.S. government agencies on the COVID-19 pandemic. 

In his letter to HHS Secretary Xavier Becerra, FDA Commissioner Robert Califf, CDC Director Mandy Cohen, and NIH Acting Director Lawrence Tabak, the senator wrote, “As the top U.S. health officials, and for some of you, medical doctors who have sworn to uphold the Hippocratic Oath, you and your colleagues also bear the absolute responsibility of providing patients and the American public the benefit of informed consent.”

Sen. Johnson added, “You and your colleagues have a duty to provide the American people with complete and transparent data regarding the safety and effectiveness of the COVID-19 ‘vaccines.’ It is completely unacceptable that public health agencies have ignored requests for detailed information about ‘vaccine’ lots that are associated with higher rates of adverse events and have failed to provide CDC’s and FDA’s complete data analyses (Proportional Reporting Ratio tables and empirical Bayesian data mining – if they exist) on ‘vaccine’ adverse events. The fact that the vast majority of my questions and information requests remain unanswered or outstanding only heightens my level of suspicion.”

The senator emphasized the health agencies’ lack of transparency by highlighting his numerous oversight requests to various government agencies that remain unanswered. 

Sen. Johnson noted, “Individuals who willingly or reluctantly received the COVID-19 ‘vaccines’ deserve to know the full truth about the adverse health outcomes they or their loved ones may face following ‘vaccination.’ However, your agencies continue to obstruct my efforts to provide the public with the truth about the COVID-19 ‘vaccines.’ 

This letter also raised questions regarding a recently released, FDA-funded preprint study which found multiple adverse health outcomes, including seizures, associated with the COVID-19 vaccines among vaccinated children.

“The results of this FDA-funded study reaffirm previous concerns about the safety of the COVID-19 ‘vaccines’—particularly for children—and underscore the need for federal health agencies to be transparent with the American people and responsive to Congress,” the senator wrote.

In addition to reiterating the outstanding requests that health agencies have failed to address, the senator asked for new information and materials following the results of the FDA-funded study.

“It is well past time for U.S public health agencies to be transparent,” he concluded.

Read more about the senator’s October 25, 2023 letter to HHS, FDA, CDC, and NIH  in the Epoch Times.

The full letter can be found here.

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Letter from RHJ to Health Agencies Re Outstanding Oversight Requests PDF 10-25-23

Letter-From-RHJ-to-Health-AgenciesRe-Outstanding-Oversight-Requests-10-25-23

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