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

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 studyโ€™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 โ€“ 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 senatorโ€™s numerous requests on the COVID-19 vaccines and other aspects of the pandemic. This correspondence marks the senatorโ€™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, โ€œAs 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.โ€

Sen. Johnson added, โ€œYou 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 โ€˜vaccines.โ€™ It is completely unacceptable that public health agencies have ignored requests for detailed information about โ€˜vaccineโ€™ lots that are associated with higher rates of adverse events and have failed to provide CDCโ€™s and FDAโ€™s complete data analyses (Proportional Reporting Ratio tables and empirical Bayesian data mining โ€“ if they exist) on โ€˜vaccineโ€™ adverse events. The fact that the vast majority of my questions and information requests remain unanswered or outstanding only heightens my level of suspicion.โ€

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

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

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.

โ€œThe results of this FDA-funded study reaffirm previous concerns about the safety of the COVID-19 โ€˜vaccinesโ€™โ€”particularly for childrenโ€”and underscore the need for federal health agencies to be transparent with the American people and responsive to Congress,โ€ 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.

โ€œIt is well past time for U.S public health agencies to be transparent,โ€ he concluded.

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

The full letter can be found here.

###

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

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Columns

Why States Are Pausing Cage-Free Mandates During Bird Flu Crisis

As U.S. continues a protracted battle with bird flu, some states are temporarily rolling back laws governing how egg-laying hens are housed.

Shifting Gears 2025

That grinding you hear is the sound of the Democrat party hopelessly stuck in first gear while Trump and Republicans zoom ahead of them in overdrive.

More Proof, the Democratic Party is Imploding!

Jason Pizzo, the leading Democrat in the Florida Senate announced his departure from the Democratic Party saying he sees the party as dead in Florida.

American Psychiatric Association vs. MAHA: Shots Fired

When Trump formed the MAHA Commission, the parameters were so reasonable that it was hard to imagine how the biomedical establishment could object.

Evaluating Foreign Affairsโ€™ Warning About The Risks Of An Emboldened & Remilitarized Germany

Foreign Affairs warned earlier this month that an emboldened...

News

US Attorney General Releases Details on New Mexico Judgeโ€™s Arrest

AG Pam Bondi provided details about former NM judgeโ€™s arrest for allegedly allowing an illegal immigrant and suspected TdA gang member to live at his residence.

Thousands of Illegal Immigrants Have Registered on CBP Home App to Self-Deport, CBP Says

DHS said thousands of illegal immigrants registered on CBP Home app to self-deport, and those who have not yet done so will face consequences.

5 Things We Know About Wisconsin Judgeโ€™s Arrest for Allegedly Obstructing ICE

Court papers detail Judge Hannah Dugan was arrested for allowing an illegal immigrant to escape through a jury door before arrest by federal officials.

ICE Backtracks on Revoking More Than 1,200 Student Visas

ICE reversed decision to automatically revoke student visas, after State Dept said it would use AI to review foreign studentsโ€™ records for criminal activity or arrests.

Court Ruling Limits Ozempic Copies in Favor of FDA, Novo Nordisk

Federal court ruled against trade group representing compounding pharmacies, siding with FDA and Novo Nordisk in dispute over copies of Ozempic and Wegovy.

Judge Blocks Removal of Potential Deportees From Texas District

Federal judge temporarily restrained Trump admin from removing individuals from Southern District of Texas in attempt to deport Venezuelan gang members under the Alien Enemies Act.

Former Rep. George Santos Sentenced to More Than 7 Years in Prison

Former Rep. George Santos (R-N.Y.) was sentenced on April 25 to more than 7 years in federal prison on wire fraud and aggravated identity theft charges.

FBI Arrests Wisconsin Judge Hannah Dugan Over Obstructing, Kash Patel Says

FBI arrested a Milwaukee County, Wisconsin, circuit judge for allegedly assisting an illegal immigrant in evading arrest, FBI Director Kash Patel said.
spot_img

Related Articles