Senator Demands Answers From FDA On Safety Signal For COVID Vaccines And Children

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by Tyler Durden
Sunday, Oct 29, 2023 - 12:10 AM

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.

Other Concerns

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."