Senator seeks clarification from FDA regarding safety concerns of COVID vaccines for children.
The U.S. Agencies Urged to Disclose Seizure Risks in Children from COVID-19 Vaccines
A U.S. senator is calling for transparency from the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) regarding their knowledge of the potential link between COVID-19 vaccines and seizures in children. Sen. Ron Johnson (R-Wis.) insists that these agencies should reveal when they first became aware of this information, after both organizations declined to disclose it to The Epoch Times.
In a preprint paper published on Oct. 15, FDA researchers revealed the detection of a safety signal for seizures and convulsions in children aged 2 to 5 following COVID-19 vaccination.
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The FDA researchers’ paper only included data up until April. However, about a month before its release, the FDA authorized COVID-19 shots from Moderna and Pfizer for children as young as 6 months old. The CDC then recommended these shots for almost all Americans, despite limited supporting data. Notably, neither agency mentioned the potential risk of seizures and convulsions.
Sen. Johnson directly questioned the FDA and CDC heads on Oct. 25, asking when they first became aware of the findings from the FDA-funded study published on Oct. 15, 2023. He demanded the names and titles of the individuals initially informed about the study’s findings.
The FDA researchers emphasized the need for further investigation of the seizure signal ”in a robust epidemiological study.” Sen. Johnson inquired about the FDA’s progress in conducting such a study and any actions taken by the FDA and CDC in response to the signal.
Sen. Johnson believes that this new information could challenge the prevailing notion that the benefits of the vaccines outweigh the risks. While the CDC and FDA maintain that this is true for most Americans, other countries like Denmark have limited COVID-19 vaccination to specific groups due to declining vaccine effectiveness and high levels of prior infection in the population.
The FDA has refused to disclose when its officials first became aware of the seizure 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,” stated an FDA spokeswoman in an email to The Epoch Times, sidestepping the question about the signal’s initial detection. The CDC did not respond to inquiries regarding when they were first informed of the signal. Pfizer and Moderna have also remained unresponsive.
Transparency advocates argue that the lack of openness undermines public trust in these health agencies. Barbara Loe Fisher, founder and co-president of the National Vaccine Information Center, expressed her concerns, stating, “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.”
Other Concerns
Sen. Johnson, as the ranking member of the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations, has been particularly focused on COVID-19 vaccine safety. He has persistently requested information from federal officials that has either been withheld or reported in the media.
For example, Sen. Johnson asked the FDA for the results of data mining conducted on adverse event reports. The Epoch Times obtained similar results from their own mining, which revealed hundreds of signals for the Pfizer and Moderna shots.
In September, the FDA refused to provide Sen. Johnson with the requested data, citing ongoing litigation. The FDA and CDC have also withheld information on post-vaccination deaths, COVID-19 cases among the vaccinated, subclinical heart inflammation studies, and early warnings about myocarditis after Pfizer vaccination.
Sen. Johnson has sent 60 letters to federal agencies in his pursuit of answers but has received minimal responses. He emphasized that “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,” and demanded that they disclose their knowledge.
Sen. Johnson concluded his message to the FDA, CDC, and U.S. Department of Health and Human Services leaders by stating that they have a duty to provide complete and transparent data on the safety and effectiveness of COVID-19 vaccines. He expressed his disappointment in their lack of transparency, stating that their refusal to do so is ”completely unacceptable.”
“The fact that the vast majority of my questions and information requests remain unanswered or outstanding,” he wrote, “only heightens my level of suspicion.”
The FDA researchers in their preprint paper.
Regarding adverse reactions, long-term effects, and risk assessments associated with COVID-19 vaccines. In a letter sent to Dr. Rochelle Walensky, Director of the CDC, and Dr. Janet Woodcock, Acting Commissioner of the FDA, Sen. Johnson expressed his concerns and demanded transparency in disclosing information related to the potential link between COVID-19 vaccines and seizures in children.
The call for transparency stems from a preprint paper published on October 15 by FDA researchers, which revealed a safety signal for seizures and convulsions in children aged 2 to 5 following COVID-19 vaccination. While the paper only included data up until April, it is alarming that both the FDA and CDC authorized and recommended COVID-19 shots for children as young as 6 months without mentioning the potential risks associated with seizures and convulsions.
Sen. Johnson directly questioned the heads of the FDA and CDC, seeking information on when they first became aware of the findings from the FDA-funded study published on October 15, 2023. He demanded the names and titles of the individuals who were initially informed about the study’s findings. Additionally, Sen. Johnson inquired about the progress of the FDA in conducting a robust epidemiological study to further investigate the seizure signal, as mentioned by
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