FDA Silent on Discovery of Seizure Risk in Children from COVID Vaccines
U.S. Drug Regulators Silent on Link Between Seizures and COVID-19 Vaccines in Children
The U.S. Food and Drug Administration (FDA) has come under fire for withholding information about a potential link between seizures and COVID-19 vaccines in children. Despite detecting a safety signal for seizures and convulsions in young children following Pfizer and Moderna COVID-19 vaccinations, the FDA has refused to disclose when it first identified this connection.
“It is important for the FDA to be completely transparent about the safety signal suggesting there may be an increased risk for seizures in young children following COVID-19 shots,” said Barbara Loe Fisher, founder and co-president of the National Vaccine Information Center.
The FDA’s lack of transparency has raised concerns among drug safety advocates, who argue that convulsions are known complications of other vaccines. They emphasize the importance of providing information to help individuals assess the risks for themselves, especially for parents with young children who have a history of seizures.
Data From Paper
In a preprint paper, researchers from the FDA and three healthcare companies analyzed data from health claims databases and identified 72 cases of seizures and convulsions in young children within seven days of receiving a COVID-19 vaccine. However, the signal disappeared when background rates from 2022 were used, indicating the need for further investigation.
Despite these findings, the FDA has not issued an alert regarding the signal, unlike previous instances where signals were identified among older age groups. This delay in reporting has hindered other researchers from taking action.
When questioned about the FDA’s identification of the signal and whether it looked for the signal with more recent versions of the vaccines, an FDA spokeswoman expressed confidence in the safety and effectiveness of the COVID-19 vaccines.
“The available data continue to demonstrate that the benefits of these vaccines outweigh their risks,” stated the FDA spokeswoman.
While Pfizer and Moderna have not provided comments on the matter, concerns remain regarding the FDA and CDC’s transparency issues surrounding COVID-19 vaccines. The agencies have been criticized for hiding information, including signals, and refusing to release documents related to investigations into adverse events and deaths following vaccination.
It was only through legal intervention that the FDA began sharing documents analyzed for emergency authorization of the Pfizer and Moderna vaccines.
How important is it for the FDA to address concerns and provide clear information on the link between seizures and COVID-19 vaccines in children for maintaining trust and ensuring public health
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“Parents and healthcare professionals need to be fully informed about the potential risks associated with these vaccines, especially when it comes to our most vulnerable population – our children.”
The lack of transparency from the FDA is cause for concern, as parents and healthcare professionals rely on accurate and up-to-date information to make informed decisions about their children’s health. By withholding this crucial information, the FDA is undermining trust in the vaccination process and potentially putting children at risk.
Seizures and convulsions are serious medical conditions that can have long-lasting effects on a child’s health. It is essential that any potential risks associated with COVID-19 vaccines, including the possibility of seizures, are thoroughly investigated and communicated to the public. This allows parents to weigh the risks and benefits and make the best decision for their child’s well-being.
Currently, the FDA has not provided any public statements regarding the link between seizures and COVID-19 vaccines in children. This silence raises questions about the agency’s commitment to transparency and its duty to protect public health. It is imperative that the FDA addresses these concerns and provides clear and accurate information regarding the safety of COVID-19 vaccines in children.
The National Vaccine Information Center (NVIC) has been advocating for vaccine safety and informed consent since its founding in 1982. They have called on the FDA to release all available data and analysis regarding the potential link between seizures and COVID-19 vaccines in children. Transparency and open communication are crucial in maintaining trust in the vaccination process and ensuring that parents have the necessary information to make educated decisions about their children’s health.
In the absence of official statements from the FDA, it is important for parents and healthcare professionals to stay informed through reputable sources such as medical journals and trustworthy health organizations. By seeking out credible information and engaging in open discussions with healthcare providers, parents can make informed decisions regarding COVID-19 vaccinations for their children.
Ultimately, it is the responsibility of drug regulators like the FDA to prioritize public health and safety. By providing timely and complete information about potential risks associated with COVID-19 vaccines, the FDA can empower parents and healthcare professionals to make informed decisions and ensure the well-being of children. The silence from the FDA on the possible link between seizures and COVID-19 vaccines in children is a disservice to the public and must be addressed promptly.
It is crucial that the FDA acts transparently and releases all available information on this safety signal. Parents deserve to have access to complete information regarding any potential risks associated with COVID-19 vaccines for their children. Only through open and honest communication can trust be maintained and public health be protected.
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