FDA Acknowledges Potential link Between covid Shots and Child Deaths, Announces Vaccine Review
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The Food and Drug Administration is reassessing its vaccine evaluation processes following claims that Covid-19 vaccines may have contributed to the deaths of ten children, and is preparing for a significant discussion on the childhood vaccine schedule. The agency’s shift comes amid scrutiny from newly appointed officials and growing questions about the safety and efficacy of certain vaccines.
This development has far-reaching implications for public health policy and parental confidence in vaccinations. The upcoming review, coupled with proposed changes to how the FDA assesses vaccine safety and effectiveness, could reshape the landscape of preventative medicine in the United States.The changes will affect millions of children and families, and the outcome of the CDC‘s advisory committee meeting next week will be closely watched by healthcare professionals and the public alike.
New Leadership, New Scrutiny
Recent internal memos reveal a critical stance taken by FDA officials regarding past vaccine policies. robert Prasad, a senior FDA official, reportedly described previous vaccine regulation as dishonest
and suggested that vaccine regulation may have harmed more children than we saved.
He also reportedly instructed staff with differing opinions to resign. Prasad has outlined proposed changes to the FDA’s vaccine evaluation process, specifically targeting the annual flu shot evaluation, which he labeled an evidence-based catastrophe of low quality evidence.
Prasad also indicated that manufacturers of pneumonia vaccines will have to show their products reduce pneumonia (at least in the post-market setting),and not merely generate antibody titers.
He further criticized the Biden administration for allegedly dismissing early safety concerns and accused former Centers for Disease Control and Prevention Director Rochelle Walensky of dishonest and manipulative
public statements.
Upcoming CDC Meeting and Covid Vaccine Adjustments
The internal memo precedes a two-day meeting of the CDC’s vaccine advisory committee, scheduled to begin on November 25, 2025, where the childhood vaccine schedule and the hepatitis B vaccine will be discussed. The draft agenda for the meeting is available on the CDC website.
Earlier in 2024, the FDA and CDC already narrowed eligibility for this fall and winter’s Covid-19 vaccines, prioritizing individuals 65 and older and those with underlying medical conditions that increase their risk of severe illness.
Concerns Raised by Kennedy and Makary
These developments align with concerns voiced by Robert F. Kennedy Jr., an anti-vaccine activist, who has downplayed the benefits of vaccines and labeled mRNA vaccines as notably perilous, calling the mRNA Covid vaccine the deadliest vaccine ever made.
In September 2024, FDA Commissioner Marty Makary told CNN that the agency was investigating reports of deaths in otherwise healthy children following Covid-19 vaccination.
Though, extensive research continues to demonstrate the safety and effectiveness of Covid-19 vaccines for children.A 2023 analysis published in JAMA Pediatrics, reviewing 17 studies encompassing over 10 million children aged 5 to 11, found that vaccinated children experienced a lower risk of infection and hospitalization compared to their unvaccinated peers.
Furthermore, a 2024 study in Nature Communications revealed no increased risk of serious adverse events in young children after Covid-19 vaccination, although it did identify a small increase in myocarditis cases in teenage boys within the first two days post-vaccination.
Key Vaccine Data
| Vaccine | Reported Issue | FDA Response |
|---|---|---|
| Covid-19 | Potential link to 10 child deaths | Reviewing safety data; adjusting eligibility |
| Flu | low-quality evidence for annual shots | Revisiting evaluation process |
| Pneumonia | Antibody titers not sufficient proof | Requiring pneumonia reduction data |
Did You Know?
The FDA’s current vaccine evaluation process relies heavily on clinical trial data and post-market surveillance, but concerns have been raised about the rigor of the evidence used to support certain vaccine recommendations.
Pro Tip:
Stay informed about vaccine updates and recommendations by consulting reliable sources such as the CDC and the FDA websites.
What are your thoughts on the FDA’s decision to review vaccine safety data? Do you believe the benefits of vaccination outweigh the potential risks?
Vaccine Safety: A Historical Perspective
Vaccine safety has been a topic of public debate since the earliest days of vaccination. While vaccines have demonstrably eradicated or considerably reduced the incidence of numerous infectious diseases,concerns about potential adverse effects have persisted. Historically, these concerns have often been fueled by misinformation or a lack of understanding of the scientific process.The development of robust surveillance systems and rigorous clinical trials has significantly improved vaccine safety monitoring over time. Though, ongoing vigilance and clarity are crucial to maintaining public trust.
Frequently asked Questions About Vaccine Safety
- What are the common side effects of Covid-19 vaccines? Common side effects include pain at the injection site, fatigue, headache, muscle aches, chills, and fever. These side effects are typically mild and resolve within a few days.
- Are mRNA vaccines safe for children? Extensive research has shown that mRNA vaccines are safe and effective for children, protecting against severe illness from Covid-19.
- What is myocarditis, and is it a risk associated with Covid-19 vaccines? Myocarditis is an inflammation of the heart muscle. A small increased risk of myocarditis has been observed in teenage boys after receiving mRNA Covid-19 vaccines, but the risk is generally low and most cases are mild.
- How does the FDA monitor vaccine safety? The FDA monitors vaccine safety through a variety of systems, including the Vaccine Adverse Event Reporting System (VAERS) and post-market surveillance studies.
- Where can I find more facts about vaccine safety? Reliable sources of information about vaccine safety include the CDC (https://www.cdc.gov/vaccines/index.html) and the FDA (https://www.fda.gov/vaccines-blood-biologics).
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