The FDA has acknowledged certain serious risks associated with COVID-19 vaccines

EPL- INFORMATION FOR YOUR BUILDING SOUL

The FDA has acknowledged certain serious risks associated with COVID-19 vaccines and has taken steps to address them through updated labeling, revised approval criteria, and enhanced safety monitoring. 

⚠️ Key FDA-Recognized Risks

1. Myocarditis and Pericarditis in Young Males

In April 2025, the FDA mandated that Pfizer and Moderna update their vaccine labels to reflect an expanded warning about the risk of heart inflammation—specifically myocarditis and pericarditis.  This risk is most pronounced in males aged 16 to 25, with an estimated incidence of 38 cases per million doses.  While most cases are mild and resolve over time, the FDA emphasized the need for transparency and ongoing study of potential long-term effects  .

2. Guillain-Barré Syndrome (GBS) and Ischemic Stroke in Older Adults

During the 2023–2024 season, the CDC’s Vaccine Safety Datalink (VSD) detected statistical signals indicating a possible increased risk of:

GBS following the Pfizer vaccine in individuals aged 65 and older (estimated 4.1 excess cases per million doses).

Ischemic stroke following Pfizer (ages 50–64) and Moderna (ages 65+) vaccines. 

These findings are still under investigation, and no definitive causal link has been established.  The FDA and CDC are conducting further studies to assess these risks  .

🧪 Regulatory and Policy Changes

Narrowed Vaccine Approval: The FDA has limited approval of Moderna's new lower-dose vaccine, mNexspike, to adults aged 65 and older and individuals aged 12 to 64 with certain health conditions. This reflects a more cautious approach to vaccine authorization  .

Placebo-Controlled Trials: Moderna has agreed to conduct a true placebo-controlled trial for its new COVID-19 vaccine, as announced by Health and Human Services Secretary Robert F. Kennedy Jr. This move aims to ensure rigorous evaluation of vaccine safety and efficacy  .

Resignation of CDC Vaccine Adviser: Lakshmi Panagiotakopoulos, a key CDC vaccine adviser, resigned following federal decisions to halt recommendations for COVID-19 vaccinations in healthy children and pregnant women. Her resignation highlights internal disagreements over vaccine policy and safety assessments  .

📊 Ongoing Safety Monitoring

The FDA continues to monitor vaccine safety through systems like the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).  These systems are designed to detect potential adverse events and ensure that any risks are promptly identified and addressed.