The FDA Memo That Shakes the World

 A memo from Dr. Vinay Prasad, the head of the Center for Biologics Evaluation and Research at the FDA, has raised significant concerns about the safety of COVID-19 vaccines, particularly regarding children's health. The memo indicates that at least 10 children have died after receiving the vaccine, which could prompt a reevaluation of the U. S. vaccine program.

1. Deaths Linked to Vaccination:

• Dr. Prasad reports that the FDA has verified at least 10 child deaths related to COVID-19 vaccinations. This number is believed to be an underestimate due to underreporting.

• The memo asserts that these deaths are significant and warrant immediate attention and reevaluation of vaccine policies.

2. Previous Acknowledgments:

• Prior to this memo, concerns about vaccine-induced myocarditis, particularly in young boys, were raised but not thoroughly acknowledged by health authorities, including the FDA and CDC.

• The memo brings attention to the delayed recognition of safety signals that could have affected vaccine recommendations for children.

3. Focus on Risk vs. Benefit:

• Dr. Prasad questions whether vaccines have saved more children's lives than they have harmed. He highlights the lack of reliable data to determine the true benefits of vaccinating children against COVID-19.

• The memo calls for a more rigorous assessment of the risks associated with vaccination compared to the risks posed by COVID-19 in children.

4. Concerns About Reporting:

• The vaccine adverse events reporting system (VAERS) is acknowledged as being underutilized, leading to a potential underreporting of adverse effects.

• The memo emphasizes the challenges in assessing causality in case reports, which complicates understanding the true impact of vaccines.

5. Calls for Systemic Changes:

• Dr. Prasad expresses a need for introspection and reform within the FDA. He suggests that the systematic review of vaccine safety signals should be prioritized over historical practices.

• The memo advocates for evidence-based regulations regarding vaccines and calls for randomized clinical trials to provide clearer data on vaccine safety and efficacy.

6. Response to Public Opinion:

• There are concerns regarding the leaking of FDA information to the media, which could distort public perception of vaccine safety.

• Dr. Prasad stresses the importance of maintaining confidence in the vaccine regulatory process while addressing public concerns honestly.

7. Future Direction for FDA:

• The memo outlines a new direction for the FDA, advocating for improved methods of assessing vaccine risks and benefits.

• Dr. Prasad plans to revise current frameworks for approving vaccines and ensure that they are subjected to stringent evidence-based practices.

This memo from Dr. Vinay Prasad represents a critical turning point in the ongoing conversation about the safety of COVID-19 vaccines for children. It raises essential questions about the balance between the benefits of vaccination and the potential risks, calling for a substantial reevaluation of current vaccine mandates and policies. The document reflects an urgent need for systemic changes within the FDA to ensure that vaccine safety is prioritized and transparently communicated.

https://brownstone.org/articles/the-fda-memo-that-shakes-the-world/