Promise or Peril: COVID-19 mRNA Vaccine Issues Series (Part 4)
In this series, “Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues,” we explore how the introduction of mRNA technology lacked an adequate regulatory framework, setting the stage for serious adverse events and other concerns related to inadequate safety testing of lipid nanoparticles, spike protein, and residual DNA- and lipid-related impurities, as well as truncated/modified mRNA species.
Previously: In Part 1, we introduced how the U.S. Food and Drug Administration (FDA) relaxed the rules for mRNA vaccines compared to mRNA therapies and discussed the available data regarding LNP distribution throughout the body based on animal testing, the fact that human testing was not done, and the lack of mRNA or spike protein biodistribution data. In Parts 2 and 3, we explored how the LNPs are constructed and how they behave in the body and affect health.
Now we turn to another problem—the cargo contained in the LNP capsules: the mRNA and its encoded spike protein. We introduce the inflammatory response to the spike protein and one of its subunit proteins and how they may contribute to serious adverse events such as myocarditis and blood clotting.
Rochelle Walensky, former director of the U.S. Centers for Disease Control and Prevention (CDC), stated on “Good Morning America” in June 2021 that myocarditis cases are “really quite rare … minor, self-limited, they generally resolve with rest and standard medications.” However, this assertion was made based on a preliminary review of 300 cases and before conducting long-term follow-up.
A study published on Aug. 1 followed 40 adolescents in Hong Kong for up to a year. Follow-up testing performed in 26 patients with initial abnormal findings revealed that 58 percent of those with vaccine-associated myocarditis had persistent heart muscle scarring. The authors concluded: “There exists a potential long-term effect on exercise capacity and cardiac functional reserve during stress.”
This series demonstrates how exposure to the spike protein results in downstream cardiovascular issues. Given that vaccination causes the body to produce more spike protein, it is clear that additional research was needed to understand the health impacts of vaccination prior to licensure.
Summary of Key Facts
- The SARS-CoV-2 spike protein and its S1 subunit have known impacts on the cardiovascular system, such as an increased risk of blood clotting.
- The vaccine-induced spike protein and its S1 subunit have been found in the blood following vaccination.
- In lab studies, the spike protein activates white blood cells and may trigger an inflammatory response or clotting.
- Free spike protein was found in the blood of adolescents and young adults with post-mRNA vaccine myocarditis but not in healthy control subjects without myocarditis.
- The S1 subunit can interact with ACE2, platelets, and fibrin and may be what leads to an inflammatory response driving serious adverse events, including clots, myocarditis, and neurological problems.
- As discussed in Part 3, lipid nanoparticles (LNPs) act as adjuvants, stimulating the immune system. This innate immune response peaks within six hours of vaccination and returns to baseline by about day nine, temporally corresponding to the onset of myocarditis, which typically occurs within the first seven days following mRNA COVID-19 vaccination.
- Studies have not been done to evaluate how vaccination affects those who have already been infected with SARS-CoV-2.
- The spike protein was implicated in small vessel microclots during COVID-19 illness; thus, postvaccination cardiovascular effects should have been anticipated.
- The first deadline for FDA-mandated post-authorization safety studies has passed, yet to the best of our knowledge, the full report has not been made available to the public.
By Allison Krug, MPH and Dr. Ram Duriseti
