Letter to U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee in response to “Request for Comments related to consideration of vaccines against SARS-CoV-2”

“Dear Colleagues, 

I am a pediatric specialist caring for children with the multisystem inflammatory syndrome (MIS-C). I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer) have the potential to cause microvascular injury to the brain, heart, liver, and kidneys in a way that is not currently being assessed in safety trials of these potential drugs…

While there are pieces to this puzzle that have yet to be worked out, it appears that the viral spike protein that is the target of the major SARS-CoV-2 vaccines is also one of the key agents causing the damage to distant organs that may include the brain, heart, lung, and kidney. Before any of these vaccines are approved for widespread use in humans, it is important to assess in vaccinated subjects the effects of vaccination on the heart (perhaps using cardiac MRI, as Puntmann et al. did). Vaccinated patients could also be tested for distant tissue damage in deltoid area skin biopsies, as employed by Magro et al. As important as it is to quickly arrest the spread of the virus by immunizing the population, it would be vastly worse if hundreds of millions of people were to suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on these other organs....

Patrick Whelan MD PhD
UCLA Pediatric Rheumatology”