By Peter A. McCullough, MD, MPH
One of the early product warnings came in July 2021 with COVID-19 vaccination was Guillain-Barre Syndrome (GBS) or life-threatening ascending paralysis with the Janssen adenoviral COVID-19 vaccine. Using VAERS, Abara et al reported 211 cases of GBS submitted from December 2020 through January 2022 occurred with mRNA vaccines (Pfizer, Moderna) presenting with symptoms 8-10 days after taking the shot.
Of note, only 16% of cases reported by the patients themselves to the CDC leaving the majority to be reported by healthcare workers or the vaccine companies. The mean age was 59 years and sadly, 10 patients died after developing GBS. All but one of these cases died on the mechanical ventilator suggesting the systemic syndrome was far more lethal than GBS survived in other conditions (West Nile virus, Campylobacter jejuni, influenza vaccine etc.) These data strongly support FDA warnings for GBS in the FAQ for EUA vaccination and in all consent forms. This illness is a disaster for so many patients causing severe short and sometimes long term disability.
These findings are a severe blow to the mRNA vaccine development programs active in several companies including Moderna who recently received FDA Breakthrough Therapy Designation for their investigational respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, in adults aged 60 years or older. Data safety monitoring boards and advisory committees should be on a alert for GBS which can occur days to weeks after injection with mRNA.
This paper illustrates several points: 1) the CDC believes VAERS is a solid database for research and is using it, 2) the majority of serious events like GBS are reported by healthcare providers and vaccine manufactures, not the patients or families, 3) the FDA/CDC are not updating EUA FAQ or consent documents, thus Americans are not getting fair informed consent with COVID-19 vaccination, 4) GBS is likely to occur to occur with mRNA and should be tagged as a special adverse event of interest in mRNA development programs.
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Abara WE, Gee J, Marquez P, Woo J, Myers TR, DeSantis A, Baumblatt JAG, Woo EJ, Thompson D, Nair N, Su JR, Shimabukuro TT, Shay DK. Reports of Guillain-Barré Syndrome After COVID-19 Vaccination in the United States. JAMA Netw Open. 2023 Feb 1;6(2):e2253845. doi: 10.1001/jamanetworkopen.2022.53845. PMID: 36723942.
FDA Grants Breakthrough Therapy Designation to Moderna for Investigational RSV Vaccine Feb 2, 2023 Aislinn Antrim, Editor