Reproduced with permission from Dr. Marian P. Laderoute – Open Letter on the Safety and Effectiveness of COVID-19 Vaccines to Dr. Patrick Fandja, Executive Director, Bureau of Biologics, Pharmaceuticals and Self Care Products, Marketed Health Products Directorate, Health Products and Food Branch, Health Canada. Dr. Laderoute holds a Ph.D. degree in Medical Sciences in Immunology, and she has been able to speak her mind freely on the COVID-19 vaccines since she retired from Health Canada (HC). In her letter, she questions the safety of the COVID-19 mRNA vaccines and the failed surveillance and corresponding lack of risk assessment by PHAC/HC.
Dr. Laderoute has a background both in the regulation of biological products that carry infectious disease risks (blood products & in theory, xenografts) while at HC and in infectious disease (xenozoonoses) risk assessment/minimization strategies while Research Manager of the Blood Zoonotics Unit at the Public Health Agency of Canada (PHAC). Equally relevant, from 2008 until 2015, Dr. Laderoute was a working member of the Brighton Collaboration Viral Vector Vaccine Safety Working Group (V3SWG) that had the goal of improving surveillance for Adverse Events Following Immunization (AEFI) for new vaccine technologies under the leadership of Dr. Robert Chen. The V3SWG was initiated on the heels of the unexpected finding of higher rates of HIV acquisition among participants of the STEP trial published in Lancet November 13, 2008. Dr. Laderoute also has experience in the post-market (safety) surveillance of biological products and was involved in the risk assessment of Raptiva, which eventually was withdrawn from the Canadian and worldwide markets in 2009 associated with three deaths.
In addition to the above, while at PHAC, Dr. Laderoute discovered a novel ‘virus anti-virus’ innate immunity defense system of human foamy macrophages. International patent applications were filed by PHAC in 2005. It was recently proposed that the production of particles in macrophages pertaining to this human endogenous retrovirus K102 (HERV-K102), a protector foamy retrovirus that maps to 1q22, bestows trained (innate) immunity in the host. Moreover, accumulating evidence indicates that it is this trained innate immunity which promotes recovery from COVID-19 and which underscores why antibody dependent enhancement (ADE) of infection into macrophages can be so dangerous to the host. In other words, Dr. Laderoute has potentially discovered why ADE is such a barrier to safe and effective vaccines to various pandemic infectious agents including SARS-CoV-2. Owing also to her understanding of the immunosenescence (dysfunction) of these foamy macrophages associated with co-morbidities or as commandeered by SARS-CoV-2 or even spike protein, Dr. Laderoute has several risk mitigation strategies in mind on how to fight pandemics moving forward.
In summary, Dr. Laderoute is in a unique expert position to question the COVID-19 mRNA vaccines’ safety, the failed adverse events surveillance and corresponding lack of risk assessment by PHAC/HC. At the CCCA, we are pleased to be able to post her recent letter to Health Canada that outlines her concerns regarding the COVID-19 genetic vaccines.