To authors of the NEJM article on COVID-19 vaccine: An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
I have several points to raise with you.
Severe reaction was observed in 3 participants following the second dose. This is a textbook case of sensitization by first dose. Elicitation by second dose. An IgE mediated hypersensitivity reaction. This CANNOT be dismissed as just a dose issue and that only lower doses will be used. The reason is, upon real world virus exposure, there is no exposure dose control. These participants may develop life-threatening reactions. This has been documented in previous SARS vaccines. In fact, severe COVID-19 is caused by this same mechanism. Coronavirus-like proteins that contaminate vaccines caused allergic sensitization. Upon exposure to the virus the allergic reaction causes severe COVID-19. That is why histamine blockers such as cetirizine and famotidine help in COVID-19.1,2
At a minimum, the team should have measured specific IgE directed at protein(s) encoded in (and contaminating) the vaccine. They report no such thing. They report specific IgG which is not sufficient. They have to break down specific IgG1,2,3,4 subclass levels. They have to report how the severe reaction was treated.
This whole idea of depending on testing alone for safety, is UNACCEPTABLE.
The U.S. Consumer Product Safety Commission (CPSC) says: Design is the dominant influence on product safety. Product safety starts in the mind of the product designers. If all the elements of manufacturing were ranked in order of their potential effect on consumer product safety, the design function would lead the list. Additionally, design importantly affects subsequent decisions and practices related to materials, production, testing, processes, labeling, packaging and distribution.3
Safety engineering dictates that vaccines must be DESIGNED and design FMEA (Failure Modes and Effects Analysis) must be published BEFORE any testing in trials. It is impossible to establish long term safety in a 3 month trial. YOU HAVE TO DESIGN FOR SAFETY, you CANNOT just TEST FOR IT.
Nothing has been learned from the Pandemrix induced narcolepsy disaster. 4, 5
No vaccine should be approved without publishing FMEA and FIXING ALL IDENTIFIED DESIGN ISSUES.
Example of the types of analysis that need to occur before human trials:
ERVEBO Ebola vaccine will create a rice allergy epidemic, add to numerous autoimmune diseases, cancer and make Ebola disease even more severe. Design for safety and vaccine safety regulation remain abject failures. Incompetence or indifference?
Immunological mechanisms explaining the role of IgE, mast cells, histamine, elevating ferritin, IL-6, D-dimer, VEGF levels in COVID-19 and dengue, potential treatments such as mast cell stabilizers, antihistamines, Vitamin C, hydroxychloroquine, ivermectin and azithromycinCOVID-19: Famotidine, Histamine, Mast Cells, and MechanismsVaccine safety: Learning from the Boeing 737 MAX disastersPandemrix and Arepanrix vaccine safety analysis and scrutiny fell shortPharmacovigilance is no substitute for good vaccine design