December 16, 2020
The Weston A. Price Foundation submits these comments to the agency for consideration in assessing the Moderna mRNA-1273 vaccine.
WAPF was founded in 1999 to disseminate the research of nutrition pioneer Dr. Weston Price, whose studies of isolated nonindustrialized peoples established the parameters of human health and determined the optimum characteristics of human diets. The Foundation is dedicated to restoring nutrient-dense foods to the human diet through education, research and activism.
WAPF opposes Emergency Use Authorization of the mRNA-1273 vaccine because the risks outweigh the benefits, as discussed below.
Unknown levels of long-term risks
Participants in every Covid-19 vaccine trial have reported adverse reactions including high fever, chills, muscle pains and headaches. Some have even reported severe reactions that required hospitalization and invasive treatment. Potential long-term effects may include Guillain-Barré syndrome, brain swelling, muscle weakness and paralysis, convulsions and seizures, stroke, narcolepsy, shock, heart attack, autoimmune disease, arthritis and joint pain, multisystem inflammatory syndrome in children, and death. Yet the trials only followed participants for approximately two months, far from enough time to assess the long-term impacts.
Early trials of the mRNA-1273 vaccine in particular raised red flags. Twenty percent of the mRNA-1273 vaccine recipients in the Phase 1 trial high dose cohort suffered Grade 3 Adverse Reactions, serious enough that they prevent daily activity and require medical intervention.
In the most recent trials, Moderna’s report notes that “In the mRNA-1273 group, the incidence and severity of solicited systemic ARs appeared to increase after the second injection.” This could indicate that the vaccine is triggering immune responses beyond the desired response to COVID. This is of particular concern given that some U.K. health workers have experienced anaphylactic shock after receiving one dose of the Pfizer approved vaccine that uses the mRNA technology. It is also a serious concern in terms of the potential long-term effects, in particular auto-immune conditions. As noted in one study, “[i]n the last decade, reports have accumulated on various autoimmune disorders, such as idiopathic thrombocytopenia purpura, myopericarditis, primary ovarian failure, and systemic lupus erythematosus (SLE), following vaccination.” The mRNA technology poses even greater risks for long-term complications than current vaccination technologies.
At a minimum, the vaccine should not be approved for use in women who are pregnant or likely to become pregnant. The initial trial was intentionally designed to exclude pregnant women, and thus we cannot know if it is safe. Two prominent doctors, including the ex-head of Pfizer’s respiratory research, have warned that Covid-19 vaccines contain a spike protein called syncytin-1, vital for the formation of the placenta. If the vaccine triggers an immune response to this protein, then female infertility, miscarriage or birth defects could result.
In return for the exposing millions of people to unknown levels of risks for long-term complications, the vaccine provides only minor benefits. The claims of effectiveness are based on the “prevention of mild symptoms.” The studies are not designed to detect a reduction in outcomes such as severe illness, hospitalization or death. Individuals at risk for developing sever cases would be better served focusing on nutritional and oxidative support to help keep the illness from going into “overdrive.”
Simply reducing the incidence of mild COVID symptoms does not provide significant relief in our current situation. Since the vaccine has not been shown to prevent the spread of the virus, it will not reduce the pressure for restrictive social practices that are causing so many problems in our country.
We urge the FDA not to provide an emergency use authorization for the mRNA-1723 vaccine and instead to require additional trials, with longer term observation of the any adverse reactions.
Sally Fallon Morell
Weston A. Price Foundation
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Sponsor Briefing Document at Section 188.8.131.52
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