FDA adds warning to J&J vaccine for possible link to rare neurological disorder
The US Food and Drug Administration (FDA) added a warning on July 12, 2021 to the fact sheet for Johnson & Johnson’s COVID-19 vaccine, saying that data suggests there is an increased risk of a rare neurological disorder within the six weeks following inoculation*. The FDA warning about the Johnson & Johnson Covid-19 vaccine follows reports of 100 cases of Guillain-Barré syndrome (GBS)** in vaccine recipients, including 95 serious cases that required hospitalization and one reported death.
*European regulators have recently recommended a similar warning for AstraZeneca’s COVID-19 vaccine, which is based on a similar technology as Johnson & Johnson’s vaccine.
**Guillain-Barré syndrome is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. Most people fully recover from GBS.
The condition has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.
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Covid Vaccines: Medical experts warn people with history of severe allergic reactions
Medical experts are warning people who have a history of severe allergic reactions (such as anaphylactic shock) to vaccines, food, or medications to avoid getting the new Covid vaccination until they first discuss their situation with their healthcare provider. The warning follows severe allergic reactions suffered by at least two people after receiving the Covid vaccine from Pfizer in early December 2020 (source). The reason for the warning is that some people may have a severe allergic reaction to the primary ingredient (for the Pfizer vaccine that is BNT162b2 RNA) or to the secondary ingredients (commonly called “inactive” ingredients because they support the delivery and/or activation of a drug rather than act as the primary medicating ingredient) in Pfizer’s or any of the other manufacturers’ vaccines. The secondary ingredients for the Pfizer Covid vaccination are listed below.
Pfizer /BioNTech’s vaccine contains a range of ingredients, alongside the active substance, called BNT162b2 RNA.
The other ingredients are:
– ALC-0315 = (4-hydroxybutyl)azanediyl)bis(hexane*-6,1-diyl)bis(2-hexyldecanoate),
– ALC-0159 = 2[(polyethylene glycol*)-2000]-N,N-ditetradecylacetamide,
– cholesterol, 5
– potassium chloride,
– potassium dihydrogen phosphate*,
– sodium chloride,
– disodium hydrogen phosphate* dihydrate,
*A number of these secondary, inactive ingredients have been linked to adverse health reactions/conditions in previous studies of food additives. Source
Covid Vaccines: Additives of Concern* for some people
-Disodium edetate dihydrate (EDTA)
-Monobasic potassium phosphate (Potassium phosphate)
-Dibasic sodium phosphate dihydrate (Sodium phosphate)
*To learn about the scientific findings linking adverse health effects with these additives, see our book here (or contact us here). If you already know that one or more of these additives (inactive ingredients) is a potential problem, discuss your options with your healthcare provider.