Last week the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a strong warning to those who have a history of significant allergic reactions to medicines, foods or vaccines or who carry an epi-pen that they may be at increased individual risk for suffering a serious allergic reaction after receiving the Pfizer/BioNTech COVID-19 vaccine. The warning came after two British National Health Service health professionals with a history of severe allergic reactions requiring them to carry an epi-pen experienced a serious allergic reaction to the new coronavirus vaccine released on Dec. 9, 2020 for public use in the U.K.
U.K. Health officials stated:
Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine.
The U.K. is the first country to approve use of the experimental mRNA COVID-19 vaccine under Emergency Use Authorization (EUA). Several thousand people were vaccinated in one day, and the new vaccine will be administered first at 50 hospitals with frontline health professionals, as well as to home health care workers and to individuals over 80 years of age in the U.K.
Not Known Which Ingredients in Pfizer-BioNTech COVID-19 Vaccine Caused Allergic Reactions
A list of ingredients in the Pfizer/BioNTech COVID-19 vaccine was released by the U.S. Food and Drug Administration (FDA) on Dec. 11 in a letter to Pfizer authorizing emergency use of the COVID-19 vaccine in the U.S. for individuals 16 years of age or older.6 The FDA issued the EUA 24 hours after a nine hour meeting of the Vaccines and Related Biological Products Advisory Committee Advisory Committee (VRBPAC) when the committee voted 71 to 4 with 1 abstention that the vaccine’s that “based on the totality of scientific evidence available, the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh its risks for individuals 16 years of age and older.”
Listed ingredients of the Pfizer/BioNTech COVID-19 vaccine include:
- 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2
- lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
- .05 mg 2[polyethylene glycol)-2000]-N,N-ditetradecylacetamide
- .09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol)
- .01 potassium chloride
- .01 mg monobasic potassium phosphate
- .36 mg sodium chloride
- .07 mg dibasic sodium phosphate dehydrate
- 6 mg. sucrose
- the diluent (.09 percent Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose
However, it is not known which ingredients in the vaccine caused allergic reactions in the two U.K. health care workers or which unique genetic, epigenetic, environmental or other biological host factors potentially increases individual susceptibility for an allergic response in vaccine recipients. The vaccine does not contain common triggers found in other vaccines such as eggs, gelatin and preservatives.
In the Pfizer/BioNTech COVID-19 vaccine trials conducted in the United States, there were more allergic reactions reported in the vaccine group than in the placebo control group. While allergic reactions occurred in less than one percent of those receiving the COVID vaccine, it is important to note that individuals with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)” were excluded from Pfizer’s clinical trials.