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.1 2 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.3
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.4 5
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 17 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.”7
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 susceptibility8 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.9 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.10 11
FDA EUA Fact Sheet for Pfizer/BioNTech COVID-19 Vaccine Does Not List History of Severe Allergic Reactions to Drugs, Foods or Other Vaccines as Contraindication
According to a Dec. 9 USA Today article, Moncef Slaoui, MD, co-head of Operation Warp Speed (OWS) said that he assumed that the U.S. Food and Drug Administration (FDA) would advise those with severe allergies that they, “should not take the vaccine until we know exactly what happened.”12
However, on Dec. 11 when the FDA issued its EUA giving Pfizer the go-ahead to distribute its COVID-19 vaccine in the U.S. for persons aged 16 and older, the FDA Fact Sheet for Vaccine Recipients and Caregivers included only one contraindication (reason to not get the vaccine) that was confined to an allergic reaction to a previous dose of Pfizer’s COVID-19 vaccine or an ingredient in the vaccine: “You should not get the Pfizer/BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of this vaccine [or] had a severe allergic reaction to any ingredients of this vaccine.”13
The only other mention in the FDA Fact Sheet about allergic reactions was a recommendation to “tell the vaccination provider about all your medical conditions, including if you have any allergies” and this warning:14
There is a remote chance that the Pfizer/BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer/BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include: • Difficulty breathing • Swelling of your face and throat • A fast heartbeat • A bad rash all over your body • Dizziness and weakness. These may not be all the possible side effects of the Pfizer/BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer/BioNTech COVID-19 Vaccine is still being studied in clinical trials.
Pfizer and Moderna mRNA COVID-19 Vaccines Have “Significantly Noticeable” Side Effects Greater Than for Most Flu Vaccines
About 10-15 percent of volunteers in clinical trials of both of the Pfizer/BioNTech and Moderna experimental mRNA COVID-19 vaccines experienced “significantly noticeable” side effects. Arnold Monto, MD professor of epidemiology at the University of Michigan School of Public Health concluded about the COVID vaccine trials, “This is higher reactogenicity than is ordinarily seen with most flu vaccines, even the high-dose ones.”15
In anticipation of numerous adverse events following a mass COVID vaccination campaign, U.K. health officials at the MHRA recently spent £1.5 million on a software tool “to process the expected high volume of COVID-19 adverse drug reactions [ADRs] and ensure that no details from the ADRs’ reaction text are missed”.16
The MHRA has issued the warning that individuals with a history of allergic reactions should not receive the COVID vaccine while further investigation of the two reported cases of allergic reaction takes place.17
FDA Says All Covid Vaccine “Side Effects” Should Be Reported to VAERS
Under EUA authorization, COVID-19 vaccines remain experimental vaccines until formally licensed. The FDA’s EUA Fact Sheet states, “The Pfizer/BioNTech COVID-19 vaccine is an unapproved vaccine,” and directs directs vaccine recipients to call 9-1-1 or go to the nearest hospital “if you experience an allergic reaction” and to “call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.”18
FDA also emphasizes in the Fact Sheet that vaccine side effects should be reported to the FDA/CDC’s Vaccine Adverse Event Reporting System (VAERS), a open-access vaccine safety monitoring system that was created by Congress under the 1986 National Childhood Vaccine Injury Act.
Report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html and include ‘Pfizer/BioNTech COVID-19 Vaccine EUA’ in the first line of box #18 of the report form.19
Vaccine providers are supposed to report adverse events that occur after vaccinations to VAERS but vaccinated persons who experienced the reaction or a family member also can file a report if a health care provider does not do it. According to one government funded study in 2011, fewer than one percent of all vaccine reactions are reported to VAERS.20
Click here to view References:
1 Triggle N, Scraer R. Covid-19 vaccine: Allergy warning over new jab. BBC News Dec. 9, 2020.
2 Reynolds E, Braithwaite S, Cassidy A. Allergy warning for Pfizer/BioNTech vaccine after UK health workers with allergy history suffer reaction. CNN Dec. 9, 2020.
3 Ellyatt H. People With a History of ‘Significant’ Allergic Reactions Shouldn’t Have Pfizer Vaccine, UK Regulator Warns. CNBC Dec. 9, 2020.
4 See Footnote 1.
5 Ellyat H. UK begins rollout of Pfizer’s coronavirus vaccine: Here’s what you need to know. CNBC Dec. 8, 2020.
6 FDA. Approval letter to Pfizer, Inc. authorizing emergency use of Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age or older. Dec. 11, 2020.
7 FDA. Question for VRBPAC Vote. Dec. 10, 2020.
8 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Evaluation of Biologic Mechanisms of Adverse Effects: Increased Susceptibility. Chapter 3 (p. 82). Washington, DC The National Academies Press 2012.
9 FDA. FDA Briefing Document: Pfizer-BioNTech COVID-19 Vaccine. VRBPAC Committee Meeting Dec. 10, 2020.
10 Pfizer. Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults. Exclusion Criteria. Sept. 28, 2020.
11 Weintraub K. ‘Very inconsistent’: 2 allergic reactions in the UK to COVID-19 vaccine puzzle researchers. USA Today Dec. 9, 2020.
13 FDA. Fact Sheet for Recipients and Caregivers. Emergency Use Authorization (EUA) of the Phizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 16 Years of Age and Older.
15 Cáceres M. Pfizer, Moderna COVID-19 Vaccines Produce ‘Significantly Noticeable’ Side Effects. The Vaccine Reaction Dec. 6, 2020.
16 NHS told not to give Covid vaccine to those with history of allergic reactions. The Guardian Dec. 9, 2020.
18 See Footnote 13.
20 Harvard Pilgrim Health Care, Inc. Electronic System for Public Health Vaccine Adverse Event Reporting System. AHRQ 2011.