COVID-19 Vaccinations – A Message from the Director
I am aware that COVID-19 mRNA vaccines have been associated with rare acute side effects. I am following the information as it emerges. Vaccines and drugs all have side effects, including acute reactions to first doses, generally called anaphylactoid, rather than anaphylaxis, as a true immunoglobulin E (IgE) allergy is unlikely. Severe allergic vaccine reactions generally occur in about one per million doses of vaccines and are treatable events. Though more information is being gathered, I support the precautionary recommendations below.
The updated temporary recommendations of the Centers for Disease Control and Prevention (CDC) of the USA are (see Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for most current recommendations):
- Any person with a history of immediate-onset anaphylaxis to any components of the Pfizer BioNTech vaccine should not receive the Pfizer BioNtech vaccine. This includes polyethylene glycol (PEG). PEG is used as a bowel prep for colonoscopy procedures and as a laxative. It is also used in some injectable medications at high enough concentrations to cause an allergic reaction.
- A second dose of the mRNA vaccines should not be given to those who have experienced anaphylaxis to the first dose of mRNA vaccination.
- Any person with a history of immediate-onset anaphylaxis to a first COVID-19 mRNA vaccine should undergo evaluation with an allergist/immunologist to discuss alternatives to vaccination.
Precaution (For allergic concerns/table: skip to Appendix B of Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States)
- Any person with a history of allergies (food, pet, insect, venom, environmental, latex, etc.), history of anaphylaxis to oral medication, non-anaphylactic reactions to other vaccines or injectable medication, family history of anaphylaxis, history of immunocompromising conditions, or who is currently pregnant or lactating is currently recommended to receive the Pfizer BioNtech vaccine. Vaccine recipients should be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment.
- A protocol for the management of anaphylaxis and an anaphylaxis pack should be available whenever the Pfizer BioNtech vaccine is given. Immediate treatment should include early treatment with intramuscular adrenaline with an early call for help and further intramuscular adrenaline every 5 minutes. The health professionals overseeing the immunization service must be trained to recognize an anaphylactic reaction and be familiar with techniques for resuscitation of a patient with anaphylaxis.
- Like all medicines and vaccines, COVID-19 vaccines can cause side effects. Most of these are mild and short-term, and not everyone gets them.
View the CDC Recommendations to help decide what course of action to take regarding the COVID-19 mRNA vaccines.
Like all medicines and vaccines, this vaccine can cause side effects. Most of these are mild and short-term, and not everyone gets them.
COVID Treatment of Individuals with Asthma
There is now an injected medication that is recommended for individuals with asthma and mild-moderate COVID who are high-risk for severe disease. Please see the information below.
- Details on the emergency use authorization (EUA) for bamlanivumab, Eli Lilly’s IgG1 neutralizing monoclonal antibody, can be found here. This drug is indicated for patients 12 years of age or older with mild-moderate COVID-19 and high risk for severe disease. Overall markers for high risk include having a: body mass index (BMI) greater or equal to 35, chronic kidney disease, diabetes mellitus (DM), or immunosuppression or, being 65 years of age and older. In patients 55 years and older, high risk includes having: cardiovascular disease, hypertension, or chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease. In 12- to 17-year- olds, high risk includes having : sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders, a medical-related technological dependence (e.g., tracheostomy, gastrostomy), or asthma or other chronic respiratory disease that requires daily treatment. The drug is not authorized for use in patients who are hospitalized or require oxygen therapy because of COVID-19.
Allergen and Ingredient Considerations (consistent with AAAAI recommendations)
Milk allergy is not a contraindication for the Moderna and Pfizer COVID-19 vaccines. There is no detectable milk protein in the vaccines. These are the ingredients of the vaccines:
- The Moderna vaccine also includes the following ingredients: lipids (SM-102, 1,2-dimyristoyl-rac-glycero3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-snglycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid,
sodium acetate, and sucrose.
- The Pfizer vaccine also includes the following ingredients: lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-snglycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
Marc E. Rothenberg, MD, PhD (immediate cell phone access: 513-307-6768)
Director, Division of Allergy and Immunology
Director, Cincinnati Center for Eosinophilic Disorders
Info on Eosinophilic Diseases and COVID-19
- Eosinophilic Gastrointestinal Diseases (EGID) are not immunodeficiency disorders.
- The medical literature does not support a concerning association between eosinophil-associated diseases and coronaviruses.
- There is no known increased risk for viral infections in patients with EGID.
- Patients on eosinophil-depleting drugs, such as benralizumab, mepolizumab, and reslizumab, as well as patients on dupilumab, have not been reported to have an increased risk of viral infections and / or complications from viral infections.
- Patients with eosinophilia have not been reported to have an increased risk of viral infections.
- Eosinophils are not the primary cells involved in protective immunity against viruses.
- Topical glucocorticoids (fluticasone and budesonide) are not systemically immunosuppressive, unlike prednisone, which is systemically immunosuppressive.
- A caveat to this information concerns rare EGID and other eosinophilic syndromes that may have other underlying disease components, such as immunosuppression induced by systemic steroids such as prednisone; these patients may have increased risk for complications. Such patients should consult with their primary doctor for specific advice and guidance.
- It is important to emphasize that we do not have substantial data to demonstrate that there is increased risk of harm with COVID-19 when EGID or hypereosinophilic syndromes are present.
- Patients in research studies should make personal decisions about the risk / reward of continuing to participate and adhere to local and national health department guidelines regarding travel and preparedness.
- Subjects with concurrent viral-like illnesses should reschedule their study visits.
- If you have specific questions regarding your trial related to the known risks of the COVID-19 virus, contact your specific research trial team.