COVID-19 Vaccinations – A Message from the Director

I am aware that the first deployment of the COVID-19 vaccine in England has 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:

  • Any person with a history of immediate-onset anaphylaxis to any components of the Pfizer BioNTech vaccine should not receive the Pfizer BioNtech vaccine. The component of the vaccine that has been implicated is polyethylene glycol (PEG). PEG is used as an inactive ingredient in some drugs. PEG is also used as a bowel prep for colonoscopy procedures and as a laxative. 
  • A second dose of the Pfizer BioNtech vaccine should not be given to those who have experienced anaphylaxis to the first dose of Pfizer BioNtech vaccination.
  • Any person with current moderate/severe illness should undergo risk assessment with a healthcare professional and consider deferring receiving the Pfizer BioNtech vaccine until later. Vaccine recipients should be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment.
  • Any person with a history of immediate-onset anaphylaxis to any components of another vaccine (not BioNTech) or injectable medication should undergo risk assessment with a healthcare professional and consider deferring receiving the Pfizer BioNtech vaccine until later. Vaccine recipients should be monitored for 30 minutes after vaccination, with a longer observation period when indicated after clinical assessment.
  • 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 0.5 mg intramuscular adrenaline (0.5 mL of 1:1000 or 1 mg/mL 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, this vaccine can cause side effects. Most of these are mild and short-term, and not everyone gets them.

View the CDC chart for helping decide what course of action to take regarding the Pfizer-BioNTech COVID-19 vaccine.

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

Appointment Changes at Cincinnati Children's

During the national health emergency, routine follow-up appointments for established patients are being reviewed and may be rescheduled for a later date. You will be contacted if these changes affect your child. If you have questions for your clinical team, contact them via MyChart.

Rescheduling

To our patients who had appointments at any of our Allergy and Immunology clinics: We sincerely apologize for having to cancel your appointments at our clinics. While we were looking forward to seeing you and evaluating your child, this step was necessary to protect you and your child due to the COVID-19 pandemic. We are working on performing visits through a phone contact or video contact (telemedicine). We will be contacting you with further details and to assess your willingness to have the visit conducted remotely. Please be assured that all cancelled visits will be rescheduled as soon as the situation allows.

Allergen Immunotherapy

To our patients who are receiving allergen immunotherapy (also known as allergy shots) at any of our Allergy / Immunology clinics: The Division of Allergy and Immunology knows the value of this important treatment to your child. However, in an effort to contain the spread of the COVID-19 pandemic and to protect you and your child, we have halted all administration of allergy shots till further notice. Please be assured that your allergist will work with you on adjusting treatment once the clinics are able to be resumed safely.

Asthma and Allergies

  • Asthma exacerbations are frequently triggered by viral infections, including coronaviruses. But coronaviruses are not common triggers compared with other viruses (such as rhinovirus, respiratory syncytial virus, adenovirus, herpes simplex virus, enterovirus, and influenza virus).
  • People with moderate to severe asthma may be at higher risk of getting very sick from COVID-19.  COVID-19 can affect your respiratory tract (nose, throat, lungs), cause an asthma attack, and possibly lead to pneumonia and acute respiratory disease. Read more from the CDC

Research

  • 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.