Pfizer-BioNTech COVID-19 Vaccine

The Pfizer-BioNTech COVID-19 vaccine is administered as an intramuscular injection on day 0 and again on day 21.  The full benefit from the vaccine occurs 2 weeks after the second injection.  It has FDA emergency use authorization for people ages 12 and up. 

This vaccine is not a live virus vaccine and can be given to immunocompromised patients, including patients on immunosuppressant therapy (examples include prednisone, methotrexate, and biologic DMARDs).  However, currently available data does not establish safety and efficacy in immunocompromised patients.  It is possible that the vaccine may not be as effective in immunocompromised patients.  I recommend that my patients receive this COVID-19 vaccination when it is available locally, but continue to practice social distancing, wearing masks, and frequent hand washing.

It is contraindicated (cannot be given to) patients with a history of severe allergic reaction (anaphylactic shock and angioedema) to any of the compenents of the vaccine.  Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients:  lipids (0.43 mg
(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-
N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol),
0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg
dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP)
contributes an additional 2.16 mg sodium chloride per dose.

Note that there are no avian proteins.  I expect patients with egg and feather allergies to be able to take this vaccine. 

Severe allergic reactions have been reported during mass vaccination outside of clinical trials.  The CDC recommends that patients with a history of severe allergic reactions to other vaccines, injectable medications and infusion medications should avoid this vaccine.  This would include patients who have had severe allergic reactions to IV treatments for their rheumatologic condition (such as anaphylaxis during Remicade or Rituxan infusion).  All patients will need to be observed 15-30 minutes after vaccination for signs of an allergic reaction.  Clinics administering this vaccine are required to have treatment available for severe allergic reaction.

The side effect profile of this vaccine is as follows:

Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the lining around the heart.  Both conditions cause chest pain.  This typically occurs a few days after the second dose of the vaccine.  To date, most people who develop this rare adverse effect have resolution of their symptoms. 

It is ok to take acetaminophen, ibuprofen or naproxen to manage these side effects (unless you have conditions that preclude the use of these medications).  

For pateints who have had COVID-19 already, the chance of reinfection is very low in the first 90 - 180 days after initial infection.  They should receive vaccination after their COVID-19 symptoms have resolved and their quarantine period has ended.  It is ok to delay the vaccine for 90 days after infection. 

As more vaccines are approved, it is important to note that this vaccine is not interchangeable with other COVID-19 vaccines.  Patients who get the first vaccine with the Pfizer-BioNTech product, should receive the second Pfizer-BioNTech vaccine injection. 

The CDC recommends that this vaccine should be administered alone with a minimum interval of 14 days between this and other vaccines (such as influenza, pneumovax, etc.).   

I recommend this vaccine to my patients and their family members (as long as they do not have a history of servere allergic reactions as described above).   At Rheumatology Solutions, we plan to administer COVID-19 vaccines to our patients.  We will, however, not have this particular vaccine in our office due to the requirements to store the vaccine at -112  to -76 degrees Farenheit (we do not have an ultra low temperature freezer).  

Author
Jeffrey Feinstein, MD

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