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Adult Pediatric All

Criteria & Principles

Please find up to date COVID-19 vaccine information for Duke Health Team Members here.  

Vaccination against COVID-19 is strongly encouraged. Due to adequate vaccine supply and experience with inpatient vaccination, this can occur in the outpatient or inpatient setting. Inpatients interested in vaccination and meeting operational and clinical requirements in the Inpatient COVID-19 Vaccination Guideline (attachments section) may be considered for receipt of the COVID-19 vaccine while inpatient. Third doses for immunocompromised will go live 9.1 (see attachment section Inpatient Vaccine Policy-4th Update)

PRODUCT INFORMATION

Pfizer COVID-19 vaccine: (EUA 12/11/20; FDA approval for >15 year olds: 8/23/21) authorization letter and fact sheets below. 

Fact Sheet for Providers: https://www.fda.gov/media/144413/download

Fact sheet for Recipients: https://www.fda.gov/media/144414/download

Authorization Letter: https://www.fda.gov/media/144412/download

mRNA vaccine separated by 21 days for first two doses.FDA approved for persons ≥ 16 years old.EUA approved for persons ≥ 12-15 years old.Third dose recommended for specific immunocompromised patients (see attachment section Inpatient Vaccine Policy) separated by 28 days from second Pfizer vaccine dose.

Moderna COVID-19 vaccine (EUA approval 12/20/20) application documents and fact sheets are at the links below:

Fact Sheet for Providers: https://www.fda.gov/media/144637/download

Fact sheet for Recipients: https://www.fda.gov/media/144638/download

Additional helpful links: https://www.fda.gov/media/144434/download; https://www.fda.gov/media/14...

mRNA vaccine separated by 28 days for first two doses.  EUA approved for persons ≥ 18  years old.  Third dose recommended for specific immunocompromised patients (see attachment section Inpatient Vaccine Policy) separated by 28 days from second Moderna vaccine dose.

Johnson and Johnson/Janssen Vaccine (EUA approval 2/27/21) application documents and fact sheets are at the links below:

Authorization Letter: https://www.fda.gov/media/146303/download

Fact Sheet for Providers: https://www.fda.gov/media/146304/download

Fact sheet for Recipients: https://www.fda.gov/media/146305/download

Single dose vaccination.  Cases of thrombosis have occurred in females ages 18-49 years receiving the Johnson & Johnson vaccine; some have been fatal. EUA approved for persons ≥ 18 years old.

General Information and FAQs:

CDC COVID-19 Vaccine page - information for healthcare professionals include ACIP, storage/handeling, EUA, safety reporting, etc

What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine - concise information about vaccinating special populations, time interval between vaccine doses, etc

See slides from Pharmacy Town Hall in attachment section

FAQs

Q:  Can pregnant persons get the vaccine, is it as effective for this population, and will the vaccine protect a fetus?

A: Geeta Swamy, MD addresses these questions here: https://warpwire.duke.edu/w/bf8EAA/

Q: Are there contraindications to recieve either Pfizer or Moderna COVID-19 vaccines? 

A:    Contraindications:

  • Severe allergic reaction (e.g., anaphylaxis) to a previous dose or component of either mRNA COVID-19 vaccine
  • Immediate allergic reaction* of any severity to a previous dose or component of an mRNA COVID-19 vaccine (including polyethylene glycol [(PEG]). See /Appendix B: Ingredients included in Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines.
  • Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
  • NOTE propylene glycol (PG) is NOT the same as PEG, thus not a contraindication 

Precautions:

  • History of an immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies not related to a component of mRNA COVID-19 vaccines or polysorbate)
  • Moderate to severe acute illness

*For the purpose of this guidance, an immediate allergic reaction is defined as any hypersensitivity-related signs or symptoms, such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis, that occur within 4 hours following exposure to a vaccine or medication.

Q: When should the second dose of the vaccine be administered?

A: There is no maximum interval between the first and second doses, but both the Pfizer/BioNTech and Moderna vaccines should be given as close as possible to the manufacturers' recommendation:

  • Pfizer/BioNTech's second doses should be administered 3 weeks (21 days) from the date of the first dose.
  • Moderna's second doses should be administered one month (28 days) from the date of the first dose.

*CDC clarified recently that doses given early, but still within the 4-day grace period (i.e. days 17-20 for Pfizer/BioNTech; days 24-27 for Moderna) should be the exception, not the norm. Scheduling second doses within this early "grace period" risks introducing "interval creep," and data do not exist for second doses given at short intervals.

Q: When should the first or second dose be administered in these special populations?

  • Known SARS-CoV-2 exposure or during COVID-19 outbreaks
  • Previously received passive antibody therapy
  • Current or prior history of SARS-CoV-2 infection

A: Find detail response in the Vaccination of persons with a SARS-CoV-2 infection or exposure section of the CDC webpage (https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considera...)

Q: Do I need to separate administration of the COVID-19 vaccine from other vaccines?

A: No.  The CDC updated its guidance on coadministration of COVID-19 vaccines with other vaccines in May 2021. People who receive the COVID-19 vaccine no longer need to wait 14 days before or after administration to receive another vaccination. DUHS has updated our patient handouts in English and Spanish to remove this recommendation.

Find answers to more FAQs here: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considera...