Model Standing Order and Immunization Protocol Template

1 IP COVID-19 Vaccine Page 1 of 19 OHA 8285 (7/19) A. PUBLIC HEALTH DIVISION Immunization Program Immunization Protocol COVID-19 Vaccine (Pfizer-BioNTech, Moderna, Janssen [Johnson & Johnson]) Last Reviewed 7 January 2022 Last Revised 7 January 2022 This Order expires 30 June 2022 Table of contents What s new .. 1 Oregon Immunization Protocol .. 2 Vaccine schedule for COVID-19 Vaccine .. 3 Licensed COVID-19 vaccine .. 4 Recommendations for use .. 5 Contraindications .. 6 Warnings and precautions .. 7 Other considerations .. 8 Side effects and adverse reactions .. 9 Storage and handling .. 9 Adverse events reporting .. 11 References .. 12 Appendix A .. 15 Appendix B .. 16 Appendix C .. 17 Appendix D.

2 19 What s new CDC now recommends that all people 12 years of age receive a booster dose of Pfizer vaccine 5 months after completing their initial Pfizer vaccination The interval between the final dose in the primary series and the booster dose has been shortened to 5 months for the Moderna IP COVID-19 Vaccine Page 2 of 19 Immunocompromised children 5 through 11 years old should receive a third dose of Pfizer vaccine 28 days after the previous ACIP recommends the use of Pfizer and Moderna mRNA vaccines over the Janssen Ad26 vaccine for adults 18 years of age and Oregon Immunization Protocol A. Check the ALERT Immunization Information System (IIS) to determine whether the patient needs this vaccine.

3 If ALERT IIS is unavailable, use available documentation and patient statement. B. Screen client for contraindications and precautions. C. Provide a Vaccine Information Fact Sheet for Recipients and Caregivers, and answer any questions. People aged 15 17 years may consent for their own vaccinations and do not need a parent to consent or to be present. For more information, see appendix D. D. Record all required data elements in the client s permanent health record. E. Verify needle length for IM injection. F. To avoid injury related to vaccine administration, make sure staff who administer vaccines recognize the anatomic landmarks for identifying the vastus lateralis or deltoid muscle and use proper IM administration technique.

4 G. For Pfizer vaccine only: thaw, if needed. The purple- and orange-cap formulations require reconstitution; the gray-cap formulation is ready to H. For Moderna vaccine only: thaw vaccine prior to I. Administer a dose of Pfizer2,14 or Moderna5 COVID-19 vaccine according to ACIP recommendations and vaccine package insert. J. Janssen vaccine may be used if there is a contraindication to an mRNA vaccine; or if preferred by the recipient, after a discussion of the risks and benefits of the Janssen K. The same brand of COVID-19 vaccine should be used for all doses of the primary series. Booster doses may be of either mRNA COVID-19 Janssen vaccine may be used after a discussion of the risks and L. Immunocompromised persons receiving an mRNA vaccine should receive a three-dose primary series of the same vaccine brand.

5 A different brand of vaccine may be used if the same brand is unknown or M. People 12 years of age who completed a Pfizer vaccine series are recommended to receive a booster dose of Pfizer vaccine 5 months after their last IP COVID-19 Vaccine Page 3 of 19 N. People 18 years of age who completed a Moderna mRNA vaccine series should receive a booster dose 5 months after their last O. People aged 18 years who received the Janssen vaccine should receive a booster dose 2 months after their previous Pfizer and Moderna vaccines are P. COVID-19 vaccines appear to be more reactogenic than Inform patient that symptoms of immune system activation are normal (see Table) and should improve without intervention in 12 24 hours.

6 Q. Anaphylaxis has been reported after COVID-19 vaccination. Vaccinator must be prepared to respond to a severe allergic reaction. See Section 6 for a list of excipients. R. Ask patient to remain seated in the clinic for 15 minutes after vaccination to decrease the risk of injury should they faint. Patients with a history of severe allergic reactions should be asked to remain for 30 S. Report all administered COVID-19 doses to ALERT IIS within 72 hours of administration. Health Officer Signature Date Health Officer Signature Date Vaccine schedule for COVID-19 Vaccines Preferred vaccines17 Dose and Route: Pfizer Pediatric mRNA vaccine mL, 10 g, IM14 Dose Minimum acceptable age Maximum acceptable age Minimum acceptable spacing 1 5 years 11 years 2 12 years* 21 days 3 12 years* 28 days *Children who turn 12 years of age between the first and second doses may receive either the pediatric or the adolescent/adult Only for certain moderately to severely immunocompromised patients.

7 See Section 5. IP COVID-19 Vaccine Page 4 of 19 Dose and Route: Pfizer mRNA vaccine mL, 30 g, IM2 Dose Minimum acceptable age Minimum acceptable spacing 1 12 years 2 21 days 3* 28 days Booster15 5 months after primary dose 2 or 3 *Only for certain moderately to severely immunocompromised patients. See Section Dose and Route: Moderna mRNA vaccine mL, 100 g, IM5 Dose Minimum acceptable age Minimum acceptable spacing 1 18 years 2 28 days 3* 28 days Booster Dose and Route: Moderna mRNA vaccine mL, 50 g, IM5 Dose Minimum acceptable age Minimum acceptable spacing Booster 18 years 5 months after primary dose 2 or 3 *Only for certain moderately to severely immunocompromised patients. See Section Use only after risk/benefit discussion with patient17 Dose and Route.

8 Janssen Ad26 vaccine mL, 5 1010 viral particles, IM7 Dose Minimum acceptable age Minimum acceptable spacing 1 18 years Booster 2 months Licensed COVID-19 vaccine Product Name Vaccine Components Presentation Acceptable age range Thimerosal Preferred vaccines BNT162b2 (Pfizer/BioNTech) mRNA , 10-dose vial14 5 11 years No IP COVID-19 Vaccine Page 5 of 19 , 6-dose vial2 12 years mRNA-1273 (Moderna)5 mRNA , 10-dose vial or 14-dose* vial 18 years No Use only after risk/benefit discussion with patient (Janssen)7 recombinant adenovirus type 26 , 5-dose vial 18 years No *Moderna vial stoppers may not be punctured more than 20 times. Any remaining doses must be discarded. Recommendations for use A. The 1- or 2-dose series of a mRNA COVID-19 vaccine should be offered to all persons aged 18 years and older.

9 Additionally, Pfizer COVID-19 vaccine should be offered to all persons aged 5 years through 17 years of B. Children who turn 12 years of age after their first dose of Pfizer vaccine may be given either the pediatric formulation (orange cap) or adolescent/adult formulation (purple cap) of Pfizer for the second C. People 12 years of age who completed a Pfizer vaccine series are encouraged to receive a booster dose of Pfizer vaccine 5 months after their last D. Persons 18 years of age who completed a Moderna mRNA primary vaccine series 5 months ago should receive a booster dose. E. Persons who are 18 years of age and received the Janssen vaccine 2 months ago should receive a mRNA booster ,17 F. Some persons vaccinated as part of a clinical trial or vaccinated outside of the United States may be eligible for a booster dose of Pfizer mRNA vaccine.

10 See Appendix C for more information. G. Moderate to severely immunocompromised persons should be offered a third dose of either Pfizer or Moderna COVID-19 vaccine, 28 days after the previous dose. This dose is considered an additional primary series dose, not a booster dose. If possible, this dose should be the same brand as previously received, and only Pfizer COVID-19 vaccine may be used for children under 5 17 years of H. Persons who receive a third primary dose should be offered a booster dose 5 months after dose 3. The booster dose may be any brand of approved IP COVID-19 Vaccine Page 6 of 19 I. Immunocompromised persons 12 years of age who were vaccinated outside the may receive an additional primary dose of Pfizer COVID-19 vaccine 28 days after their previous dose.