COVID-19 Vaccines- MPR

COVID-19 Vaccines

COVID-19 VACCINES
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the following vaccines (two bivalent mRNA vaccines and a protein subunit vaccine) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The monovalent mRNA COVID-19 vaccines and the Janssen vaccine are no longer authorized for use in the US for the 2023-2024 season. Adverse reactions for the mRNA vaccines¹ (Pfizer-BioNTech, Moderna) include: inj site pain, swelling and/or erythema, fatigue, headache, myalgia, chills, arthralgia, fever, nausea, malaise, lymphadenopathy. Rare reactions include severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritis, urticaria, angioedema), myocarditis/pericarditis (esp. adolescents and young adults). Side effects of the Novavax vaccine include: inj site pain, swelling and/or erythema, headache, fatigue, myalgia, nausea, fever; rare: severe allergic reactions, including anaphylaxis, clotting events such as TTS (esp. women aged 18-49yrs).
Vaccine	Vial Cap Color/Volume	Vaccine History	Dosing	Storage/Stability²
mRNA VACCINES³
Pfizer-BioNTech COVID-19 vaccine, bivalent (Original and Omicron BA.4/BA.5	Maroon cap vial: 0.2mL Orange cap vial: 0.2mL Gray cap vial: 0.3mL	Unvaccinated	6mos–4yrs (maroon cap only): 0.2mL IM x 2 doses 3wks apart, then 0.2mL single dose ≥8wks after the 2nd dose 5–11yrs (orange cap only): 0.2mL IM single dose 12–64yrs: 0.3mL IM single dose ≥65yrs: 0.3mL IM single dose; may give 1 additional dose ≥4mos after the first bivalent vaccine dose	Ultra-low Temperature Freezer⁴ (–90° to –60°C/-130°F to -76°F): up to 18mos from manufacture date Refrigerator (2°C to 8°C/35°F to 46°F): up to 10wks (up to 12hrs after vial puncture) Room Temperature (8°C to 25°C/46°F to 77°F): up to 12hrs before vial puncture (then up to 12hrs after vial puncture)
		Previously vaccinated with 1, 2 or 3 doses of monovalent Pfizer-BioNTech COVID-19 vaccine	6mos–4yrs (maroon cap only): 1 previous monovalent dose: 0.2mL IM single dose 3wks after monovalent vaccine, then 0.2mL single dose ≥8wks after the 1st bivalent dose. 2 previous monovalent doses: 0.2mL IM single dose ≥8wks after the 2nd monovalent vaccine dose. 3 previous monovalent doses: 0.2mL IM single dose ≥2mos after the 3rd monovalent vaccine dose
		Previously vaccinated with 1 or more doses of any monovalent COVID-19 vaccine	5–11yrs (orange cap only): 0.2mL IM single dose ≥2mos after monovalent vaccine 12–64yrs: 0.3mL IM single dose ≥2mos after monovalent vaccine ≥65yrs: 0.3mL IM single dose ≥2mos after monovalent vaccine; may give 1 additional dose ≥4mos after the first bivalent vaccine dose
		Immunocompromised	6mos–4yrs (maroon cap only): Previously received 3 doses of Pfizer-BioNTech vaccine⁵:may give 1 additional 0.2mL dose (4th dose) ≥1 month after the last dose; may give additional doses at the discretion of the physician. ≥5yrs: Previously received 1 dose of bivalent vaccine: may give 1 additional age-appropriate dose ≥2mos after the first bivalent dose; may give additional doses at the discretion of the physician
Moderna COVID-19 vaccine, bivalent (Original and Omicron BA.4/BA.5)	Dark pink cap vial: 0.2mL Dark blue cap vial: 0.25mL, 0.5mL	Unvaccinated	6mos–5yrs: 0.25mL IM x 2 doses 1 month apart 6–11yrs: 0.25mL IM single dose 12–64yrs: 0.5mL IM single dose ≥65yrs: 0.5mL IM single dose; may give 1 additional dose ≥4mos after the first bivalent vaccine dose	Freezer (–50°C to –15°C/–58°F to 5°F): until expiration date Refrigerator (2°C to 8°C/36°F to 46°F): up to 30 days (up to 8hrs after vial puncture for formulation with pink caps or up to 12hrs for formulation with dark blue caps) Room Temperature (8°C to 25°C/46°F to 77°F): up to 24hrs (up to 8hrs after vial puncture for formulation with pink caps or up to 12hrs for formulation with dark blue caps)
		Previously vaccinated with 1 or 2 doses of monovalent Moderna COVID-19 vaccine	6mos–5yrs: 1 previous monovalent dose: 0.25mL IM single dose 1 month after monovalent vaccine. 2 previous monovalent doses (pink cap only): 0.2mL IM single dose ≥2mos after monovalent vaccine
		Previously vaccinated with 1 or more doses of any monovalent COVID-19 vaccine	6–11yrs: 0.25mL IM single dose ≥2mos after monovalent vaccine 12–64yrs: 0.5mL IM single dose ≥2mos after monovalent vaccine ≥65yrs: 0.5mL IM single dose ≥2mos after monovalent vaccine; may give 1 additional dose ≥4mos after the first bivalent vaccine dose
		Immunocompromised	6mos–5yrs: Previously received 2 doses of Moderna vaccine⁶: may give 1 additional 0.25mL dose ≥1 month after the last dose; may give additional doses at the discretion of the physician. ≥6yrs: Previously received 1 dose of bivalent vaccine: may give 1 additional age-appropriate dose ≥2mos after the first bivalent dose; may give additional doses at the discretion of the physician
PROTEIN SUBUNIT VACCINE⁷
Novavax COVID-19 vaccine, adjuvanted	0.5mL	Primary series	≥12yrs: 0.5mL IM x 2 doses 3wks apart	Refrigerator (2°C to 8°C/36°F to 46°F) Hold vial between 2°C to 25°C/36°F to 77°F for up to 6hrs after first puncture
Novavax COVID-19 vaccine, adjuvanted	0.5mL	Booster⁸	≥18yrs: 0.5mL single dose ≥6mos after completion of primary series of an authorized or approved COVID-19 vaccine
NOTES
Key: EUA = Emergency Use Authorization; IM = intramuscular ¹ mRNA vaccines: most systemic post-vaccination symptoms are mild to moderate in severity, occur within the first 3 days of vaccination, and resolve with 1-3 days of onset. Symptoms are more frequent and severe following 2nd dose and among younger people compared with older (eg, >55yrs/Pfizer-BioNTech, ≥65yrs/Moderna). Those with prior SARS-CoV-2 infection may be more likely to experience symptoms such as fever, chills, and myalgia after the 1st dose. ² Stability is for unopened vials unless otherwise specified. Frozen vaccines must be thawed and diluted before use, either in refrigerator or at room temperature, and should not be refrozen. ³ Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. ⁴ The Pfizer-BioNTech bivalent vaccine vials should not be stored at -25°C to -15°C/-13°F to 5°F. ⁵ Individuals who have received three 0.2mL doses of either monovalent or bivalent Pfizer-BioNTech COVID-19 vaccine. ⁶ Individuals who have received two 0.25mL doses of either monovalent or bivalent Moderna COVID-19 vaccine. ⁷ Engineered portion of viral spike (S) glycoprotein from SARS-CoV-2, combined with adjuvant (saponin-based Matrix-M). ⁸ The Novavax vaccine is under EUA as a first booster dose to adults age ≥18yrs for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to adults ≥18yrs who elect to receive the Novavax vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine.
REFERENCES
Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted to Prevent Coronavirus Disease 2019 (COVID-19). Accessed June 26, 2023. https://www.fda.gov/media/159897/download. Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Accessed June 26, 2023. https://www.fda.gov/media/167208/download. Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Accessed June 26, 2023. https://www.fda.gov/media/167211/download. (Rev. 6/2023)

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