COVID-19 Vaccines

COVID-19 VACCINES

Contraindications: COVID-19 vaccines are contraindicated in patients with a severe allergic reaction (eg, anaphylaxis) after a previous dose or to a component of the vaccine, or an immediate allergic reaction1 of any severity after a previous dose or known (diagnosed) allergy to a component of the vaccine.

• Those with a contraindication to one mRNA COVID-19 vaccine should not receive doses of either mRNA vaccine.

 

Precautions: caution in patients with a history of an immediate allergic reaction1 to any other vaccines or injectable therapies, contraindication to other COVID-19 vaccines, and patients with moderate to severe acute illness2 (eg, current SARS-Cov-2 infection). The Janssen vaccine includes additional precautions for women aged <50yrs and patients with a history of or risk factors for thrombosis due to rare cases of thrombosis with thrombocytopenia syndrome (TTS) after vaccine administration. Both mRNA vaccines include additional warnings for adolescents, young adults, (predominantly males and aged ≥16yrs), and patients with a history of myocarditis or pericarditis due to increased risks of these conditions following the second dose.

• Those with a contraindication to mRNA vaccines (including due to a known polyethylene glycol allergy) have a precaution to Janssen COVID-19 vaccine. Those with a contraindication to Janssen vaccine (including due to a known polysorbate 80 allergy) have a precaution to mRNA vaccines. Consultation with an allergist-immunologist should be considered and vaccination with either COVID-19 vaccine should only be undertaken in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

• Those who have previously received 1 dose of mRNA vaccine with a contraindication to the 2nd dose should wait at least 28 days to receive the Janssen vaccine.

 

Underlying conditions: vaccines may be administered to patients with immunocompromising conditions, autoimmune conditions, history of Guillain-Barré syndrome, Bell’s palsy, dermal filler use. However, immunocompromised patients, including those receiving immunosuppressants, may have a diminished immune response to the vaccines.

 

Prior SARS-CoV-2 infection: vaccines may be administered regardless of history of prior symptomatic or asymptomatic infection.

 

Pregnancy and lactation: any authorized COVID-19 vaccines may be administered, however, patients should be aware of the rare risk of TTS after administration of the Janssen vaccine.

 

Vaccine coadministration: COVID-19 vaccines and other vaccines may be administered without regard to timing; simultaneous administration on the same day and coadministration within 14 days are now accepted.

 

Passive antibody therapy: defer vaccination for ≥90 days for persons who received passive antibody therapy (eg, monoclonal antibodies or convalescent plasma) as part of COVID-19 treatment.

 

Developer Vaccine Status Dosing Storage/Stability4 Side Effects5,6
mRNA3
Pfizer-BioNTech Comirnaty (BNT162b2)

Primary series:
2-dose series: Approved for ≥16yrs; EUA for 5–15yrs
3-dose series: EUA for ≥5yrs who are immunocompromised or organ transplant

 

Booster:
EUA for ≥12yrs

Primary series:
2-dose series:
≥12yrs: 30mcg (0.3mL) IM × 2 doses, 3wks apart7,8
5–11yrs (orange cap only): 10mcg (0.2mL) IM × 2 doses, 3wks apart7,8
3-dose series:
≥12yrs:
30mcg (0.3mL) IM × 2 doses, 3wks apart7,8, then 30mcg (0.3mL) IM × 1 dose, ≥28 days after the 2nd dose
5–11yrs (orange cap only): 10mcg (0.2mL) IM × 2 doses, 3wks apart7,8, then 10mcg (0.2mL) IM × 1 dose, ≥28 days after the 2nd dose

 

Booster:
≥12yrs: 30mcg (0.3mL) IM × 1 dose, ≥5mos after completing the primary series of the Pfizer vaccine (≥18yrs: ≥5mos after Moderna series or ≥2mos after Janssen vaccine)

Ultra-Cold Freezer
(–90° to –60°C/-130°F to -76°F): until expiration date for formulation with purple caps or up to 12mos from date of manufacture for gray and orange caps

 

Thermal Shipper9
(–90°C to –60°C/–130°F to –76°F): up to 30 days from delivery

 

Freezer10
(–25°C to –15°C/–13°F to 5°F): up to 2wks for formulation with purple caps only

 

Refrigerator
(2°C to 8°C/35°F to 46°F): up to 1 month for formulation with purple caps or up to 10wks for gray and orange caps

 

Room Temperature
(up to 25°C/up to 77°F): up to 2hrs for formulation with purple caps or up to 12hrs for gray and orange caps

Inj site pain, swelling and/or erythema, fatigue, headache, myalgia, chills, arthralgia, fever, nausea, malaise, lymphadenopathy.
Rare: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritis, urticaria, angioedema), myocarditis/pericarditis (esp. adolescents and young adults)
Moderna

Spikevax (mRNA-1273)

Primary series:
2-dose series: Approved for ≥18yrs
3-dose series: EUA for ≥18yrs who are immunocompromised or organ transplant

 

Booster:
EUA for ≥18yrs

Primary series:
2-dose series: ≥18yrs: 100mcg (0.5mL) IM × 2 doses, 1 month apart7,8
3-dose series: ≥18yrs: 100mcg (0.5mL) IM × 2 doses, 1 month apart7,8, then 100mcg (0.5mL) IM × 1 dose, ≥1 month after the 2nd dose

 

Booster:
≥18yrs:
50mcg (0.25mL) IM × 1 dose, ≥5mos after completing the primary series of the Moderna vaccine (≥5mos after Pfizer series or ≥2mos after Janssen vaccine)

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 12hrs after vial puncture)

 

Room temperature
(8°C to 25°C/46°F to 77°F): up to 24hrs (up to 12hrs after vial puncture)

Inj site pain, swelling and/or erythema, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, axillary swelling/tenderness, fever.

Rare: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritis, urticaria, angioedema), myocarditis/pericarditis (esp. adolescents and young adults)

VIRAL VECTOR11
Janssen (Johnson & Johnson) JNJ-78436735 Primary vaccination and booster:
EUA for ≥18yrs

Primary vaccination:
≥18yrs:
5×1010 viral particles (0.5mL) IM × 1 dose8

 

Booster:
≥18yrs:
5×1010 viral particles (0.5mL) IM × 1 dose, ≥2mos after completing the primary vaccination of the Janssen vaccine (≥5mos after Pfizer or Moderna series)

Refrigerator
(2°C to 8°C/36°F to 46°F): up to 11mos (up to 6hrs after vial puncture)

 

Room temperature
(9°C to 25°C/47°F to 77°F): up to 12hrs (up to 2hrs after vial puncture)

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)
AstraZeneca-Oxford AZD1222 Phase 3 clinical trials in US 5 × 1010 viral particles (0.5mL) IM × 2 doses, 4-12wks apart13 Refrigerator
(2°C to 8°C/36°F to 46°F): at least 6mos
 
PROTEIN SUBUNIT12
Novavax NVX-CoV2373 Phase 3 clinical trials in US 0.5mL IM × 2 doses, 21 days apart Refrigerator
(2°C to 8°C/36°F to 46°F): up to 6mos
 
Sanofi-GSK Monovalent (D614)-AS03 Phase 3 clinical trials in US 10mcg x 2 doses, 21 days apart Refrigerator
(2°C to 8°C/36°F to 46°F)
 
Monovalent (B.1.351)-AS03
Bivalent (D614 + B.1.351)-AS03
NOTES

Key: EUA = Emergency Use Authorization (given by FDA); IM = intramuscular

 1 Defined as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress, or anaphylaxis that occur within 4hrs following exposure to a vaccine or medication.

 2 If known current COVID-19 infection, vaccination should be deferred until person has recovered and has met criteria to discontinue isolation.

 3 Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2.

 4 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.

 5 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.

 6 Janssen vaccine: most systemic post-vaccination symptoms are mild in severity, resolve within 1-2 days after vaccination, and are more frequent in younger vs older people (≥60yrs).

 7 2nd dose should be administered as close to the recommended interval as possible. 2nd doses inadvertently administered earlier than the recommended dosing interval (earlier than the 4-day grace period) do not need to be repeated. If 2nd dose is not administered within 42 days of the 1st dose, the series does not need to be restarted (only limited data available on efficacy beyond this window).

 8 Providers should observe patients for the occurrence of immediate adverse reactions for at least 15mins after vaccinations and for 30mins for those with the following precautions: history of any immediate allergic reaction to any other vaccines or injectable therapy, contraindication to mRNA COVID-19 vaccine who receive Janssen vaccine and vice versa, or history of anaphylaxis due to any cause.

 9 For temporary storage only. Dry ice must be replenished within 24hrs of delivery and every 5 days. Remaining doses must be transferred to refrigerator.

10 Vials stored in freezer may be returned one time to ultra-cold freezer at which time the 2-week time frame is suspended.

11 Recombinant, replication-incompetent Ad26 vector, encoding stabilized variant of the SARS-CoV-2 Spike (S) protein.

12 Engineered portion of viral spike (S) glycoprotein from SARS-CoV-2, combined with adjuvant (saponin-based Matrix-M).

13 Longer inter-dose interval of 12 weeks or more have been evaluated in clinical trials with increased efficacy reported.

REFERENCES

AZD1222 US phase III primary analysis confirms safety and efficacy. [press release]. AstraZeneca PLC; March 25, 2021.

Clinical considerations: myocarditis and pericarditis after receipt of mRNA COVID-19 vaccines among adolescents and young adults. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html. Accessed July 6, 2021.

Comirnaty [package insert].Mainz, Germany and New York, NY: BioNTech and Pfizer, Inc.; 2021.

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. News release. US Food and Drug Administration. Accessed September 23, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised.

COVID-19 Vaccine: Quick Reference Guide for Healthcare Professionals. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-quick-reference-guide-2pages.pdf. Accessed May 25, 2021.

FDA in brief: FDA authorizes longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 Vaccine prior to dilution, making vaccine more widely available. [press release]. Silver Spring, MD: US Food and Drug Administration; May 19, 2021.

FDA roundup: April 8, 2022. News release. US Food and Drug Administration. April 8, 2022. Accessed April 20, 2022. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-8-2022

FDA roundup: April 15, 2022. News release. US Food and Drug Administration. April 15, 2022. Accessed April 20, 2022. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-15-2022

Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. ACIP COVID-19 Vaccines Work Group. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. Published March 1, 2021. Updated May 14, 2021. Accessed May 21, 2021.

Janssen COVID-19 Vaccine. [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2022.

Johnson & Johnson statement on FDA approval of shelf life extension for company’s COVID-19 vaccine. [press release]. New Brunswick, NJ: Johnson & Johnson; June 10, 2021.

Spikevax [package insert]. Cambridge, MA: Moderna, Inc.; 2022.

Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 phase 3 trial. [press release]. Gaithersburg, MD: Novavax, Inc.; June 14, 2021.

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine. [press release]. Sanofi; February 23, 2022. https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-23-11-15-00-2390091#.

(Rev. 4/2022)