COVID-19 Vaccines

(Updated November 23, 2021)

The chart below provides dosing, storage, adverse effects, and efficacy information for COVID-19 vaccines available or submitted for approval in the U.S. and/or Canada. The American Society of Health System Pharmacists has resources related to COVID-19 vaccines at https://www.ashp.org/COVID-19/Vaccines?loginreturnUrl=SSOCheckOnly. See end of chart for links to the fact sheets and product labeling.

Vaccinee/Type/Status

Dosing

Storage/Stabilityd

Adverse Effects

Efficacy

BNT162b2
(Pfizer-BioNTech)/mRNA
(Comirnaty)c

PURPLE cap17,18
(NOT for ages 5 to 11 yearsh)

U.S.: approved for ages ≥16 years; EUA for ages 12 to 15 years; third dose for immuno-compromised; and booster for adults

Canada: approved

Two 0.3 mL (30 mcg) doses (0, 21 days) IM for ≥12 years of age17-19

Third dose: (Immunocompromised):

≥28 days after the second dose.f,17,29

Booster (≥18 years of age):
≥6 months after second dose17,18,30,g

Requires dilution with 1.8 mL of NS per vial.17-19

Special dry ice shipper: see footnote b for storage/handling

Ultra-low temp freezer
(-75°C±15°C) Mfr expiration date (undiluted)17-19
May transport once at -20°C±5°C and return to ultracold storage.17-19

Freezer (-20°C±5°C):
≤2 weeks.17-19 Any hours spent in transport (above) count toward the 2-week limit.

Thawing (before diluting): may take ~two to three hours in the refrigerator, or 30 minutes at room temperature. Allow vial to reach room temperature before diluting. Do not refreeze.17-19

Refrigerator (2°C to 8°C):
1 month undiluted (includes transport [up to 12 hours]); 6 hours once diluted (vial or pre-drawn syringe)10,17-19

Room Temp (up to 25°C): 2 hours, undiluted, 6 hours once diluted (vial or pre-drawn syringe)10,17-19

Most common adverse effects (mostly mild to moderate, resolving within a few days):  injection site reactions, fatigue, headache, myalgia, chills, joint pain, fever, and diarrhea.18

Side effect profile after the third dose is similar to the second dose.17,29

Clinical trial participants were allowed to use analgesics/antipyretics.5

Anaphylaxis reported.17-19 

Lymphadenopathy (16%) may interfere with imaging (e.g., mammography) for four to six weeks after vaccination.28

Myocarditis/pericarditis reported postmarketing, most after the second dose in males <40 years of age.17 Most cases resolved without intensive care.17

At least four cases of Bell’s palsy have occurred after vaccination, but causality is unceratin.17,19

Up to 80% effective for preventing hospitalization and 77% effective for preventing urgent care or emergency department visit where delta strain predominates (U.S. cohort studies).1,2  Whether this moderate decline in efficacy vs the clinical trial data is due to the change in the virus or waning immunity (or both) is unclear.1

Immunocompromised patients were excluded from the clinical trials.  A third dose increases antibody levels somewhat, but may not be clinically protective.17,29

In immunocompetent patients, a booster dose restores neutralizing antibody titers to levels seen one month after the second dose.17

BNT162b2 for 5 through 11 years of age

(Pfizer-BioNTech)/mRNA

 

U.S.:  EUA

 

Canada (Comirnaty): approved

 

ORANGE cap and label with orange border18,31

Two 0.2 mL (10 mcg) doses (0, 21 days) IM for 5 to 11 years of age.18,31

 

Requires dilution with

1.3 mL of NS per vial.18,31

Ultra-low temp freezer

(-75oC±15oC) (option only if vials arrive frozen):  6 months after date of manufacture.18,31

 

Thawing (before diluting):  may take up to 4 hours in the refrigerator, or 30 minutes at room temperature.  Do not refreeze.18,31

 

Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated):  10 weeks undiluted; 12 hours once diluted.18,31

 

Room Temp (up to 25oC): 12 hours undiluted, 12 hours once diluted.18,31

 

Vaccine should not be used after 6 months from date of manufacture.18,31

Most common adverse effects (none serious, resolving within a few days):  injection site reactions, fatigue, headache, myalgia, chills, fever, joint pain, lymphadenopathy, nausea, rash, malaise, anorexia.18,31

No serious events were deemed to be caused by the vaccine.18,31

Clinical trial participants were allowed to use analgesics/antipyretics.18,31

Anaphylaxis reported postmarketing in patients ≥12 years of age.18,31

Myocarditis/pericarditis reported postmarketing in patients ≥12 years of age.31  Most cases resolved without intensive care.31  (See above row.) 

90.9% effective for prevention of symptomatic infection in children five to 11 years of age (n=2,268).31 (Safety was studied in 4,647 children.33)

Infection was defined as at least one symptom of COVID-19 plus a positive polymerase chain reaction (PCR) test, at least seven days after the second dose.31 

mRNA-1273
(Moderna)/mRNA

U.S.: EUA

Canada (SpikeVax): approved

Two 0.5 mL doses (0, 1 month [day 28]) IM for ≥18 (≥12 yrs Canada) years of age6,21,22

Third dose (Immunocompromised):
≥28 days after the second dose.f,21,29

Booster (≥18 years of age):
0.25 mL, ≥6 months after second dose21,22,30,g

Does not require dilution.21,22

Shipping and long-term storage: -50°C to -15°C until mfr expiration date.6 (Canada: -25°C to -15°C.)22

Refrigerator (2°C to 8°C): 30 days after thawing (prior to first use).21,22 After 30 days, contact manufacturer for guidance before discarding.6
In-use vial/pre-drawn syringe: 12 hours.10,21 (Canada In-use vial: 24 hours.)22

Room temperature: (8°C to 25°C):
Unused vial: 24 hours21,22
In-use vial/pre-drawn syringe: 12 hours.10,21 (Canada In-use vial: 24 hours.)22

Most common adverse effects (mostly mild to moderate, resolving within a few days):  injection site reactions, fatigue, headache, myalgia, joint pain, chills, nausea/vomiting, lymphadenopathy, and fever.4,21,22

Side effect profile after the third dose is similar to the second dose.21,22,29

Clinical trial participants were allowed to use analgesics/antipyretics.4

Anaphylaxis reported.21,22,27

Lymphadenopathy (16%) may interfere with imaging (e.g., mammography) for four to six weeks.28

At least three cases of Bell’s palsy have occurred after vaccination, but causality is uncertain.21,22

Delayed-type hypersensitivity reaction (e.g., large, red area near injection site about a week after shot) is not a contraindication to subsequent vaccination.15  May be itchy, painful, warm, or swollen, and can also involve fingers, elbow, or palm.  More common with first shot.15

Up to 95% effective for preventing hospitalization and 92% effective for preventing urgent care or emergency department visit where delta strain predominates (U.S. cohort studies).1,2  Whether this moderate decline in efficacy vs the clinical trial data is due to the change in the virus or waning immunity (or both) is unclear.1

Immunocompromised patients were excluded from the clinical trials.  A third dose increases antibody levels somewhat, but may not be clinically protective.21,29

Efficacy of the booster dose was based on neutralizing antibody titers.21


Ad26.COV2.S
Janssen (J&J)/
/Viral vector (non-replicating)

U.S.: EUA

Canada:authorized by interim order

One 0.5 mL IM dose for ≥18 years of age9,24 (two-dose regimen also being studied)

Immunocompromised (Canada):

Second dose (mRNA vaccine preferred) ≥28 days after first dose.f,29

Booster (U.S.):  ≥2 months after the first dose9 (Canada see footnote “g”)

If arrives frozen, refrigerate, or for immediate use, thaw at room temperature (max 25°C). May take 1 to 4 hours to thaw.9

Refrigerator (2°C to 8°C): Mfr expiration date (unused vial);11,24 In-use vial/pre-drawn syringe: 6 hrs.10,11,24

Room temperature (9°C to 25°C): Unused vial: 12 hours. In-use vial/pre-drawn syringe: 2 hours (Canada: 3 hours)10,11,24

Most common adverse effects (mostly mild to moderate, resolving within a few days):   injection site reactions, headache, fatigue, myalgia, nausea, fever.9,24

Side effect profile after the second/booster dose is similar to the first dose.9,29

Anaphylaxis reported.9,24

Plausible association with rare instances of thrombocytopenia with thrombosis, mostly in females <50 years old, within the first two weeks post-dose.9,12

60% effective for preventing hospitalization and 65% effective for preventing urgent care or emergency department visit where delta strain predominates (U.S. cohort studies).1 Whether this moderate decline in efficacy vs the clinical trial data is due to the change in the virus or waning immunity (or both) is unclear.1

Immunocompromised patients were excluded from the clinical trials.  A second dose increases antibody levels somewhat, but may not be clinically protective.29

Efficacy of the booster dose was based on neutralizing antibody titers.9

 

ChAdOx1-Sa
(AstraZeneca)/Viral vector (non-replicating)(Vaxzevria)

Phase III data published.

Canada: authorized by interim order

 

Two 0.5 mL doses (0 and 4 to 12 weeks) IM for ≥18 years of age8,16

Immunocompromised:

Third dose (mRNA vaccine preferred) ≥28 days after the second dose.f,29

Booster (Canada): see footnote "g"


Refrigerator(2°C to 8°C): Mfr expiration date (unused vial); 48 hours (punctured vial)8,16

Room temperature (≤30°C): 6 hours (punctured vial). Vial can be re-refrigerated, but the cumulative storage at room temperature cannot exceed 6 hours, and the total cumulative storage time cannot exceed 48 hours8,16

Most common adverse effects (mostly mild to moderate, resolving within a few days):  injection site reactions, fatigue, headache, myalgia, malaise, fever, chills, joint pain, nausea.8,16

Side effect profile after the third dose is similar to the second dose.29

Transverse myelitis occurred in three patients (one placebo) in clinical trials.  A possible vaccine relationship was not ruled out in one case.20

Anaphylaxis reported.8,13,16

Current evidence does not suggest thrombosis risk, except cerebral sinus vein thrombosis with low platelets (rare; 1 in 250,000 to 500,000).25

60% effective for preventing infection by the delta variant (Scottish cohort).3

Immunocompromised patients were excluded from the clinical trials.  A third dose increases antibody levels somewhat, but may not be clinically protective.29 

 

NVX-CoV2373
(Novavax)/Protein subunit, adjuvanted

Phase III; rolling review process in U.S. and Canada14

Two doses IM (0, 21 to 28 days)7

Refrigerator (2°C to 8°C)7

Most common adverse effects (mostly mild to moderate, resolving within a few days):  injection site reactions, headache, myalgia, fatigue, joint pain, malaise, nausea, vomiting, fever.26

No efficacy data for delta variant.

 
  1. In Canada, AstraZeneca vaccine is also manufactured by Serum Institute of India (Covishield).
  2. Pfizer vaccine storage and dry ice safety handling resources at https://www.cvdvaccine-us.com/product-storage-and-dry-ice.
  3. Comirnaty and the authorized Pfizer-BioNTech COVID-19 vaccine for adults are the same formulation and can be used interchangeably.18,19
  4. USP: Vaccines should be prepared in accordance with the manufacturer’s labeling. This means that USP engineering controls, risk levels, and beyond-use dating is not required. See https://www.usp.org/compounding.
  5. Tips to minimize vaccine waste include:10,23
    • Maintain the cold chain to prevent waste due to inappropriate storage conditions.
    • Maximize doses drawn from multidose vials using:
      • low dead-volume syringes/needles.
      • techniques to minimize leakage (e.g., multiple puncture locations in the rubber stopper, instead of the same location over and over [this can create a larger hole]).
    • Draw up an appropriate number of syringes based on expected vaccination appointments for the day.
      • Monitor appointment cancellations and no shows throughout the day. Then draw up afternoon doses based on the revised appointment list.
    • Use syringes in order of expiration time, starting with the earliest expiration date.
    • Maintain a waiting list to contact people at the end of the day if there are extra doses available.
  6. U.S.: At this time, the EUA only allows for the third dose for immunocompromised patients such as solid organ transplant patients or similar level of immunocompromise. For a full list of CDC-recommended conditions, see https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.
    Canada:  See a full list of immunocompromising conditions per NACI here:  https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/statement-september-10-2021-additional-dose-covid-19-vaccine-immunocompromised-following-1-2-dose-series.html?hq_e=el&hq_m=2190151&hq_l=1&hq_v=42f995eed6 Ontario Ministry of Health recommendations for the third dose are available at https://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/COVID-19_vaccine_third_dose_recommendations.pdf.
  7. Canada: NACI recommends a booster for seniors living in congregate settings ≥6 months after completing the primary series.30  An mRNA booster is preferred (even if the patient originally received a viral-vector COVID-19 vaccine).30  A booster using a viral-vector COVID-19 vaccine can be considered ONLY when an mRNA vaccine is not available or is contraindicated.30  Your province may have different guidance for who qualifies for a booster. 
  8. The adult formulation of the Pfizer-BioNTech vaccine CANNOT be used for children 5 to 11 years of age by using a dose-adjusted volume.  This is because this volume (10 mcg = 0.1 mL) is too small for an intramuscular injection.  The pediatric formulation is delivers 10 mcg in 0.2 mL.32

     

    Abbreviations: EUA = Emergency Use Authorization; IM = intramuscular; NS = normal saline; UK = United Kingdom

    The CDC has interim recommendations for COVID-19 vaccine administration errors and deviations available at https://cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations-poster.pdf.

    Fact Sheets and Product Labeling

    References

    1. Grannis SJ, Rowley EA, Ong TC, et al.  Interim estimates of COVID-19 vaccine effectiveness against COVID-19-associated emergency department or urgent care clinic encounters and hospitalizations among adults during SARS-CoV-2 B.1.617.2.  MMWR Morb Mortal Wkly Rep 2021 Sept 10.    http:dx.doi.org/10.15585/mmwr.mm7037e2.  (Accessed September 11, 2021).
    2. Puranik A, Lenehan PJ, Silvert E, et al. Comparison of two highly effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence.  August 9, 2021. https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v2.full.pdf.  (Accessed September 11, 2021).
    3. Sheikh A, McMenamin J, Taylor B, et al.  SARS-CoV-2 delta VOC in Scotland:  demographics, risk of hospital admission, and vaccine effectiveness.  Lancet 2021;397:2461-2.
    4. FDA. FDA Briefing document. Moderna COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting. December 17, 2020. https://www.fda.gov/media/144434/download. (Accessed February 7, 2021).
    5. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020;383:2603-15.
    6. CDC. Moderna COVID-19 vaccine questions. Last reviewed June 22, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/moderna-faqs.html. (Accessed September 11, 2021).
    7. Novavax. Clinical trial protocol. A phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of a SARS-Co-V-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1 adjuvant in adult participants ≥18 years. November 16, 2020. https://www.novavax.com/sites/default/files/2020-12/Novavax_2019nCoV-301_Protocol_%20Phase%203-Redacted.pdf. (Accessed September 12, 2021).
    8. Product monograph for Covishield/COVID-19 Vaccine (ChAdOx1-S). Verity Pharmaceuticals. Mississauga, ON L4W 4Y9. August 2021.
    9. FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency use authorization (EUA) of the Janssen COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). October 20, 2021. https://www.fda.gov/media/146304/download. (Accessed October 22, 2021).
    10. USP.  COVID-19 vaccine handling toolkit:  operational considerations for healthcare practitioners.  Version 4.0  June 2021.  https://www.usp.org/covid-19/vaccine-handling-toolkit.  (Accessed September 11, 2021).
    11. CDC.  Janssen COVID-19 vaccine (Johnson & Johnson).  Storage and handling summary.  August 24, 2021.  https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/downloads/janssen-storage-handling-summary.pdf.  (Accessed September 12, 2021).
    12. CDC.  CDC recommends use of Johnson & Johnson’s Janssen COVID-19 vaccine resume. August 27, 2021.  https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html.  (Accessed September 12, 2021).
    13. FDA News.  Severe allergy added to EMA’s list of AstraZeneca vaccine side effects.  March 16, 2021.  https://www.fdanews.com/articles/201861-severe-allergy-added-to-emas-list-of-astrazeneca-vaccine-side-effects.  (Accessed September 12, 2021).
    14. Novavax. Press release Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorization. February 4, 2021. https://ir.novavax.com/node/15531/pdf. (Accessed February 7, 2021).
    15. Blumenthal KG, Freeman EE, Saff RR, et al.  Delayed large local reactions to mRNA-1273 vaccine against SARS-CoV-2.  N Engl J Med 2021;384:1273-7.
    16. Product monograph for Vaxzevria.  AstraZeneca Canada.  Mississauga, ON L4Y 1M4.  September 2021.
    17. FDA.  Fact sheet for healthcare providers administering vaccine (vaccination providers).  Emergency use authorization (EUA) of the Pfizer-Biontech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) for 12 years of age and older.  Revised November 19, 2021.  https://www.fda.gov/media/153713/download.  (Accessed November 19, 2021). 
    18. Product monograph for Comirnaty.  Pfizer Canada.  Kirkland, QC H9J 2M5.  November 2021.
    19. Product information for Comirnaty.  Pfizer.  New York, NY 10017.  August 2021.
    20. Voysey M, Costa Clemens SA, Madhi SA, et al. Safety and efficacy of the ChAdOx1CoV-19 vaccine (AZS1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021;397:99-111.
    21. FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency use authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). November 19, 2021. https://www.fda.gov/media/144637/download. (Accessed November 19, 2021).
    22. Product monograph for SpikeVax. Moderna Therapeutics. Cambridge, MA 02139. November 2021.
    23. Coppock K. ISMP provides recommendations for avoiding COVID-19 vaccination administration errors.  January 15, 2021.  https://www.pharmacytimes.com/view/ismp-provides-recommendations-for-avoiding-covid-19-vaccination-administration-errors.  (Accessed May 10, 2021).
    24. Product monograph for Janssen COVID-19 vaccine.  Janssen.  Toronto, ON M3C 1L9.  August 2021.
    25. Thrombosis Canada.  Thrombosis Canada updated statement on AstraZeneca vaccine and blood clots.  March 18, 2021.  https://thrombosiscanada.ca/tc-updated-statement-march-18/#:~:text=%C2%A0Toronto,%20Ontario%20(March%2018,%202021)%E2%80%93%20Thrombosis%20Canada%20has,that%20is%20associated%20with%20thrombocytopenia%20(low%20blood%20platelets).  (Accessed September 12, 2021).
    26. Shinde V, Bhikha S, Hoosain Z, et al.  Efficacy of NVX-CoV2373 Covid-19 vaccine against the B.1.351 variant.  N Engl J Med 2021;384:1899-909
    27. CDC COVID-19 Response Team, Food and Drug Administration.  Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine-United States, December 21, 2020-January 10, 2021.  MMWR Morb Mortal Wkly Rep 2021;70:125-9.
    28. NCCN:  Cancer and COVID-19 Vaccination.  Recommendations of the NCCN COVID-19 vaccination Advisory Committee.  Version 2.0.  March 10, 2021.  https://www.nccn.org/docs/default-source/covid-19/2021_covid-19_vaccination_guidance_v2-0.pdf?sfvrsn=b483da2b_56.  (Accessed March 19, 2021).
    29. National Advisory Committee on Immunization (NACI) rapid response:  additional dose of COVID-19 vaccine in immunocompromised individuals following 1- or 2- dose primary series.  September 10, 2021 (modified September 13, 2021).  https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/statement-september-10-2021-additional-dose-covid-19-vaccine-immunocompromised-following-1-2-dose-series.html?hq_e=el&hq_m=2190151&hq_l=1&hq_v=42f995eed6.  (Accessed September 15, 2021).
    30. National Advisory Committee on Immunization (NACI) rapid response:  booster dose in long-term care residents and seniors living in other congregate settings.  September 28, 2021.  https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/statement-september-28-2021-booster-dose-long-term-care-residents-seniors-living-other-congregate-settings.html#a5.  (Accessed October 22, 2021).
    31. FDA.  Fact sheet for healthcare providers administering vaccine (vaccination providers).  Emergency use authorization (EUA) of the Pfizer-Biontech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) for 5 through 11 years of age.  October 29, 2021.  https://www.fda.gov/media/153714/download.  (Accessed October 29, 2021).
    32. American Pharmacists Association.  COVID-19 vaccination in adolescents and children.  November 9, 2021. https://www.pharmacist.com.  (Accessed November 16, 2021).
    33. Woodworth KR, Moulia D, Collins JP, et al.  The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years-United States, November 2021. MMWR Morb Mortal Wkly Rep 2021;70:1579-83.
    Cite this document as follows: Clinical Resource, COVID-19 Vaccines. Pharmacist’s Letter/Prescriber’s Letter. March 2021. [370301]

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