COVID-19 Vaccines
Full update January 2023
The charts below provide dosing, storage, adverse effects, efficacy, and other information for COVID-19 vaccines approved or authorized in the US and 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 the chart for links to the fact sheets and product labeling.
COVID-19 Vaccines Available in the UNITED STATES
VACCINEe |
DOSE (Primary Series) |
DOSE (Booster) |
STORAGE/STABILITY |
COMMENTS |
BNT162b2 (Pfizer-BioNTech)/ mRNA (Comirnaty)c PURPLE cap*,17,19 (NOT for ages <12 yearsa) Approved for ages ≥12 years;19 EUA for ages ≥12 years; third dose for immunocompromised.f,17 Requires dilution with 1.8 mL NS per vial.17,19 *Purple cap formulation is being phased out. See Gray cap formulation, below. |
Primary vaccination for ≥12 years: two 0.3 mL (30 mcg) IM doses 3 weeks apart.**,17,19 Immunocompromisedf: As above, plus 3rd dose ≥28 days after the 2nd dose.17 **CDC: An 8-week interval between the first two doses may increase efficacy, but stick with labeled interval for those who need rapid protection (e.g., age ≥65 years, immunocompromised).25 |
See age-appropriate bivalent mRNA booster. |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC): one month thawed/undiluted vials (includes transport [up to 12 hours]); 6 hours once diluted (vial or pre-drawn syringe).10,17,19 Room Temp (up to 25oC): 2 hours (thawed/undiluted); 6 hours once diluted (vial or pre-drawn syringe).10,17,19 |
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BNT162b2 (Pfizer-BioNTech)/ mRNA (Comirnaty)c GRAY cap13,27 (NOT for ages <12 yearsa) Approved for ages ≥12 years;27 EUA for ages ≥12 years; third dose for immunocompromised.f Do NOT dilute.13,27 |
See above. |
See above. |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC): 10 weeks (unpunctured vial); 12 hours (pre-drawn syringe).10,13,27 Room Temp (up to 25oC): 12 hours (unpunctured vial or pre-drawn syringe).10,13,27 Discard vials 12 hours after first puncture.13,27 Vaccine should not be used after 18 months from date of manufacture.13 |
See above. |
BNT162b2 for 5 through 11 years of age (Pfizer-BioNTech)/ mRNA ORANGE cap and label with orange border30 EUA Requires dilution with 1.3 mL of NS per vial.30 |
Primary vaccination for 5 to 11 years: two 0.2 mL (10 mcg) IM doses 3 weeks apart.30 Immunocompromised: as above, plus 3rd dose ≥28 days after the second dose.30 |
See age-appropriate bivalent mRNA booster. |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated): 10 weeks undiluted; 12 hours once diluted (vial).30 Room Temp (up to 25oC): 12 hours (undiluted); 12 hours once diluted (vial).30 Stable in pre-drawn syringe for 24 hours, with no more than 12 hours at room temperature (up to 30oC).10 Vaccine should not be used after 18 months from date of manufacture.30 |
|
BNT162b2 for 6 months through 4 years of age (Pfizer-BioNTech)/ mRNA MAROON cap and label with maroon border32 EUA Requires dilution with 2.2 mL of NS per vial.32 |
Primary vaccination for 6 months to through 4 years: three 0.2 mL (3 mcg) IM doses. The initial two doses are given 3 weeks apart, followed by a third dose (USING THE BIVALENT vaccine) ≥8 weeks after the second dose.32 |
N/A |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated): 10 weeks (undiluted); 12 hours (once diluted).32 Room Temp (up to 25oC): 12 hours (undiluted); 12 hours (once diluted; vial or pre-drawn syringe).10,32 Vaccine should not be used after 18 months from date of manufacture.32 |
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Pfizer BioNTech Bivalent for 6 months through 4 years of age (Pfizer-BioNTech)/ mRNA MAROON cap and label with maroon border32 EUA Requires dilution with 2.2 mL of NS per vial.32 |
Third dose of primary series (6 months through 4 years of age): one 0.2 mL (3 mcg) IM dose ≥8 weeks after the second dose of the primary series.32 |
N/A |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated): 10 weeks (undiluted); 12 hours (once diluted).32 Room Temp (up to 25oC): 12 hours (undiluted); 12 hours once diluted.32 Vaccine should not be used after 18 months from date of manufacture.32 |
|
Pfizer BioNTech Bivalent booster for ≥12 years of age (original and Omicron BA.4/BA.5) (Pfizer-BioNTech)/ mRNA EUA Do NOT dilute.38 |
N/A |
Booster (≥12 years of age): one 0.3 mL IM dose ≥2 months after completion of primary series of any COVID-19 vaccine or booster.38 |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated): 10 weeks (undiluted); 12 hours (in-use vial).38 Room Temp (up to 25oC): 12 hours prior to first puncture; 12 hours (in-use vial).38 Vaccine should not be used after 18 months from date of manufacture.38 |
|
Pfizer-BioNTech Bivalent booster for 5 through 11 years of age (original and Omicron BA.4/BA.5) (Pfizer-BioNTech)/ mRNA EUA Requires dilution with 1.3 mL of NS per vial.37 |
N/A |
Booster (5 through 11 years of age): one 0.2 mL IM dose ≥2 months after completion of primary series of any COVID-19 vaccine or booster.37 |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated): 10 weeks (undiluted); 12 hours (once diluted).37 Room Temp (up to 25oC): 12 hours (undiluted); 12 hours (once diluted).37 Vaccine should not be used after 18 months from date of manufacture.37 |
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mRNA-1273 (Moderna)/ mRNA (Spikevax)g RED cap and label with a light blue border Approved (Spikevax) for primary two-dose series in adults ≥18 years of age.21 EUA for primary series for ages 12 to 17 years of age, and a third primary series dose for immunocompromised people ≥12 years of age.2 |
Primary vaccination for ≥12 years: two 0.5 mL (100 mcg) IM doses one month (4 weeks) apart.*,2,21,25 Immunocompromised: as above plus 3rd dose ≥1 month (≥4 weeks) after the second dose.2,25 *CDC: An 8-week interval between the first two doses may increase efficacy, but stick with labeled interval for those who need rapid protection (e.g., age ≥65 years, immunocompromised).25 |
See age-appropriate bivalent booster. |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).2.21 After 30 days, contact manufacturer for guidance before discarding.6 In-use vial/pre-drawn syringe: 12 hours.2,10,21 Room temperature (8oC to 25oC): 24 hours total. Discard 12 hours after first puncture.2,21 Pre-drawn syringe: 12 hours after first puncture of source vial.10 |
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mRNA-1273 (Moderna)/ mRNA 50 mcg in 0.5 mL DARK blue cap and a label with a PURPLE/TEAL border34 (0.1 mg/mL) EUA for primary series (6 through 11 years).34 |
Primary vaccination for 6 through 11 years: two 0.5 mL (50 mcg) IM doses one-month apart.34 Immunocompromised: as above plus 3rd dose ≥1 month after the second.34 |
See age-appropriate bivalent mRNA booster. |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).34 After 30 days, contact manufacturer for guidance before discarding.6 In-use vial/pre-drawn syringe: 12 hours.10,34 Room temperature (8oC to 25oC): 24 hours total.34 Discard 12 hours after first puncture.34 Pre-drawn syringe: 12 hours after first puncture of source vial.10 |
|
mRNA-1273 for 6 months through 5 years of age (Moderna)/ mRNA DARK blue cap and label with a MAGENTA border33 EUA |
Primary vaccination for 6 months through 5 years: two 0.25 mL (25 mcg) IM doses one month apart.33 Immunocompromised: as above, plus 3rd dose one month after the second dose.33 |
N/A |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).33 After 30 days, contact manufacturer for guidance before discarding.6 In-use vial/pre-drawn syringe: 12 hours.10,33 Room temperature (8oC to 25oC): 24 hours total. Discard 12 hours after first puncture.33 Pre-drawn syringe: 12 hours after first puncture of source vial.10 |
|
mRNA-1273 Bivalent Booster (original and Omicron BA.4/BA.5) (Moderna)/ mRNA DARK blue cap and a label with a GRAY border3 EUA |
N/A |
Booster (6 through 11 years of age): one 0.25 mL IM dose ≥2 months after completion of primary series of any COVID-19 vaccine or booster.3 Booster (≥12 years of age): one 0.5 mL IM dose ≥2 months after completion of primary series of any COVID-19 vaccine or booster.3 |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).3 After 30 days, contact manufacturer for guidance before discarding.6 In-use vial: 12 hours.3 Pre-drawn syringe: 12 hours after first puncture of source vial.10 Room temperature (8oC to 25oC): 24 hours total. Discard 12 hours after first puncture.3 Pre-drawn syringe: 12 hours after first puncture of source vial.10 |
|
mRNA-1273 Bivalent Booster (original and Omicron BA.4/BA.5) (Moderna)/ mRNA Dark pink cap and a label with a YELLOW border.41 EUA |
N/A |
Booster (6 months through 5 years of age): 0.2 mL IM dose ≥2 months after completion of a primary series with Moderna COVID-19 vaccine.41 |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).41 After 30 days, contact manufacturer for guidance before discarding.6 In-use vial: 8 hours.41 Room temperature (8oC to 25oC): 24 hours total. Discard 8 hours after first puncture.41 |
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Ad26.COV2.S Janssen (J&J)/ Viral vector (non-replicating) EUA for adults for whom other vaccines are not available or appropriate, or if they refuse other vaccines.9 |
Primary vaccination for ≥18 years: one 0.5 mL IM dose.9 Immunocompromised: as above, plus 2nd dose, (mRNA vaccine) ≥28 days later.25 |
Booster: one |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): Up to 11 months, not to exceed manufacturer expiration date (unpunctured vial).31 In-use vial: 6 hours.9 Pre-drawn syringe: 6 hours after first puncture of source vial.9,10 Room temperature (9oC to 25oC): unpunctured vial: 12 hours.9 In-use vial: 2 hours.9 Pre-drawn syringe: 2 hours after first puncture of source vial.10 |
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NVX-CoV2373 (Novavax)/ Recombinant protein subunit, adjuvanted EUA |
Primary vaccination for ≥12 years of age: two 0.5 mL IM doses three weeks apart.14 Immunocompromised: response may be diminished.14 |
Booster (≥18 years of age): one 0.5 mL IM dose ≥6 months after primary vaccination with any COVID-19 vaccine, for patients unable or unwilling to receive the bivalent mRNA booster.14 |
Refrigerator (2oC to 8oC): 6 hours (in-use vial or pre-drawn syringe).10,14 Room temperature (≤25oC): 6 hours (in-use vial or pre-drawn syringe).10,14 |
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--Continue to the next page for the COVID-19 Vaccines Available in Canada chart.--
COVID-19 Vaccines Available in CANADA
VACCINEe |
DOSE (Primary Series) |
DOSE (Booster) |
STORAGE/STABILITY |
COMMENTS |
BNT162b2 (Pfizer-BioNTech)/ mRNA (Comirnaty) PURPLE cap18 (NOT for ages <12 yearsa) Requires dilution with 1.8 mL NS per vial.18 |
Primary vaccination for ≥12 years: two 0.3 mL (30 mcg) IM doses 3 weeks apart (8-week interval preferred).18,20 Immunocompromisedf: As above plus 3rd dose, with 4 to 8 weeks between each of the three doses.18,20 |
Bivalent booster preferred.20,h Booster (≥12 years [approved for ≥16 years]):h one 0.3 mL (30 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.11,18 Immunocompromisedf,h: as above.20 |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC): 1 month thawed/undiluted vials (includes transport [up to 12 hours]); 6 hours once diluted (vial or pre-drawn syringe).10,18 Room Temp (up to 25oC): 2 hours (thawed/undiluted); 6 hours (once diluted [vial or pre-drawn syringe]).10,18 |
|
BNT162b2 (Pfizer-BioNTech)/ mRNA (Comirnaty) GRAY cap18 (NOT for ages <12 yearsa) Do NOT dilute.18 |
See above. |
See above. |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC): 10 weeks (unpunctured vial).18 12 hours (pre-drawn syringe).10 Room Temp (up to 25oC): 12 hours (unpunctured vial or pre-drawn syringe).10,18 Discard vials 12 hours after first puncture.18 Vaccine should not be used after 12 months from date of manufacture.18 |
See above. |
BNT162b2 for 5 through 11 years of age (Pfizer-BioNTech)/ mRNA (Comirnaty) ORANGE cap and label with orange border18 Requires dilution with 1.3 mL of NS per vial.18 |
Primary vaccination for 5 to 11 years: two 0.2 mL (10 mcg) IM doses 21 days apart. (≥8-week interval preferred).18,20 Immunocompromised: as above plus 3rd dose, with 4 to 8 weeks between each of the three doses.18,20 |
First Booster: one 0.2 mL (10 mcg) IM dose ≥6 months after last primary dose.18 |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC) (option if vials arrive frozen or refrigerated): 10 weeks undiluted; 12 hours once diluted (vial).18 Room Temp (up to 25oC): 12 hours (undiluted); 12 hours (once diluted [vial]).18 Stable in pre-drawn syringe for 24 hours, with no more than 12 hours at room temperature (up to 30oC).10 Vaccine should not be used after 12 months from date of manufacture.18 |
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Pfizer-BioNTech Bivalent booster (original and Omicron BA.1) (original and Omicron BA.4/BA.5) for ≥12 years of age (Pfizer-BioNTech)/ mRNA (Comirnaty) Do NOT dilute.39,40 |
N/A |
Booster (≥12 years of age): one 0.3 mL IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.11,39,40 |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC): 10 weeks (unpunctured vial).39,40 Room Temp (up to 25oC): 12 hours (unpunctured vial).39,40 Discard vials 12 hours after first puncture.39,40 Vaccine should not be used after 12 months from date of manufacture.39 |
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Pfizer-BioNTech Bivalent booster (original and Omicron BA.4/BA.5) for 5 through 11 years of age (Pfizer-BioNTech)/ mRNA (Comirnaty) Orange cap40 Requires dilution with 1.3 mL of NS per vial.40 |
N/A |
Booster (5 through 11 years of age): one 0.2 mL IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.11,40 |
Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2oC to 8oC): 10 weeks (undiluted). 12 hours once diluted.40 Room Temp (up to 25oC): 12 hours (undiluted). 12 hours once diluted.40 Vaccine should not be used after 12 months from date of manufacture.40 |
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mRNA-1273 (Moderna)/ mRNA (Spikevax) RED cap and label with a light blue border (0.2 mg/mL)22 |
Primary vaccination for ≥12 years: two 0.5 mL (100 mcg) IM doses 1 month (4 weeks) apart (8-week interval preferred).20,22 6 to 11 years: two 0.25 mL (50 mcg) IM doses 4 weeks apart (≥8-week interval preferred).20,22 Immunocompromisedf: as above plus 3rd dose, with 4 to 8 weeks between each of the three doses.20 |
If age ≥18 years, bivalent booster preferred.11,h Booster (≥12 yearsb): one 0.25 mL (50 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.11,22 Immunocompromisedf: as above, but 100 mcg (0.5 mL) instead of 50 mcg (0.25 mL) can be used for first or second booster if ≥18 years.20 |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).22 In-use vial: 24 hours.22 Pre-drawn syringe: 12 hours from first puncture of source vial.10 Room temperature (8oC to 25oC): unpunctured or in-use vial: 24 hours total.12,22 Pre-drawn syringe: 12 hours from first puncture of source vial.10 |
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mRNA-1273 (Moderna)/ mRNA (Spikevax) ROYAL blue cap and a label with a PURPLE border22 (0.1 mg/mL) Approved for primary series (6 months through 11 years) and 50 mcg booster (adults)22 |
Primary vaccination for 6 months through 5 years: two 0.25 mL (25 mcg) IM doses 4 weeks apart (≥8 weeks preferred).22,35 Primary vaccination for 6 through 11 years: two 0.5 mL (50 mcg) IM doses 4 weeks apart (≥8 weeks preferred).20,22 Immunocompromised: as above plus 3rd dose, with 4 to 8 weeks between each of the three doses.20,35 |
Bivalent booster preferred if ≥18 years of age.11,h Booster (≥18 years): one 0.5 mL (50 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.11,20 |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).22 In-use vial: 24 hours.22 Room temperature (8oC to 25oC): in-use vial: 24 hours.22 |
|
mRNA-1273 Bivalent Booster (original and Omicron BA.1) (original and Omicron BA.4/BA.5) (Moderna)/ mRNA (Spikevax Bivalent) |
N/A |
Booster (≥18 years of age): one 0.5 mL IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.1,11.42 |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).1,42 In-use vial: 24 hours.1,42 Room temperature (8oC to 25oC): 24 hours total, in-use or unpunctured.1,42 |
|
Ad26.COV2.S Janssen (J&J)/ Viral vector (non-replicating) (Jcovden) mRNA vaccine preferred.20 |
Primary vaccination for ≥18 years: one 0.5 mL IM dose.24 Immunocompromised: as above, plus 2nd dose, (mRNA vaccine) ≥28 days later.20 |
Bivalent booster preferred.11,h First Booster (only when all other vaccines are contraindicated): ≥2 months after the first dose.11,24 |
Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): up to 11 months, not to exceed manufacturer expiration date (unpunctured vial).24 In-use vial/pre-drawn syringe: 6 hours.10,24 Room temperature (9oC to 25oC): unpunctured vial: 12 hours.24 In-use vial: 3 hours.24 Pre-drawn syringe: 2 hours.10 |
|
ChAdOx1-S (AstraZeneca)/Viral vector (non-replicating) (Vaxzevria) mRNA vaccine preferred.20 |
Primary vaccination for ≥18 years of age: two 0.5 mL IM doses 4 to 12 weeks apart (≥8-week interval preferred).16,20 Immunocompromised: As above plus 3rd dose (mRNA vaccine) ≥28 days later.20 |
N/A |
Refrigerator (2oC to 8oC): manufacturer expiration date (unpunctured vial); 48 hours (in-use vial).16 Room temperature (≤30oC): 6 hours (in-use 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 hours.16 |
|
NVX-CoV2373 (Novavax)/ Recombinant protein subunit, adjuvanted (Nuvaxovid) mRNA vaccine preferred.20 |
Primary vaccination for ≥12 years of age: two 0.5 mL IM doses three weeks apart (8-week interval preferred).8,20 Immunocompromisedf: As above, plus 3rd dose, with 4 to 8 weeks between each of the three doses (mRNA vaccine preferred).20 |
Bivalent booster preferred.11,h Booster (≥18 years of age): one 0.5 mL IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.8,11 |
Refrigerator (2oC to 8oC): 6 hours (in-use vial or pre-drawn syringe).8,10 Room temperature (≤25oC): 6 hours (in-use vial or pre-drawn syringe).8,10 |
|
Covifenz (Medicago)/ Recombinant spike protein in plant-based virus-like particles, adjuvanted mRNA vaccine preferred.20 |
Primary vaccination for 18 to 64 years of age: two 0.5 mL IM doses 21 days apart (8-week interval preferred).20,26 Immunocompromisedf: As above, plus 3rd dose, with 4 to 8 weeks between each of the three doses (mRNA vaccine preferred).20 |
N/A |
Refrigerator (2oC to 8oC). Until expiration date on vaccine and adjuvant vials (unpunctured).26 In-use vial (mixed): 20oC to 30oC for 6 hours (do not refrigerate once mixed).26 |
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- The adult formulation of the Pfizer-BioNTech vaccine CANNOT be used for children <12 years of age by using a dose-adjusted volume. This is because the resulting volume is too small for an intramuscular injection.29
- Canada: For Moderna, 100 mcg (0.5 mL) instead of 50 mcg can be used as the booster in high-risk adults.20
- Comirnaty and the Pfizer-BioNTech COVID-19 vaccine authorized (EUA) for ages ≥12 years of age (purple and gray cap vials) can be used interchangeably when prepared according to their respective instructions for use.25
- See product labeling for storage in ultra-low freezer, freezer, and thawing before use, if applicable.
- 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.
- US: Immunocompromise = solid organ transplant patients or similar level of immunocompromise. For a full list of CDC-recommended conditions, see https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised.
Canada: See a full list of immunocompromising conditions, see the Canadian Immunization Guide: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-3-vaccination-specific-populations/page-8-immunization-immunocompromised-persons.html. 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. - Spikevax and the authorized (EUA) RED cap Moderna COVID-19 vaccine with a label with a light blue border can be used interchangeably to provide primary series doses or booster doses.2
- Bivalent booster (age-appropriate) preferred, regardless of the number of booster doses previously received, and can be offered to all individuals ≥12 years of age, especially those at increased risk.11
- Efficacy: Absolute efficacy of the bivalent booster against hospitalization vs receiving no previous COVID-19 vaccine doses was 84% (95% CI 64% to 93%) in one US cohort.4 Absolute efficacy of the bivalent booster against infection vs receiving no previous COVID-19 vaccine doses varied based on age and number of previous monovalent doses and ranged from 19% to 50%.5 The bivalent booster was also more effective than previous vaccination with the monovalent booster in regard to preventing infection and hospitalization.4,5 Note that many of the patients with no previous doses probably had at least some natural immunity. For the most current CDC-authored vaccine effectiveness studies, see COVID-19 Vaccine Effectiveness Monthly Update at https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness.
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://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us-appendix.html#appendix-d.
Fact Sheets and Product Labeling
- Comirnaty (PURPLE cap) prescribing information (US): https://www.fda.gov/vaccines-blood-biologics/comirnaty
- Comirnaty (GRAY cap) prescribing information (US): https://www.fda.gov/vaccines-blood-biologics/comirnaty
- Pfizer-BioNTech vaccine EUA fact sheet (12 years of age and older) for healthcare professionals (US): https://www.fda.gov/media/153713/download
- Pfizer-BioNTech vaccine EUA fact sheet (12 years of age and older [including bivalent booster]) for patients (US): https://www.fda.gov/media/153716/download
- Pfizer-BioNTech vaccine EUA fact sheet (12 years of age and older-Do Not Dilute) for healthcare professionals (US): https://www.fda.gov/media/153715/download
- Pfizer-BioNTech vaccine EUA fact sheet (5 through 11 years of age) for healthcare professionals (US): https://www.fda.gov/media/153714/download
- Pfizer-BioNTech vaccine EUA fact sheet (5 through 11 years of age [including bivalent booster]) for patients (US): https://www.fda.gov/media/153717/download
- Pfizer-BioNTech vaccine EUA fact sheet (6 months through 4 years of age [including bivalent booster]) for healthcare professionals (US): https://www.fda.gov/media/159312/download
- Pfizer-BioNTech vaccine EUA fact sheet (6 months through 4 years of age) for patients (US): https://www.fda.gov/media/159313/download
- Pfizer-BioNTech vaccine EUA fact sheet (booster dose for 12 years of age and older) for healthcare professionals (US): https://www.fda.gov/media/161327/download
- Pfizer-BioNTech vaccine EUA fact sheet (booster dose for 5 through 11 years of age) for healthcare professionals (US): https://www.fda.gov/media/162250/download
- Spikevax prescribing information (US): https://www.fda.gov/vaccines-blood-biologics/spikevax
- Moderna vaccine EUA fact sheet for healthcare professionals (US) (Primary series, ≥12 years of age): https://www.fda.gov/media/157233/download
- Moderna vaccine EUA fact sheet for healthcare professionals (US) (Bivalent booster, 6 years of age and older): https://www.fda.gov/media/161318/download
- Moderna vaccine EUA fact sheet for patients (US) (12 years of age and older [including bivalent booster]): https://www.fda.gov/media/144638/download
- Moderna vaccine EUA fact sheet for healthcare professionals (US) (Primary series, 6 through 11 years of age): https://www.fda.gov/media/159308/download
- Moderna vaccine EUA fact sheet for patients (US) (6 years of age and older [primary series and bivalent booster]): https://www.fda.gov/media/159310/download
- Moderna vaccine EUA fact sheet for healthcare professionals (US) (Primary series presentation, 6 months through 5 years of age): https://www.fda.gov/media/159307/download
- Moderna vaccine EUA fact sheet for patients (US) (6 months through 5 years of age [primary series and bivalent booster]): https://www.fda.gov/media/159309/download
- Moderna vaccine EUA fact sheet for healthcare professionals (US) (Bivalent booster, 6 months through 5 years of age): https://www.fda.gov/media/163785/download
- Moderna vaccine EUA fact sheet for patients (US) (Bivalent booster, 6 months through 5 years of age): https://www.fda.gov/media/159309/download
- Janssen (J&J) vaccine EUA fact sheet for healthcare professionals (US): https://www.fda.gov/media/146304/download
- Janssen (J&J) vaccine fact sheet for patients (US): https://www.fda.gov/media/146305/download
- Novavax vaccine EUA fact sheet for healthcare professionals (US): https://www.fda.gov/media/159897/download
- Novavax vaccine fact sheet for patients (US): https://www.fda.gov/media/159898/download
- Current Canadian product monographs for Covid-19 vaccines available in Canada can be found at Health Canada’s Drug Product Database (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp).
- Product monograph for Spikevax Bivalent. Moderna Therapeutics. Cambridge, MA 02139. September 2022.
- 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). Primary series for 12 years and older. December 8, 2022. https://www.fda.gov/media/157233/download. (Accessed December 16, 2022).
- FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency use authorization (EUA) for the Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5). December 8, 2022. https://www.fda.gov/media/161318/download. (Accessed December 16, 2022).
- Surie D, DeCuir J, Zhu Y, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years — IVY Network, 18 States, September 8–November 30, 2022. MMWR Morb Mortal Wkly Rep. 2022 Dec 30;71(5152):1625-1630.
- Link-Gelles R, Ciesla AA, Fleming-Dutra KE, et al. Effectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection — Increasing Community Access to Testing Program, United States, September–November 2022. MMWR Morb Mortal Wkly Rep. 2022 Dec 2;71(48):1526-1530.
- CDC. Vaccine storage and handling kit. Updated April 12, 2022. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. (Accessed August 30, 2022).
- Accorsi EK, Britton A, Shang N, et al. Effectiveness of Homologous and Heterologous Covid-19 Boosters against Omicron. N Engl J Med. 2022 Jun 23;386(25):2433-2435.
- Product monograph for Nuvaxovid. Novavax. Gaithersburg, MD 20878. December 2022.
- 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). May 5, 2022. https://www.fda.gov/media/146304/download. (Accessed August 30, 2022).
- USP. COVID-19 vaccine handling toolkit: operational considerations for healthcare practitioners. Version 6.0. October 2022. https://www.usp.org/covid-19/vaccine-handling-toolkit. (Accessed November 17, 2022).
- National Advisory Committee on Immunization (NACI). An Advisory Committee Statement (ACS). Recommendations on the use of bivalent Omicron-containing mRNA COVID-19 vaccines. September 1, 2022. https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-bivalent-Omicron-containing-mrna-covid-19-vaccines.pdf. (Accessed September 1, 2022).
- Moderna. Spikevax dosage and administration. July 2022. https://assets.ctfassets.net/qxn1nenx7ve8/4n0cJMbQSI8z2hNJCVA43u/6fcf0f6a71cc0989c89630767743b63f/SPX-Dosing_Administrations-Storage-Handling_DASH_-CA-English.pdf. (Accessed November 17, 2022).
- 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-do not dilute. December 8, 2022. https://www.fda.gov/media/153715/download. (Accessed December 17, 2022).
- FDA, 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). October 19, 2022. https://www.fda.gov/media/159897/download. (Accessed November 9, 2022).
- 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;384:1273-1277.
- Product monograph for Vaxzevria. AstraZeneca Canada. Mississauga, ON L4Y 1M4. December 2022.
- 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). Primary series for 12 years of age and older. Dilute before use. December 22, 2022. https://www.fda.gov/media/153713/download. (Accessed December 17, 2022).
- Product monograph for Comirnaty. Pfizer. Canada. Kirkland, QC H9J 2M5. September 2022.
- Product information for Comirnaty(purple cap). Pfizer. New York, NY 10017. July 2022.
- Government of Canada. COVID-19 vaccine: Canadian Immunization Guide. Date modified: December 22, 2022. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html#t4. (Accessed December 17, 2022).
- Product information for Spikevax. Moderna US. Cambridge, MA 02139. January 2022.
- Product monograph for Spikevax. Moderna Therapeutics. Cambridge, MA 02139. July 2022.
- 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 September 1, 2022).
- Product monograph for Janssen COVID-19 vaccine. Janssen. Toronto, ON M3C 1L9. December 2022.
- CDC. Use of COVID-19 vaccines in the United States. Interim clinical considerations. Last updated November 14, 2022. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. (Accessed August 29, 2022).
- Product monograph for Covifenz. Medicago. Quebec, CA G1V 3V9. February 2022.
- Product information for Comirnaty (gray cap). Pfizer. New York, NY 10017. August 2022.
- NCCN: Cancer and COVID-19 Vaccination. Recommendations of the National Comprehensive Cancer Network (NCCN) Advisory Committee on COVID-19 vaccination and pre-exposure prophylaxis. Version 7.0. September 22, 2022. https://www.nccn.org/docs/default-source/covid-19/2021_covid-19_vaccination_guidance_v5-0.pdf?sfvrsn=b483da2b_110. (Accessed August 29, 2022).
- American Pharmacists Association. Considerations for COVID-19 vaccination in adolescents and children. July 7, 2022. https://www.pharmacist.com/Practice/COVID-19/Know-the-Facts/Considerations-for-COVID-19-vaccination-in-adolescents-and-children. (Accessed August 29, 2022).
- 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). Primary series for 5 through 11 years of age. Dilute before use. December 8, 2022. https://www.fda.gov/media/153714/download. (Accessed December 17, 2022).
- FDA. Amended Emergency Use Authorization-Concurrence. Janssen COVID-19 vaccine. April 7, 2022. https://www.fda.gov/media/157554/download. (Accessed September 1, 2022).
- FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency use authorization (EUA) of the Pfizer-BionNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) for 6 months through 4 years of age. Dilute before use. December 8, 2022. https://www.fda.gov/media/159312/download. (Accessed December 16, 2022).
- 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). Primary series presentation. 6 months through 5 years of age. December 8, 2022. https://www.fda.gov/media/159307/download. (Accessed December 16, 2022).
- 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). Primary series. 6 years through 11 years of age. December 8, 2022. https://www.fda.gov/media/159308/download. (December 16, 2022).
- Government of Canada. NACI statement. Recommendations on the use of Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age. July 14, 2022. https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-moderna-spikevax-covid-19-vaccine-children-6-months-5-years.pdf. (Accessed August 31, 2022).
- Price AM, Olson SM, Newhams MM, et al. BNT162b2 Protection against the Omicron Variant in Children and Adolescents. N Engl J Med. 2022 May 19;386(20):1899-1909.
- FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency use authorization (EUA). Pfizer-Biontech COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5). Booster dose for 5 through 11 years of age. Dilute before use. December 8, 2022. https://www.fda.gov/media/162250/download. (Accessed December 17, 2022).
- FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency use authorization (EUA). Pfizer-Biontech COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5). Booster dose for 12 years of age and older. Do not dilute. December 8, 2022. https://www.fda.gov/media/161327/download. (Accessed December 17, 2022).
- Product monograph for Comirnaty Original/Omicron BA.1. Pfizer Canada. Kirkland, QC H9J 2M5. October 2022.
- Product monograph for Comirnaty Original/Omicron BA.4/BA.5. Pfizer Canada. Kirkland, QC H9J 2M5. December 2022.
- FDA. Fact sheet for healthcare providers administering vaccine (vaccine providers). Emergency use authorization (EUA). Moderna COVID-19 vaccine bivalent (original and Omicron BA.4/BA.5) Booster dose for 6 months through 5 years of age. December 8, 2022. https://www.fda.gov/media/163785/download. (Accessed December 16, 2022).
- Product monograph for Spikevax Bivalent. Original/Omicron BA.4/BA.5. Ingmar Strategies. Oakville, ON L6L 0C4. September 2022.
Cite this document as follows: Clinical Resource,COVID-19 Vaccines. Pharmacist’s Letter/Prescriber’s Letter. January 2023. [390126]