COVID-19 Vaccines

The charts below provide dosing, storage, adverse effects, 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

VACCINE^e	DOSE	STORAGE/STABILITY	COMMENTS
Pfizer BioNTech 2023-2024 formula (Omicron XBB.1.5) for ages 6 months through 4 years Pfizer-BioNTech/ mRNA YELLOW cap and label with YELLOW border EUA Requires dilution with 1.1 mL NS per vial.²⁸	Each dose is 0.3 mL (3 mcg) IM. Number and timing of doses depends on COVID-19 vaccine history and immunocompetence.²⁸ No previous COVID-19 vaccine: give three doses (at week 0, at week 3, and ≥8 weeks after the 2^nd dose).²⁸ Previously vaccinated with one dose of any Pfizer-BioNTech COVID-19 vaccine: give two doses (≥3 weeks after receipt of the previous dose, and ≥8 weeks after the 2^nd dose).²⁸ Previously vaccinated with two, three, or four doses of any Pfizer-BioNTech COVID-19 vaccine: give a single dose ≥8 weeks after receipt of the last dose.²⁸ Immunocompromised^f individuals should receive at least three doses of COVID-19 vaccine, with at least one dose being the 2023-2024 formula.²⁸If not previously vaccinated for COVID-19, give three doses, as above. If previously vaccinated with one or two doses of any Pfizer-BioNTech COVID-19 vaccine, complete the remaining dose(s) in the three-dose series as above. If previously vaccinated with ≥3 doses of any Pfizer-BioNTech COVID-vaccines, give one dose ≥2 months after the last dose.²⁸	Shipping/long-term storage (ultra-low temp freezer): See footnote d. Refrigerator (2^oC to 8^oC) (option if vials arrive frozen or refrigerated): 10 weeks (undiluted); 12 hours (diluted).²⁸ Room temperature (up to 25^oC): 12 hours undiluted;²⁸ 12 hours once diluted.²⁸	Anticipated to be effective against current variants based on neutralizing titers against variants XBB.1.5, EG.5.1, and BA.2.86 in volunteers ≥12 years of age.²⁹ Neutralizing activity is higher compared to the old bivalent vaccine.²⁹
Pfizer-BioNTech 2023-2024 formula (Omicron XBB.1.5) f or ages 5 through 11 years Pfizer-BioNTech/ mRNA BLUE cap and label with BLUE border²⁸ EUA Do NOT dilute.²⁸	Each dose is 0.3 mL (10 mcg) IM.²⁸ No previous COVID-19 vaccine: give a single dose.²⁸ Previously vaccinated with ≥1 dose of a COVID-19 vaccine: give a single dose ≥2 months after receipt of the last dose.²⁸ Immunocompromised^f individuals should receive at least three doses of COVID-19 vaccine, with at least one dose being the 2023-2024 formula.²⁸If not previously vaccinated for COVID-19, give three doses, as above. If previously vaccinated with one or two doses of any Pfizer-BioNTech COVID-19 vaccine, complete the remaining dose(s) in the three-dose series as above. If previously vaccinated with ≥3 doses of any Pfizer-BioNTech COVID-vaccines, give one dose ≥2 months after the last dose.²⁸	Shipping/long-term storage (ultra-low temp freezer): See footnote d. Refrigerator (2^oC to 8^oC) (option if vials arrive frozen or refrigerated): 10 weeks.²⁸ Room temperature (up to 25^oC): 12 hours.²⁸	Anticipated to be effective against current variants based on neutralizing titers against variants XBB.1.5, EG.5.1, and BA.2.86 in volunteers ≥12 years of age.²⁹ Neutralizing activity is higher compared to the old bivalent vaccine.²⁹
*Comirnaty* 2023-2024 formula (Omicron XBB.1.5) for ages ≥12 years^a Pfizer BioNTech/ mRNA Do NOT dilute.	Each dose is 0.3 mL (30 mcg) IM.² No previous COVID-19 vaccine: give a single dose.² Previously vaccinated with ≥1 dose of a COVID-19 vaccine: give a single dose ≥2 months after the last dose.²	Shipping/long-term storage (ultra-low temp freezer): See footnote d. Refrigerator (2^oC to 8^oC): 10 weeks (option if vial/syringes arrive frozen or refrigerated).² Room Temp (8^oC to 25^oC): 12 hours, except that frozen prefilled syringes thawed individually at room temp outside the carton must be used within four hours of thawing.²	Anticipated to be effective against current variants based on neutralizing titers against variants XBB.1.5, EG.5.1, and BA.2.86 in volunteers ≥12 years of age. Neutralizing activity was higher compared to the old bivalent vaccine.²⁹ Myocarditis/pericarditis: 16.6 cases/million doses in males ages 18 to 29 years (bivalent booster).⁴
Spikevax 2023-2024 formula (Omicron XBB.1.5) for ages ≥12 years Moderna/mRNA	Each dose is 0.5 mL (50 mcg) IM.² No previous COVID-19 vaccine: give a single dose.² Previously vaccinated with ≥1 dose of a COVID-19 vaccine: give a single dose ≥2 months after receipt of the last previous dose.³	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).³ In-use multi-dose vial: 12 hours.³ Room temperature (8^oC to 25^oC): 24 hours total. Discard multidose vials 12 hours after first puncture.³	Anticipated to be effective against current variants based on neutralizing titers against XBB.1.5, XBB.1.16, EG.5.1, FL.1.5.1, and BA.2.86 in volunteers 21 to 84 years of age.³⁰ Local and systemic reactions are similar or less than with older Moderna COVID-19 vaccines.³⁰ Myocarditis/pericarditis: 23.9 cases/million doses in men 30 to 39 years of age.⁴
Moderna 2023-2024 formula (Omicron XBB.1.5) for ages 6 months through 11 years Moderna/ mRNA DARK BLUE cap and a label with a GREEN box.³¹ EUA	6 months through 4 years of age (dose is 0.25 mL [25 mcg]):³¹ No previous COVID-19 vaccine: give two doses at month 0 and at month 1. Previously vaccinated with one dose of any Moderna COVID-19 vaccine: one dose ≥1 month after receipt of the previous dose. Previously vaccinated with ≥2 doses of any Moderna COVID-19 vaccine: one dose ≥2 months after receipt of the last previous dose. 5 through 11 years of age (dose is 0.25 mL [25 mcg]): give one dose. If previously vaccinated for COVID-19, give ≥2 months after receipt of the last previous dose.³¹ Immunocompromised^f individuals should receive at least three doses of COVID-19 vaccine, each dose ≥1 months apart, with at least one dose being the 2023-2024 formula.³¹If previously vaccinated with ≥3 doses, give one dose ≥2 months after the last dose.³¹	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).³¹ Room temperature (8^oC to 25^oC): 24 hours total.³¹	See above.
NVX-CoV2373 (Novavax)/ Recombinant protein subunit, adjuvanted EUA	Primary series for ≥12 years of age: two 0.5 mL IM doses three weeks apart.¹⁴ An eight-week interval may reduce the risk of myocarditis/pericarditis.²⁵ Individuals ≥12 years of age who previously received one or more doses of Novavax COVID-19 vaccine are recommended to receive a bivalent mRNA vaccine ≥8 weeks after the last dose.²⁵ Use as a booster: in individuals ≥18 years of age who completed primary vaccination with any COVID-19 vaccine and have not received any boosters, and an mRNA vaccine is not available or appropriate, or is refused, Novavax COVID-19 vaccine 0.5 mL IM can be given ≥6 months after completion of primary vaccination.^14,25 Immunocompromised^f: response may be diminished.¹⁴	Refrigerator (2^oC to 8^oC): 6 hours (in-use vial or pre-drawn syringe).^10,14 Room temperature(≤25^oC): 6 hours (in-use vial or pre-drawn syringe).^10,14	Effectiveness estimates unknown for current variants.²⁰

--Continue to the next section for the COVID-19 Vaccines Available in Canada chart.—

COVID-19 Vaccines Available in CANADA

VACCINE^e	DOSE (Primary Series)	DOSE (Booster) (also see footnote c)	STORAGE/STABILITY	COMMENTS
BNT162b2 for ages 6 months through 4 years (Pfizer-BioNTech)/ mRNA (Comirnaty) MAROON cap and label border¹⁸ Requires dilution with 2.2 mL NS per vial.¹⁸	Primary vaccination for 6 months through 4 years of age: three 0.2 mL (3 mcg) IM doses. The first two doses are given three weeks apart (8-week interval preferred), followed by a 3^rd dose ≥8 weeks after the 2^nd dose.^18,20 Immunocompromised^f: As above plus 4^th dose, with 4 to 8 weeks between each of the four doses.²⁰	N/A	Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2^oC to 8^oC) (option if vials arrive frozen or refrigerated): 10 weeks undiluted; 12 hours once diluted (vial).¹⁸ Room Temp (up to 25^oC): 12 hours (undiluted); 12 hours (once diluted [vial]).¹⁸ Stable in pre-drawn syringe for 12 hours at room temperature (up to 30^oC).¹⁰ Vaccine should not be used after 18 months from date of manufacture.¹⁸	Efficacy against symptomatic infection ~2 months after the third dose was >70% (Omicron-predominant period).²⁰
BNT162b2 for ≥12 years of age^a (Pfizer-BioNTech)/ mRNA (Comirnaty) GRAY cap and label border¹⁸ Do NOT dilute.¹⁸	Primary vaccination for ≥12 years of age: two 0.3 mL (30 mcg) IM doses 3 weeks apart (8-week interval preferred).^18,20 Immunocompromised^f: As above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^18,20	Booster (≥12 years of age [approved for ≥16 years]):^c 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 Immunocompromised^f,h: as above.²⁰	Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2^oC to 8^oC): 10 weeks (unpunctured vial).¹⁸ 12 hours (pre-drawn syringe).¹⁰ Room Temp (up to 25^oC): 12 hours (unpunctured vial or pre-drawn syringe).^10,18 Discard vials 12 hours after first puncture.¹⁸ Vaccine should not be used after 18 months from date of manufacture.¹⁸	Case-control data in adults suggests that three doses were 61% effective against symptomatic infection, and 95% effective against severe outcomes from the Omicron variant circulating in Ontario in December 2021.¹³
BNT162b2 for ages 5 through 11 years (Pfizer-BioNTech)/ mRNA (Comirnaty) ORANGE cap and label border¹⁸ Requires dilution with 1.3 mL of NS per vial.¹⁸	Primary vaccination for 5 to 11 years of age: two 0.2 mL (10 mcg) IM doses 3 weeks apart. (≥8-week interval preferred).^18,20 Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^18,20	Booster:^c 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 (2^oC to 8^oC) (option if vials arrive frozen or refrigerated): 10 weeks undiluted; 12 hours once diluted (vial).¹⁸ Room Temp (up to 25^oC): 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 30^oC).¹⁰ Vaccine should not be used after 18 months from date of manufacture.¹⁸	Efficacy was 68% against hospitalization about one month after the second dose (Omicron BA.1-predominant period).¹⁷
Pfizer-BioNTech Bivalent (original and Omicron BA.4/BA.5) for ≥12 years of age^a (Pfizer-BioNTech)/ mRNA (Comirnaty) GRAY cap and label border.²⁶ Do NOT dilute.²⁶	Primary vaccination for ≥12 years of age: two 0.3 mL (30 mcg) IM doses 3 weeks apart (≥8-week interval preferred).^16,26 Immunocompromised^f: As above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶(Spikevax bivalent may be preferred.¹⁶)	Booster (≥12 years of age):^c one 0.3 mL IM dose ≥3 to 6 months (≥6 months preferred; ≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.^11,26	Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2^oC to 8^oC): 10 weeks (unpunctured vial).²⁶ Room Temp (up to 25^oC): 12 hours (unpunctured vial).²⁶ Discard vials 12 hours after first puncture.²⁶ Vaccine should not be used after 18 months from date of manufacture.²⁶	Approval based on immunogenicity data from a different bivalent vaccine (original and Omicron BA.1) in individuals ≥55 years of age.²⁶Also see footnote b.
Pfizer-BioNTech Bivalent (original and Omicron BA.4/BA.5) for 5 through 11 years of age (Pfizer-BioNTech)/ mRNA (Comirnaty) ORANGE cap and label border²⁶ Requires dilution with 1.3 mL of NS per vial.²⁶	Primary vaccination for 5 to 11 years of age: two 0.2 mL (10 mcg) IM doses ≥8-weeks aprt.¹⁶ Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶(Spikevax bivalent may be preferred.¹⁶)	Booster (5 through 11 years of age):^c one 0.2 mL IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.^11,26	Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d. Refrigerator (2^oC to 8^oC): 10 weeks (undiluted). 12 hours once diluted.²⁶ Room Temp (up to 25^oC): 12 hours (undiluted). 12 hours once diluted.²⁶ Vaccine should not be used after 18 months from date of manufacture.²⁶	See above.
Spikevax XBB.1.5 for ages 6 months and older Moderna/mRNA ROYAL BLUE cap with label with LIGHT BLUE border	Primary vaccination: 6 months to 4 years of age: two 0.25 mL (25 mcg) doses four weeks apart.²⁴ 5 to 11 years of age: one 0.25 mL: (25 mcg) dose.²⁴ ≥12 years of age: one 0.5 mL (50 mcg) dose.²⁴	Booster: 6 months to 4 years of age: one 0.25 mL (25 mcg) dose ≥6 months after the previous COVID-19 vaccine dose.²⁴ 5 to 11 years of age: one 0.25 mL (25 mcg) dose ≥6 months after the previous COVID-19 vaccine dose.²⁴ ≥12 years of age: one 0.5 mL (50 mcg) dose ≥6 months after the previous COVID-19 vaccine dose.²⁴	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).²⁴ In-use vial: 24 hours.²⁴ Room Temp (8^oC to 25^oC): unpunctured or in-use vial: 24 hours total.²⁴	Anticipated to be effective against current variants based on neutralizing titers against XBB.1.5, XBB.1.16, EG.5.1, FL.1.5.1, and BA.2.86 in volunteers 21 to 84 years of age.³⁰ Local and systemic reactions are similar or less than with older Moderna COVID-19 vaccines.³⁰
mRNA-1273 (Moderna)/ mRNA (Spikevax) RED cap and label with a light blue border (0.2 mg/mL)²²	Primary vaccination for ≥12 years of age: two 0.5 mL (100 mcg) IM doses 1 month (4 weeks) apart (8-week interval preferred).^20,22 (Comirnaty preferred if 18 to 29 years of age.²⁰) 6 to 11 years of age: two 0.25 mL (50 mcg) IM doses 4 weeks apart (≥8-week interval preferred).^20,22 Immunocompromised^f: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^20,22	Booster (≥12 years of age):^c 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 Immunocompromised^f: as above.²⁰	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).²² In-use vial: 24 hours.²²Pre-drawn syringe: 12 hours from first puncture of source vial.¹⁰ Room Temp (8^oC to 25^oC): unpunctured or in-use vial: 24 hours total.²² Pre-drawn syringe: 12 hours from first puncture of source vial.¹⁰	Case-control data in adults suggests that three doses were 61% effective against symptomatic infection, and 95% effective against severe outcomes from the Omicron variant circulating in Ontario in December 2021.¹³ Delayed-type hypersensitivity reaction (e.g., large, red area near injection site) reported most often about a week after first shot. May be itchy, painful, warm, or swollen, and can also involve fingers, elbow, or palm. Not a contraindication to subsequent vaccination.¹⁵
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 (≥12 years of age)²²	Primary vaccination for 6 months through 5 years of age: two 0.25 mL (25 mcg) IM doses 4 weeks apart (≥8 weeks preferred).^20,22 Primary vaccination for 6 through 11 years of age: two 0.5 mL (50 mcg) IM doses 4 weeks apart (≥8 weeks preferred).^20,22 Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^20,22	Booster (≥12 years of age):^c 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.^11,22	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).²² In-use vial: 24 hours.²² Room Temp (8^oC to 25^oC): in-use vial: 24 hours.²²	Efficacy ~60% against symptomatic Omicron infection (ages 3 to 5 years, 2 weeks to 2 months post-vaccination).¹²
mRNA-1273 Bivalent (original and Omicron BA.1) (Moderna)/ mRNA (Spikevax Bivalentoriginal and Omicron BA.1) ROYAL blue cap and label with GREEN border¹	Primary vaccination for 6 months through 11 years of age: two 0.25 mL (25 mcg) IM doses ≥8 weeks apart.¹⁶ Primary vaccination for ≥12 years of age: two 0.5 mL (50 mcg) IM doses 8 weeks apart.¹⁶ (Comirnaty bivalent preferred for ages 12 to 29 years.¹⁶) Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶	Booster (6 to 11 years of age):^c one 0.25 mL (25 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11 Booster (≥12 years of age): one 0.5 mL (50 mcg) dose ≥6 months (approved ≥4 months) (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).¹ In-use vial: 24 hours.¹ Room Temp (8^oC to 25^oC): 24 hours total, in-use or unpunctured.¹	Approval based on immunogenicity data.¹
mRNA-1273 Bivalent (original and Omicron BA.4/BA.5) (Moderna)/ mRNA (Spikevax Bivalentoriginal and Omicron BA.4/BA.5) ROYAL blue cap and label with GREY border¹⁹	Primary vaccination for 6 months through 11 years of age: two 0.25 mL (25 mcg) IM doses ≥8 weeks apart.¹⁶ Primary vaccination for ≥12 years of age: two 0.5 mL (50 mcg) IM doses 8 weeks apart.¹⁶(Comirnaty bivalent preferred for ages 12 to 29 years.¹⁶) Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶	Booster (6 to 11 years of age):^c one 0.25 mL (25 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11 Booster (≥12 years of age): one 0.5 mL (50 mcg) dose ≥6 months (approved ≥4 months)(≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11	Shipping/long-term storage (freezer): See footnote d. Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).¹⁹ In-use vial: 24 hours.¹⁹ Room Temp (8^oC to 25^oC): 24 hours total, in-use or unpunctured.¹⁹	Approval based on immunogenicity data.¹Also see footnote b.
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 Immunocompromised^f: As above, plus 3^rd dose, with 4 to 8 weeks between each of the three doses (mRNA vaccine preferred).²⁰	Booster (≥18 years of age):^c 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 (2^oC to 8^oC): 12 hours (in-use vial) or 6 hours (pre-drawn syringe).^8,10 Room Temp (≤25^oC): 6 hours (in-use vial or pre-drawn syringe).^8,10	Effectiveness estimates unknown for current variants.²⁰

VACCINE^e

DOSE (Primary Series)

DOSE (Booster)

(also see footnote c)

STORAGE/STABILITY

COMMENTS

BNT162b2 for ages

6 months through 4 years

(Pfizer-BioNTech)/

mRNA

(Comirnaty)

MAROON cap and label border¹⁸

Requires dilution with

2.2 mL NS per vial.¹⁸

Primary vaccination for 6 months through 4 years of age: three 0.2 mL (3 mcg) IM doses. The first two doses are given three weeks apart (8-week interval preferred), followed by a 3^rd dose ≥8 weeks after the 2^nd dose.^18,20

Immunocompromised^f: As above plus 4^th dose, with 4 to 8 weeks between each of the four doses.²⁰

N/A

Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d.

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

Room Temp (up to 25^oC):

12 hours (undiluted); 12 hours (once diluted [vial]).¹⁸

Stable in pre-drawn syringe for 12 hours at room temperature (up to 30^oC).¹⁰

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

Efficacy against symptomatic infection ~2 months after the third dose was >70% (Omicron-predominant period).²⁰

BNT162b2 for ≥12 years of age^a

(Pfizer-BioNTech)/

mRNA

(Comirnaty)

GRAY cap and label border¹⁸

Do NOT dilute.¹⁸

Primary vaccination for ≥12 years of age: two 0.3 mL (30 mcg) IM doses 3 weeks apart (8-week interval preferred).^18,20

Immunocompromised^f: As above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^18,20

Booster (≥12 years of age [approved for ≥16 years]):^c 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

Immunocompromised^f,h: as above.²⁰

Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d.

Refrigerator (2^oC to 8^oC):

10 weeks (unpunctured vial).¹⁸ 12 hours (pre-drawn syringe).¹⁰

Room Temp (up to 25^oC): 12 hours (unpunctured vial or pre-drawn syringe).^10,18 Discard vials 12 hours after first puncture.¹⁸

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

Case-control data in adults suggests that three doses were 61% effective against symptomatic infection, and 95% effective against severe outcomes from the Omicron variant circulating in Ontario in December 2021.¹³

BNT162b2 for ages

5 through 11 years

(Pfizer-BioNTech)/

mRNA

(Comirnaty)

ORANGE cap and label border¹⁸

Requires dilution with

1.3 mL of NS per vial.¹⁸

Primary vaccination for 5 to 11 years of age: two 0.2 mL (10 mcg) IM doses 3 weeks apart. (≥8-week interval preferred).^18,20

Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^18,20

Booster:^c 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 (2^oC to 8^oC) (option if vials arrive frozen or refrigerated): 10 weeks undiluted; 12 hours once diluted (vial).¹⁸

Room Temp (up to 25^oC): 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 30^oC).¹⁰

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

Efficacy was 68% against hospitalization about one month after the second dose (Omicron BA.1-predominant period).¹⁷

Pfizer-BioNTech Bivalent

(original and Omicron BA.4/BA.5) for ≥12 years of age^a

(Pfizer-BioNTech)/

mRNA

(Comirnaty)

GRAY cap and label border.²⁶

Do NOT dilute.²⁶

Primary vaccination for ≥12 years of age: two 0.3 mL (30 mcg) IM doses 3 weeks apart (≥8-week interval preferred).^16,26

Immunocompromised^f: As above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶(Spikevax bivalent may be preferred.¹⁶)

Booster (≥12 years of age):^c one 0.3 mL IM dose ≥3 to 6 months (≥6 months preferred; ≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.^11,26

Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d.

Refrigerator (2^oC to 8^oC):

10 weeks (unpunctured vial).²⁶

Room Temp (up to 25^oC): 12 hours (unpunctured vial).²⁶

Discard vials 12 hours after first puncture.²⁶

Vaccine should not be used after 18 months from date of manufacture.²⁶

Approval based on immunogenicity data from a different bivalent vaccine (original and Omicron BA.1) in individuals ≥55 years of age.²⁶Also see footnote b.

Pfizer-BioNTech Bivalent (original and Omicron BA.4/BA.5) for 5 through 11 years of age

(Pfizer-BioNTech)/

mRNA

(Comirnaty)

ORANGE cap and label border²⁶

Requires dilution with

1.3 mL of NS per vial.²⁶

Primary vaccination for 5 to 11 years of age: two 0.2 mL (10 mcg) IM doses ≥8-weeks aprt.¹⁶

Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶(Spikevax bivalent may be preferred.¹⁶)

Booster (5 through 11 years of age):^c one 0.2 mL IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the primary series, booster, or infection.^11,26

Shipping/long-term storage (ultra-low temp freezer, freezer): See footnote d.

Refrigerator (2^oC to 8^oC):

10 weeks (undiluted). 12 hours once diluted.²⁶

Room Temp (up to 25^oC): 12 hours (undiluted). 12 hours once diluted.²⁶

Vaccine should not be used after 18 months from date of manufacture.²⁶

See above.

Spikevax XBB.1.5 for ages 6 months and older

Moderna/mRNA

ROYAL BLUE cap with label with LIGHT BLUE border

Primary vaccination:

6 months to 4 years of age: two 0.25 mL (25 mcg) doses four weeks apart.²⁴
5 to 11 years of age: one 0.25 mL: (25 mcg) dose.²⁴
≥12 years of age: one 0.5 mL (50 mcg) dose.²⁴

Booster:

6 months to 4 years of age: one 0.25 mL (25 mcg) dose ≥6 months after the previous COVID-19 vaccine dose.²⁴
5 to 11 years of age: one 0.25 mL (25 mcg) dose ≥6 months after the previous COVID-19 vaccine dose.²⁴
≥12 years of age: one 0.5 mL (50 mcg) dose ≥6 months after the previous COVID-19 vaccine dose.²⁴

Shipping/long-term storage (freezer): See footnote d.

Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).²⁴

In-use vial: 24 hours.²⁴

Room Temp (8^oC to 25^oC): unpunctured or in-use vial: 24 hours total.²⁴

Anticipated to be effective against current variants based on neutralizing titers against XBB.1.5, XBB.1.16, EG.5.1, FL.1.5.1, and BA.2.86 in volunteers 21 to 84 years of age.³⁰
Local and systemic reactions are similar or less than with older Moderna COVID-19 vaccines.³⁰

mRNA-1273

(Moderna)/

mRNA

(Spikevax)

RED cap and label with a light blue border (0.2 mg/mL)²²

Primary vaccination for ≥12 years of age: two 0.5 mL (100 mcg) IM doses 1 month (4 weeks) apart (8-week interval preferred).^20,22 (Comirnaty preferred if 18 to 29 years of age.²⁰)

6 to 11 years of age: two 0.25 mL (50 mcg) IM doses 4 weeks apart (≥8-week interval preferred).^20,22

Immunocompromised^f: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^20,22

Booster (≥12 years of age):^c 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

Immunocompromised^f: as above.²⁰

Shipping/long-term storage (freezer): See footnote d.

Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).²²

In-use vial: 24 hours.²²Pre-drawn syringe: 12 hours from first puncture of source vial.¹⁰

Room Temp (8^oC to 25^oC): unpunctured or in-use vial: 24 hours total.²² Pre-drawn syringe: 12 hours from first puncture of source vial.¹⁰

Case-control data in adults suggests that three doses were 61% effective against symptomatic infection, and 95% effective against severe outcomes from the Omicron variant circulating in Ontario in December 2021.¹³
Delayed-type hypersensitivity reaction (e.g., large, red area near injection site) reported most often about a week after first shot. May be itchy, painful, warm, or swollen, and can also involve fingers, elbow, or palm. Not a contraindication to subsequent vaccination.¹⁵

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 (≥12 years of age)²²

Primary vaccination for 6 months through 5 years of age: two 0.25 mL (25 mcg) IM doses 4 weeks apart (≥8 weeks preferred).^20,22

Primary vaccination for 6 through 11 years of age: two 0.5 mL (50 mcg) IM doses 4 weeks apart (≥8 weeks preferred).^20,22

Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.^20,22

Booster (≥12 years of age):^c 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.^11,22

Shipping/long-term storage (freezer): See footnote d.

Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).²² In-use vial: 24 hours.²²

Room Temp (8^oC to 25^oC): in-use vial: 24 hours.²²

Efficacy ~60% against symptomatic Omicron infection (ages 3 to 5 years, 2 weeks to 2 months post-vaccination).¹²

mRNA-1273 Bivalent (original and Omicron BA.1)

(Moderna)/

mRNA

(Spikevax Bivalentoriginal and Omicron BA.1)

ROYAL blue cap and label with GREEN border¹

Primary vaccination for 6 months through 11 years of age: two 0.25 mL (25 mcg) IM doses ≥8 weeks apart.¹⁶

Primary vaccination for ≥12 years of age: two 0.5 mL (50 mcg) IM doses 8 weeks apart.¹⁶ (Comirnaty bivalent preferred for ages 12 to 29 years.¹⁶)

Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶

Booster (6 to 11 years of age):^c one 0.25 mL (25 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11

Booster (≥12 years of age): one 0.5 mL (50 mcg) dose ≥6 months (approved ≥4 months) (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11

Shipping/long-term storage (freezer): See footnote d.

Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).¹ In-use vial: 24 hours.¹

Room Temp (8^oC to 25^oC): 24 hours total, in-use or unpunctured.¹

Approval based on immunogenicity data.¹

mRNA-1273 Bivalent (original and Omicron BA.4/BA.5)

(Moderna)/

mRNA

(Spikevax Bivalentoriginal and Omicron BA.4/BA.5)

ROYAL blue cap and label with GREY border¹⁹

Primary vaccination for 6 months through 11 years of age: two 0.25 mL (25 mcg) IM doses ≥8 weeks apart.¹⁶

Primary vaccination for ≥12 years of age: two 0.5 mL (50 mcg) IM doses 8 weeks apart.¹⁶(Comirnaty bivalent preferred for ages 12 to 29 years.¹⁶)

Immunocompromised: as above plus 3^rd dose, with 4 to 8 weeks between each of the three doses.¹⁶

Booster (6 to 11 years of age):^c one 0.25 mL (25 mcg) IM dose ≥6 months (≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11

Booster (≥12 years of age): one 0.5 mL (50 mcg) dose ≥6 months (approved ≥4 months)(≥3 months in the event of heightened epidemiologic risk) after the last COVID-19 vaccine dose or infection.^1,11

Shipping/long-term storage (freezer): See footnote d.

Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use).¹⁹ In-use vial: 24 hours.¹⁹

Room Temp (8^oC to 25^oC): 24 hours total, in-use or unpunctured.¹⁹

Approval based on immunogenicity data.¹Also see footnote b.

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

Immunocompromised^f: As above, plus 3^rd dose, with 4 to 8 weeks between each of the three doses (mRNA vaccine preferred).²⁰

Booster (≥18 years of age):^c 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 (2^oC to 8^oC):

12 hours (in-use vial) or 6 hours (pre-drawn syringe).^8,10

Room Temp (≤25^oC): 6 hours (in-use vial or pre-drawn syringe).^8,10

Effectiveness estimates unknown for current variants.²⁰

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.⁶
Efficacy: In a US cohort September 2022 to August 2023, absolute efficacy of the bivalent booster (Original and Omicron BA.4/BA.5) against hospitalization in immunocompetent adults vs receiving no previous COVID-19 vaccine doses was as high as 65% (95% CI 61 to 69), seven to 59 days post-vaccination.⁵ This waned to 48% (95% CI 42 to 53) 60 to 119 days post-vaccination.⁵ Note that many of the patients in these studies likely had at least some natural immunity, which would reduce relative efficacy of the booster. 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.
XXB.1.5-containing formulation is recommended to all individuals ≥6 months of age previously vaccinated against COVID-19, especially those at increased risk, if it has been ≥6 months since their last COVID-19 vaccine dose.⁹
See product labeling for storage in ultra-low freezer or freezer and thawing before use, as 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.

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

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 vaccine. Product information (US): https://www.fda.gov/media/151707/download?attachment.
Pfizer-BioNTech vaccine for 6 months through 11 years of age. EUA fact sheet for healthcare professionals (US): https://www.fda.gov/media/167211/download?attachment.
Pfizer-BioNTech vaccine for 6 months through 11 years of age. EUA fact sheet for patients (US): https://www.fda.gov/media/167212/download?attachment.
Spikevaxvaccine. Prescribing information (US): https://www.fda.gov/media/155675/download?attachment.
Spikevax vaccine.Patient package insert (US): https://www.fda.gov/media/155762/download?attachment.
Moderna vaccine for 6 months through 11 years of age. . EUA fact sheet for healthcare professionals (US): https://www.fda.gov/media/167208/download?attachment.
Moderna vaccine for 6 months through 11 years of age: EUA fact sheet for patients (US): https://www.fda.gov/media/167209/download?attachment.
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 COVID-19 Vaccines and Treatments Portal (https://covid-vaccine.canada.ca/)

References

Product monograph for Spikevax Bivalent (Original and Omicron BA.1). Moderna Therapeutics. Cambridge, MA 02139. February 2023.
Product information for Comirnaty. Pfizer. New York, NY 10001. September 2023.
Product information for Spikevax. Moderna US. Princeton, NJ 08540. September 2023.
Wallace M. Evidence to recommendations framework: 2023-2024 (monovalent, XBB containing) COVID-19 vaccine. September 12, 2023.https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/11-COVID-Wallace-508.pdf.) Accessed September 13, 2023).
Link-Gelles R. CDC. National Center for Immunization and Respiratory Disease. Updates to COVID-19 vaccine effectiveness (VE) in the U.S. September 12, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/05-COVID-Link-Gelles-508.pdf. (Accessed September 13, 2023).
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 September 14, 2023).
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. July 2023.
National Advisory Committee on Immunization (NACI). An Advisory Committee Statement 9ACS). Addendum to the guidance on the use of COVID-19 vaccine in the fall of 2023. September 12, 2023. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-addendum-guidance-use-covid-19-vaccines-fall-2023/statement.pdf. (Accessed September 13, 2023).
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 September 14, 2023).
National Advisory Committee on Immunization (NACI). An Advisory Committee Statement (ACS). Guidance on COVID-19 vaccine booster doses: initial considerations for 2023. January 20, 2023. https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/guidance-covid-19-vaccine-booster-doses-initial-considerations-2023/guidance-covid-19-vaccine-booster-doses-initial-considerations-2023.pdf. (Accessed September 14, 2023).
Fleming-Dutra KE, Ciesla AA, Roper LE, et al. Preliminary Estimates of Effectiveness of Monovalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection Among Children Aged 3-5 Years - Increasing Community Access to Testing Program, United States, July 2022-February 2023. MMWR Morb Mortal Wkly Rep. 2023 Feb 17;72(7):177-182.
Buchan SA, Chung H, Brown KA, et al. Estimated Effectiveness of COVID-19 Vaccines Against Omicron or Delta Symptomatic Infection and Severe Outcomes. JAMA Netw Open. 2022 Sep 1;5(9):e2232760.
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). March 28, 2023. https://www.fda.gov/media/159897/download. (Accessed September 12, 2023).
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.
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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.
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Government of Canada. COVID-19 vaccine: Canadian Immunization Guide. Date modified: June 27, 2023. 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 September 12, 2023).
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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 14, 2023).
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Cite this document as follows:Clinical Resource, COVID-19 Vaccines. Pharmacist’s Letter/Pharmacy Technician’s Letter/Prescriber Insights. October 2023. [391007]