COVID-19 Vaccines

Full update October 2022

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

  • Efficacy: See footnote i. In adolescents, 43% effective against hospitalization 2 to 22 weeks after second dose (Omicron BA.1-predominant period).36
  • Lymphadenopathy (16%) may interfere with imaging (e.g., mammography) for four to six weeks after vaccination.28
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

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).13,27

Room Temp (up to 25oC):
12 hours (unpunctured vial).13,27

Discard vials 12 hours after first puncture.13,27

Vaccine should not be used after
12 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

First Booster: one
0.2 mL (10 mcg) IM dose ≥5 months
(≥3 months if immunocompromised) after last primary dose.30

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
12 months from date of manufacture.3

  • Efficacy 68% against hospitalization about one month after the second dose (Omicron BA.1-predominant period).36 See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

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 ≥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).32

Vaccine should not be used after
12 months from date of manufacture.32

  • Immune response in this age group is similar to that of people 16 through 25 years of age.32 See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

BNT162b2 Bivalent booster (original and omicron BA.4/BA.5)

(Pfizer-BioNTech)/
mRNA

EUA

Do NOT dilute.3

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.3

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).3

Room Temp (up to 25oC):
12 hours (undiluted); 12 hours (once diluted).3

Vaccine should not be used after
12 months from date of manufacture.3

  • Approval based on immunogenicity data from animals, and a different bivalent booster (original and Omicron BA.1) in humans.3

mRNA-1273
(Moderna)/
mRNA
(Spikevax)g

RED cap and label with a light blue border
(0.2 mg/mL)21

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.

In-use vial/pre-drawn syringe:
12 hours.2,10,21

Room temperature (8oC to 25oC): Unused vial: 24 hours2,21 In-use vial/pre-drawn syringe: 12 hours.2,10,21 Total room temperature storage time must not exceed 24 hours.2,21

  • Efficacy: See footnote i. In children 12 through 17 years of age, 93.3% effective in preventing symptomatic infection (pre-Omicron data).2
  • Lymphadenopathy(16%) may interfere with imaging (e.g., mammography) for four to six weeks after vaccination.28
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.
  • 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
50 mcg in 0.5 mL

DARK blue cap and a label with a PURPLE border4
(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

N/A

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

Refrigerator (2oC to 8oC):
30 days after thawing (prior to first use).4 After 30 days, contact manufacturer for guidance before discarding.In-use vial: 12 hours.4

Room temperature (8oC to 25oC):
24 hours total.4 Discard 12 hours after first puncture.4

  • Immune response in children 6 through 11 years of age is similar to that of adults 18 to 25 years of age.34 See footnote i.
  • Lymphadenopathy (16%) may interfere with imaging (e.g., mammography) for four to six weeks after vaccination.28
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

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: 12 hours.33

Room temperature
(8oC to 25oC): 24 hours total. Discard
12 hours after first puncture.33

  • Efficacy 36.8% (2 through 5 years of age) to 50.6% (6 through 23 months of age) against symptomatic infection (Omicron B.1.1.529-predominant period).33 See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

mRNA-1273 Bivalent Booster (original and omicron BA.4/BA.5)>br /> (Moderna)/
mRNA

DARKblue cap and a label with aGRAYborder3

EUA

N/A

Booster (≥18 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

Room temperature

(8oC to 25oC):

24 hours total. Discard 12 hours after first puncture.3

  • Approval based on immunogenicity data from animals, and a different bivalent booster (original and Omicron BA.1) in humans.3

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
0.5 mL IM dose
≥2 months after primary vaccination (mRNA booster preferred).9,25

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

Refrigerator (2oC to 8oC): Up to
11 months, not to exceed mfr expiration date (unused vial).31 In-use vial/pre-drawn syringe: 6 hrs.9,10

Room temperature (9oC to 25oC):
unused vial: 12 hours.9 In-use vial/pre-drawn syringe: 2 hours.9,10

  • Efficacy 45.3% against symptomatic infection two to four months after mRNA booster (Omicron BA.1-predominant period).See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about thrombosis with thrombocytopenia syndrome (TTS) and other rare side effects of viral vector COVID-19 vaccines.

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

See age-appropriate bivalent mRNA booster.

Refrigerator (2oC to 8oC):
6 hours (punctured vial).14

Room temperature (≤25oC): 6 hours (punctured vial).14

  • Efficacy: See footnote i.

--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
21 days apart (8-week interval preferred).18,20

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

Bivalent booster preferred if ≥18 years of age.11,h

Booster (≥12 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

  • Efficacy: See footnote i. In adolescents, 43% effective against hospitalization 2 to 22 weeks after second dose (Omicron BA.1-predominant period).36
  • Lymphadenopathy(16%) may interfere with imaging (e.g., mammography) for four to six weeks after vaccination.28
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

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

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

  • Efficacy 68% against hospitalization about one month after the second dose (Omicron BA.1-predominant period).36 See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

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 See footnote j.

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

Room temperature (8oC to 25oC): unused vial:
24 hours.22 In-use vial:
24 hours.22

  • Efficacy: See footnote i. In children 12 through 17 years of age, 93.3% effective in preventing symptomatic infection (pre-Omicron data).2
  • Lymphadenopathy (16%) may interfere with imaging (e.g., mammography) for four to six weeks after vaccination.28
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.
  • 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

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 See footnote j.

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

  • Efficacy 36.8% (2 through 5 years of age) to 50.6% (6 through 23 months of age) against symptomatic infection (Omicron B.1.1.529-predominant period).33 See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about myocarditis/pericarditis.

mRNA-1273 Bivalent Booster (original and omicron BA.1)
(Moderna)/
mRNA

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

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

Refrigerator (2oC to 8oC):

30 days after thawing (prior to first use).1 In-use vial:
24 hours.1

Room temperature

(8oC to 25oC):

24 hours total, punctured or unpunctured.1

  • Approval based on immunogenicity data.1

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 mfr expiration date (unused vial).24 In-use vial/pre-drawn syringe: 6 hrs.10,24

Room temperature (9oC to 25oC): unused vial:
12 hours.24 In-use vial:
3 hours.24

  • Efficacy: See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about thrombosis with thrombocytopenia syndrome (TTS) and other rare side effects of viral vector COVID-19 vaccines.

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): mfr expiration date (unused vial); 48 hours (punctured vial).16

Room temperature (≤30oC):
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 hours.16

  • Efficacy: See footnote i.
  • See our FAQ, Communicating About COVID-19 Vaccination, for information about thrombosis with thrombocytopenia syndrome (TTS) and other rare side effects of viral vector COVID-19 vaccines.

NVX-CoV2373
(Novavax)/
Recombinant protein subunit, adjuvanted
(Nuvaxovid)

mRNA vaccine preferred.20

Primary vaccination for ≥18 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

Nuvaxovid can be used off-label as a first or second booster for adults unable or unwilling to receive an mRNA vaccine.11

Refrigerator (2oC to 8oC):
6 hours (punctured vial).8

Room temperature (≤25oC): 6 hours (punctured vial).8

  • Effectiveness estimates unknown for current variants.20 See footnote i.

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

  • Effectiveness estimates unknown for current variants. See footnote i.
  • Requires mixing of adjuvant and antigen before use (see product labeling for instructions).26
  • Produced using the genomic sequence of the spike protein of the original strain.26
  • May contain trace amounts of kanamycin or carbenicillin.26
  1. 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
  2. Canada: For Moderna, 100 mcg (0.5 mL) instead of 50 mcg can be used as the booster in high-risk adults.20
  3. 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
  4. See product labeling for storage in ultra-low freezer, freezer, and thawing before use, if applicable.
  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. 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.
  7. 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
  8. 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
  9. Efficacy: Clinical trials in patients ≥6 years of age were conducted prior to the emergence of Omicron.20 Evidence suggests lower efficacy against symptomatic infection by Omicron variants due to partial immune escape.20 mRNA vaccines remained highly effective at protecting boosted adults against hospitalization when Omicron BA.1 and BA.2/BA.2.12.1 variants were circulating.5,12  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.
  10. Moderna 100 mcg (monovalent) vaccine can be used for the first or second booster for patients ≥70 years of age or ≥30 years of age living in senior care settings.20

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

References

  1. Product monograph for Spikevax Bivalent. Moderna Therapeutics. Cambridge, MA 02139. September 2022.
  2. 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. August 31, 2022. https://www.fda.gov/media/157233/download. (Accessed August 31, 2022).
  3. 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). August 31, 2022. https://www.fda.gov/media/161318/download. (Accessed August 31, 2022).
  4. 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). Booster dose only presentation for 18 years of age and older. June 17, 2022. https://www.fda.gov/media/157232/download. (Accessed August 29, 2022).
  5. Link-Gelles R, Levy ME, Gaglani M, et al. Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated - VISION Network, 10 States, December 2021-June 2022. MMWR Morb Mortal Wkly Rep. 2022 Jul 22;71(29):931-939.
  6. CDC. Vaccine storage and handling kit. Updated April 2, 2022. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. (Accessed August 30, 2022).
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Cite this document as follows: Clinical Resource, COVID-19 Vaccines. Pharmacist’s Letter/Prescriber’s Letter. October 2022[381001]


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