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
VACCINEe |
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 |
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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 |
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Comirnaty 2023-2024 formula (Omicron XBB.1.5) for ages ≥12 yearsa Pfizer BioNTech/ mRNA Do NOT dilute. |
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Spikevax 2023-2024 formula (Omicron XBB.1.5) for ages ≥12 years Moderna/mRNA |
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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 |
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See above. |
NVX-CoV2373 (Novavax)/ Recombinant protein subunit, adjuvanted EUA |
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--Continue to the next section for the COVID-19 Vaccines Available in Canada chart.—
COVID-19 Vaccines Available in CANADA
VACCINEe |
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 3rd dose ≥8 weeks after the 2nd dose.18,20 Immunocompromisedf: As above plus 4th 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 (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 12 hours at room temperature (up to 30oC).10 Vaccine should not be used after 18 months from date of manufacture.18 |
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BNT162b2 for ≥12 years of agea (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 Immunocompromisedf: As above plus 3rd 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 Immunocompromisedf,h: as above.20 |
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 18 months from date of manufacture.18 |
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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 3rd 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 (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 18 months from date of manufacture.18 |
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Pfizer-BioNTech Bivalent (original and Omicron BA.4/BA.5) for ≥12 years of agea (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 Immunocompromisedf: As above plus 3rd 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 (2oC to 8oC): 10 weeks (unpunctured vial).26 Room Temp (up to 25oC): 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 |
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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 3rd 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 (2oC to 8oC): 10 weeks (undiluted). 12 hours once diluted.26 Room Temp (up to 25oC): 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:
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Booster:
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Shipping/long-term storage (freezer): See footnote d. Refrigerator (2oC to 8oC): 30 days after thawing (prior to first use).24 In-use vial: 24 hours.24 Room Temp (8oC to 25oC): unpunctured or in-use vial: 24 hours total.24 |
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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 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 Immunocompromisedf: as above plus 3rd 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 Immunocompromisedf: as above.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 Temp (8oC to 25oC): unpunctured or in-use vial: 24 hours total.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 (≥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 3rd 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 (2oC to 8oC): 30 days after thawing (prior to first use).22 In-use vial: 24 hours.22 Room Temp (8oC to 25oC): in-use vial: 24 hours.22 |
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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 3rd 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 (2oC to 8oC): 30 days after thawing (prior to first use).1 In-use vial: 24 hours.1 Room Temp (8oC to 25oC): 24 hours total, in-use or unpunctured.1 |
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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 3rd 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 (2oC to 8oC): 30 days after thawing (prior to first use).19 In-use vial: 24 hours.19 Room Temp (8oC to 25oC): 24 hours total, in-use or unpunctured.19 |
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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 |
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 (2oC to 8oC): 12 hours (in-use vial) or 6 hours (pre-drawn syringe).8,10 Room Temp (≤25oC): 6 hours (in-use vial or pre-drawn syringe).8,10 |
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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.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.
- Government of Canada. Interim guidance on the use of bivalent Omicron-containing COVID-19 vaccines for primary series. June 9, 2023. https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-interim-guidance-use-bivalent-omicron-containing-covid-19-vaccines-primary-series.html. (Accessed September 14, 2023).
- 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.
- Product monograph for Comirnaty. Pfizer. Canada. Kirkland, QC H9J 2M5. March 2023.
- Product monograph for Spikevax Bivalent. Original/Omicron BA.4/BA.5. Ingmar Strategies. Oakville, ON L6L 0C4. May 2023.
- 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).
- Menegale F, Manica M, Zardini A, et al. Evaluation of Waning of SARS-CoV-2 Vaccine-Induced Immunity A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 May 1;6(5):e2310650.
- Product monograph for Spikevax. Moderna Therapeutics. Cambridge, MA 02139. January 2023.
- 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).
- Product monograph for Spikevax XBB.1.5. Moderna Biopharma CanadaXXB.1.5. Toronto, ON M5V 3L3. September 2023.
- CDC. Use of COVID-19 vaccines in the United States. Interim clinical considerations. Last updated May 12, 2023. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. (Accessed September 14, 2023).
- Product monograph for Comirnaty Original/Omicron BA.4/BA.5. Pfizer Canada. Kirkland, QC H9J 2M5. July 2023.
- CDC. Vaccine storage and handling toolkit. January 2023. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. (Accessed September 14, 2023).
- Fact sheet for healthcare providers administering vaccine: emergency use authorization of Pfizer-Biontech COVID-19 vaccine (2023-2024 formula), for 6 months through 11 years of age. September 12, 2023. https://www.fda.gov/media/167211/download?attachment. September 2023.
- Pfizer. ACIP presentation. Monovalent XBB.1.5 BNT162b2 COVID-19 vaccine. September 12, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/10-COVID-Modjarrad-508.pdf. (Accessed September 12, 2023).
- Priddy F. Moderna. Safety and immunogenicity of Moderna COVID-19 vaccine (2023-2024 formula). Monovalent XBB.1.5 variant vaccine.https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/08-COVID-Priddy-508.pdf, (Accessed September 12, 2023).
- Fact sheet for healthcare providers administering vaccine: emergency use authorization of Moderna COVID-19 vaccine (2023-2024 formula), for individuals 6 months through 11 years of age. September 12, 2023. https://www.fda.gov/media/167208/download?attachment. (September 12, 2023).
Cite this document as follows:Clinical Resource, COVID-19 Vaccines. Pharmacist’s Letter/Pharmacy Technician’s Letter/Prescriber Insights. October 2023. [391007]