COVID-19 Vaccines 2025-26 (United States)

full update September 2025

The first chart below provides dosing and storage information for COVID-19 vaccines approved in the US. Links to the prescribing information and the patient package insert are provided in footnote a. A second chart provides information and resources to help you address frequently asked questions about COVID-19 vaccination.

--Information in this chart is from the US product information (prescribing information or fact sheet) cited in footnote a, unless otherwise cited.--

Vaccine

Dosing

Storage/Stability

Comirnaty COVID-19 vaccine, mRNA

2025 to 2026 formula (Omicron LP.8.1) for patients

≥65 years of age and
 12 through 64 years of age with certain risk factorsc

Pfizer-BioNTech

Syringe with gray label border.

For patients ≥12 years of age:

  • Each dose is 0.3 mL (30 mcg) IM.
  • Administer ≥2 months after any previous COVID-19 vaccine dose.
  • Immunocompromised:b If not previously vaccinated for COVID-19, give three doses (week 0, week 3, ≥4 weeks after the second dose [initial series]). If previously vaccinated with one or two doses of any Pfizer-BioNTech COVID-19 vaccine, complete the remaining dose(s) in the three-dose initial series. Then give one dose of any COVID-19 vaccine 6 months (minimum 2 months) after the last dose. For patients who have already completed the initial series of any COVID-19 vaccine, give two doses of any COVID-19 vaccine 6 months (minimum 2 months) apart, starting ≥8 weeks after the last dose. One or more additional doses may be given ≥2 months apart.8
  • Prefilled glass syringe:
    • Store in refrigerator (2oC to 8oC).
    • Room temperature (8oC to 25oC):
      12 hours total

Comirnaty COVID-19 vaccine, mRNA.

2025 to 2026 formula

(Omicron LP.8.1) for patients

5 years through 11 years of age with certain risk factorsc

Pfizer-BioNTech

Vial with blue cap and label border.

For patients 5 years through 11 years of age.

  • Dose is 0.3 mL (10 mcg) IM.
  • Administer ≥2 months after any previous COVID-19 vaccine dose.
  • Immunocompromised:b If not previously vaccinated for COVID-19, give three doses (week 0, week 3, ≥4 weeks after the second dose [initial series]). If previously vaccinated with one or two doses of any Pfizer-BioNTech COVID-19 vaccine, complete the remaining dose(s) in the three-dose initial series. Then give one dose of either mRNA COVID-19 vaccine 6 months (minimum 2 months) after the last dose. For patients who have already completed the three-dose initial series of either mRNA vaccine, give two doses of either mRNA COVID-19 vaccine 6 months (minimum 2 months) apart, starting ≥8 weeks after the last dose. One or more additional doses may be given ≥2 months apart.8
  • May arrive frozen at ultra-cold temperatures in thermal containers with dry ice. May store in ultra-low temp freezer at -90oC to -60oC or transfer to a refrigerator.
  • Refrigerator (2oC to 8oC):
    10 weeks.
  • Room temperature (8oC to 25oC):
    12 hours total.

Spikevax COVID-19 vaccine, mRNA.

2025 to 2026 formula (Omicron LP.8.1) for patients ≥65 years of age and
 12 through 64 years of age with certain risk factorsc

Moderna

Syringe with blue box on label19

For patients ≥12 years of age.

  • Dose is 0.5 mL IM.
  • Administer ≥2 months after any previous COVID-19 vaccine dose.
  • Immunocompromised:b If not previously vaccinated for COVID-19, give three doses 4 weeks apart. If previously vaccinated with one or two doses of any Moderna COVID-19 vaccine, complete the remaining dose(s) in the initial three-dose series. Then give one dose of any COVID-19 vaccine 6 months (minimum 2 months) after the last dose. For patients who have already completed an initial COVID-19 vaccine series, give two doses of any COVID-19 vaccine 6 months (minimum 2 months) apart, starting ≥8 weeks after the last dose. One or more additional doses may be given ≥2 months apart.8
  • Store frozen between -50oC and -15oC.
  • After thawing:
    • Refrigerator (2oC to 8oC):
      60 days or until the expiration date on the carton, whichever is first.
    • Room temperature (8oC to 25oC): up to 12 hours

Spikevax COVID-19 vaccine, mRNA.

2025 to 2026 formula

(Omicron LP.8.1) for patients

6 months to 11 years of age with certain risk factorsc

Moderna

Syringe with red box on label19
  • 6 months through 23 months of age (dose is 0.25 mL IM):
    • 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.
  • 2 years through 11 years of age (dose is 0.25 mL IM): give one dose. If previously vaccinated for COVID-19, give ≥2 months after receipt of the last previous dose.
  • Immunocompromised:b If not previously vaccinated for COVID-19, give three doses 4 weeks apart. If previously vaccinated with one or two doses of any Moderna COVID-19 vaccine, complete the remaining dose(s) in the initial three-dose series. Then give one dose of Spikevax (or Comirnaty if 5 to 11 years of age) 6 months (minimum 2 months) after the last dose. For patients who have already completed the three-dose initial series, give two doses of Spikevax (or Comirnaty if 5 to 11 years of age) 6 months (minimum 2 months) apart, starting ≥8 weeks after the last dose. One or more additional doses may be given ≥2 months apart.8
  • Store frozen between -50oC and -15oC.
  • After thawing:
    • Refrigerator (2oC to 8oC):
      60 days or until the expiration date on the carton, whichever is first.
    • Room temperature (8oC to 25oC): up to 12 hours

mNexspike COVID-19 vaccine, mRNA.

2025 to 2026 formula (Omicron LP.8.1) for patients ≥65 years of age, and
 12 to 64 years of age with certain risk factorsc

Moderna

Syringe with green box on label20

For patients ≥12 years of age.

  • Dose is 0.2 mL IM ≥3 months after any previous COVID-19 vaccine dose.
  • Immunocompromised:b at time of writing, CDC guidelines for COVID-19 vaccination in immunocompromised patients had not been updated since before mNexspike approval. See Spikevax, above.
  • Store frozen between
    -40oC and -15oC.
  • After thawing:
    • Refrigerator (2oC to 8oC):
      90 days or until the expiration date on the carton, whichever is first.
    • Room temperature
      (8oC to 25oC): up to 24 hours

Nuvaxovid COVID-19 vaccine, adjuvanted.
2025 to 2026 formula (Omicron JN.1) for patients ≥65 years of age and
 12 through 64 years of age with certain risk factorsc

Novavax

Syringe with yellow box on label23
  • For patients ≥12 years of age.
  • Dose is 0.5 mL IM.
  • Give ≥2 months after any previous COVID-19 vaccine dose.
  • Immunocompromised:b If not previously vaccinated for COVID-19, give two doses 3 weeks apart [initial series]. Then give one dose of any COVID-19 vaccine 6 months (minimum 2 months) after the last dose. If previously vaccinated with one or two doses of an mRNA COVID-19 vaccine, complete the initial three-dose series with the mRNA vaccine, then give one dose of Nuvaxovid 6 months (minimum 2 months) after the last dose. If previously vaccinated with one dose of any Novavax vaccine, complete the initial two-dose series. Then give one dose of any COVID-19 vaccine 6 months (minimum 2 months) after the last dose. For patients who have already completed the initial series of any COVID-19 vaccine, give two doses 6 months (minimum 2 months) apart, starting ≥8 weeks after the last dose. One or more additional doses may be given ≥2 months apart.8
  • Store in refrigerator
    (2oC to 8oC).
 

Abbreviations: CDC = Centers for Disease Control; IM = intramuscular

  1. US prescribing information used in creation of this chart, and corresponding patient package inserts for recipient/caregiver:
  2. Immunocompromise = solid organ transplant patients or similar level of immunocompromise. For a full list of CDC-recommended conditions and vaccination recommendations, see CDC guidance at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.
  3. Risk factors: https://www.cdc.gov/covid/risk-factors/index.html. NOTE: Some organizations have recommendations for use that differ from the FDA-approved labeling (not all-inclusive):

 

 

Frequently asked questions about COVID-19 vaccination

Question

Pertinent information or Suggested Resources

How do COVID-19 vaccines work?

Do mRNA vaccines affect DNA?
  • No. COVID-19 vaccines to not interact with DNA in any way.5

Can a COVID-19 vaccine cause a COVID-19 infection?
  • No. COVID-19 vaccines do not contain the COVID-19 virus.5

Can a patient get a COVID-19 vaccine if they have a COVID infection?
  • Patients with respiratory virus symptoms should delay vaccination to avoid exposing healthcare providers and others.4
  • Patients can wait three months after symptom onset (or positive test if asymptomatic) to receive a COVID-19 vaccination.8
    • Reinfection is unlikely in the first three months post-infection.8
    • Delaying vaccination for three months may improve vaccine response.8
    • Reasons to get vaccinated sooner include high personal risk of severe disease or high COVID-19 transmission in the community.8

How effective are COVID-19 vaccines?
  • For adults, the 2023 to 2024 COVID-19 vaccines reduced the risk of:15
    • Critical illness from COVID-10 by almost 70% in the first two months after vaccination. During the 10 months after vaccination, the vaccines reduced critical illness by ~50%.
    • COVID-19 hospitalization by ~50% in the first two months after vaccination. During the 10 months after vaccination, the vaccines reduced COVID-19 hospitalization risk by ~30%.
    • need for COVID-19 urgent/emergency care by ~50% in the first two months.
  • Preliminary evidence for the 2024 to 2025 COVID-19 vaccines suggests vaccine effectiveness of ~45% against hospitalization in immunocompetent patients ≥65 years of age.16

What is the difference between Spikevax and mNexspike?
  • Spikevax provides mRNA that codes for the COVID-19 spike protein, while mNexspike vaccine provides mRNA that encodes for only two parts of the COVID-19 virus spike protein, so the dose is lower. These two parts (the receptor-binding domain [RBD] and the N-terminal domain [NTD]) are responsible for most of the effective antibody production.21
  • In a clinical trial (n = 11,366 participants ≥12 years of age), mNexspike providing mRNA encoding the RBD and NTD of the original and Omicron BA/4/BA.5 variants was compared to the Moderna COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5 vaccine [2022-2023]). About 60% of patients had at least one risk factor for severe COVID-19. Relative vaccine efficacy for prevention of symptomatic COVID-19 infection was 9.3% (NNT = 112). Among participants ≥65 years of age, relative vaccine efficacy was 13.5% (NNT = 73).22

Can COVID-19 vaccines be given with other vaccines?
  • Generally yes, but there are special considerations for mpox vaccination.8

What are some common adverse effects of COVID-19 vaccines, and what can be done about them?
  • As with other vaccines, side effects are usually mild and go away in few days, if they occur at all.4
  • Common side effects include fatigue, muscle pain, headache, chills, nausea, fever, and pain, swelling, and redness in the arm where the vaccine was administered.4
  • It is not recommended to take analgesics before vaccination to prevent side effects, but they can be taken to treat side effects if they occur.4
  • For arm pain and swelling, a clean, cool, wet washcloth can be applied over the area. The patient should keep using their arm normally.4

Do COVID-19 vaccines cause heart problems?
  • Many viruses, including COVID-19, can cause myocarditis and pericarditis.6
    • In one study, patients with COVID-19 had almost 16 times the risk of myocarditis compared with patients who did not have COVID-19.14
  • Although rare, the COVID-19 vaccine has been associated with myocarditis and pericarditis.6
    • Myocarditis associated with COVID-19 vaccination is less common and less severe than with COVID-19 infection.7
    • Most cases associated with COVID-19 vaccination are mild, transient, and resolve on their own.7
    • The incidence of myocarditis/pericarditis in the first week after receipt of the 2023-2024 COVID-19 vaccine was ~8 cases/million doses in patients 6 months through 64 years of age, and ~27 cases/million doses in males 12 through 24 years of age.18
  • Waiting at least 8 weeks between doses may decrease risk.8,9

Do COVID-19 vaccines cause Bell’s palsy?
  • It is unclear if mRNA COVID-19 vaccines are associated with Bell’s palsy.13

Do COVID-19 vaccines cause Guillain-Barre syndrome?
  • mRNA COVID-19 vaccines do not seem to be associated with Guillain-Barre syndrome.11

Will COVID-19 vaccination cause a positive COVID test?
  • No.8

Can antibody testing be used to assess the need for COVID-19 vaccination?
  • This is not recommended. Vaccination should proceed regardless of the result.17
  • Antibody testing is appropriate in the context of public health and epidemiologic purposes, and for fulfilling the case definition of multisystem inflammatory response syndrome.12

Do you need to stick with the same vaccine every year?
  • Generally no, but immunocompromised patients should ideally receive the same vaccine for the initial series.8

Should a child receive one or two doses of Spikevax if they turn 2 years of age during the two-dose series?
  • Individuals turning from 23 months to 2 years of age during the vaccination series should receive both doses of Spikevax.

Do COVID-19 vaccines prevent “long COVID”?
  • Vaccination is the best available tool to prevent long COVID.1
  • Vaccination may reduce the risk of long COVID-19 by almost 50%.2,3

Can patients who are pregnant or breastfeeding get a COVID vaccine?
  • COVID-19 vaccinations are recommended for people who are pregnant, trying to get pregnant, or who might become pregnant in the future, and for people who are breastfeeding.10

References

  1. CDC. Long COVID basics. July 24, 2025. https://www.cdc.gov/covid/long-term-effects/index.html. (Accessed September 7, 2025).
  2. Trinh NT, Jödicke AM, Català M, et al. Effectiveness of COVID-19 vaccines to prevent long COVID: data from Norway. Lancet Respir Med. 2024 May;12(5):e33-e34.
  3. Al-Aly Z, Davis H, McCorkell L, et al. Long COVID science, research and policy. Nat Med. 2024 Aug;30(8):2148-2164.
  4. CDC. Getting your COVID-19 vaccine. June 11, 2025. https://www.cdc.gov/covid/vaccines/getting-your-covid-19-vaccine.html. (Accessed September 7, 2025).
  5. CDC. COVID-19 Vaccine Basics. September 3, 2024. https://www.cdc.gov/covid/vaccines/how-they-work.html. (Accessed September 7, 2025).
  6. Fairweather D, Beetler DJ, Di Florio DN, et al. COVID-19, Myocarditis and Pericarditis. Circ Res. 2023 May 12;132(10):1302-1319.
  7. Buoninfante A, Andeweg A, Genov G, Cavaleri M. Myocarditis associated with COVID-19 vaccination. NPJ Vaccines. 2024 Jun 28;9(1):122.
  8. CDC. Interim clinical considerations for use of COVID-19 vaccines in the United States. May 1, 2025. https://www.cdc.gov/covid/media/pdfs/2025/07/iCC_document_7.18.25.pdf. (Accessed September 7, 2025).
  9. Wallace M, Moulia D, Blain AE, et al. The Advisory Committee on Immunization Practices' Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines - United States, February 2022. MMWR Morb Mortal Wkly Rep. 2022 Mar 18;71(11):416-421.
  10. American College of Obstetricians and Gynecologists. Practice Advisory. COVID-19 vaccination considerations for obstetric-gynecologic care. Last updated August 2025. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care. (Accessed September 7, 2025).
  11. Jaffry M, Mostafa F, Mandava K, et al. No significant increase in Guillain-Barré syndrome after COVID-19 vaccination in adults: A vaccine adverse event reporting system study. Vaccine. 2022 Sep 22;40(40):5791-5797.
  12. CDC. Overview of testing for SARS-CoV-2. August 29, 2024. https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html. (Accessed September 7, 2025).
  13. Willison AG, Pawlitzki M, Lunn MP, et al. SARS-CoV-2 Vaccination and Neuroimmunological Disease: A Review. JAMA Neurol. 2024 Feb 1;81(2):179-186.
  14. Boehmer TK, Kompaniyets L, Lavery AM, et al. Association Between COVID-19 and Myocarditis Using Hospital-Based Administrative Data - United States, March 2020-January 2021. MMWR Morb Mortal Wkly Rep. 2021 Sep 3;70(35):1228-1232.
  15. CDC. Benefits of getting vaccinated. https://www.cdc.gov/covid/vaccines/benefits.html?CDC_AAref_Val=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. (Accessed September 7, 2025).
  16. Link-Gelles R, Chickery S, Webber A, et al. Interim Estimates of 2024-2025 COVID-19 Vaccine Effectiveness Among Adults Aged ≥18 Years - VISION and IVY Networks, September 2024-January 2025. MMWR Morb Mortal Wkly Rep. 2025 Feb 27;74(6):73-82.
  17. CDC. Implementation guidance. May 1, 2025. https://www.cdc.gov/covid/hcp/vaccine-considerations/implementation.html. (Accessed September 7, 2025).
  18. FDA. FDA approves required updated warning in labeling of mRNA COVID-19 vaccines regarding myocarditis and pericarditis following vaccination. June 25, 2025. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and. (Accessed September 7, 2025).
  19. Spikevax. Product reimbursement information. August 2025. https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/41920bca-959f-4e5b-a77c-582a5e5b2dd1/41920bca-959f-4e5b-a77c-582a5e5b2dd1_viewable_rendition__v.pdf (Accessed September 13, 2025).
  20. mNexspike. 2025-2026 formula: product information guide. August 2025. https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/73cb8fd2-e19e-4e0b-8cd6-665a90b4b757/73cb8fd2-e19e-4e0b-8cd6-665a90b4b757_viewable_rendition__v.pdf (Accessed September 13, 2025).
  21. Chalkias S, Pragalos A, Akinsola A, et al. Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine. J Infect Dis. 2025 Apr 15;231(4):e754-e763.
  22. Prescribing information for mNexspike. Moderna US. Princeton, NJ 08540. August 2025.
  23. Prescribing information for Nuvaxovid. Novavax. Gaithersburg, MD 20878. August 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a20513c-d255-46d7-8e6b-294cec4b44f4. (Accessed September 15, 2025).

Cite this document as follows: Clinical Resource, COVID-19 Vaccines 2025-26 (United States). Pharmacist’s Letter/Pharmacy Technician’s Letter/Prescriber Insights. September 2025. [410968]


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