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COVID-19 vaccines (2026–2027 formula): Comirnaty, Spikevax, mNexspike and Nuvaxovid

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Vaccine School · Routine adult

A pharmacist-focused lesson on the four FDA-approved COVID-19 vaccines for the 2026–2027 season: how FDA labeling and CDC's interim clinical considerations differ, who is recommended which dose and interval by age and immune status, administration, storage, myocarditis and other safety information, and counseling. Older CDC documents are shown with their dates. Unreviewed draft.

Content current as of October 11, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.

The disease and why it matters

COVID-19 is caused by the coronavirus SARS-CoV-2, which spreads easily from person to person; illness can be mild to moderate, lasting only a few days, or severe, requiring hospitalization, intensive care or a ventilator, and it can result in death. [1]

Older adults and people of any age with certain underlying medical conditions (like heart or lung disease or diabetes) are more likely to get very sick with COVID-19, and after illness some people get Long COVID, a chronic condition with symptoms lasting 3 months or longer. [1]

Symptoms may appear 2 to 14 days after exposure. CDC notes that COVID-19 vaccination is not guaranteed to prevent infection with or spread of SARS-CoV-2. [1] [2]

CDC lists groups at increased risk of SARS-CoV-2 infection that include healthcare workers and residents and employees in long-term care facilities and other residential congregate settings. [3]

Video and figures

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COVID-19: Nursing Science
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Products available

CDC describes two types of COVID-19 vaccines recommended in the United States for 2026–2027: mRNA vaccines (Moderna and Pfizer-BioNTech) and a protein subunit vaccine (Novavax, now manufactured by Sanofi US Inc.). The 2026–2027 formulations are based on the Omicron JN.1 lineage of SARS-CoV-2 (XFG strain for all three manufacturers), and the 2025–2026 vaccines should not be used once 2026–2027 vaccines are available. [2]

FDA-approved COVID-19 vaccines for 2026–2027, from FDA product pages, prescribing information and approval letters
VaccineType and manufacturer (FDA page)FDA-approved useDoseInitial FDA approval
ComirnatymRNA vaccine; BioNTech Manufacturing GmbH [4]65 years and older; 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 [5]0.3 mL [5]August 23, 2021 (individuals 16 years and older at that time) [6]
SpikevaxmRNA vaccine; Moderna Tx, Inc [7]65 years and older; 6 months through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 [8]0.5 mL for 12 years and older; 0.25 mL for 6 months through 11 years [8]January 31, 2022 (individuals 18 years and older at that time) [9] [7]
mNexspikemRNA vaccine; ModernaTX, Inc. [10]65 years and older; 12 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 [11]0.2 mL [11]May 30, 2025 [12]
NuvaxovidAdjuvanted protein subunit vaccine (recombinant spike protein with Matrix-M adjuvant); Sanofi Vaccines US, Inc [13]65 years and older; 12 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 [14]0.5 mL [14]May 16, 2025 [15]

CDC states that there is no preferential recommendation for any one COVID-19 vaccine over another when more than one recommended and age-appropriate vaccine is available. [2]

CDC notes that there is currently no FDA-approved or FDA-authorized Pfizer-BioNTech COVID-19 vaccine for individuals ages 6 months through 4 years; the only FDA-approved COVID-19 vaccine available for that age group is Moderna (Spikevax). [2] [16]

Who should get it

CDC (interim clinical considerations, 2026–2027)

As of September 23, 2026

A 2026–2027 COVID-19 vaccine is recommended for all adults ages 18 years and older, and for all children ages 6 months through 17 years with moderate to severe immunocompromise; for all other children it is recommended through shared clinical decision-making. CDC states that because of legal uncertainties and inquiries, the recommendations from the July 2025 immunization schedule remain in effect for the 2026–2027 season. [16]

FDA labels (all four vaccines)

As of August 27, 2026

FDA approval is limited to people 65 years and older and to younger people with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (age floors: Spikevax 6 months, Comirnaty 5 years, mNexspike and Nuvaxovid 12 years). CDC states that recommendations for an age-appropriate vaccine in persons 6 months through 64 years without such a condition are based on off-label use. [8] [5] [11] [14] [2]

CDC adult schedule notes (edition July 2, 2025)

As of July 2, 2025

Describes routine vaccination for ages 19 through 64 years (not pregnant) and 65 years and older using 2024–25 vaccines (for unvaccinated persons 19 through 64: 1 dose Moderna or Pfizer-BioNTech, or 2 doses Novavax 3 to 8 weeks apart; 65 years and older: a second dose 6 months later). This edition predates the 2026–2027 vaccines. [17]

AAFP (its adopted adult schedule; page checked 2026-10-11, no version date shown on the page)

As of October 11, 2026

Lists for ages 19 to 64 years unvaccinated: 1 dose Spikevax, mNexspike, Comirnaty or Nuvaxovid, and for ages 65 years and older a second dose 6 months later (minimum interval 2 months), with product names for the 2025–26 vaccines. [18]

CDC Vaccine Information Statement (edition January 31, 2025; 2024–2025 vaccine)

As of January 31, 2025

States that the updated 2024–2025 vaccine is recommended for everyone 6 months of age and older, including women who are pregnant, breastfeeding, trying to get pregnant or who might become pregnant. This predates the current CDC interim considerations. [1]

CDC adds that the risk-benefit of vaccination for children is most favorable for those at increased risk for severe COVID-19 and least favorable for those not at increased risk, according to CDC's list of risk factors; CDC also notes that the Spikevax package insert states prematurity (birth at less than 37 weeks gestational age) has been associated with COVID-19-related hospitalizations in children 6 through 23 months. [2]

COVID-19 vaccination is recommended for people ages 6 months and older who are moderately or severely immunocompromised; people can self-attest to being moderately or severely immunocompromised and receive vaccination, and COVID-19 vaccination should not be delayed in patients taking immunosuppressive therapies. [19]

Dosing and schedule, including catch-up

CDC 2026–2027 schedule for people without immunocompromise, ages 12 years and older (Table 1d and 1e, CDC page dated September 23, 2026)
Age group and historyDosesInterval
12 through 64 years, unvaccinated1 doseModerna, Novavax or Pfizer-BioNTech 2026–2027 vaccine on day 0; Novavax is a single dose for initial vaccination. [3]
12 through 64 years, previously vaccinated with any COVID-19 vaccine1 doseAt least 8 weeks after the last dose (Spikevax, Novavax, Pfizer-BioNTech) or at least 3 months after the last dose (mNexspike); a mNexspike dose given at least 2 months after the last dose should not be repeated. [3]
65 years and older, unvaccinated2 dosesDose 1 on day 0; dose 2 at 6 months (minimum interval 2 months; 3 months for mNexspike). [3]
65 years and older, previously vaccinated2 dosesDose 1 at least 8 weeks after the last dose (at least 3 months for mNexspike); dose 2 at 6 months (minimum interval 2 months; 3 months for mNexspike). [3]

FDA labeling and CDC differ in dose count for adults 65 years and older: the FDA-approved indication for available COVID-19 vaccines is a single dose in this age group, and CDC states that giving more than one dose to adults 65 and older is off-label use. [3]

Label dosing intervals: Comirnaty and Nuvaxovid are given at least 2 months after the last dose of any COVID-19 vaccine, and Spikevax in individuals 2 years and older is a single dose given at least 2 months after the last dose; mNexspike is given at least 3 months after the last dose. [5] [14] [8] [11]

For moderately or severely immunocompromised people ages 12 years and older who are unvaccinated, CDC's Table 2 schedule is 4 doses with Moderna (day 0, 4 weeks later, and at least 4 weeks after dose 2, then a fourth dose 6 months later with a minimum interval of 2 months, or 3 months for mNexspike), or 3 doses with Novavax (day 0, 3 weeks later, then 6 months later), or 4 doses with Pfizer-BioNTech (day 0, 3 weeks, at least 4 weeks after dose 2, then 6 months later). [19]

CDC's Table 1 notes that an 8-week interval between the first and second COVID-19 vaccine doses (extended interval) might reduce the rare risk of myocarditis and pericarditis associated with COVID-19 vaccines. [3]

Younger children: CDC schedules for ages 6 through 23 months (2 doses of Moderna for unvaccinated children, 4 to 8 weeks apart), 2 through 4 years (a single dose of Moderna) and 5 through 11 years (a single dose) are in CDC's Table 1 and are not reproduced here. [3]

Administration

COVID-19 vaccine doses should be administered by the intramuscular route. Patients may receive an age-appropriate vaccine product and dosage based on their age on the day of vaccination. [2]

Dosage by product (CDC): mNexspike 0.2 mL (10 µg); Spikevax 0.5 mL (50 µg) for 12 years and older; Novavax 0.5 mL (5 µg rS protein and 50 µg Matrix-M adjuvant); Pfizer-BioNTech 0.3 mL (30 µg). [3]

Routine simultaneous administration of all age-appropriate vaccines is acceptable for children, adolescents and adults if there are no contraindications at the time of the visit. There is no required minimum interval between a COVID-19 vaccine and an orthopoxvirus vaccine (JYNNEOS or ACAM2000); people who are recommended to receive both, particularly adolescent or young adult males, might consider waiting 4 weeks out of an abundance of caution, but vaccination should not be delayed if risk of mpox or severe COVID-19 is increased. [20]

Interchangeability: where multiple doses are given off-label, the same vaccine should be used whenever recommended; a different age-appropriate vaccine may be given if the same vaccine is not available, the previous dose is unknown, the person would otherwise not receive a recommended dose, or the person cannot complete the series with the same vaccine because of a contraindication. [20]

Syncope can occur with injectable vaccines, including Comirnaty; procedures should be in place to avoid injury from fainting. [5]

Storage and handling

Storage by product, from prescribing information
VaccineStorage
ComirnatyPrefilled syringes: store refrigerated at 2°C to 8°C (35°F to 46°F), do not freeze; total time out of refrigeration at 8°C to 25°C must not exceed 12 hours. Single-dose vials may be thawed and stored refrigerated for up to 10 weeks, or stored at -90°C to -60°C; do not store at -25°C to -15°C. [5]
SpikevaxStore frozen between -50°C to -15°C (-58°F to 5°F); after thawing, refrigerated at 2°C to 8°C for up to 60 days or until the expiration date, whichever comes first, and 8°C to 25°C for up to 12 hours; do not refreeze once thawed. [8]
mNexspikeStore refrigerated between 2°C to 8°C (36°F to 46°F); do not freeze; may be stored at 8°C to 25°C for up to 12 hours; minimize exposure to room light and avoid direct sunlight and ultraviolet light. [11]
NuvaxovidStore in the original carton to protect from light, in a refrigerator at 2°C to 8°C (36°F to 46°F); do not freeze. [14]

The 2026–2027 mNexspike label records that frozen presentation and thawing instructions were removed in 8/2026, and the Spikevax label that thawing instructions for the carton of 2 syringes were removed in 8/2026; check the current label for the presentation in your stock. [11] [8]

Contraindications and precautions

  • Comirnaty: known history of a severe allergic reaction (e.g., anaphylaxis) to any component. [5]
  • Spikevax and mNexspike: known history of severe allergic reaction to any component, or a severe allergic reaction following a previous dose of a Moderna COVID-19 vaccine (Spikevax) or of Spikevax or any Moderna COVID-19 vaccine authorized for emergency use (mNexspike). [8] [11]
  • Nuvaxovid: known history of severe allergic reaction to any component, or following a previous dose of Novavax COVID-19 Vaccine, Adjuvanted. [14]
  • Ask about prior myocarditis or pericarditis and multisystem inflammatory syndrome, and defer for moderate or severe illness: people with minor illnesses such as a cold may be vaccinated, while people who are moderately or severely ill, including with COVID-19, should usually wait until they recover. [1]

Safety and adverse events

Myocarditis and pericarditis: for the mRNA vaccines (Comirnaty, Spikevax, mNexspike) analyses of postmarketing data have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week after vaccination and the highest observed risk in males 12 through 24 years of age. For Nuvaxovid, clinical trial data provide evidence for increased risks of myocarditis and pericarditis, and there have been postmarketing reports. [5] [8] [11] [14]

Most commonly reported adverse reactions in participants 18 through 64 years of age, as stated in the Highlights (separate trials; not head-to-head comparisons; ranges are "up to")
VaccineReactions reported (18 through 64 years)
mNexspikePain at the injection site up to 74.8%, fatigue up to 54.3%, headache up to 47.8%, myalgia up to 41.6%, arthralgia up to 32.4%, chills up to 24.3%, axillary swelling or tenderness up to 21.7%, nausea/vomiting up to 13.8%. [11]
NuvaxovidInjection site tenderness up to 71.7%, injection site pain up to 58.6%, muscle pain up to 52.7%, fatigue up to 50.5%, headache up to 47.4%, malaise up to 38.9%, joint pain up to 22.2%, nausea/vomiting up to 12.1%. [14]
Comirnaty (12 years and older)Pain at the injection site up to 90.5%, fatigue up to 77.5%, headache up to 75.5%, chills up to 49.2%, muscle pain up to 45.5%, joint pain up to 27.5%, fever up to 24.3%, injection site swelling up to 11.8%, injection site redness up to 10.4%. [5]

CDC's VIS lists pain, swelling and redness where the shot is given, fever, tiredness, headache, chills, muscle pain, joint pain, nausea, vomiting and swollen lymph nodes, and advises seeking medical attention right away for chest pain, shortness of breath, or a fast-beating, fluttering or pounding heart after vaccination. [1]

CDC states that the incidence of myocarditis after COVID-19 illness was 0.05% and after COVID-19 vaccination 0.005% in a retrospective cohort study of more than 4 million persons 16 through 25 years of age during 2020–2025. [3]

COVID-19 vaccine injuries may be eligible for the Countermeasures Injury Compensation Program, and a claim generally must be submitted within one year of vaccination; adverse reactions should be reported to VAERS at 1-800-822-7967. [1]

Special populations

Pregnancy: for Comirnaty there are no available data in pregnant women before 24 weeks gestation to inform risks for major birth defects and miscarriage; for mNexspike and Nuvaxovid, available data in pregnant women are insufficient to inform vaccine-associated risks. A rat developmental toxicity study of Comirnaty showed no evidence of harm to the fetus. [5] [11] [14]

Immunocompromised people: CDC's July 2025 adult notes said to use vaccine from the same manufacturer for all doses in the initial vaccination series, while CDC's 2026–2027 Table 2 states that mNexspike and Spikevax may be used interchangeably in the initial 3-dose series. [17] [19]

Children transitioning ages during a series: those who transition from age 23 months to 2 years during the initial vaccination with 2026–2027 vaccine (after dose 1 but before dose 2) may receive 1 dose of Spikevax 4 to 8 weeks after dose 1; Pfizer-BioNTech is no longer authorized for children 6 months through 4 years, and children who began with it cannot complete the series with the same product. [3] [2]

Counseling pearls for the pharmacy counter

  • As with all medical decision making, CDC says patients should discuss the benefits and risks of COVID-19 vaccination with their healthcare provider to make informed and personalized decisions. [16]
  • Sore arm, tiredness, headache, chills, muscle and joint pain, nausea and swollen lymph nodes can happen; seek care promptly for chest pain, shortness of breath or palpitations after vaccination. [1]
  • Tell patients that COVID-19 vaccine may be given at the same time as other vaccines, and that signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness) need 9-1-1. [1]
  • Encourage patients to enroll in V-Safe to share how they feel after vaccination. [1]

Common patient questions

Is a 40-year-old with no medical conditions eligible?

CDC recommends a 2026–2027 COVID-19 vaccine for all adults 18 years and older, but FDA approval for people 12 through 64 years is limited to those with at least one underlying high-risk condition, so use in a healthy adult is off-label; CDC identifies such recommendations as off-label. [2]

A 72-year-old had a COVID shot last fall. How many doses now?

CDC's 2026–2027 schedule for adults 65 years and older who were previously vaccinated is 2 doses: dose 1 at least 8 weeks after the last dose (at least 3 months for mNexspike) and dose 2 six months later; the FDA label itself approves a single dose in this age group. [3]

Which vaccine should I use?

CDC has no preferential recommendation among recommended, age-appropriate COVID-19 vaccines. [2]

Can it be given with flu or RSV vaccines?

CDC says routine simultaneous administration of all age-appropriate vaccines is acceptable if there are no contraindications at the time of the visit. [20]

We do not have the same product the patient got before. May I use another?

Yes, in listed circumstances: the same vaccine is not available, the previous dose is unknown, the person would otherwise not receive a recommended dose, or they cannot complete the series with the same vaccine because of a contraindication. [20]

References

  1. Centers for Disease Control and Prevention. COVID-19 vaccine: what you need to know. Vaccine Information Statement, January 31, 2025 (2024-2025 vaccine). Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/covid-19.html. Accessed October 11, 2026.
  2. Centers for Disease Control and Prevention. Overview of COVID-19 vaccines and vaccination. Page dated September 23, 2026. Accessed October 11, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/overview.html. Accessed October 11, 2026.
  3. Centers for Disease Control and Prevention. COVID-19 vaccination guidance for persons who are not immunocompromised (Table 1, 2026-2027 schedule). Page dated September 23, 2026. Accessed October 11, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/routine-guidance.html. Accessed October 11, 2026.
  4. U.S. Food and Drug Administration. COMIRNATY (STN 125742), product page (content current as of 08/27/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/comirnaty. Accessed October 11, 2026.
  5. COMIRNATY (COVID-19 vaccine, mRNA) injectable suspension, for intramuscular use, 2026-2027 formula: prescribing information. BioNTech Manufacturing GmbH and Pfizer Inc.; revised 8/2026. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/151707/download?attachment. Accessed October 11, 2026.
  6. U.S. Food and Drug Administration. BLA approval letter, COVID-19 Vaccine, mRNA (COMIRNATY), STN BL 125742/0. August 23, 2021. Accessed October 11, 2026. https://www.fda.gov/media/151710/download?attachment. Accessed October 11, 2026.
  7. U.S. Food and Drug Administration. SPIKEVAX (STN 125752), product page (content current as of 08/27/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/spikevax. Accessed October 11, 2026.
  8. SPIKEVAX (COVID-19 vaccine, mRNA) injectable suspension, for intramuscular use, 2026-2027 formula: prescribing information. ModernaTX, Inc.; revised 8/2026. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/155675/download?attachment. Accessed October 11, 2026.
  9. U.S. Food and Drug Administration. BLA approval letter, COVID-19 Vaccine, mRNA (SPIKEVAX), STN BL 125752/0. January 31, 2022. Accessed October 11, 2026. https://www.fda.gov/media/155815/download?attachment. Accessed October 11, 2026.
  10. U.S. Food and Drug Administration. MNEXSPIKE (STN 125835), product page (content current as of 08/27/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/mnexspike. Accessed October 11, 2026.
  11. MNEXSPIKE (COVID-19 vaccine, mRNA) injectable suspension, for intramuscular use, 2026-2027 formula: prescribing information. ModernaTX, Inc.; revised 8/2026. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/186738/download?attachment. Accessed October 11, 2026.
  12. U.S. Food and Drug Administration. BLA approval letter, COVID-19 Vaccine, mRNA (MNEXSPIKE), STN BL 125835/0. May 30, 2025. Accessed October 11, 2026. https://www.fda.gov/media/186740/download?attachment. Accessed October 11, 2026.
  13. U.S. Food and Drug Administration. NUVAXOVID (STN 125817), product page (content current as of 08/27/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/nuvaxovid. Accessed October 11, 2026.
  14. NUVAXOVID (COVID-19 vaccine, adjuvanted) injectable suspension, for intramuscular use, 2026-2027 formula: prescribing information. Sanofi Vaccines US Inc.; revised 8/2026. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/186544/download?attachment. Accessed October 11, 2026.
  15. U.S. Food and Drug Administration. BLA approval letter, COVID-19 Vaccine, Adjuvanted (NUVAXOVID), STN BL 125817/0. May 16, 2025. Accessed October 11, 2026. https://www.fda.gov/media/186545/download?attachment. Accessed October 11, 2026.
  16. Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines in the United States. Page dated September 23, 2026. Accessed October 11, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/index.html. Accessed October 11, 2026.
  17. Centers for Disease Control and Prevention. Adult immunization schedule notes: recommendations for ages 19 years or older, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html. Accessed October 11, 2026.
  18. American Academy of Family Physicians. Adults 19 and older immunization schedules (adopted version; page shows no version date). Accessed October 11, 2026. https://www.aafp.org/clinical-insights/immunizations-and-vaccines/immunizations-schedules-resources/adult-immunization-schedules. Accessed October 11, 2026.
  19. Centers for Disease Control and Prevention. COVID-19 vaccination for people who are moderately or severely immunocompromised (Table 2, 2026-2027 schedule). Page dated September 23, 2026. Accessed October 11, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/immunocompromised.html. Accessed October 11, 2026.
  20. Centers for Disease Control and Prevention. COVID-19 vaccine implementation guidance: simultaneous administration and interchangeability. Page dated September 23, 2026. Accessed October 11, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/implementation.html. Accessed October 11, 2026.

For professional education. Check current labeling and guidance before acting. Not medical advice.

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