Spikevax

Spikevax is Moderna's FDA-approved mRNA COVID-19 vaccine. The 2026-2027 Formula targets the SARS-CoV-2 JN.1-descendent variant XFG, and helps your body develop immunity against COVID-19 for the 2026-2027 respiratory virus season.

Key features

• Updated targeting: formulated against the JN.1-descendent variant XFG
• Initial U.S. approval: 2022
• No live virus: cannot cause COVID-19
• mRNA technology: instructs cells to produce the spike protein for immune recognition
• Two dose strengths: 0.25 mL (25 mcg mRNA) and 0.5 mL (50 mcg mRNA)

Spikevax is approved for active immunization to prevent COVID-19 in individuals who are:

• 65 years of age and older, or
• 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The prescribing information points to the CDC's published list of medical conditions that place people at higher risk of severe COVID-19 outcomes. It also notes that prematurity has been associated with COVID-19-related hospitalization in children aged 6 months through 23 months.

Note: In the U.S., some states may have differing rules on vaccinations. Some states allow pharmacists to vaccinate adults directly, while others require a prescription for people outside the approved age and risk groups, and pharmacy chain policies vary. If you are unsure of your vaccination eligibility, check with your local healthcare provider or pharmacist.

Important: Spikevax may not protect all individuals who receive the vaccine.

The mNEXSPIKE option

Moderna's other COVID-19 vaccine, mNEXSPIKE, is approved for adults 65 years and older, and for people aged 12 through 64 years with at least one high-risk underlying condition. Unlike Spikevax, it is not approved for children under 12.

Spikevax delivers nucleoside-modified messenger RNA (mRNA), formulated in lipid particles, into your cells. The mRNA instructs the cells to produce the pre-fusion stabilized spike glycoprotein of SARS-CoV-2. Your immune system recognizes this protein as foreign and mounts a response, which protects against COVID-19.

Spikevax does not contain any live virus particles, and it cannot give you COVID-19.

Do not get Spikevax if you have

• A known history of a severe allergic reaction (such as anaphylaxis) to any component of Spikevax, or
• Had a severe allergic reaction following a previous dose of a Moderna COVID-19 vaccine.

Tell your healthcare provider if you

• Have any allergies
• Had a severe allergic reaction after a previous dose of any COVID-19 vaccine
• Have a history of myocarditis or pericarditis
• Have a fever or have recently had a COVID-19 infection
• Have received other COVID-19 vaccines, especially recently
• Have a bleeding disorder or take blood thinners
• Are immunocompromised or take medicines that affect your immune system
• Have a history of fainting with injections
• Are pregnant, plan to become pregnant, or are breastfeeding

Pregnancy

Available data on Spikevax administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

A developmental toxicity study in female rats, given the equivalent of a single primary series dose twice before mating and twice during gestation, revealed no evidence of harm to the fetus and no adverse effect on postnatal development.

Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant individuals. Discuss vaccination with your healthcare provider to make an informed decision based on your circumstances.

Breastfeeding

It is not known whether Spikevax is excreted in human milk, and data are not available to assess the effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Spikevax and any potential adverse effects on the breastfed infant.

Children

Safety and effectiveness in individuals 6 months through 17 years of age with at least one high-risk factor for severe COVID-19 outcomes is based on data in this age group and in adults. Safety and effectiveness have not been established in infants younger than 6 months of age.

The most commonly reported adverse reactions (10% or more) in clinical trials, by age group, were:

• 6 months through 36 months: irritability or crying (up to 82.8%), injection site pain (up to 77.2%), sleepiness (up to 52.2%), loss of appetite (up to 46.5%), fever (up to 26.8%), injection site redness (up to 19.2%), injection site swelling (up to 19.2%), and armpit or groin swelling or tenderness (up to 12.2%).
• 37 months through 11 years: injection site pain (up to 98.4%), fatigue (up to 73.2%), headache (up to 62.2%), muscle pain (up to 35.3%), chills (up to 34.6%), nausea or vomiting (up to 29.3%), armpit or groin swelling or tenderness (up to 27.0%), fever (up to 25.8%), injection site redness (up to 24.1%), injection site swelling (up to 22.3%), and joint pain (up to 21.3%).
• 12 through 17 years: injection site pain (up to 90.6%), fatigue (up to 58.1%), headache (up to 56.3%), muscle pain (up to 40.1%), chills (up to 30.2%), armpit swelling or tenderness (up to 27.8%), joint pain (up to 23.9%), nausea or vomiting (up to 17.9%), and injection site swelling (up to 13.3%).
• 18 through 64 years: injection site pain (up to 86.3%), fatigue (up to 62.0%), headache (up to 58.9%), muscle pain (up to 49.6%), joint pain (up to 41.9%), chills (up to 40.3%), armpit swelling or tenderness (up to 24.8%), and nausea or vomiting (up to 16.7%).
• 65 years and older: injection site pain (up to 76.3%), fatigue (up to 58.1%), muscle pain (up to 47.4%), headache (up to 42.1%), joint pain (up to 39.5%), chills (up to 18.4%), and armpit swelling or tenderness (up to 14.3%).

Serious side effects and warnings

Severe allergic reactions

Rarely, a severe allergic reaction may occur, usually within minutes to 1 hour after vaccination. Appropriate medical treatment must be immediately available, and your vaccination provider may ask you to stay for a short time at the place where you received your vaccine. Symptoms include:

• Trouble breathing
• Swelling of the face and throat
• A fast heartbeat
• A rash all over the body
• Dizziness and weakness

Heart inflammation (myocarditis and pericarditis)

Analyses of postmarketing data from mRNA COVID-19 vaccines, including Spikevax, have demonstrated increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart), with symptoms typically starting in the first week after vaccination. The observed risk has been highest in males aged 12 through 24 years.

Estimated unadjusted incidence in the 1 to 7 days after a dose of the 2023-2024 Formula of mRNA COVID-19 vaccines, based on commercial health insurance claims data:

• approximately 8 cases per million doses in people aged 6 months through 64 years
• approximately 27 cases per million doses in males aged 12 through 24 years.

Although some people have required intensive care support, available data suggest that symptoms typically resolve within a few days with conservative management. In a longitudinal study of patients aged 5 through 29 years diagnosed with vaccine-associated myocarditis, abnormal cardiac MRI findings marking myocardial injury were commonly still present at a median follow-up of about 5 months, although severity decreased over time. The clinical and prognostic significance of these findings is not known.

Seek immediate medical attention for:

• Chest pain
• Shortness of breath
• Feelings of a fast-beating, fluttering, or pounding heart

Fainting

Fainting (syncope) may occur in association with the administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Reduced response in immunocompromised people

People who are immunocompromised, including those receiving immunosuppressive therapy, may have a diminished immune response to Spikevax.

Reported after marketing

Adverse events reported during post-approval use include myocarditis, pericarditis, anaphylaxis, hives, fainting, and febrile seizures.

These may not be all the possible side effects of Spikevax. Ask your healthcare provider about any side effects that concern you. Report vaccine side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov/reportevent.html, or to ModernaTX, Inc. at 1-866-663-3762.

Spikevax is given by a healthcare provider as an intramuscular injection, usually into the deltoid muscle of the upper arm. It is supplied in single-dose prefilled syringes.

Children aged 6 months through 23 months

The schedule depends on how many previous doses of a Moderna COVID-19 vaccine the child has received:

• No previous doses: 2 doses of 0.25 mL, given at month 0 and month 1.
• 1 previous dose: a single 0.25 mL dose, one month after the previous Moderna COVID-19 vaccine dose.
• 2 or more previous doses: a single 0.25 mL dose, at least 2 months after the last previous Moderna COVID-19 vaccine dose.

Children who turn 2 years of age during the vaccination series should receive both doses with Spikevax.

Age 2 years and older

A single dose is given, regardless of COVID-19 vaccination status:

• 2 years through 11 years: a single 0.25 mL dose (25 mcg mRNA)
• 12 years and older: a single 0.5 mL dose (50 mcg mRNA)

If previously vaccinated with any COVID-19 vaccine, the dose is given at least 2 months after the last dose of COVID-19 vaccine.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tell your healthcare provider if you take:

• a blood thinner, such as warfarin
• a medicine that affects your immune system, such as cyclosporine

Also, tell your healthcare provider if you have received any other COVID-19 vaccines.

• Frozen storage: −50°C to −15°C (−58°F to 5°F).
• After thawing, refrigerated: 2°C to 8°C (36°F to 46°F) for up to 60 days, or until the expiration date printed on the carton, whichever comes first.
• After thawing, 8°C to 25°C (46°F to 77°F): up to 12 hours.
• Do not refreeze once thawed.
• During storage, minimize exposure to room light and avoid direct sunlight and ultraviolet light. Thawed syringes can be handled in room light conditions.

Spikevax is supplied in cartons of 10 single-dose prefilled syringes — 0.25 mL syringes for ages 6 months through 11 years (NDC 80777-115-80) and 0.5 mL syringes for ages 12 years and older (NDC 80777-114-96).

Manufactured for Moderna US, Inc., Princeton, NJ 08540. Spikevax is a trademark of ModernaTX, Inc.

Active ingredient: nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein of the SARS-CoV-2 JN.1-descendent variant XFG.

• 0.5 mL dose: 50 mcg mRNA, with a total lipid content of 1.01 mg (SM-102, PEG 2000 DMG, cholesterol, and DSPC), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose.
• 0.25 mL dose: 25 mcg mRNA, with a total lipid content of 0.50 mg (SM-102, PEG 2000 DMG, cholesterol, and DSPC), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose.

• Spikevax does not contain a preservative.
• The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.