mNEXSPIKE

mNEXSPIKE is a COVID-19 vaccine containing messenger RNA (mRNA) technology designed to protect against COVID-19 infection. The 2026-2027 Formula is the latest updated version of Moderna's next-generation mRNA COVID-19 vaccine, targeting the SARS-CoV-2 JN.1-descendent variant XFG.

mNEXSPIKE cannot cause COVID-19 because it does not contain the SARS-CoV-2 virus. Instead, it uses mRNA technology to instruct cells to produce a protein that triggers immune protection against COVID-19.

Key facts about mNEXSPIKE

• Generic name: COVID-19 Vaccine, mRNA (2026-2027 Formula)
• Brand name: mNEXSPIKE
• Drug class: Vaccines
• Mechanism of action: mRNA technology
• Initial U.S. approval: 2025
• Dose: a single 0.2 mL dose containing 10 mcg of nucleoside-modified mRNA
• Manufacturer: Moderna US, Inc.

mNEXSPIKE is FDA-approved for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals who are:

• 65 years of age and older, or
• 12 years 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 does not list which conditions count as high risk. The CDC maintains the list of underlying conditions associated with higher risk of severe COVID-19; check current CDC guidance or ask your healthcare provider or pharmacist whether a particular condition qualifies.

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: mNEXSPIKE may not protect all people who receive the vaccine.

mNEXSPIKE uses messenger RNA (mRNA) formulated in lipid particles to deliver genetic instructions into host cells. Unlike vaccines that encode the entire spike protein, mNEXSPIKE encodes only two parts of it — the N-terminal domain (NTD) and the receptor-binding domain (RBD) of the SARS-CoV-2 spike glycoprotein. The vaccine elicits an immune response to these targets, which protects against COVID-19.

Contraindications

Do not receive mNEXSPIKE if you have a known history of a severe allergic reaction (such as anaphylaxis) to:

• any component of mNEXSPIKE (see ingredients below), or
• a previous dose of SPIKEVAX (COVID-19 Vaccine, mRNA) or any Moderna COVID-19 vaccine authorized for emergency use.

Tell your healthcare provider if you have

• Any allergies or a history of severe allergic reactions
• Had a reaction to a previous COVID-19 vaccine
• A history of myocarditis or pericarditis
• A current illness or fever
• A bleeding disorder, or are taking blood-thinning medication
• Immune system problems, or are taking immunosuppressive medication
• Pregnancy, or are planning a pregnancy
• Are breastfeeding
• A history of fainting with injections

Pregnancy

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

An animal developmental toxicity study, in which female rats received 8 times the human mRNA dose twice before mating and twice during gestation, revealed no evidence of harm to the fetus and no evidence of effects on female fertility.

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 individual circumstances.

Breastfeeding

It is not known whether mNEXSPIKE 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 mNEXSPIKE and any potential adverse effects on the breastfed infant.

Children

Safety and effectiveness in individuals 12 through 17 years of age with at least one underlying high-risk condition is based on data in this age group and in adults. Safety and effectiveness have not been established in individuals younger than 12 years of age.

Common side effects

The most commonly reported side effects (10% or more) in clinical trials were:

• Ages 12 through 17 years: injection site pain (up to 68.8%), headache (up to 54.5%), fatigue (up to 47.3%), muscle pain (up to 39.2%), swelling or tenderness in the armpit (up to 34.6%), chills (up to 31.6%), joint pain (up to 23.9%), and nausea or vomiting (up to 16.1%).
• Ages 18 through 64 years: injection site pain (up to 74.8%), fatigue (up to 54.3%), headache (up to 47.8%), muscle pain (up to 41.6%), joint pain (up to 32.4%), chills (up to 24.3%), swelling or tenderness in the armpit (up to 21.7%), and nausea or vomiting (up to 13.8%).
• Ages 65 years and older: injection site pain (up to 54.6%), fatigue (up to 43.0%), headache (up to 33.1%), muscle pain (up to 30.5%), joint pain (up to 25.7%), chills (up to 16.5%), nausea or vomiting (up to 11.4%), and swelling or tenderness in the armpit (up to 10.7%).

Serious side effects and warnings

Severe allergic reactions (anaphylaxis)

There is a small risk that mNEXSPIKE could cause a severe allergic reaction. Appropriate medical treatment must be immediately available to manage a potential anaphylactic reaction, and your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Seek emergency medical attention immediately if you experience:

• Difficulty breathing or shortness of breath
• Swelling of the face, lips, tongue, or throat
• Rapid heartbeat or palpitations
• Widespread skin rash or hives
• Severe dizziness or fainting
• Weakness or feeling faint

Timeline: usually occurs within minutes to 1 hour after vaccination.

Heart inflammation (myocarditis and pericarditis)

Analyses of postmarketing data from mRNA COVID-19 vaccines 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.

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

• 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 retrospective study of hospitalized patients diagnosed with COVID-19 vaccine-associated myocarditis, abnormal cardiac MRI findings that mark myocardial injury were commonly still present at a median follow-up of about 5 months. The clinical and prognostic significance of these findings is not known, and information is not yet available on potential long-term effects.

Warning signs to watch for, particularly in the first 2 weeks after vaccination:

• Chest pain or pressure
• Shortness of breath or difficulty breathing
• 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 mNEXSPIKE.

Report vaccine side effects to VAERS (Vaccine Adverse Event Reporting System) at 1-800-822-7967 or vaers.hhs.gov, or tell your healthcare provider. You can also report to ModernaTX, Inc. at 1-866-663-3762.

mNEXSPIKE is given as a single injection into a muscle, usually the deltoid muscle of the upper arm. It is supplied in single-dose prefilled syringes and is administered by a healthcare professional.

Dosing information

• Volume: 0.2 mL per dose (10 mcg of nucleoside-modified mRNA)
• Route: intramuscular injection only
• Schedule: a single dose, given at least 3 months after the last dose of any COVID-19 vaccine

If you have recently had a COVID-19 infection, talk to your healthcare provider about how long to delay vaccination.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Immunosuppressive medications may reduce the immune response to the vaccine
• Blood thinners may increase the risk of bruising at the injection site.

• Refrigerated storage: 2°C to 8°C (36°F to 46°F). Do not freeze.
• 8°C to 25°C (46°F to 77°F): up to 12 hours.
• During storage, minimize exposure to room light and avoid direct sunlight and ultraviolet light. Syringes can be handled in room light conditions.

mNEXSPIKE is supplied as a carton of 10 single-dose prefilled syringes (NDC 80777-401-60), each containing one 0.2 mL dose.

Active ingredient: 10 mcg nucleoside-modified messenger RNA (mRNA) encoding the N-terminal domain (NTD) and receptor-binding domain (RBD) of the spike glycoprotein of the SARS-CoV-2 JN.1-descendent variant XFG.

Other ingredients: a total lipid content of 0.2 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.09 mg tromethamine, 0.51 mg tromethamine hydrochloride, and 17 mg sucrose.

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