Spikevax

Pronunciation: SPIK-vax
Generic name: COVID-19 Vaccine, mRNA
Other brand names of COVID-19 Vaccine, mRNA include: Spikevax 2025-2026 Formula, mNEXSPIKE
Dosage form: suspension for intramuscular injection (0.25 mL, 0.5 mL)
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 19, 2025.

What is Spikevax? COVID-19 Vaccine

Spikevax 2025-2026 formula is Moderna's latest FDA-approved COVID-19 vaccine designed to target the LP.8.1 variant of SARS-CoV-2. This updated mRNA vaccine helps your body develop immunity against currently circulating COVID-19 strains for the 2025-2026 respiratory virus season.

Key Features:

• Updated targeting: Formulated against LP.8.1 variant (JN.1 lineage)
• FDA approved: August 27, 2025
• No live virus: Cannot cause COVID-19
• mRNA technology: Instructs cells to produce spike protein for immune recognition
• Global approval: Also approved in Canada, Europe, Japan, and Switzerland.

Who Can Get Spikevax 2025-2026?

Approved Age Groups:

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

High-Risk Conditions Include:

• Chronic respiratory diseases (asthma, COPD)
• Heart disease and cardiovascular conditions
• Diabetes (Type 1 and Type 2)
• Chronic kidney disease
• Chronic liver disease
• Immunocompromised conditions
• Obesity (BMI ≥30)
• Cancer or history of cancer
• Neurologic conditions
• Pregnancy.

Note: In the U.S., some states may have differing rules on vaccinations, particularly if you live in the West. If you are unsure of your vaccination eligibility, check with your local healthcare provider or pharmacist.

Important: Spikevax may not provide protection to all individuals who receive the vaccine. Breakthrough infections can still occur, but vaccination significantly reduces the risk of severe COVID-19, hospitalization, and death.

New mNEXSPIKE Option

Moderna's new COVID-19 vaccine mNEXSPIKE is available for:

• Ages 12 through 64 years with high-risk conditions
• All adults 65 years and older.

Update: ACIP Meeting September 19, 2025:

Key COVID-19 vaccination decisions made, awaiting CDC director approval (typically accepted).

• No Prescription Required: The ACIP voted 6-6 against requiring prescriptions for COVID-19 vaccines, with the chair casting a dissenting vote. Members argued that prescriptions create barriers for underinsured populations at the highest risk.
• Updated Recommendations: Unanimous approval for individual decision-making approach. Adults 65 and older, as well as individuals aged 6 months to 64 years, use shared clinical decision-making, emphasizing a higher benefit for those with increased severe COVID-19 risk factors.

How Spikevax Works

Spikevax delivers modified messenger RNA (mRNA) into your cells, instructing them to produce the coronavirus spike protein. Your immune system learns to recognize this protein, creating protection against COVID-19. The 2025-2026 formula specifically targets the LP.8.1 variant based on FDA guidance for current circulating strains.

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

Spikevax Side Effects

Common Side Effects by Age Group

Infants (6-36 months):

• Irritability/crying
• Pain and swelling at the injection site
• Sleepiness
• Loss of appetite
• Fever
• Armpit or groin swelling.

Children (37 months-11 years):

• Pain and swelling at the injection site
• Fatigue and headache
• Muscle pain (myalgia)
• Chills and nausea/vomiting
• Armpit (axillary) or groin swelling/tenderness
• Fever and joint pain.

Adolescents (12-17 years):

• Injection site pain and swelling
• Fatigue and headache
• Muscle and joint pain
• Nausea/vomiting.

Adults (18-64 years):

• Pain at the injection site
• Fatigue and headache
• Muscle and joint pain
• Chills and lymph node swelling
• Nausea/vomiting.

Adults (65+ years):

• Injection site pain
• Fatigue and headache
• Muscle and joint pain
• Chills and lymph node swelling. 

Serious Side Effects and Warnings

Serious Allergic Reactions

Rarely, severe allergic reactions may occur within minutes to 1 hour after vaccination. For this reason, 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 your face and throat
• A fast heartbeat
• A rash all over your body
• Dizziness and weakness.

Heart Inflammation (Myocarditis/Pericarditis)

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including Spikevax.

• Most common in: Males aged 12-24 years
• Occurrence rate: 8 cases per million doses (ages 6 months-64 years); 27 cases per million in males 12-24 years
• Timing: Usually within two weeks of vaccination.

Seek immediate medical attention for:

• Chest pain
• Shortness of breath
• Heart palpitations

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). The VAERS toll-free number is 1-800-822-7967, or report online to https://vaers.hhs.gov/reportevent.html.

Related/similar drugs

Before receiving Spikevax

Do Not Get Spikevax if You:

• Have had a severe allergic reaction to a previous Spikevax or Moderna COVID-19 vaccine
• Are allergic to any vaccine components. 

Tell Your Healthcare Provider if You: 

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

Pregnancy and Breastfeeding

Spikevax during pregnancy is generally considered safe. Major health organizations (CDC, ACOG, AAP) recommend COVID-19 vaccination for pregnant individuals. Pregnant women with COVID-19 face increased risk of severe outcomes.  

Pregnancy Registry: Call 1-866-MODERNA (1-866-663-3762) to enroll.

Breastfeeding: Limited data available: discuss benefits vs risks with your healthcare provider. 

How is Spikevax given?

Spikevax is given to you by a healthcare provider as an injection into the deltoid muscle of the upper arm.

Administration:

• Method: Intramuscular injection (usually deltoid muscle)
• Single dose: One injection per person
• Timing: At least 2 months after last COVID-19 vaccine (if previously vaccinated)

Dose Sizes:

• Ages 6 months-11 years: 0.25 mL (25 mcg mRNA)
• Ages 12 years and older: 0.5 mL (50 mcg mRNA)

Special Dosing for Infants (6-23 months):

• No previous Moderna doses: 2 doses of 0.25 mL (months 0 and 1)
• 1 previous dose: Single 0.25 mL dose (one month after previous Moderna COVID-19 vaccine)
• 2+ previous doses: Single 0.25 mL dose (≥2 months after previous Moderna COVID-19 vaccine)

What other drugs will affect Spikevax?

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.

Spikevax 2025-2026 Ingredients

Active Ingredient:

LP.8.1 variant mRNA: Nucleoside-modified messenger RNA encoding pre-fusion stabilized Spike glycoprotein of SARS-CoV-2 Omicron variant LP.8.1

Inactive Ingredients:

• Lipid content (SM-102, PEG 2000 DMG, cholesterol, DSPC)
• Tromethamine and tromethamine hydrochloride
• Acetic acid and sodium acetate trihydrate
• Sucrose
• No preservatives or natural rubber latex.

Manufacturer

Manufactured for Moderna US, Inc., Princeton, NJ 08540.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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