TM Owner Moderna
Spikevax 0.5ml Injection
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Indications & Clinical Uses
- Spikevax (elasomeran) is a lipid-nanoparticle mRNA vaccine from Moderna that encodes the SARS-CoV-2 spike protein, used for active immunisation against COVID-19.
- In the EU, the current seasonal formula is approved for people 6 months of age and older.
- In the US, the 2025-2026 formula is approved for adults 65 and older and for people aged 6 months to 64 years who have at least one underlying condition that raises the risk of severe COVID-19 - healthy younger people are not currently included in the US-approved population, so eligibility differs by country.
- Adults and adolescents (12 years and older) receive a 0.5 mL dose; younger children receive smaller 0.25 mL doses on an age-based schedule.
- It is given as a single intramuscular injection by a healthcare professional; it is never self-administered.
Side Effects
- Very common effects (more than 1 in 10 people) include pain, swelling and tenderness at the injection site, tiredness, headache, muscle and joint pain, and chills; these usually resolve within a few days.
- No boxed warning currently appears on the Spikevax label; however, the label carries a specific warning that Spikevax increases the risk of myocarditis (heart muscle inflammation) and pericarditis, typically within days of vaccination and most often after a second dose in younger males - most cases recover, but some patients have needed hospital or intensive care, and fatal cases have been reported.
- Seek emergency care straight away for new or worsening chest pain, shortness of breath, or a rapid or irregular heartbeat, especially in the two weeks after a dose.
Precautions & Warnings
- Do not give Spikevax to anyone with a known severe allergic reaction, such as anaphylaxis, to a previous dose or to any vaccine component; observe patients after injection in case of an immediate reaction, and have treatment for anaphylaxis available on site.
- Vaccination is usually delayed during acute moderate-to-severe illness with fever until recovery.
- Anyone with a history of myocarditis or pericarditis after a previous mRNA COVID-19 vaccine dose should discuss the risks and benefits with their provider before another dose.
- There is no controlled-distribution programme; it is given only by trained staff in a clinic setting, never at home, so there is no patient home-storage or missed-dose situation for the recipient to manage.
Avoid Interactions
- Spikevax can be given at the same visit as other vaccines, using separate injection sites, though this may increase the chance of injection-site reactions from each shot.
- Tell your healthcare provider about any immunosuppressive treatment or condition, since a weakened immune system can reduce the vaccine's protective response.
- There are no known food interactions or specific medicines you must avoid entirely.
- Discuss any recent or planned vaccinations, immunosuppressant medicines, or a previous episode of myocarditis or pericarditis with your provider beforehand, so the timing and monitoring around your dose can be adjusted appropriately.
References
Frequently Asked Questions
Spikevax is an mRNA vaccine from Moderna that helps prevent COVID-19. In the EU it's approved from 6 months of age; in the US, the current formula is approved for people 65 and older and those aged 6 months to 64 with a condition that raises COVID-19 risk.
Spikevax is given as a single injection into the muscle, usually in the upper arm, by a healthcare professional. Adults and children 12 and older receive 0.5 mL; younger children get smaller 0.25 mL doses. It's never given at home or self-injected.
Very common Spikevax side effects include pain, swelling and tenderness where the injection was given, tiredness, headache, muscle aches, joint pain, and chills, usually settling within days. Get emergency help for chest pain, shortness of breath, or a fast or irregular heartbeat, as these can signal myocarditis or pericarditis.
Tell your provider about any severe allergic reaction to a previous dose, or any history of myocarditis or pericarditis after an mRNA COVID-19 vaccine, before getting Spikevax. Vaccination is usually delayed if you have a moderate or severe acute illness with fever, until you recover.
Yes. Spikevax carries a warning for myocarditis and pericarditis, most often within days of vaccination and more common in younger males after a second dose. Most people recover, but some have needed hospital care, and fatal cases have occurred. Seek urgent care for chest pain or breathlessness.
Eligibility depends on where you live. In the EU, Spikevax is approved from 6 months of age. In the US, the current formula covers adults 65 and older and people aged 6 months to 64 with an underlying condition raising COVID-19 risk. Ask your provider which applies to you.
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