Spikevax (previously COVID-19 Vaccine Moderna)
Authorised
This medicine is authorised for use in the European Union
COVID-19 mRNA vaccine
MedicineHumanAuthorised
- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.
The originally authorised Spikevax contains elasomeran, a molecule called messenger RNA (mRNA) with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.
As SARS-CoV-2 keeps evolving, Spikevax has been adapted to target the most recent strains of the virus. This helps maintain protection against COVID-19.
Therefore, Spikevax is also authorised as four adapted vaccines, with Spikevax JN.1 being the most recent:
- Spikevax bivalent Original/Omicron BA.1 contains elasomeran and an additional mRNA molecule, imelasomeran, with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2;
- Spikevax bivalent Original/Omicron BA.4-5 contains elasomeran and an additional mRNA molecule, davesomeran, with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2;
- Spikevax XBB.1.5 contains andusomeran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2;
- Spikevax JN.1 contains SARS‑CoV‑2 JN.1 mRNA, an mRNA molecule with instructions for producing a protein from the Omicron JN.1 subvariant of SARS-CoV-2.
Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.
The originally authorised Spikevax is given in people from the age of 6 months as two injections, usually into the muscle of the upper arm, or the thigh in infants and young children, 28 days apart. A booster dose may be given to adults and children from the age of 6 years, at least 3 months after primary vaccination with Spikevax, or another mRNA vaccine or an adenoviral vector vaccine.
Spikevax bivalent Original/Omicron BA.1 may be given as a single injection to adults and children from the age of 6 years, at least 3 months after primary vaccination or a booster dose with a COVID-19 vaccine.
Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 and Spikevax JN.1 are given as a single injection to adults and children aged 5 years and older, irrespective of their previous COVID-19 vaccination history. In children from 6 months to 4 years of age, they are given as a single injection in those who have completed a primary vaccination course or have had COVID-19 before, or as two injections 28 days apart in those who have not previously been vaccinated against COVID-19 or had COVID-19.
An additional dose of Spikevax, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1 may be given to adults and children aged 6 months and older with a severely weakened immune system.
The vaccines should be used according to official recommendations, issued at national level, by public health bodies.
For more information about using Spikevax, including information about the adapted vaccines and doses for different age groups, see the package leaflet or consult a healthcare professional.
If, later on, the person comes into contact with SARS-CoV-2, their immune system will recognise it and be ready to defend the body against it.
After vaccination, the mRNA from the vaccine is broken down and removed from the body.
Adapted vaccines work in the same way as the original vaccine and are expected to maintain protection against the virus as they contain mRNA more closely matching circulating variants of the virus.
Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.
Another study showed that an additional dose of Spikevax increased the ability to produce antibodies against SARS-CoV-2 in organ transplant patients with severely weakened immune systems.
The effects of Spikevax were also investigated in a study involving over 3,000 children aged 12 to 17 years. The study showed that Spikevax produced a comparable immune response in 12- to 17-year-olds to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. In addition, none of the 2,163 children who received the vaccine developed COVID-19, compared with four of 1,073 children given a dummy injection. These results allowed to conclude that the efficacy of Spikevax in children 12 to 17 years old is similar to that in adults.
An additional study involving three groups of children aged 6 months to under 2 years, 2 to 5 years and 6 to 11 years showed that Spikevax produced a comparable immune response in these age groups to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. These results indicate that the efficacy of Spikevax in children 6 months to 11 years old is similar to that in adults.
Additional data showed that subsequent doses, including boosters, lead to a rise in levels of antibodies against SARS‑CoV‑2.
Based on available data, vaccines adapted to target circulating strains of the virus are expected to elicit a strong immune response against these strains.
Originally authorised Spikevax, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 and Spikevax JN.1 are authorised for adults and children from 6 months of age.
Spikevax bivalent Original/Omicron BA.1 is authorised for adults and children from 6 years of age.
Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.
Severely immunocompromised people may be given an additional dose of Spikevax as part of their primary vaccination.
Spikevax can be used during pregnancy.
A large amount of data from pregnant women vaccinated with Spikevax during the second or third trimester of their pregnancy has been analysed and showed no increase in pregnancy complications. Although data in women in the first trimester of pregnancy are more limited, no increased risk of miscarriage was seen.
Spikevax can be used during breast-feeding. Data from women who were breast-feeding after vaccination have not shown a risk of adverse effects in breast-fed babies.
No data are currently available regarding the use of the adapted vaccines in pregnant or breast-feeding women. However, based on the similarity with the originally authorised Spikevax, including a comparable safety profile, the adapted vaccines can be used during pregnancy and breast-feeding.
People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.
Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred. Therefore, as for all vaccines, Spikevax, including the adapted vaccines, should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when they are given a dose of one of the Spikevax vaccines should not receive subsequent doses.
The main clinical trials for Spikevax included people of different ethnicities and genders. The high efficacy was maintained across genders and ethnic groups.
For the full list of side effects and restrictions with Spikevax, see the package leaflet.
The most common side effects with Spikevax are usually mild or moderate and get better within a few days after vaccination. These include redness, pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea (feeling sick) and vomiting. They may affect more than 1 in 10 people. In infants under 3 years of age, irritability, crying, sleepiness and loss of appetite are also very common side effects (affecting more than 1 in 10 infants).
Hives and rash at the injection site, sometimes occurring more than a week after injection, rash affecting areas other than the injection site and diarrhoea may affect less than 1 in 10 people. Itching at the injection site, dizziness and abdominal pain may affect less than 1 in 100 people. Swelling of the face, which may affect people who had facial cosmetic injections in the past, weakness in muscles on one side of the face (acute peripheral facial paralysis or palsy), paraesthesia (unusual feeling in the skin, such as tingling or a crawling feeling) and hypoaesthesia (reduced sensation to touch, pain and temperature) may affect less than 1 in 1,000 people.
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) may occur in up to 1 in 10,000 people.
A very small number of cases of erythema multiforme (red patches on the skin with a dark red centre and paler red rings) have occurred. Allergic reactions have also occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis).
The safety of the adapted vaccines is comparable to that of the originally authorised Spikevax vaccine.
Data have shown that originally authorised Spikevax and its adapted vaccines cause the production of antibodies against SARS-CoV-2 that can protect against COVID-19. The main trials showed that the originally authorised vaccine has a high efficacy in all age groups. Most side effects are mild to moderate in severity and are gone within a few days.
The European Medicines Agency therefore decided that the benefits of Spikevax, including its adapted vaccines, are greater than its risks, and it can be authorised for use in the EU.
Spikevax was originally given ‘conditional authorisation’ because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety, efficacy, and how well Spikevax prevents severe disease. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spikevax and its adapted vaccines have been included in the summary of product characteristics and the package leaflet.
A risk management plan (RMP) is also in place and contains important information about the vaccine’s safety, how to collect further information and how to minimise any potential risks.
Safety measures for Spikevax and its adapted vaccines are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Spikevax provides regular reports on the safety and efficacy of the vaccine.
As for all medicines, data on the use of Spikevax and its adapted vaccines are continuously monitored. Suspected side effects are carefully evaluated and any necessary action taken to protect patients.
COVID-19 Vaccine Moderna received a conditional marketing authorisation valid throughout the EU on 6 January 2021. This was switched to a standard marketing authorisation on 3 October 2022.
More information about the COVID-19 vaccines is available on the COVID-19 vaccines key facts page.
This overview was last updated in 09-2023.
| Date | Key developments |
|---|---|
| 09/09/2024 | Recommendation to authorise Spikevax vaccine targeting the JN.1 variant |
| 14/09/2023 | Recommendation to authorise monovalent Spikevax vaccine targeting the Omicron XBB.1.5 subvariant |
| 20/07/2023 | Recommendation to authorise use of Spikevax bivalent Original/Omicron BA.4-5 as a single-dose vaccination in people aged 5 years and older, with or without prior vaccination against COVID-19 |
| 20/07/2023 | Recommendation to authorise use of Spikevax bivalent Original/Omicron BA.4-5 for use in infants and children aged 6 months to 4 years, with or without prior vaccination against COVID-19 |
| 26/04/2023 | Recommendation to authorise Spikevax bivalent Original/Omicron BA.4-5 for use as a booster in children aged 6 to 11 years who have received at least primary vaccination against COVID-19 |
| 15/12/2022 | Recommendation to authorise Spikevax and Spikevax bivalent Original/Omicron BA.1 for use as a booster in children aged 6 to 11 years who have received at least primary vaccination against COVID-19 |
| 19/10/2022 | Recommendation to authorise Spikevax bivalent Original/Omicron BA.4-5, a vaccine targeting the original SARS-CoV-2 and the Omicron BA.4 and BA.5 subvariants, for use as a booster in people aged 12 years and older who have received at least primary vaccination against COVID-19 |
| 19/10/2022 | Recommendation to authorise use of Spikevax as a primary vaccination course in children aged 6 months to 5 years |
| 15/09/2022 | Recommendation to convert the conditional marketing authorisation into a standard marketing authorisation |
| 01/09/2022 | Recommendation to authorise Spikevax bivalent Original/Omicron BA.1, a vaccine targeting the original SARS-CoV-2 and the Omicron BA.1 subvariant, for use as a booster in people aged 12 years and older who have received at least primary vaccination against COVID 19 |
| 21/07/2022 | Recommendation to authorise Spikevax as a booster dose for adolescents from 12 years of age already vaccinated with Spikevax |
| 21/07/2022 | Recommendation to approve new manufacturing site for the finished product in Madrid, Spain. |
| 20/07/2022 | Update of the product information to state that stability has been demonstrated for 12 months when Spikevax is stored under certain conditions. |
| 24/02/2022 | Recommendation to authorise Spikevax for children aged 6 to 11 years |
| 24/02/2022 | Recommendation to authorise use of Spikevax as a booster dose for adults who have had another mRNA vaccine or an adenoviral vector vaccine |
| 24/02/2022 | Recommendation to reduce the interval between primary vaccination and booster dose to 3 months |
| 24/02/2022 | Recommendation to approve new manufacturing site for the finished product in Granada, Spain |
| 24/02/2022 | Recommendation to approve changes to increase capacity at active substance manufacturing site in Visp, Switzerland |
| 15/02/2022 | Update of product information with data on use during pregnancy and when breastfeeding |
| 08/12/2021 | Approval of increased shelf life from 7 to 9 months |
| 25/10/2021 | Recommendation to authorise Spikevax as a booster dose for adults already vaccinated with Spikevax |
| 04/10/2021 | Renewal of conditional marketing authorisation |
| 04/10/2021 | Recommendation to authorise third dose for immunocompromised people |
| 23/07/2021 | Recommendation to authorise Spikevax for adolescents aged 12 to 17 years |
| 08/07/2021 | Recommendation to include myocarditis and pericarditis as side effects in product information |
| 06/01/2021 | Conditional marketing authorisation of Spikevax |
The 'Assessment history' section contains a complete list of developments since authorisation.
The 'News' section contains information on manufacturing changes before 2022.
Product information
Latest procedure affecting product information:
X/0140 & VAR/0000264865
23/04/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Spikevax (previously COVID-19 Vaccine Moderna)
- Active substance
- SARS-CoV-2 JN.1 mRNA
- International non-proprietary name (INN) or common name
- COVID-19 mRNA vaccine
- Therapeutic area (MeSH)
- COVID-19 virus infection
- Anatomical therapeutic chemical (ATC) code
- J07BN01
Pharmacotherapeutic group
VaccinesTherapeutic indication
Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.
Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. The use of this vaccine should be in accordance with official recommendations.
Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.
Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.
Assessment history
Safety updates
News on Spikevax (previously COVID-19 Vaccine Moderna)
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