Spikevax (previously COVID-19 Vaccine Moderna)
Authorised
This medicine is authorised for use in the European Union
COVID-19 mRNA vaccine
MedicineHumanAuthorised
Portuguese is available via eTranslation, the European Commission's machine translation service.
Translate to Portuguese | Important information about machine translation
- 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.
It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from 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.
Three versions of Spikevax are currently authorised, with Spikevax XFG being the most recent:
- Spikevax XFG contains SARS‑CoV‑2 XFG mRNA, an mRNA molecule with instructions for producing a protein from the Omicron XFG subvariant of SARS-CoV-2;
- Spikevax LP.8.1 contains SARS‑CoV‑2 LP.8.1 mRNA, an mRNA molecule with instructions for producing a protein from the Omicron LP.8.1 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 does not contain the virus itself and cannot cause COVID-19.
Spikevax is given as an injection into the muscle of the upper arm.
Adults and children aged 5 years and older should receive a single injection, irrespective of their previous COVID-19 vaccination history.
Children from 6 months to 4 years of age who have previously been vaccinated against COVD-19 or have had COVID-19 should also receive a single injection.
Children from 6 months to 4 years of age who have not previously been vaccinated against COVID-19 and have not had COVID-19 before should receive two injections, given 4 weeks apart.
An additional dose may be given to people with a severely weakened immune system.
The vaccines should be used according to official recommendations in EU Member States.
For more information about using Spikevax, see the package leaflet or consult a healthcare professional.
Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of SARS-CoV-2 which the virus needs to enter the body’s cells and which can differ between variants of the virus.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.
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.
A very large clinical trial showed that the originally authorised Spikevax, given as a two-dose regimen, was effective at preventing COVID‑19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.
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.
Further data showed that vaccines adapted to target circulating strains of the virus are expected to elicit a strong immune response against these strains.
Studies carried out with Spikevax are described in more detail in the medicine’s assessment reports.
Spikevax is authorised for adults and children from 6 months 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 has been analysed and showed no increase in pregnancy complications or problems affecting the newborn baby.
Spikevax can also be used during breast-feeding. Data from women who were breast-feeding after vaccination with Spikevax have not shown a risk of side effects in breast-fed babies.
People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet must 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 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 Spikevax 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 pain, joint pain, nausea (feeling sick) and vomiting. They may affect more than 1 in 10 people. In children 5 years of age and below, irritability, crying, sleepiness and loss of appetite are also very common side effects (affecting more than 1 in 10 children).
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, abdominal pain and hives may affect less than 1 in 100 people. Swelling of the face, which may affect people who had facial cosmetic injections in the past, temporary 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), extensive swelling of the vaccinated limb, heavy menstrual bleeding, mechanical urticaria (hives caused by physical triggers) and chronic (long-lasting) hives have occurred. Allergic reactions have also occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis).
Data have shown that Spikevax, including the adapted vaccines, causes 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 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 was switched to a standard one.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spikevax 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.
As for all medicines, data on the use of Spikevax 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.
The name of the vaccine was changed to Spikevax on 22 June 2021.
More information about the COVID-19 vaccines is available on the COVID-19 vaccines key facts page.
| Date | Key developments |
|---|---|
| 23/07/2026 | Recommendation to authorise Spikevax vaccine targeting the XFG variant |
| 24/07/2025 | Recommendation to authorise Spikevax vaccine targeting the LP.8.1 variant |
| 04/06/2025 | Withdrawal of an application for Spikevax vaccine targeting the KP.2 variant |
| 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:VR/0000356879
28/07/2026
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
- single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
- 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.
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.
Spikevax LP.8.1 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.
Spikevax XFG 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)
Exceptional transparency measures
EMA is making data from the marketing authorisation application for Spikevax publicly available. This is in line with the exceptional transparency measures that EMA adopted during the COVID-19 pandemic.
The documents relate to residual DNA measurement, some quality and non-clinical aspects of the dossier as of 12 June 2025 or released prior to this date under Regulation (EC) 1049/2001.
You will find quality and non-clinical documents grouped according to the structure presented in ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD.
This structure divides the types of documents into 5 modules, of which the sub-modules listed below will be published regularly following consultation with the marketing authorisation holder.
You can subscribe to update notifications by selecting the RSS option available at the top of this page. You will need a news reader or other similar device. To learn more about RSS and news readers, see our RSS user guide.
Reading guide
In the context of these exceptional transparency measures, documents published by EMA that contain Commercially Confidential Information (CCI) and Protected Personal Data (PPD) shall be subject to redaction prior to their disclosure.
CCI and PPD are redacted here following the principles laid out in the HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier. This entails consultation with the Marketing Authorisation Holder (MAH) and a thorough assessment of their justified proposal of redaction by EMA.
In this guidance, Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) agreed on a common approach on what should be considered personal data (PD) and CCI in the Marketing Authorisation Application (MAA) dossier of medicinal products for human use. The definition of CCI and PPD and the principles for the redaction of this information are set out from pages 5 to 13.The Annex to the above-mentioned guidance provides a non-exhaustive list of information that may be considered PPD or CCI in each of the modules of the MAA dossier based on the agreed Common Technical Document (CTD) laid out in the ICH guideline on common technical documents (CTD) for the registration of pharmaceuticals for human use.
As regards the documents published under the exceptional transparency measures, the following pages of the Annex are of relevance:
- For Module 2.3 - Quality Overall Summary: pages 30-33
- For Module 2.4 - Nonclinical Overview: pages 33-34
- For Module 2.6 - Nonclinical Summary: pages 37-39
- For Module 3.2 - Body of quality data: pages 42-47
- For Module 4.2 - Nonclinical study reports: pages 47-49
Therefore, the documents published under the exceptional transparency measures may contain redactions, which are coloured and labelled as follows:
- for CCI: black background with "CCI" overlay text
- for PPD: blue background with "PPD" overlay text
Documents published within the scope of the exceptional transparency measures that have been previously released under an access to document procedure under Regulation (EC) No 1049/2001 follow the above-referred principles regarding the redaction of CCI and PPD. However, the formatting of these labels is different, and the overlay text states the exceptions applied in accordance with Article 4 of Regulation (EC) No 1049/2001.
- for CCI: black background with "4.2 1 ind." overlay text (corresponding to Article 4.2 1st indent of Regulation (EC) No1049/2001) 4.2 1 ind.
- for PPD: black background with "4.1(b)" overlay text (corresponding to Article 4.1 (b) of Regulation (EC) No1049/2001) 4.1(b)
This page was last updated on