mCombriax
Authorised
This medicine is authorised for use in the European Union
influenza mRNA vaccine / COVID-19 mRNA vaccine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
mCombriax is a vaccine for protecting people aged 50 years and older against seasonal influenza (flu) and COVID-19.
mCombriax contains as its active substance messenger RNA (mRNA) with instructions for producing proteins from the influenza virus and SARS-CoV-2, the virus that causes COVID-19.
mCombriax does not contain the viruses themselves and cannot cause flu or COVID-19.
mCombriax is given as a single injection into the muscle of the upper arm. In people previously vaccinated against COVID-19, mCombriax should be given at least 3 months after the last COVID-19 vaccine.
The vaccine should be used according to official recommendations issued at national level by public health bodies.
mCombriax can only be obtained with a prescription. For more information about using mCombriax, see the package leaflet or contact your doctor or pharmacist.
mCombriax works by preparing the body to defend itself against influenza and COVID-19. It contains a molecule called mRNA which has instructions for making proteins from the influenza virus and SARS-CoV-2.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce these proteins. The person’s immune system will then recognise the proteins as foreign and produce antibodies and activate T cells (white blood cells) to attack them.
If, later on, the person comes into contact with the viruses, the immune system will recognise them and be ready to defend the body against them.
After vaccination, the mRNA from the vaccine is broken down and removed from the body.
Data from a main study involving over 8,000 people from 50 years of age showed that people who received mCombriax had levels of antibodies against influenza and SARS-CoV-2 that were similar to those seen in people who received either Fluzone HD or Fluarix (authorised influenza vaccines) and Spikevax (an authorised COVID-19 mRNA vaccine) at the same time.
In addition, a study of a similar mRNA vaccine containing only the influenza component in mCombriax showed that the influenza component (at a different dose) can trigger an adequate immune response to prevent influenza illness.
mCombriax is only authorised for adults aged 50 years and older.
There are no data on immunocompromised people (people with weakened immune systems). 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 and influenza.
There is a lack of data on the use of mCombriax in pregnancy. Animal studies do not show harmful effects in pregnancy. As a precaution, it is preferable not to use mCombriax during pregnancy.
No effects on breastfed babies are expected. mCombriax can be used during 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 must not receive the vaccine. As for all vaccines, mCombriax should be given under close medical supervision, with the appropriate medical treatment available.
People who have had a severe allergic reaction after being given mCombriax should not receive the vaccine again.
The main mCombriax trial included people of different ethnicities and genders. Studies showed no differences in how the vaccine works in people of different genders and ethnicities.
For the full list of side effects and restrictions with mCombriax, see the package leaflet.
The most common side effects with mCombriax (which may affect more than 1 in 10 people) include injection site pain, tiredness, muscle pain, joint pain, headache, chills, swollen or tender lymph nodes under the arm, nausea (feeling sick), vomiting and fever. They typically start 2 days after vaccination and last for around 3 days.
The main study showed that people from 50 years of age who receive mCombriax have levels of antibodies against influenza and SARS-CoV-2 comparable to those seen in people who received an authorised COVID-19 and influenza vaccine at the same time. Data from another study showed that the influenza component of mCombriax (at a different dose) can prevent influenza.
Although side effects were more common with mCombriax than with the comparator combinations, they were generally mild and short-lived.
The European Medicines Agency therefore decided that mCombriax’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of mCombriax have been included in the summary of product characteristics and the package leaflet.
A risk management plan (RMP) for mCombriax is 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 mCombriax are continuously monitored. Suspected side effects reported with mCombriax are carefully evaluated and any necessary action taken to protect patients.
mCombriax received a marketing authorisation valid throughout the EU on 20 April 2026.
Product information
20/04/2026
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
- mCombriax
- Active substance
- single-stranded, 5’-capped messenger RNAs (mRNAs) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding seasonal influenza haemagglutinin (HA) glycoproteins: A/H1N1, A/H3N2, B/Victoria
- International non-proprietary name (INN) or common name
- influenza mRNA vaccine
- COVID-19 mRNA vaccine
- Therapeutic area (MeSH)
- Influenza, Human
- COVID-19 virus infection
- Anatomical therapeutic chemical (ATC) code
- J07B
Pharmacotherapeutic group
VaccinesTherapeutic indication
mCombriax is indicated for active immunisation for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
News on mCombriax
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