Mosquirix - opinion on medicine for use outside EU
Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)
EU-M4allHuman
Overview
Mosquirix is a vaccine that is given to children aged 6 weeks to 17 months to help protect against malaria caused by the parasite Plasmodium falciparum.
The vaccine should only be used in areas of the world where malaria caused by Plasmodium falciparum is prevalent, and according to official recommendations in those areas. Mosquirix also helps protect against infection of the liver with the hepatitis B virus but should not be used only for this purpose.
Mosquirix is given as a 0.5 ml injection into a muscle of the thigh or in the muscle around the shoulder (the deltoid). The child is given three injections with one month between each injection. A fourth injection is recommended 18 months after the third. The medicine can only be obtained with a prescription.
The active substance in Mosquirix is made up of proteins found on the surface of the Plasmodium falciparum parasites and the hepatitis B virus.
When a child is given the vaccine, the immune system recognises the proteins from the parasite and virus as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when the child is naturally exposed to the malaria parasites and the hepatitis B virus in the future.
Mosquirix induces antibodies against malaria parasites that have entered the blood (via a mosquito bite) and have reached or are traveling to the liver, where they can mature and multiply. The vaccine thus limits the ability of the parasites to mature in the liver and cause clinical disease.
Mosquirix is effective at reducing the number of children who have Plasmodiumfalciparum malaria in the 12 months following the third injection. In a study involving over 12,000 children in 7 African countries, the number of children who had malaria in a 12 month period was lower by 24% among children aged 6 to 12 weeks (at first dose) who were given Mosquirix and by 43% in children given the first dose between the age of 5 to 17 months.
Mosquirix was also shown to induce antibodies against the hepatitis B virus as least as effectively as a currently authorised hepatitis B vaccine.
The most serious side effect reported in clinical studies with Mosquirix was febrile seizures (fits with fever), which occurred in 1 child in 1,000. The most common side effects were fever (in about 1 child in 4), irritability and injection site reactions such as pain (in around 3 children in 20) and swelling (in less than 1 in 10).
Mosquirix must not be used in children who have had a hypersensitivity (allergic) reaction to a previous dose of Mosquirix or to a hepatitis B vaccine.
For the full list of restrictions, see the package leaflet.
Mosquirix provides short-term protection that could potentially save lives in the age group most at risk from malaria. The main study of Mosquirix showed that the vaccine can prevent malaria in children aged 6 weeks to 17 months at the time of the first dose. The protection afforded by the vaccine reduced over time after three doses and, for this reason, a fourth injection is recommended 18 months after the first three injections.
With regard to its risk, the safety of Mosquirix is similar to that of other vaccines. A small number of children may have seizures caused by high fever and can be managed with fever medication in accordance to local guidelines.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of the vaccine outweigh its risks and issued a positive scientific opinion.
A risk management plan has been developed to ensure that Mosquirix is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mosquirix, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the summary of the risk management plan.
The CHMP gave a positive scientific opinion on Mosquirix on 23 July 2015. This opinion was given as part of the EMA’s cooperation with the World Health Organisation, whereby the CHMP provides opinions on medicines that are not intended for use in the EU but are needed to prevent or treat diseases of major public health importance around the world.
For more information about treatment with Mosquirix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: II/0086
27/03/2025
Product information documents contain:
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Pharmacotherapeutic group
Malaria vaccinesTherapeutic indication
Active immunisation of children aged 6 weeks up to 17 months against malaria caused by Plasmodium falciparum and against hepatitis B.
The use of Mosquirix should be based on official recommendations considering Plasmodium falciparum malaria epidemiology in different geographical areas.
Opinion details
Product details
- Name of medicine
- Mosquirix
- EMA opinion number
- H-W-2300
- Opinion status
- Positive opinion
- Active substance
- RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)]
- International non-proprietary name (INN) or common name
- Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)
- Therapeutic area (MeSH)
- Malaria
- Anatomical therapeutic chemical (ATC) code
- J07XA01
Publication details
- Opinion holder
- GlaxoSmithKline Biologicals S.A.
Rue de l'institut 89
1330 Rixensart
Belgium - Date of opinion