TM Owner Serum Institute of India
R21/Matrix-M 0.5 mL Vial (Suspension for Injection)
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Indications & Clinical Uses
- R21/Matrix-M is a recombinant protein-based malaria vaccine combining the R21 circumsporozoite antigen from Plasmodium falciparum with Novavax's Matrix-M adjuvant, developed by the University of Oxford and manufactured at scale by the Serum Institute of India.
- It is given as a single-dose vial suspension for intramuscular injection and is indicated for active immunisation of children aged 5 to 36 months for the prevention of clinical malaria caused by P. falciparum in malaria-endemic areas; it is not intended for travellers or for adults.
- R21/Matrix-M received WHO prequalification on 21 December 2023 -- the second malaria vaccine to do so, after RTS,S/AS01 -- enabling procurement through UNICEF and Gavi, and has separately received national regulatory approval in Ghana, Nigeria and Burkina Faso.
- It is administered only by trained healthcare or immunisation programme staff, never self-administered, and is given as part of a national malaria vaccination schedule alongside other recommended malaria-prevention measures, not as a stand-alone replacement for them.
Side Effects
- In clinical trials of R21/Matrix-M, the most common reactions after the fourth (booster) dose were fever (reported in almost half of vaccinated children), pain and swelling at the injection site, loss of appetite and drowsiness; these are typical of paediatric vaccines and usually resolve within a few days.
- The most notable serious adverse event identified was febrile convulsion occurring within 7 days of vaccination, reported in a small proportion of recipients (about 0.15%) -- caregivers should seek prompt medical attention if a child develops a high fever with seizure-like movements after vaccination.
- There is no boxed warning on the WHO-prequalified product information.
- As with any vaccine, a severe allergic reaction (anaphylaxis) is possible shortly after the injection, so vaccination is generally given where this can be recognised and treated immediately, and children are typically observed for a short period afterward.
Precautions & Warnings
- R21/Matrix-M should not be given to a child with a known hypersensitivity to the vaccine's active substances or excipients, or who has had a previous allergic reaction to this vaccine or to a hepatitis B-containing vaccine.
- Vaccination should be postponed in a child with acute severe febrile illness until they have recovered, though minor illnesses such as a cold do not require delay.
- Caution is advised in children with thrombocytopenia or any bleeding disorder because of the intramuscular injection route.
- There is no efficacy or safety data in children who are significantly immunocompromised, so protection cannot be guaranteed in this group.
- R21/Matrix-M does not eliminate the need for other malaria-prevention measures such as insecticide-treated bed nets and prompt treatment of suspected malaria; it is a preventive addition to, not a replacement for, these measures.
- It is given only by trained immunisation staff and is not for parental self-administration.
Avoid Interactions
- R21/Matrix-M has been studied for co-administration with other childhood vaccines used in African immunisation schedules, including measles-rubella and yellow fever vaccines given at 9 months of age, with no evidence of reduced immune response to either vaccine when given together.
- When R21/Matrix-M is given at the same visit as another injectable vaccine, each vaccine should be injected at a different site, typically a different limb, to allow separate monitoring of any local reaction.
- There are no known food or drug interactions relevant to this vaccine.
- As with other vaccines, immunosuppressive therapies or significant immunocompromise may reduce the immune response generated, so healthcare providers should be told about any immunosuppressive treatment, chronic illness or prior vaccine reactions before a dose is given.
References
Frequently Asked Questions
R21/Matrix-M is a malaria vaccine that protects young children from clinical malaria caused by Plasmodium falciparum. It's approved for children aged 5 to 36 months in malaria-endemic areas. Oxford University developed it; the Serum Institute of India manufactures it.
R21/Matrix-M is given as a 0.5 mL injection into the muscle by a trained healthcare worker. The primary series is three monthly doses, followed by a fourth booster dose about 12 months later. It is never given by a parent at home.
R21/Matrix-M commonly causes fever, injection-site pain and swelling, loss of appetite and drowsiness, especially after the booster dose. Rarely, a child may have a febrile seizure within a week of vaccination -- seek urgent care if this happens. Most reactions settle within a few days.
Yes. Studies show R21/Matrix-M can be given at the same visit as measles-rubella and yellow fever vaccines without reducing either vaccine's effect. Each vaccine is injected at a separate site. Vaccination is delayed if the child has an acute severe fever until they recover.
The WHO granted R21/Matrix-M prequalification on 21 December 2023, the second malaria vaccine to reach this status. It had already been approved in Ghana, Nigeria and Burkina Faso. Prequalification allows UNICEF and Gavi to procure it for national immunisation programmes across Africa.
No. R21/Matrix-M reduces the risk of clinical malaria but doesn't replace insecticide-treated bed nets or prompt treatment of suspected malaria. It works best combined with these measures. Efficacy was around 75% at high-transmission sites and 68% at year-round transmission sites over 12 months.
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