Table 1.
EU prescribing summary of RTS,S/AS01 malaria vaccine (Mosquirix®) [6]. Consult local prescribing information for further details
| What is the approved indication? | |
| Active immunisation of children aged 6 weeks up to 17 months against Plasmodium falciparum malaria and hepatitis B (article 58 approval) | |
| Use should be based on official recommendations that consider the epidemiology of P. falciparum malaria in different geographical areas | |
| How is RTS,S/AS01 available? | |
| Powder (RTS,S antigen) and suspension (AS01 adjuvant), which must be reconstituted prior to administration | |
| What is the composition of RTS,S/AS01? | |
| After reconstitution, one 1 mL vial contains two 0.5 mL vaccine doses. One vaccine dose (0.5 mL) contains 25 µg of RTS,S, adjuvanted with AS01 | |
| RTS,S is a portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS) and combined with hepatitis B surface antigen (S) in the form of non-infectious virus-like particles produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology | |
| AS01 is a liposome-based vaccine adjuvant that comprises 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 25 µg and Quillaja saponaria Molina, fraction 21 (QS-21) 25 µg. MPL is manufactured by GSK while QA-21 is licensed by GSK from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. | |
| How should RTS,S/AS01 be stored? | |
| Shelf-life is 3 years. Do not freeze the product. Store in the original package to protect it from light | |
| From a microbiological standpoint, reconstituted RTS,S/AS01 should be used immediately, although chemical and physical in-use stability has been demonstrated for 6 h at 25° C. If not used immediately, normal storage time is < 6 h in a refrigerator (2°–8° C) | |
| How should RTS,S/AS01 be administered? | |
| Intramuscular injection; the preferred injection site in children aged ≥ 5 months is the deltoid muscle | |
| What are the contraindications to the use of RTS,S/AS01? | |
| Hypersensitivity to the active substance or any of the excipients of RTS,S/AS01, previous doses of RTS,S/AS01 or hepatitis B vaccines | |
| What other special warnings/precautions pertain to the use of RTS,S/AS01? | |
| Protection against P. falciparum malaria | Does not provide complete protection; may delay the natural acquisition of immunity; efficacy wanes over time; efficacy data limited to children from sub-Saharan Africa; does not protect against malaria caused by pathogens other than P. falciparum |
| Protection against hepatitis B | Should not be used for the prevention of hepatitis B when prevention against P. falciparum malaria is not sought |
| Infants at risk of bleeding | Administer with caution in individuals with thrombocytopenia or any coagulation disorders, as bleeding may occur after intramuscular injection |
| Infants with immunodeficiency | No data other than for HIV infection for which data are limited |
| Preterm infants (born ≤ 28 weeks of gestation) | When administering the first three doses, consider the potential risk of apnoea and the need for respiratory monitoring for 48–72 h in infants who remain hospitalized at the time of vaccination, particularly those with a history of respiratory immaturity |
| Which vaccines can be administered concomitantly with RTS,S/AS01? | |
| Monovalent or combination vaccines including diphtheria, tetanus, whole cell pertussis, acellular pertussis, hepatitis B, Haemophilus influenzae type b, oral polio, measles, rubella, yellow fever, rotavirus and pneumococcal conjugate vaccines | |
| What are the potential clinically relevant drug interactions between RTS,S/AS01 and other drugs/vaccines? | |
| Pneumococcal conjugate vaccines | May increase the risk of fever within 7 days after vaccination |
| Rotavirus and pneumococcal conjugate vaccines | May reduce the antibody response to the circumsporozoite antigen of RTS,S/AS01 |
| Immunosuppressive therapy | No data, but decreased efficacy cannot be ruled out |
| Antipyretic prophylaxis | May decrease the immune response to the vaccine, and hence, not recommended |