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[The RTS,S/AS01 malaria vaccine in children aged 5-17 months at first vaccination]
Pascale Vandoolaeghe1, Lode Schuerman1
1GSK Vaccines, Wavre, Belgium.
Insights
The RTS,S/AS01 malaria vaccine pilot program evaluates its real-world effectiveness and safety in children. Successful implementation of the four-dose schedule could lead to wider malaria vaccine use.
Area of Science:
- Vaccinology
- Public Health
- Infectious Diseases
Background:
- The RTS,S/AS01 malaria vaccine received European Medicines Agency (EMA) scientific opinion in July 2015.
- The World Health Organization (WHO) recommended pilot introduction for children aged 5 months and older.
- A four-dose schedule was proposed: 3 initial doses and a 4th dose 15-18 months later.
Purpose of the Study:
- To evaluate the real-world effectiveness of the RTS,S/AS01 malaria vaccine.
- To assess the vaccine's impact on mortality and safety within routine immunization programs.
- To determine the feasibility of implementing the four-dose vaccination schedule.
Main Methods:
- Pilot introduction of the RTS,S/AS01 vaccine in children aged 5 months or older.
- Utilizing a four-dose vaccination schedule.
- Evaluating vaccine effectiveness under real-life conditions.
Main Results:
- Clinical trials and models indicate substantial public health impact, especially in highly endemic areas.
- The most significant impact was observed in children aged 5 months and older receiving four doses.
- Real-world evaluation will assess mortality impact, safety, and implementation feasibility.
Conclusions:
- The RTS,S/AS01 malaria vaccine shows promise for reducing malaria burden when combined with other control measures.
- Pilot studies are crucial for understanding the vaccine's performance in routine settings.
- Successful implementation could facilitate broader use of this malaria vaccine.
Abstract:
RTS,S/AS01 malaria vaccine received a favorable scientific opinion from the European Medicines Agency (EMA) in July 2015. The World Health Organization (WHO) recommended the pilot introduction of this vaccine in children aged 5 months or older using a vaccination schedule which included 3 initial doses separated by at least 1 month and a 4th dose administered 15-18 months after the 3rd dose. Clinical trials and mathematical models showed that the partial protection against malaria conferred by vaccine RTS,S/AS01 Malaria Vaccine could have a substantial impact on public health if the vaccine was used in association with other control measures for malaria, in particular in highly endemic areas. The most significant impact was observed in children aged 5 months or older who received 4 doses of RTS,S/AS01. Vaccine effectiveness will then be evaluated under real-life conditions in order to determine its impact on mortality, its safety in the context of routine immunization and the feasibility of implementing the 4-dose vaccination schedule requiring new immunization contacts. If successful, this would pave the way for larger-scale implementation.
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