[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.

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