Despite recent progress in reducing deaths attributable to
malaria, it continues to claim approximately 500,000 lives per year and is associated with approximately 200 million
infections. New tools, including safe and effective
vaccines, are needed to ensure that the gains of the last 15 years are leveraged toward achieving the ultimate goal of
malaria parasite eradication. In 2015, the European Medicines Agency announced the adoption of a positive opinion for the
malaria vaccine candidate most advanced in development, RTS,S/AS01, which provides modest protection against clinical
malaria; in early 2016, WHO recommended large-scale pilot implementations of RTS,S in settings of moderate-to-high
malaria transmission. In alignment with these advancements, the community goals and preferred product characteristics for next-generation
vaccines have been updated to inform the development of
vaccines that are highly efficacious in preventing clinical
malaria, and those needed to accelerate parasite elimination. Next-generation
vaccines, targeting all stages of the parasite lifecycle, are in early-stage development with the most advanced in Phase 2 trials. Importantly, progress is being made in the definition of feasible regulatory pathways to accelerate timelines, including for
vaccines designed to interrupt transmission of parasites from humans to mosquitoes. The continued absence of financially lucrative, high-income markets to drive investment in
malaria vaccine development points to continued heavy reliance on public and philanthropic funding.