Immunization, Vaccines and Biologicals

Malaria vaccines

Introduction and malaria vaccine development

Up-to-date information on malaria disease burden, status of malaria control and elimination, and evidence-based policy on malaria preventive, diagnostic and treatment measures is available on the WHO Global Malaria Programme web site.

Status of vaccine development

The complexity of the malaria parasite makes development of a malaria vaccine a very difficult task. Given this, there is currently no commercially available malaria vaccine, despite many decades of intense research and development effort. Over 20 subunit vaccine constructs are currently being evaluated in clinical trials or are in advanced preclinical development. See link to Rainbow table below.

The malaria vaccine candidate RTS,S/AS01

RTS,S/AS01 is the most advanced vaccine candidate against the most deadly form of human malaria, Plasmodium falciparum. A Phase III trial began in May 2009 and has now completed enrolment with 15 460 children in the following seven countries in sub-Saharan Africa: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and the United Republic of Tanzania.

There are two groups in the trial:

  • children aged 5-17 months at first dose receiving only the RTS,S/AS01 vaccine; and
  • children aged 6-14 weeks at first dose who receive the same malaria vaccine in co-administration with pentavalent vaccines in the routine immunization schedule.

Both groups receive 3 doses of RTS,S/AS01 vaccine at 1 month intervals.

According to the current trial schedule, the Phase III trial data required in order for WHO to consider making a policy recommendation is expected to become available to WHO in late 2014.

A comprehensive WHO Q&A on RTS,S/A01 gives further information on policy and regulatory pathways. See link below.