First-Ever Malaria Vaccine Will Soon Be Available

The European Medicines Agency is recommending the first-ever malaria vaccine, GSK’s Mosquirix, as a protection for children ages six weeks to 17 months in sub-Saharan Africa

Developed with the PATH Malaria Vaccine Initiative and grants from the Bill & Melinda Gates foundation, Mosquirix — also known as RTS,S — also protects against hepatitis B, according to the EMA’s Committee for Medicinal Products for Human Use.

The vaccine targets the most prevalent and deadly form of the disease, which kills 584,000 annually — 90 percent in sub-Saharan Africa and 83 percent are children younger than 5.

Although it will not be available in any EU member states, the EMA put the vaccine through its review process as a prerequisite for a World Health Organization review scheduled for October. WHO will consider factors not addressed by the EMA, such as ease of implementation, affordability and how the vaccine compares with other malaria control measures in meeting public health needs. The organization expects to issue a decision in November.

If the vaccine receives WHO approval, regulators in individual African countries where it will be used will make their own approval decisions. GSK will need to apply for country-by-country authorization.

CHMP based its recommendation on a Phase 3 clinical trial involving more than 16,000 young children in eight African countries — Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria and Tanzania. — Kellen Owings