Malaria vaccine gets go-ahead from EU regulators

The European drug regulators recommended that the drug should be licensed to be used on babies in Africa who are at high risk of the mosquito-borne disease.

The vaccine, which is aimed at young children, received a positive scientific opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on Thursday.

The jab, which is also known as RTS, S and was developed in partnership with the PATH Malaria Vaccine Initiative, is targeted towards children aged six weeks to 17 months, and is the first candidate vaccine for the prevention of the parasitic infection to reach this milestone.

Malaria caused about 584,000 deaths in 2013, and about 453,000 of those were children under the age of five, according to the World Health Organization.

The world’s first malaria vaccine is to be considered for use in national immunisation programmes after being given the scientific seal of approval. “PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps”.

Some malaria specialists have expressed concern that the complexities and potential costs of deploying this first vaccine when it provides only partial protection make it less attractive and more risky.

After decades of research, Mosquirix, developed by GlaxoSmithKline, is the first vaccine for malaria to be assessed by a regulatory agency.

GSK began research on a malaria vaccine 30 years ago and the first trials in Africa began in 1998.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS, S into local immunisation programmes supported by UNICEF. Its recommendations will take into account several additional factors not addressed by EMA, such as feasibility of implementation, affordability, cost-effectiveness, and the public health value of the vaccine in relation to other available malaria control measures and vaccines. It works by stopping the malaria parasite maturing and multiplying in the liver, after which it would normally enter the patient’s bloodstream and trigger the disease symptoms.

Agenus is an immunology company engaged in the discovery and development of novel checkpoint modulators, vaccines and adjuvants to treat cancer and other diseases.

But three doses were needed and efficacy dimmed over time, which has led some to question whether the cost of rolling out the vaccine can be justified.

“It’s massively significant”, said Allan Pamba, vice president for pharmaceuticals in East Africa for GlaxoSmithKline (GSK), which has spent more than $356 million (£230m) to date on finding a vaccine.

RTS, S is the most advanced malaria vaccine candidate in development globally.