GSK seeks approval for malaria vaccine: A huge first

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vaccAfter thirty years of research, the British drug company GlaxoSmithKline announced that it is seeking the approval of the European Medicines Agency (EMA) for its anti-malaria vaccine, known as RTS,S.

In October 2013, the company announced the results of its vaccine trial in infants 6 to 12 weeks old, and older babies 5 to 17 months old at their first vaccination. After 18 months of follow-up, the younger group experienced a 27 percent decrease in cases of clinical malaria compared to like-aged infants who had received a placebo vaccination. Babies who received their first vaccination at 5 to 17 months of age experienced 48 percent fewer cases than same-aged infants injected with the placebo. Glaxo estimated that for the older babies, the vaccination prevented an average of 941 cases of clinical malaria for every 1000 children vaccinated. For the younger group, the vaccine prevented 444 cases for every 1000 vaccinations. Since over 600,000 Africans mostly children under five years old die from malaria every year, this vaccine could potentially have a huge impact on public health.

The vaccine trials were conducted at eleven research centers in seven African countries, and over 15,000 children participated. One of the principal investigators, Halidou Tito from Burkina Faso, commented Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.

Longer-term studies indicated that the vaccine s efficacy waned over time, with efficacy being 65 percent six months after vaccination, but only about 17 percent after four years.

ACSH s Dr. Gilbert Ross had this to say: While this vaccine will not, by itself end the scourge of malaria in Africa, in combination with other measures it has the potential to significantly lessen the disease s impact on the African population. At last there is a glimmer of light at the end of the malaria tunnel. Kudos to GlaxoSmithKline for continuing their research efforts to provide hope for African children and parents.