Science Desk, Feb 2 (EFE).- A new malaria vaccine has confirmed a “uniquely high efficacy and good safety profile” in a phase 3 trial carried out in Burkina Faso, Kenya, Mali and Tanzania, and will be rolled out in the coming months, the University of Oxford said.
The phase 3 trial of the R21/Matrix-M vaccine, the results of which were published Thursday by The Lancet, immunized more than 4,800 children and found an average vaccine efficacy of 78 percent during the first year of follow-up at all sites in the 5-17 months age group.
This is the age group in which most malaria vaccines are studied, said in a statement the University of Oxford, which developed the vaccine manufactured by the Serum Institute of India.
At least 25 million doses have been manufactured and are ready for roll-out by the institute in the next three to four months, it said.
Efficacy over the one-year period was very similar in all study sites and in different transmission environments.
No other vaccine has registered an efficacy greater than 55 percent in the same age group and, in addition, a booster dose per year maintained good efficacy for the following 6-12 months, the statement added.
The vaccine also reduced infection rates in children at 12 and 18 months after the dose, “suggesting a potentially beneficial effect in reducing malaria transmission.”
Significantly greater immune responses to R21/Matrix-M and slightly higher efficacy were observed in children aged 5-17 months compared to the other vaccines aged 18-36 months, “supporting planned vaccine deployment initially from 5 months of age in young African children.”
The safety data from the trial “have been reassuring,” with no “serious adverse events linked to immunization,” it said.
The vaccine was well tolerated, with pain at the injection site and fever being the most frequent adverse events, and there were no deaths related to the treatment.
The results of this phase 3 trial have supported regulatory approval and licensing in several African countries, the statement said.
“We are dedicated to making this vaccine available, especially in Africa, where malaria poses a substantial threat to millions of lives, bringing us closer to a malaria-free world,” said Serum Institute of India CEO Adar Poonawalla.
The R21/Matrix-M vaccine was designed in 2011 as a potential improvement to the RTS, S/AS01 designed in the 1980s.
Malaria is the leading cause of death among young African children, with more than 600,000 deaths each year worldwide. EFE