The University of Oxford announced in February 2024 that results from a Phase III trial of the R21/Matrix-M vaccine developed in collaboration with Serum Institute of India and Novavax have “confirmed high efficacy”, supporting regulatory approvals and licensure in “several African countries”. The data, shared in The Lancet, reveal safety and efficacy of the vaccine in a trial that followed over 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania.
The trial
The trial was a double-blind, randomised Phase III trial of the vaccine across five sites in four countries. Children between the ages of 5 and 36 months were enrolled. The investigators found an average of 78% vaccine efficacy in the first year of follow-up in the most studied age range for malaria vaccines: 5-17-month-olds.
The observed increase in immune responses and “slightly higher” efficacy in 5-17-month-olds supports planned vaccine deployment from 5 months of age. This improves upon previous vaccines in reporting over 55% efficacy in the age group. A booster dose, administered at one year, maintained “good efficacy”. Furthermore, safety data “have been reassuring” with “no serious adverse events linked to immunisation”.
Encouraging efficacy rates
Professor Adrian Hill, chief investigator of the trial, commented that the “continued high efficacy of this new vaccine in field trials is very encouraging”, suggesting that it is “consistent with the high efficacy and excellent durability” that was previously observed.
“These data support an important role for the unique high-density nanoparticle display of the conserved repeat region of the malaria parasite circumsporozoite protein, a feature in the design of the R21 vaccine, in providing such high vaccine efficacy and, thereby, an important new tool for malaria control.”
Adar Poonawalla, Serum Institute of India’s CEO described the results as a “significant advancement in our battle against this global threat”.
“Our collaboration with the University of Oxford has been instrumental in development the R21/Matrix-M malaria vaccine. 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.”
Principal Investigator in Mali, Professor Alassane Dicko, finds the quick generation of “high efficacy data” a “very exciting” step.
“I predict that this vaccine should be very impactful in preventing malaria deaths in African children.”
John C Jacobs, CEO at Novavax, reflected that “approximately 1,300 children die from malaria every day”, which he described as a “staggering statistic for a preventable disease”. However, the latest data “reinforce the potential” that this vaccine has.
“We are proud of the role of Novavax’s patented saponin-based Matrix-M adjuvant, which has been demonstrated to enhance the immune response, in the outcome of this clinical trial and are eager to see the realised impact of the vaccine when it is rolled out globally.”
We’re looking forward to hearing more from Professor Adrian Hill in a panel on global efforts towards malaria elimination at the Congress in Washington this April. Do get your tickets to join us there and don’t forget to subscribe for more updates!
