Malaria vaccine becomes first to achieve WHO-specified 75% efficacy goal

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Researchers at Oxford University and its partners today reported the results of a phase IIb trial of the malaria vaccine candidate R21 / Matrix-M. This showed a high level of efficacy of 77% in a 12-month follow-up.Their findings (posted to SSRN / Preprints) LancetThey say they were the first to achieve the goal of the World Health Organization’s Malaria Vaccine Technology Roadmap, a vaccine with at least 75% efficacy.

Author’s report ( Lancet) Randomization, control, from Phase IIb, Double-blind study Conducted at Nanoro Clinical Research Unit (CRUN) / Sante Institute of Science (IRSS) in Burkina Faso. 450 participants from 5 to 17 months were recruited from the Nanoro catchment area, covering 24 villages and a population of about 65,000.

Participants were divided into three groups, the first two groups receiving R21 / Matrix-M (either low or high dose of Matrix-M adjuvant), and the third group Rabies vaccine As Control group..The dose was administered from early May 2019 to early August 2019, primarily before the peak. malaria Season.

Researchers reported vaccine efficacy of 77% in the high-dose adjuvant group and 71% in the low-dose adjuvant group over a 12-month follow-up period, with serious vaccine-related adverse events. Is not …

Following these results, a Phase IIb trial funded by the European Union-sponsored EDCTP2 program (Grant No. RIA2016V-1649-MMVC) was extended and boosted before the next malaria season one year later. The vaccine was administered.

The researchers are the Serum Institute of India Private Ltd. And Novavax Inc. In collaboration with, we have begun recruiting Phase III license trials to assess the safety and efficacy of 4,800 children aged 5 to 36 months across four African children. Country.

Haridu Tint, a professor of parasitology, regional director of IRSS at Nanoro, and investigator, said: Phase III trials to demonstrate large-scale safety and efficacy data for vaccines that are in great need in the region. “

Adrian Hill, director of the Jenner Institute, family professor of Lakshmi Mittal and Vaccine Science at Oxford University, and co-author of the treatise, said:

“These new results support our high expectations for the potential of this vaccine, which we believe was the first to reach WHO’s goal of a malaria vaccine with at least 75% efficacy.

“Our commercial partner, the Serum Institute of India, has a commitment to produce at least 200 million doses a year over the next few years, and if licensed, the vaccine could have a significant impact on public health. . “

Professor Charlemagne Ouédraogo, Minister of Health of Burkina Faso, said:

“Malaria is one of the leading causes of child mortality in Africa. We have helped test various new vaccine candidates in Burkina Faso. These new data are very useful for the upcoming approval of a new malaria vaccine. It shows that it can occur in the next few years. It will be a very important new tool for controlling malaria and saving many lives. “

Professor Alkassoum Maiga of the Ministry of Higher Education, Science and Research Innovation in Burkina Faso said:

“We are proud of Burkina Faso researchers who have made significant contributions to reaching this important milestone. The next Phase III trial confirms these exciting findings and the vaccine is in the millions each year. I hope it could have a real impact on this disease, which affects as many children as possible.

Dr. Cyrus Punawara and Adar Punawara, Chairman and Chief Executive Officer of the Serum Institute of India, said:

“We are very pleased to see these results in a safe and highly effective malaria vaccine available worldwide through the excellent collaboration of the Serum Institute of Oxford University and Novavax Inc. The Serum Institute is worldwide. We are working on various diseases. Burden reduction and disease elimination strategy by providing a large amount of affordable vaccine. Upon approval of the regulatory authority, we will provide more than 200 million doses per year according to the above strategy. I’m sure I can do it. “

Dr. Michael Macanga, Secretary-General of EDCTP, said:

“We congratulate the Multistage Malaria Vaccine Consortium on these highly promising results from the R21 Burkina Faso trial. This study is an important advance in the clinical development of the R21 malaria vaccine for licensing. , Malaria management and elimination. “

Gareth Jenkins, Head of Advocacy for Malaria No More UK, said:

“Effective and safe malaria vaccine It will be a very important additional weapon of the weapons needed to defeat malaria, which kills more than 270,000 children each year. For decades, British scientists have been at the forefront of developing new methods for detecting, diagnosing, testing and treating malaria. We must continue to support them.

“A world free of malaria is a safer world for children killed by this disease and for us here. A country freed from the burden of malaria will inevitably face the threat of a new disease. When you do, you’re much more ready to fight it. In the future. ”

650,000 African Children Given Malaria Jab: WHO

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Quote: Malaria vaccine is a WHO-designated 75% efficacy target obtained from on April 23, 2021. (2021, April 23) will be achieved first.html

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