Ghana FDA Approves Use of First Malaria Vaccine
In an innovative move, the Ghana Food and Drugs Authority (FDA) has approved the usage of R21/Matrix-MTM, a malaria vaccine developed by the University of Oxford and Serum Institute of India Pvt Ltd (SIIPL), ahead of Nigeria to deploy a solution against the deadly disease.
Despite carrying the largest burden of the disease in the world, with more than 23 percent of deaths recorded according to the World Malaria Report 2020, Nigeria missed the opportunity to participate in the clinical trials due to infrastructural deficits.
However, Ghana, Kenya, and Malawi took part in the trials and millions of doses were tested.
The approval marks the first regulatory clearance for the vaccine produced using Novavax’s adjuvant technology in any country, the University of Oxford stated in a statement released Thursday.
“The successful registration was notified to SIIPL by the FDA Ghana. SIIPL is the manufacturing and commercialisation license holder for the vaccine. It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat malaria.”
The vaccine is approved for use in children aged five to 36 months, the age group at the highest risk of death from malaria.
The vaccine has demonstrated high levels of efficacy and safety in Phase 2 trials, including amongst children who received a booster dose at one year following a primary three-dose regime, according to Oxford.
Adrian Hill, chief investigator of the R21/Matrix-M programme, and director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine said the result marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most.
He said the partnership with the Serum Institute of India was instrumental to the large-scale manufacturing and rapid development of the vaccine, an effort similar to what was done for the Oxford-AstraZeneca COVID-19 vaccine.
The malaria vaccine is a low-dose vaccine that can be manufactured at a mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden, the University said.
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It was initially designed and developed at the University of Oxford and has undergone clinical trials in the UK, Thailand, and several African countries, including an ongoing phase 3 trial in Burkina Faso, Kenya, Mali, and Tanzania that has enrolled 4,800 children.
Results from these trials are expected to be reported later this year.
Oxford researchers and their partners last year reported from a Phase 2b trial that a booster dose of R21/Matrix-M at one year following a primary 3-dose regime maintained high efficacy against malaria, and continued to meet the World Health Organization’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75 percent efficacy.
This followed 2021 results from the Phase-2b trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77 percent and recent data from the large phase 3 trial has also shown high levels of efficacy and a reassuring safety profile.
The vaccine contains Novavax’s Matrix-M, a component that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.
This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines.
Notably, the Serum Institute of India has provided vaccines and sponsored Phase III licensure clinical trials, demonstrating its commitment to combatting malaria. SIIPL has already established potential manufacturing capacities of more than 200 million doses annually.
This breakthrough is a critical step towards reducing over half a million malaria-related deaths annually and improving the health outcomes of millions of people in Africa and beyond.
Adar Poonawalla, CEO of the Serum Institute of India Pvt Ltd., said “Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult. The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world,” he said.
“We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives.”
Kofi Nsiah-Poku, managing director and CEO of DEK Vaccines Limited said “DEK Vaccines Limited, an upcoming-vaccines manufacturing factory in Accra, Ghana is thankful for the support of the Government of Ghana through the Vaccines Manufacturing Committee and Ghana FDA, who have been first in the world to approve the R21/Matrix-M malaria vaccine. DEK team is looking forward to long-term collaboration with the Serum Institute of India.”
The National Malaria Elimination Programme (NMEP) last year said Nigeria would kick off malaria vaccination by the first quarter of 2023 with an initial batch of donations to African countries.
The NEMP also stated that the federal government has set up processes to ensure that Nigeria is among the first to receive the supply, which is expected to be limited due to the initial high demand.
