Less than a week after Ghana became the first country to approve the vaccine, the R21/Matrix-M malaria vaccine that was produced by experts at the University of Oxford has been conditionally approved by Nigeria.
Mojisola Adeyeye, who is the director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), has stated that the agency “is granting registration approval for R21 malaria vaccine.” According to Adeyeye, “the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age.” Ghana is one of the countries that could benefit from the vaccine. The vaccination should be kept at a temperature between 2 and 8 degrees Celsius.
The permission will be subjected to the relevant tests for immunisation under the supervision of the health ministry and the National Primary Health Care Development Agency. “A provisional approval of the R21 malaria vaccine was recommended, and this shall be done in line with the WHO’s malaria vaccine implementation guideline,” the NAFDAC said in their statement.
The effectiveness of R21 is 77%
Adeyeye said that more Phase 4 clinical trials of the vaccine are still required in Nigeria, despite the fact that the vaccine has been approved. The vaccine has showed efficacy levels that are 77%, which is higher than the criterion set by the WHO, which is 75%.
The results of a vaccine clinical trial that is currently in phase 3 and is being conducted in Burkina Faso, Kenya, Mali, and Tanzania have not yet been published. The trial involved 4,800 children.
However, the data from Phase 2 that was published in September of last year revealed encouraging findings. “We are delighted to find that a standard four-dose immunisation regime can now, for the first time, reach the high efficacy level over two years that has been an aspirational target for malaria vaccines for so many years,” said Adrian Hill, director of the Jenner Institute at the University of Oxford, where the vaccine was developed, when discussing the results in September. The vaccine was developed at the University of Oxford’s Jenner Institute.