Clinical Trials for the R21 Malaria Vaccine Will Start in Six Weeks – NAFDAC

The director general of the organization claims that giving the vaccine is crucial for preventing transmission.

Professor Mojisola Adeyeye, Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), has stated that additional clinical trials are needed before the R21/Matrix-M malaria vaccine can be used to its full potential.

Speaking on Channels Television Sunrise Daily on Wednesday, Adeyeye pointed out that the continuation of malaria in Africa is a result of the growth of a nation’s administration.

She added that NAFDAC would conduct its own tests, trials, and levels of approval and that the availability of the vaccine is crucial for the prevention of transmission.

“Within the following six weeks, the clinical experiment will start. Nigeria was not included in the RTS,S because the effectiveness was only 30% from the start, and as a result, we declined to participate in the clinical trial, according to the NAFDAC director.

“After reading the document, I think Nigeria should join the R21. This is because there is a good chance that we will succeed. We know something is very likely to succeed if it is at least 75% effective from the start. Its efficiency against malaria is fantastic—it is 75%.

Adeyeye said that phase four clinical studies as well as more laboratory work would be carried out.

“However, we must review every line of the dossier to make sure that science is being said; it is not just what is printed that we know as the efficacy. This is based on science. We conducted two sets of reviews, she explained.

She claims that phase four of NAFDAC will be the first time in the organization’s history that an external expert body will be involved.
Phase four clinical trials will be conducted; they should be performed in our nation. We’ll conduct additional observation. This would require further laboratory work, and it cannot be administered until it has been tested in the nation before being transmitted, according to Adeyeye.

The head of NAFDAC said that the RTS,S malaria vaccine’s % efficacy was limited by the fact that it is primarily targeted at children and not adults.
“Even if only 30% of the children’s deaths are avoided or prevented, that will still be an improvement. But as an agency, we decided not to participate in the trial on that basis. The WHO received this specific R21, and they will conduct their own review, she explained.
“Specifically for kids under three years old, NAFDAC approved the R21 vaccination for children under the age of five. The second vaccine (RTSS), which NAFDAC evaluated, was determined to be insufficiently effective. After a very rigorous clearance process, we granted preliminary approval for Nigeria to participate in this one, which is R21.

Adeyeye claimed that the NAFDAC, a regulatory organization, is making every effort to carefully and wisely consider the information in the dossier and make a judgment.

“The 75%, in my opinion, is a terrific starting place or excellent efficacy in terms of our own employees. However, the medical trial will begin very soon.

“I have been speaking with the manufacturer and the Nigerian person in charge of the market authorization. The clinical trial is about to start. Younger university colleagues who will participate in the clinical experiment have been recommended by the specialists, she said.