Fidson Healthcare Plc (NGX: FIDSON) says it has received provisional approval from the National Agency for Food and Drug Administration and Control (NAFDAC) to market R21 Malaria Vaccine in Nigeria.
The company stated this on Friday in a corporate action document published on the Nigerian Exchange.
“This approval followed a collaboration between Fidson Healthcare Plc and Serum Institute of India Pvt Limited (SIIPL), the manufacturer of the Vaccine,” the document read in part.
“The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. It has been proven in clinical trials to significantly reduce the disease burden and is expected to reduce mortality related to malaria, especially in tropical Africa.”
Fidson said that its Board and Management is determined to ensure that the company “remain the preferred healthcare company that will continue to add value to life with brands that deliver Sustainable and profitable growth.”
At the close of business on Friday, FIDSON gained 4.95% to close at N9.75 per share on the floor of the Nigerian Exchange.
Clinical trial to begin in six weeks
The Director General of the National Agency For Food and Drug Administration and Control, NAFDAC, Professor Mojisola Adeyeye, said on Thursday that the approval process for the R21/Matrix-M malaria vaccine requires more clinical trials before its full use.
“The clinical trial will begin within the next six weeks. The RTS,S did not include Nigeria because from the beginning the effectiveness was 30 per cent, so we did not agree to join the clinical trial,” she said.
“For the R21, after reading the dossier, I believe Nigeria should join. This is because we have a high probability of success. If something is 75 per cent effective from the beginning, then we know they are very likely to be successful. It has 75 per cent effectiveness for a malaria vaccine, which is great.”
She added: “We are going to do phase four clinical trials, it should be tested in our country. We are going to do more observation.
”This would involve more laboratory works. This cannot be administered until it goes through a testing process in the country before the transmission process.
Ifunanya Ikueze is an Engineer, Safety Professional, Writer, Investor, Entrepreneur and Educator.
