The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the serum institute Pvt. ltd (SIIPL) R21 malaria vaccine. Prof. Mojisola Adeyeye, the director-general of NAFDAC, confirmed this new development at a news conference in Abuja.
“NAFDAC is carrying out its mandate as outlined in its enabling legislation.” The NAFDAC Act Cap1, LFN 2004, authorises the registration validation of the R21 malaria vaccine scaled up by the Serum Institute of India Pvt. Ltd.”
Ghana, on the other hand, was the first country to approve the vaccine. After seeing the results of the phase-three trial on 4,800 children in Tanzania, Kenya, Mali, and Burkina Faso, the Food and Drugs Authority approved the R21 malaria vaccine. According to Prof Hill, for the first time, a primary vaccine has been approved in Africa ahead of powerful, prosperous nations.
The vaccine was created at Oxford University and manufactured by the Serum Institute of India (SII). The R21 malaria treatment vaccine was approved as a necessary and effective response to a 2012 report that revealed Nigeria as the country with the highest number of malaria cases. The NAFAC chief also demonstrates that the global average number of deaths was 32%, highlighting that in West Africa that same year, an estimated 55.2 percent of malaria cases were reported.
Before the vaccine was approved, the NAFDAC Vaccine Advisory Committee reviewed the dosser using recognised World Health Organisation standards across relevant domains, European Medicines Agency guidelines, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, and scientific rigour on the vaccine and the malaria context in Nigeria categorically.
The vaccine’s overall evaluation is undeniably adequate and fully compliant with all standards. This means that the vaccine dossier substantially meets the highest international standards against which it was evaluated. According to Adeyeye, the joint review committee concluded that the vaccine was robust and met the quality, efficacy, and safety tests.
“The joint review committee recognised the need for a 75% effective malaria protection vaccine as an additional measure to Nigeria’s critical need, a country with a massive malaria burden.”
The vaccine focuses on preventing clinical malaria in young children aged 5 to 36 months, the age group with the highest malaria death risk. According to Prof. Mojisola, Nigeria expects at least a hundred thousand vaccine doses before the market authorization begins making efforts towards further agreements with the National Primary Health Care Development Agency.
The vaccine targets the first stage of the parasite’s life cycle, when the Anopheles mosquito bites its victim and sends the parasite through the bloodstream. The R21 vaccine, on the other hand, targets the parasite’s first stage of entry into the human body, known as plasmodium’sporozoite. The vaccine is also said to include Novavax’s Matrix-M, which is designed to boost the immune system, making it more effective and long-lasting.
The new vaccine is a significant advancement for Nigerians in the fight against malaria-related deaths in Africa. This vaccine is the first to achieve an important goal of 75% efficiency over a 12-month period. The R21 vaccine has the potential to eradicate malaria across Sub-Saharan Africa, protecting the majority of the population at risk, such as young children and pregnant women.
Sources
- https://www.malariaconsortium.org/news-centre/r21-malaria-vaccine-gives-up-to-80-percent-protection.htm
- https://www.novavax.com/science-technology/vaccine-pipeline/malaria-investigational-vaccine
- https://amp.theguardian.com/global-development/2023/apr/13/ghana-is-first-country-to-approve-oxford-r21-malaria-vaccine
- https://news.sky.com/story/amp/ghana-becomes-first-country-to-approve-oxford-malaria-vaccine-r21-matrix-m-12856453
- https://www.ripplesnigeria.com/like-ghana-nigeria-approves-r21-malaria-vaccine/
