Nigeria approves R21 Malaria Vaccine manufactured by Serum Institute of India

April 17, 2023
16 Views

Abuja, Nigeria – The National Agency for Food and Drug Administration and Control (NAFDAC) has granted approval for the R21 malaria vaccine, manufactured by the Serum Institute of India, according to Prof Mojisola Adeyeye, the Director General of NAFDAC. This makes Nigeria the second country in Africa to approve the vaccine, after Ghana. Prof Adeyeye made the announcement during a press briefing on Monday in Abuja.

The R21 malaria vaccine is indicated for the prevention of clinical malaria in children aged 5 months to 36 months. Nigeria is expecting to receive at least 100,000 doses of the vaccine through donations, and the market authorization process will commence thereafter in collaboration with the National Primary Health Care Development Agency.

In her statement, Prof Adeyeye explained that NAFDAC reviewed the dossier of the vaccine independently at two levels. The review was conducted by NAFDAC’s Vaccine Advisory Committee, following the standards of the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the European Medicines Agency guidelines. The assessment was scored as adequate and fully compliant with standards.

The Joint Review Committee, which assessed the data on the R21 malaria vaccine, concluded that the vaccine’s benefits outweigh its risks and supported the manufacturer’s recommended use. The Committee also recommended additional phase four clinical trials and pharmacovigilance studies in Nigeria, considering the unique and diverse nature of malaria in the country. The vaccine was provisionally approved in line with WHO’s Malaria Vaccine Implementation Guideline.

Malaria remains a significant health challenge in Nigeria, with the country accounting for 31.3% of all malaria deaths worldwide. According to The Punch, a Nigerian newspaper, 97% of the population in Nigeria is at risk of malaria. The approval of the R21 malaria vaccine by NAFDAC is seen as a crucial step towards reducing the burden of malaria and improving public health outcomes in Nigeria.

You may be interested

Soludo Receives Commendation for Building Solar-Powered Borehole for Another Anambra Community
News
News

Soludo Receives Commendation for Building Solar-Powered Borehole for Another Anambra Community

Webby - February 29, 2024

By Stanley NwakoThe President General of Amihie Improvement Union in Umuchu, Aguata Local Government Area of Anambra State, Sir Charles…

My Manhood Isn’t Rising Again Because Of Nigeria’s Problems – Charly Boy
News
1 views
News
1 views

My Manhood Isn’t Rising Again Because Of Nigeria’s Problems – Charly Boy

Webby - February 29, 2024

Charly Boy Veteran singer and activist Charles Oputa popularly known as Charly Boy, has revealed that his manhood no longer…

Sports Betting: A Cultural Phenomenon in Nigeria and Ethiopia
News
1 views
News
1 views

Sports Betting: A Cultural Phenomenon in Nigeria and Ethiopia

Webby - February 29, 2024

Gone are the days when enjoying a football match just meant cheering for your favorite team. In countries like Nigeria…

Leave a Comment

Your email address will not be published.