A malaria vaccine manufactured by Serum Institute of India has passed the next round of regulatory approval by the World Health Organization (WHO) on December 21, 2023.
- The R21/Matrix-M malaria vaccine developed by the University of Oxford and the Indian company meets the WHO standards for vaccine quality, safety and efficacy.
- If a vaccine has undergone thorough evaluation of relevant data, testing of samples and WHO inspection of relevant manufacturing sites — and the outcome is positive — it is included in the WHO List of Prequalified Vaccines.
- The WHO also tests the vaccine’s suitability for the target population, usability with appropriate concomitant products and compliance with operational specifications for packaging and presentation.
- The prequalification means larger access to vaccines as a key tool to prevent malaria in children, with it being a prerequisite for vaccine procurement by UNICEF and funding support for deployment by Gavi, the Vaccine Alliance.
- The R21 vaccine is the second malaria shot approved by WHO, following the RTS,S/AS01 one, which was approved in July 2022.
- In clinical trials, both vaccines have been shown to be safe and effective in preventing malaria in children.
- The vaccines are expected to have a large public health impact when widely implemented alongside other recommended malaria control interventions.
About Malaria
- Malaria is a life-threatening disease spread to humans by some types of mosquitoes. It is mostly found in tropical countries.
- It is preventable and curable. Malaria mostly spreads to people through the bites of some infected female Anopheles mosquitoes.
- Blood transfusion and contaminated needles may also transmit malaria.
- There are 5 Plasmodium parasite species that cause malaria in humans and 2 of these species – P. falciparum and P. vivax – pose the greatest threat.
- P. falciparum is the deadliest malaria parasite and the most prevalent on the African continent.
- P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa.
- Malaria places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year.
