Vaccinating against malaria is gaining traction among many countries in malaria-prone Africa region where four-year pilot scheme of administering a malaria vaccine on children has borne good results according to World Health Organization (WHO). (1)
At least 1.5 million children in Kenya, Malawi and Ghana have been reached with the RTS,S/AS01 malaria vaccine, a product of more than 30 years of research and development by British multinational pharmaceutical and biotechnology company, GSK Plc.
The first dose was administered in 2019 becoming the first malaria vaccine to have received a positive review by some regulatory authorities.
GSK has since signed a product transfer agreement for the vaccine with India’s Bharat Biotech (BBIL). The agreement includes the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to BBIL. GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to BBIL. (2)
Children who have received the RTS,S/AS01 vaccination in in the three African countries have manifested tremendous response hence affirming the vaccine’s potential safety and effectiveness.
In July 2023, WHO announced 12 countries in Africa will be allocated at least 18 million doses of RTS, S/AS01, the first-ever malaria vaccine, to meet the increasing demand. The vaccine has been recommended since late 2021 by WHO for use among children living in countries reporting moderate to high P. falciparum malaria transmission.
At least 28 African countries have expressed interest in receiving the RTS, S/AS01 malaria vaccine.
The piloting introduction of the vaccine is expected to end this year. (3)
Several other African countries have joined the race in ramping up capacity to tackle the killer disease that is spread through bites of some infected female Anopheles mosquitoes. Some of the countries have approved the second potential malaria vaccine R21/Matrix-M.
At least three countries have approved Oxford University manufactured vaccine in the fight against malaria Africa’s deadliest disease that kills nearly half a million children under the age of 5, and accounting for approximately 95% of global malaria cases and 96% of deaths in 2021 according to WHO (4)
The vaccine is being commercialized by India’s Serum Institute of India PvT Ltd leveraging on the Novavax’s adjuvant technology and expected to receive WHO prequalification soon.
Ghana, Nigeria and Burkina Faso have licensed for use the R21 vaccine as Africa and other developing nations embrace malaria prevention rather than treatment of the disease that is characterized by diverse mild symptoms such as fever, chills and headache and severe ones including fatigue, confusion, seizures, and difficulty breathing. WHO lists infants, children under 5 years, pregnant women, travellers and people with HIV or AIDS as groups at highest risk of infection.
Three pharmaceutical authorities, Burkina Faso’s Agence Nationale de la Regulation Pharmaceutique (ANRP), Ghana’s Food and Drugs Authority as well as Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), have approved the R21 vaccine that has been indicated for malaria prevention in five months to three years.
Oxford University said in July 2023, Phase IIb and phase III trials in Burkina Faso, “have demonstrated high efficacy levels and a reassuring safety profile among children who received a three-dose primary regimen and one booster dose a year later.”
“Recent data from the large phase III trial conducted in Burkina Faso, Kenya, Mali, and Tanzania and that has enrolled 4,800 children also confirm high levels of efficacy and a reassuring safety profile as reported in the Phase 2b trial in Burkina Faso,” the University said,
India’s Serum Institute has potential to manufacture at least 200 million doses annually.
Globally, approximately 80-100 million doses of malaria vaccine would be required annually according to GAVI, the Vaccine Alliance. (5)
By 2026, 40-60 million doses would be required to avert the estimated 475,000 deaths of children under 5 from malaria in Africa.
Stability testing is the process of analysing and monitoring the active pharmaceutical ingredients/APIs or the final pharmaceutical products/FPPs stability over time to ensure that it stays safe and effective during its shelf life and under that labelled