Malaria parasite connecting to a red blood cell [Image courtesy of NIAID]
The mRNA vaccine company BioNTech (Nasdaq:BNTX) has begun a Phase 1 study of BNT165b1, a multi-antigen malaria vaccine candidate that belongs to its BNT165 malaria program.
Researchers at Oxford University are farther along with their R21/Matrix-M vaccine. A recently completed Phase 3 trial focused on R21. It could win licensure in 2023.
In a Phase 2 study published in The Lancet, a booster of the R21 vaccine continued to offer strong protection against malaria one year after primary vaccination with three doses. In addition, the vaccine met the World Health Organization’s Malaria Vaccine Technology Roadmap standard of providing at least 75% efficacy.
Oxford University is working with the Serum Institute of India to develop the R21 vaccine.
Researchers at Oxford University were also instrumental in developing the ChAdOx vaccine platform used in the AstraZeneca (LON:AZN) COVID-19 vaccine, which was widely used in the first year of the pandemic.
Ultimately, however, mRNA-based vaccines dominated the COVID-19 landscape in most of the world. Moderna, BioNTech and Pfizer (NYSE:PFE) saw record sales in 2021.
Those three companies are currently working to diversify their mRNA-based vaccine portfolios.
mRNA-based vaccines for malaria prevention
BioNTech notes in a press release that it “aims to develop the first mRNA-based vaccine for malaria prevention based on a novel multi-antigen vaccine approach.”
Fellow mRNA vaccine developer Moderna (NYSE:Nasdaq) does not currently have a malaria vaccine candidate in its pipeline.
Earlier this month, a group of researchers published a preprint announcing the development of two mRNA-based vaccine candidates, which had been subjected to animal testing. Such vaccines could “potentially banish malaria from many parts of the world,” said Nirbhay Kumar, a professor at the George Washington University Milken Institute School of Public Health. “The mRNA vaccine technology can really be a game changer. We saw how successful this technology was in terms of fighting COVID, and for this study, we adapted it and used it to develop tools to combat malaria.”
In 2021, the World Health Organization (WHO) backed the first malaria vaccine for use in sub-Saharan Africa with elevated transmission rates.
GSK (NYSE:GSK) developed that vaccine known as GSK 257049 or RTS,S/AS01 (RTS,S), based on a recombinant subunit, adjuvanted platform.
The R21 vaccine mentioned earlier is an updated version of the RTS,S/AS01 vaccine.
BioNTech is working with the non-profit kENUP Foundation to fight malaria.
The company has also worked to establish a manufacturing presence in Africa. “The containers for the first BioNTainer for the African network are ready for the transport to Rwanda,” said Dr. Özlem Türeci, chief medical officer of BioNTech, in a news release. “If successfully developed and approved, an mRNA-based Malaria vaccine could be manufactured there.”
Malaria is a mosquito-borne disease. A parasite causes people to experience fever, chills, and flu-like illness — and potentially deadly complications if left untreated. The U.S. CDC says the world in 2020 saw an estimated 241 million cases and 627,000 deaths, mostly children in sub-Saharan Africa.