- German vaccine manufacturer BioNTech is boosting its commitment to Africa, announcing Monday that it has started work on a malaria shot and plans to set up manufacturing infrastructure to distribute that, and other vaccines, across the continent.
- BioNTech plans to start human testing of its first malaria vaccine candidate by the end of 2022. An effort to increase manufacturing capacity in Africa would take longer, as infrastructure will have to be built. But plants meant to make vaccines would be co-located with technology transfer hubs under development with the World Health Organization. BioNTech may also build a facility with a local partner or on its own.
- Global health charities have criticized some vaccine makers for failing to supply Africa with enough coronavirus shots, contributing to a new wave of infections and deaths. A supply deal Pfizer and BioNTech announced last week is "not enough to achieve vaccine independence" for Africa, the group Doctors Without Borders said.
While vaccine developers did what many thought unlikely at the beginning of the coronavirus pandemic — deliver a safe and effective vaccine in less than a year — Western countries have reaped most of the rewards. Doctors Without Borders points out that just 1.6% of the COVID-19 vaccines administered so far have been in African nations.
Today's announcement won't immediately address that inequity. But officials with the World Health Organization and The Bill & Melinda Gates Foundation said Monday that the deal may be a turning point in the fight against malaria, and eventually lead to broader access to vaccines for several diseases.
"I think this really is a historic moment," Mark Suzman, CEO of Bill & Melinda Gates Foundation, said at the press conference. "We may look back at this moment and see it as a transformative pivot point in the fight against malaria."
The pandemic proved messenger RNA technology could make effective vaccines, and developers like BioNTech now aim to apply it to malaria and other deadly infections. "The time is ripe," said Özlem Türeci, BioNTech's co-founder and chief medical officer.
Malaria is a mosquito-borne illness that leads to 229 million infections and 400,000 deaths each year, mostly in sub-Saharan Africa. A vaccine called Mosquirix, which emerged from a collaboration between the U.S. Army and GlaxoSmithKline, began rolling out in 2019. But Mosquirix is only 56% effective in babies and toddlers after a year and protection fades with time. The shot is also associated with higher rates of meningitis.
Another vaccine being co-developed by the University of Oxford University and Novavax has reported efficacy rates as high as 77% in a Phase 2 trial in children.
Both of those target a protein distinctive to malaria-causing protozoa. BioNTech said it's looking at an mRNA vaccine that will target the same protein "as well as new antigens discovered in the pre-clinical research phase." The company's goal is to develop a shot that makes the disease-causing parasite visible to the immune system earlier, when it's more vulnerable, according to CEO Ugur Sahin.
Sahin said the development plan for BioNTech's coronavirus vaccine showed the company could test multiple candidates in parallel and select the best one to advance further. BioNTech aims to use the same approach against malaria, he said.
The planned production facilities, meanwhile, will serve as "end-to-end" factories for vaccines, producing both drug substance as well as filling and finishing of doses delivered to healthcare facilities across the continent. That would address one criticism of BioNTech and Pfizer's deal with African manufacturing partner Biovac, an agreement that is "dependent" on drug substance manufactured in Europe, Doctors Without Borders argued.
BioNTech's chief operating officer, Sierk Poetting, said the company plans to make modular manufacturing equipment in Europe and ship it to the WHO's tech transfer hubs. Delivery of that equipment will depend on the scale up of necessary infrastructure, like sterile filling rooms and warehouses, to support it, Poetting said.