The FDA has paused BioNTech’s phase 1/2a trial of its experimental malaria vaccine, BNT165e, due to unspecified concerns, the company confirmed in an SEC filing on Monday. BioNTech is working with the FDA to address the agency's requests, though specific details have not been disclosed. Both parties are collaborating to determine the next steps for the trial, which involves nearly 180 healthy, malaria-naïve adults. The study is expected to conclude in early 2026 and is assessing the vaccine’s safety, tolerability, efficacy, and immunogenicity.
BioNTech’s malaria vaccine initiative was first announced in 2021, using the same mRNA technology that powered its successful COVID-19 vaccine. The company’s Malaria Project aims to develop multiple vaccine candidates targeting malaria antigens, including circumsporozoite protein (CSP), and to establish mRNA manufacturing facilities in Africa for sustainable vaccine production. The initiative is part of the eradicateMalaria project, aiming to combat malaria’s global impact, particularly in sub-Saharan Africa, where the disease remains a leading cause of death.
What You Need To Know
The FDA has paused BioNTech’s Phase I/IIa malaria vaccine trial, citing unspecified concerns, with both parties working on addressing the issues.
BioNTech’s malaria vaccine project, launched in 2021, uses mRNA technology and aims to combat malaria, particularly in sub-Saharan Africa, while ensuring sustainable vaccine production.
The trial pause reflects broader challenges in the vaccine space, including delays in key advisory meetings and concerns over political influence on vaccine policy.
This trial pause comes amid broader challenges within the vaccine space. Recently, the CDC’s Advisory Committee on Immunization Practices (ACIP) postponed its first meeting of 2025, originally scheduled for February 27. The FDA also canceled an advisory meeting for flu vaccine strain selection, scheduled for March 13, raising concerns about potential delays in vaccine production. These disruptions follow the appointment of Robert F. Kennedy Jr, as Secretary of Health and Human Services, which has raised concerns about political influence on vaccine policy.
In our most recent malaria-related interview with Sunil Parikh, MD, MPH, professor at the Yale School of Public Health, he said, “I think we’re at a critical crossroads in malaria control for several reasons. Progress has been difficult in recent years, and we're now facing significant challenges in terms of global funding.”
Parikh concluded by emphasizing the continued importance of innovation in malaria control. “I just want to emphasize that malaria remains a major issue, and we need continued investment to make further progress. Now is not the time to halt innovative trials and novel interventions—they’re more crucial than ever.”
Despite these setbacks, analysts at Truist Securities have expressed cautious optimism, suggesting the challenges are more political than clinical in nature.
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