The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
A Phase I/IIa trial of BioNTech’s investigational RNA vaccine for malaria has been put on hold by the FDA, the biotech announced in an SEC filing on Monday.
Details were sparse in the company’s regulatory document, revealing only that BioNTech has complied with the clinical hold and is “taking actions to address the FDA’s requests,” though it did not specify what these requests were, nor did the biotech say why the hold was imposed in the first place. BioNTech and the FDA are working to determine next steps for the vaccine trial, according to the filing.
BioNTech’s investigational malaria shot, dubbed BNT165e, is an mRNA-based vaccine designed to prevent blood-stage infection and induce long-term immunity. BNT165e is also proposed to lower disease, infection-related deaths and secondary transmissions of malaria.
The Phase I/IIa study is testing BNT165e in nearly 180 healthy and malaria-naïve adults and will primarily assess the safety and tolerability of the experimental shot, while also looking for signs of efficacy and immunogenicity. According to a federal clinical trials database, the study is set to be completed in early 2026.
The clinical hold on BioNTech’s shot comes as the broader vaccine space is battered by strong macro headwinds.
Last month, the first meeting of the year of the Centers for Disease Control and Prevention’s vaccine advisory board was postponed. The Advisory Committee on Immunization Practices is composed of public health and vaccines experts and was supposed to convene on Feb. 27 to update immunization recommendations for 10 infectious diseases.
The panelists were also scheduled to discuss newly approved and up-and-coming vaccines—including an mRNA vaccine for COVID-19.
Days later, a meeting of the FDA’s vaccines advisory panel was canceled. The regulator’s Vaccine and Related Biological Products Advisory Committee was initially scheduled to convene March 13 to finalize strains to be included in vaccines for the upcoming flu season.
These high-level disruptions follow the controversial confirmation of Robert F. Kennedy Jr. as Secretary of Health and Human Services— despite Kennedy saying during Senate hearings that he believes that “vaccines have a critical role in healthcare.”
In a note to investors on Friday, analysts at Truist Securities acknowledged that the news surrounding vaccines “have been negative” and said this could be “a signal that RFK Jr & affiliates are exerting anti-vax pressure in their new seats.”
Still, the analysts tried to allay investors’ concerns. “While a natural reaction may be deep concern, we view these developments as part political grandstanding, and part a shoot-first-ask-later approach that appears consistent with the administration’s modus operandi,” they wrote.
