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U.S. FDA places BioNTech's malaria vaccine study on clinical hold
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U.S. FDA places BioNTech's malaria vaccine study on clinical hold
Mar 4, 2025 1:52 PM

March 4 (Reuters) - The U.S. Food and Drug

Administration has placed a clinical hold on BioNTech's

early-to-mid stage trial of an experimental malaria vaccine, the

drugmaker said in a filing, sending its U.S.-listed shares down

1.5% after the bell on Tuesday.

The trial was to evaluate the safety and efficacy of the

RNA-based vaccine called BNT165e for prevention of malaria

caused by the P. falciparum parasite in healthy adults who have

never had malaria before.

The P. falciparum parasite is one of two malaria causing

parasite species that pose the greatest threat to humans.

Malaria is a life-threatening disease caused by parasites

transmitted to people through the bites of infected female

Anopheles mosquitoes.

BioNTech said it is taking actions to address the

FDA's requests and will work with the regulator to assess the

next steps.

(Reporting by Puyaan Singh in Bengaluru; Editing by Arun

Koyyur)

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