(Reuters) – Altimmune Inc said on Wednesday the U.S. Food and Drug Administration had put a clinical hold on its application to begin human testing of its single-dose COVID-19 vaccine, AdCOVID.
The FDA sought additional data on the vaccine candidate’s chemistry, manufacturing and controls, and asked the company for some protocol changes.
Altimmune said it has responded to the agency’s letter received on Dec. 22.
The company said it does not see the FDA’s hold to have a huge impact on the timeline of the overall clinical development of AdCOVID.
(Reporting by Chavi Mehta in Bengaluru; Editing by Maju Samuel)
