AstraZeneca’s U.S. vaccine trial is still on hold
Since last week’s news that AstraZeneca had halted enrollment in its Covid-19 vaccine trials over a suspected serious reaction, the company has gradually resumed studies in the U.K., Brazil, and South Africa. But not in the U.S., where the hold appears indefinite.
FDA Commissioner Stephen Hahn, making his first remarks on the matter via Instagram Live, said the agency was “going to do very significant work with the company to figure out if there’s a significant safety issue or not” before the study can start dosing volunteers again.
That complicates AstraZeneca’s plans to have Phase III data available later this year, which could put the company materially behind competing vaccines from Moderna and the partnership of Pfizer and BioNTech. It also underlines just how difficult it is to get clear information on what’s going on. Prior to Hahn’s comments, which came in a live chat with Republican Sen. Tim Scott of South Carolina, the FDA had not publicly acknowledged the pause to AstraZeneca’s trial, and it is yet to provide any details on when the study might resume.
FDA Commissioner Stephen Hahn, making his first remarks on the matter via Instagram Live, said the agency was “going to do very significant work with the company to figure out if there’s a significant safety issue or not” before the study can start dosing volunteers again.
That complicates AstraZeneca’s plans to have Phase III data available later this year, which could put the company materially behind competing vaccines from Moderna and the partnership of Pfizer and BioNTech. It also underlines just how difficult it is to get clear information on what’s going on. Prior to Hahn’s comments, which came in a live chat with Republican Sen. Tim Scott of South Carolina, the FDA had not publicly acknowledged the pause to AstraZeneca’s trial, and it is yet to provide any details on when the study might resume.
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