(Reuters) – The chief official of the U.S. Food and Drug Administration confirmed on Tuesday that testing of the US COVID-19 vaccine from AstraZeneca Plc is on hold, saying the agency is planning to do “very significant work” with the company as it conducts its investigation after an illness in a participant in Britain.
“We are here to protect the American public and we are going to do a very significant job with the company to find out if there is a significant security issue or not,” said FDA Commissioner Stephen Hahn during an interview with Instagram Live with the US Republican Senator. Tim Scott, from South Carolina.
“We don’t have all the facts, so we don’t know the cause of it in itself, but we really need to investigate it. And our main responsibility is the safety of the American people, ”said Hahn.
Enrollment in the British pharmaceutical’s global trials with the vaccine, which he is developing with researchers at the University of Oxford, was discontinued on 6 September, after a participant in his UK trial had a serious side effect, considered a spinal inflammatory disorder. rare called transverse myelitis.
The test in the United Kingdom was resumed, as well as the company’s tests in Brazil and South Africa.
Reuters reported on Monday, based on sources, that the U.S. trial was still on hold, awaiting investigations by the FDA and the security panel.
The US government’s process of reviewing the efforts of the COVID-19 vaccine is being closely watched, as some scientists and public health officials fear President Donald Trump will rush to get an approved vaccine before the presidential election on 3 December. November to reinforce the perception of how it is dealing with the pandemic.
Reporting by Manojna Maddipatla in Bengaluru, written by Caroline Humer; Editing by Arun Koyyur and Cynthia Osterman