(NewsNation Now) — Federal health regulators have given the green light to resume U.S. studies of a leading Covid-19 vaccine candidate from AstraZeneca PLC and the University of Oxford, according to a release from AstraZeneca.
The FDA Friday authorized the restart in the U.S. following the resumption of trials in other countries.
“The FDA reviewed all safety data from trials globally and decided it was safe to resume the trial,” AstraZeneca said.
AstraZeneca’s large, late-stage U.S. trial has been on hold since Sept. 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.
UK regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine. It permitted the trial to resume enrolling participants in the UK, according to a draft of the updated consent form shared with Reuters.
“In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare products Regulatory Agency) recommended that vaccinations should continue,” the draft consent form stated. “Close monitoring of the affected individual and other participants will be continued.”
Regulators in Brazil, India and South Africa also previously allowed AstraZeneca to resume its vaccine trials there.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” AstraZeneca Chief Executive Officer Pascal Soriot said in a statement to NewsNation. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
The FDA has not responded to request for comment.