AstraZeneca may restart a key study of its coronavirus vaccine in the US this week after putting it on hold for more than a month, a new report says.
The Food and Drug Administration has finally finished its review of the severe illness in a study participant that forced AstraZeneca to halt the Phase 3 clinical trial in early September, Reuters reported Tuesday.
That could allow the British drugmaker to forge ahead with the US portion of the study later this week after resuming the trial in the UK, Brazil, India and South Africa, according to the news agency, which cited four sources briefed on the matter.
AstraZeneca put the study on hold last month after a UK participant came down with what was believed to be transverse myelitis, a rare spinal inflammatory condition. British regulators allowed the trial to resume there after finding “insufficient evidence to say for certain” whether the illness was related to AstraZeneca’s COVID-19 vaccine, according to Reuters.
In a draft letter to the British study participants, vaccine researchers at Oxford University — which is developing the shot with AstraZeneca — wrote that the FDA had “completed their analysis” of the illness and had “come to the same conclusion as the other drug regulators,” Reuters reported.
But an AstraZeneca spokesperson told The Post that the company could not “verify the content” of the document Reuters referenced or comment on a pending FDA decision. The FDA declined to comment Wednesday.
AstraZeneca’s vaccine is one of four potential coronavirus inoculations currently going through late-stage trials in the US. Johnson & Johnson also had to pause its Phase 3 study last week after an unexplained illness in one of the participants.
Both Pfizer and Moderna expect to have key early results from their vaccine studies by next month and could ask US regulators to approve the shots for emergency use by the end of November.
AstraZeneca shares were down about 0.1 percent at $52.11 as of 12:51 p.m. Wednesday.
With Post wires
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