Astra Cleared by U.S. Regulators to Resume Vaccine Trial

AstraZeneca Plc, the U.K. drugmaker developing a Covid-19 vaccine with the University of Oxford, has been cleared by U.S. regulators to restart a trial halted in the country for more than a month on concerns about a volunteer who became ill, according to a person familiar with the decision.

The person asked not to be identified because the information isn’t public.

A decision to allow the study to resume would remove a significant impediment for AstraZeneca and Oxford as they try to get their coronavirus shot across the line. They are among the front-runners in the global quest for a vaccine, along with developers such asPfizer Inc. andModerna Inc.

AstraZeneca declined to comment. A representative for the U.S. Food and Drug Administration didn’t immediately respond to a request for comment.

Questions have swirled around the AstraZeneca trials since anannouncement in September that a participant in a U.K. study had developed an unexplained illness, and the partners have faced pressure to disclose more information about the episode. Although temporary halts are common, the interruption raised concerns about the prospects of one of the fastest-moving shots and highlighted the hurdles researchers face when developing a vaccine.

Trials of the Astra-Oxford vaccine resumed weeks ago outside the U.S., in locations including the U.K. and South Africa. Symptoms that prompted the partners to pause the studies were unlikely to be linked to the shot, or there was insufficient evidence to say for sure, according to documents sent to participants. Safety reviews were carried out when volunteers developed unexplained neurological symptoms including limb weakness or “changed sensation,” adocument posted by Oxford shows.

Tests to decide whether experimental Covid-19 shots are safe and effective are progressing at an unprecedented speed as drugmakers and governments look for a way out of the crisis and the virus continues to advance, killing more than 1.1 million people worldwide.

Astra faced a further flurry of headlines this week when it emerged that aparticipant in the Brazil vaccine trial had died. It was quickly determined the volunteer was in the control arm of the study and hadn’t received the shot. Brazil’s health authority said an international committee had reviewed the event and the trial would continue.

Another vaccine maker, Johnson & Johnson,said in mid-October that it would pause its trial to investigate an illness in a study participant. Operation Warp Speed head Moncef Slaoui said in an interview earlier this week that both the Astra and J&J trialscould resume in the coming days.

— With assistance by Anna Edney

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