AstraZeneca Plc, the UK drug maker developing a Covid-19 vaccine with the University of Oxford, received clearance from US regulators to restart a trial that was halted in the country for more than a month over concerns about a volunteer. who got sick.
The US Food and Drug Administration authorized the trial to resume on Friday, according to statements by AstraZeneca and Oxford. The FDA reviewed data from global studies and decided it was safe to start testing again, the partners said.
The decision removes a significant impediment to partners attempting to shoot coronavirus across the line. They are among the pioneers in the global search for a vaccine, along with developers such as Pfizer Inc. and Moderna Inc. Astra’s US trial will test the vaccine in 30,000 volunteers, taking the total number of participants in advanced trials for the jab. to 50,000, according to Oxford.
“We must be reassured by the care that independent regulators have taken to protect the public and ensure that the vaccine is safe before it is approved for use,” Pascal Soriot, CEO of the pharmaceutical company, said in a statement. This “allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.”
A representative for the FDA did not immediately respond to a request for comment.
Unprecedented speed
Trials of the Astra-Oxford vaccine resumed weeks ago outside the US, in countries such as the UK, South Africa and Brazil. The symptoms that led the partners to pause the studies were unlikely to be linked to the injection, or there was insufficient evidence to say for sure, according to documents sent to participants. Safety reviews began after volunteers developed unexplained neurological symptoms including limb weakness or “sensation change,” a paper published by Oxford shows.
The tests to decide whether experimental Covid-19 injections are safe and effective are progressing at unprecedented speed as drug manufacturers and governments seek a way out of the crisis. The virus has continued to advance, killing more than 1.1 million people worldwide.
Test results for the last stage of the Astra-Oxford injection are expected later this year and will depend on local infection rates where the studies are being conducted, according to Astra.
The British pharmaceutical company faced a series of headlines this week when it emerged that a participant in the Brazilian vaccine trial had died. It was quickly determined that the volunteer was in the control arm of the study and had not received the injection. 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 it would halt its trial to investigate a disease in a study participant. Operation Warp Speed chief Moncef Slaoui said in an interview earlier this week that both Astra and J&J testing could resume in the next few days.
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