Major US Covid-19 vaccine trials from AstraZeneca and Johnson & Johnson were given the green light to restart on Friday, after the US regulator concluded it was safe to resume testing the experimental candidates.
The two drugmakers’ US trials had been paused as the Food and Drug Administration investigated whether serious adverse events could be linked to the vaccines.
The trial of AstraZeneca’s vaccine candidate, developed with Oxford university, had been paused since September 6 after a participant fell sick with neurological symptoms, even as studies in other countries including the UK were restarted.
Pascal Soriot, AstraZeneca’s chief executive, said people should be “reassured by the care taken by independent regulators to protect the public”.
“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,” he said.
J&J’s US trial was paused less than two weeks ago after a participant suffered an unexplained illness. It has now been resumed — while there was no clear cause for the sickness, there was no evidence it had been caused by the vaccine. The company said its talks about resuming trials with regulators in other countries were “progressing”.
J&J said it had “no greater priority than the health and safety of the people we serve every day around the world”.
While pauses in trials are not unusual, these studies have been closely monitored, as companies race to develop a vaccine in hopes of stemming the spread of the virus causing the pandemic. The process has also been under intense political scrutiny in the US ahead of the presidential election.
Senior figures at Operation Warp Speed, the White House project for accelerating vaccines and treatments for coronavirus, said the delay had shown that the Trump administration was being cautious on vaccine development, despite accusations that it was rushing through the approval process to boost the US president’s re-election prospects.
Matt Hepburn, head of vaccine development at the project, said: “I am hopeful that the message this communicated to the American public is that we are following processes and procedures to the highest ethical standards. We are not interfering in the regulatory processes of the FDA. The FDA has done an exemplary job and now the trial resumes.”