AstraZeneca Plc has resumed the US trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial on Monday or Tuesday, the companies said on Friday.
The news signaled progress against the novel coronavirus that has infected more than 41 million globally, including 8 million Americans and comes 10 days before a U.S. presidential election that may hinge on plans to fight the pandemic.
AstraZeneca, one of the leading vaccine developers, paused its US trial on September 6 after a report of a serious neurological illness, believed to be transverse myelitis, in a participant in the company’s UK trial. J&J paused its large, late-stage trial last week after a study participant became ill.
Both companies have contracts to provide vaccine to the United States and other governments if they are cleared by regulators.
Officials and experts have expressed concern that the regulatory approval process overseen by the Food and Drug Administration (FDA) will be undermined by political pressure, and around a quarter of Americans say they are hesitant to take a COVID-19 vaccine.
“As this trial resumes, I am hoping the message communicated to the public is that we are following procedures to highest ethical standard and not interfering with the FDA regulatory process,” said Matthew Hepburn, head of vaccine development for Operation Warp Speed, a public-private partnership to speed inoculation efforts.
Infections are rising in 80 countries as people in the northern hemisphere spend more time indoors with winter approaching.
J&J said on Friday that the safety panel, called a Data and Safety Monitoring Board, has recommended that the drugmaker resume trial recruitment after finding no evidence that the vaccine caused the volunteer to fall ill.