ASTRAZENECA RESUMES U.S. VACCINE TRIAL, J&J PREPARES TO RESTART SOON
WASHINGTON: Astrazeneca 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 signalled progress against the coronavirus that has infected more than 42 million globally, including 8.5 million Americans, and it comes 10 days before a US 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 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.