Saturday 24 October 2020 4:11 pm

Astrazeneca and Johnson & Johnson to restart US Covid-19 vaccine trials

Regulators have given Astrazeneca the green light to resume its US trial of a Covid-19 vaccine, while Johnson & Johnson is preparing to restart next week.

Astrazeneca paused its trial on 6 September after reports of a neurological illness, believed to be transverse myelitis, in a participant in the pharmaceutical giant’s UK trial. 

J&J halted its large, late-stage trial last week after a participant fell ill.

Both firms have contracts to provide the vaccine in the US and other countries if they are approved by regulators.

Officials and experts are concerned 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.

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.

It said on Monday or Tuesday and remains on track to produce data from the trial on the vaccines’ effectiveness by the end of 2020 or early 2021, J&J’s chief scientific officer Paul Stoffels said.

J&J is also in discussions with other regulators to resume a trial outside of the United States, the company said.

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