J&J halts vaccine clinical trials over illness
Print Edition
JOHNSON & Johnson has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.
The company said in a statement on Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.
The move comes around a month after AstraZeneca also suspended trials of its experimental coronavirus vaccine, which uses a similar technology, due to a participant falling ill.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the US as officials examine whether an illness in its trial poses a safety risk.
That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.
The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.
They are both also part of the US government’s Operation Warp Speed program to support vaccine development.
“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.
J&J used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.
Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
J&J on September 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the US require two shots.
“Everybody is on the alert because of what happened with AstraZeneca,” Dr William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information. “This is likely to be a neurological event,” he said.
Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.
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