OXFORD VACCINE TRIAL DELAYED OVER ILLNESS.

LONDON • The disclosure that AstraZeneca and Oxford have suspended their Phase 3 vaccine trials following a suspected case of transverse myelitis — a rare neurological condition — in a British female participant is bad news, but it may yet prove to be just a bump in the road.

The pause will delay the vaccine’s progress, making the possibility of it receiving an emergency licence this year much less likely. But experts expect the trial will almost certainly continue to allow further data to be gathered and assessed.

The scientific community was out in force to stress the positives. The suspension of the trial, they said, demonstrated that patient safety was paramount and that the complex system of regulatory checks and balances was working as it should.

“It’s always a concern if someone in the trial develops a serious adverse reaction ... but if we had five or six cases I would be much more alarmed,” said Prof. Beate Kampmann, director of the vaccine centre at the London School of Hygiene and Tropical Medicine. “Whether this reaction is related to the vaccine under trial itself, or is unrelated, now has to be established. But to think this vaccine is now doomed is completely disproportionate.”

Yet the incident raises cause for concern.

Ever since President Gerald Ford rushed through the licensing of a novel flu vaccine in 1976, fears of vaccines prompting dangerous neurological side effects have stalked the industry.

Ford acted against scientific advice to license the mass distribution of a novel HIN1 shot in the United States after an influenza outbreak in New Jersey. There was no pandemic, but the vaccine caused Guillain-Barre syndrome — a neurological condition that can paralyze — in some 450 of the 45 million people who received the jab. More than 30 died, sparking a scandal that underpins much of today’s safety regulations.

Pascal Soriot, AstraZeneca’s chief executive, confirmed that the Oxford vaccine trial was suspended after a woman was admitted to hospital with symptoms consistent with transverse myelitis. She is expected to leave the hospital today.

Soriot added that the trial had also been paused in July after a different participant experienced neurological symptoms. However, these were found to be unrelated to the vaccine.

Transverse myelitis can cause paralysis, sensory problems and bladder and bowel dysfunction. Most people recover, but severe attacks can cause lasting and serious disabilities. Experts say it will be all but impossible for AstraZeneca to know if the adverse event was caused by the vaccine.