Illness at trial not linked to Covid shot, says Oxford

LONDON/ WASHINGTON: Symptoms that prompted the University of Oxford and partner AstraZeneca to pause trials evaluating their experimental coronavirus vaccine probably weren’t related to the shot itself, according to documents sent to participants.

Safety reviews were carried out when volunteers in the Oxford study developed unexplained neurological symptoms including limb weakness or “changed sensation”, a participant information sheet posted online by Oxford shows.

“After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine,” the letter reads. “In each of these cases, after considering the information, the independent reviewers recommended that vaccinations should continue.”

The details shed more light on an episode reported last week in the UK trial and the safety data that triggered the halt. AstraZeneca and Oxford have continued to face questions about the event, and their vaccine study remains on hold in the US pending a regulatory review, federal officials said. It’s the first indication from Oxford as to the nature of the illness, which sparked concerns about vaccine safety.

AstraZeneca CEO Pascal Soriot had said earlier that it wasn’t clear whether the participant had a condition called transverse myelitis, after news reports cited it as a suspected diagnosis. US National Institutes of Health director Francis Collins told a Senate committee last week that the trial had been halted due to a spinal cord problem.

In rare move, Moderna shares its trial protocol

US biotech firm Moderna, one of two companies holding phase 3 trials in the US for a Covid-19 vaccine, took the unusual step on Thursday of publishing its trial protocols after calls for more transparency. Moderna said it had recruited 25,296 participants of its goal of 30,000, of whom 28% were from minority communities.