Oxford vaccine trial paused after participant suffers adverse reaction

Video by Yilin Yang

Trials of a potential COVID-19 vaccine being developed by Oxford University and AstraZeneca have been put on hold after a possible adverse reaction in one of the participants. 

With billions of people around the world still suffering from the fallout of the pandemic and the global death toll nearing 900,000, a worldwide race for a vaccine is under way. Nine companies are in late-stage Phase III trials.

Worldwide infections to date stand at more than 27 million, and more than 890,000 people have died from the disease.

The vaccine has been described by the World Health Organization as probably the world's leading candidate and the most advanced in terms of development. The suspension dims prospects for an early rollout amid reports that the United States was aiming for a fast-track approval before the Nov 3 election.

The British drugmaker said it voluntarily paused trials to allow an independent committee to review safety data, and it was working to expedite the review to minimize any potential impact on the trial timeline.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials," the company said in an emailed statement.

The nature of the illness was not disclosed, although the participant is expected to recover, according to Stat News, which first reported the suspension due to a "suspected serious adverse reaction".

The US Food and Drug Administration defines an adverse event as one in which evidence suggests a possible relationship to the drug being tested.

According to a New York Times report citing a person familiar with the situation, a participant based in the United Kingdom was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.

Whether the illness was directly linked to AstraZeneca's vaccine remains unclear, the report said. AstraZeneca declined to comment on the report.

AstraZeneca's shares fell more than 8 percent in after-hours US trading, while shares in rival vaccine developer Moderna rose more than 4 percent. Shares in AstraZeneca's Indian unit, AstraZeneca Pharma India, tumbled more than 12 percent.

50,000 participants

Called AZD1222, the vaccine is in late-stage clinical trials in the United States, the UK, Brazil and South Africa, and additional trials are planned in Japan and Russia. The trials aim to enroll up to 50,000 participants globally.

South Korea said on Wednesday it would look into the suspension and review its plan to participate in the manufacturing of the vaccine.

"It's not rare that clinical trials get suspended as various factors interact," Yoon Tae-ho, a health ministry official said.

The decision to put the trial on hold has impacted clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.

The US National Institutes of Health, which is providing funding for AstraZeneca's trial, declined to comment.

Moderna said in an emailed statement it was "not aware of any impact" to its ongoing COVID-19 vaccine study.

Nine leading US and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines despite the urgency to contain the coronavirus pandemic.

The companies, including Astra-Zeneca, Moderna and Pfizer, issued what they called a "historic pledge" after a rise in concerns that safety standards might slip in the face of political pressure to rush out a vaccine.

Soumya Swaminathan, the WHO's chief scientist, said on Wednesday that safety of a prospective COVID-19 vaccine comes "first and foremost".

AGENCIES VIA XINHUA