AstraZeneca’s Vaccine Trial Paused After Suspected Adverse Reaction

Stat: AstraZeneca Covid-19 Vaccine Study Put On Hold Due To Suspected Adverse Reaction In Participant In The U.K.
A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.  (Robbins, Feuerstein and Branswell, 9/8)

The Wall Street Journal: AstraZeneca Pauses Covid-19 Vaccine Trial After Illness In A U.K. Subject
The halt is a setback for the vaccine effort, which has long been touted as one of the world’s most advanced candidates. The shot had quickly progressed to late-stage studies in various countries, with AstraZeneca already signing contracts that could result in the delivery of initial doses this fall. The pause affects a study that began last week in the U.S. aiming to enroll 30,000 people, with funding from federal agencies. The study is testing whether the vaccine reduces the rate of Covid-19 cases compared with unvaccinated study subjects. AstraZeneca and Oxford had started a large study of the vaccine in the U.K. in the spring. (Loftus and Orru, 9/9)

The New York Times: AstraZeneca Pauses Covid-19 Vaccine Trial For Safety Review 
Drug companies are racing to complete a coronavirus vaccine that could bring an end to a pandemic that has already claimed more than 890,000 lives globally. AstraZeneca is a front-runner, with late-stage clinical trials underway around the world, and has said it hoped to have a vaccine ready before the end of the year. If the cause of the reaction turns out to be related to the vaccine, those efforts could be derailed. Late-stage vaccine testing remains crucial, as large trials can turn up rare but serious side effects that would surface only if many thousands of people received a vaccine. (9/8)

AP: AstraZeneca COVID-19 Vaccine Study Paused After One Illness
Temporary holds of large medical studies aren’t unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it’s possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people. “We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the company statement said. (Neergaard, 9/8)

USA Today: COVID Vaccine: AstraZeneca Trial On Hold After 'Unexplained Illness'
The interruption represents the first major hiccup in what has been a remarkably smooth path in the historically rapid vaccine effort spanning the globe. That said, large scale, make-or-break Phase 3 clinical trials are where real issues are most likely to occur. In earlier, smaller trials none of the various candidate vaccines reported very serious reactions. But in larger trials like AstraZeneca's, rarer reactions can pop up, which is why they are conducted before a vaccine is approved. (Weintraub and Weise, 9/8)

Scientists and health officials downplay the significance of the pause —

Nature: A Leading Coronavirus Vaccine Trial Is On Hold: Scientists React
Details of the adverse event, including how serious it is and when it happened, have not been reported by Oxford or AstraZeneca. But the trial's pause comes amid concerns that US drug agencies might face political pressure to approve a vaccine before trials are completed, ahead of the November Presidential election. “The clinical hold shows that there are functioning checks and balances, in spite of political pressure," says Marie-Paule Kieny, a vaccine researcher at INSERM, the French national health-research institute in Paris. "It might indeed remind everybody — even Presidents — that for vaccines safety is paramount,“ she says. (Cyranoski, 9/9)

Reuters: Pause In AstraZeneca Vaccine Trial Not Necessarily A Setback, Says UK Health Minister 
Britain’s Health Secretary Matt Hancock said on Wednesday that AstraZeneca’s decision to pause its coronavirus vaccine trials was a challenge but would not necessarily set back efforts to develop a vaccine. ... “It is obviously a challenge to this particular vaccine trial,” Hancock said on Sky News when asked about the pause in the trial. “It’s not actually the first time this has happened to the Oxford vaccine.” (9/9)

Fortune and Bloomberg: AstraZeneca COVID Vaccine Trial Halted; Scientists Call The Pauses 'Common' 
Some scientists downplayed the significance of the halt. Eric Topol, a cardiologist and clinical-trials expert at the Scripps Research Translational Institute in San Diego, said such pauses in large studies are “not uncommon at all.” There is a high likelihood the adverse event will turn out not to be related to the vaccine, he said in an email. “It’s a safety precaution,” he said. (Cortez and Griffin, 9/8)

Newsweek: What Is Transverse Myelitis? Google Searches Up After Reported Link To AstraZeneca Coronavirus Vaccine Trial
The New York Times reported that a volunteer in the U.K. trial had been diagnosed with transverse myelitis, citing a person familiar with the situation who spoke on the condition of anonymity. It was not known whether the condition was caused by the vaccine. Following the publication of The New York Times report, there was a huge spike in Google searches for transverse myelitis. (Gander, 9/9)