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A large vaccine trial was stopped this week after one participant experienced severe neurological symptoms. It was one of the first known obstacles in the way of the highly touted vaccine candidate, which is being developed by AstraZeneca and the University of Oxford.
AstraZeneca said on Saturday it had resumed phase three trials in the UK alone, after receiving confirmation from the UK Medicines Health Regulatory Authority that it was safe to do so. The company said in a blog post that it could not disclose any medical information, saying only that the “standard review process triggered a voluntary pause,” adding that it was working with health authorities in other countries to determine when they can be resumed. other clinical trials.
Pausing on a promising vaccine candidate can be jarring, especially during a deadly pandemic. But it’s not unexpected, and it’s exactly the kind of thing that large-scale clinical trials are for. In clinical trials, researchers carefully monitor patients for any type of adverse reaction to the drug or treatment. If something goes wrong, they can pause, investigate, and then continue once it is safe to do so.
“If you take any group of 30,000 people and observe them over the course of two or three months, it is likely that someone has an unexpected illness,” said Francis Collins, director of the National Institutes of Health. he told NBC. “And until you are sure it was unrelated to the trial and should be put on clinical hold.”
The retention was first reported by STAT, which later found that the halt was triggered when a patient in the UK was hospitalized with severe neurological symptoms. The symptoms were apparently similar to those found in people with transverse myelitis, a type of inflammation of the spinal cord. The patient, who is expected to recover, apparently received the vaccine as part of the trial, but that does not mean that the vaccine caused the disease.
During a call with investors, AstraZeneca director Pascal Soriot said this was actually the second clinical suspension of the trial, according to STAT. The first hiatus was reportedly caused by a different person who developed neurological symptoms, but in that case, they were diagnosed with multiple sclerosis, something that is not related to the vaccine.
To find out what happened in this new case, researchers will have to dig into the data, a process that could take some time. Meanwhile, other trials are looking for evidence of similar symptoms that might have cropped up during their tests.
Again, this is normal. We cannot skip steps in the research process if we want to end up with a safe and effective vaccine. It is also quite common, even for tests that have already passed multiple smaller test rounds.
But you don’t have to take my word for it. In 2017, the Food and Drug Administration released a report that selected 22 different case studies showing when a promising drug, treatment, or vaccine candidate just didn’t make the final cut. In 14 cases, the therapies were not effective. In one, it was not safe. And in seven cases, both were unsafe and no cash. These were all devices, drugs, and vaccines that had worked very well in the lab, and some were even approved to treat other conditions. But the human body is complex. And as the FDA report notes, this sample of failed tests shows “how logical assumptions without corroborating clinical evidence can be unreliable.”
In developing a vaccine to combat this pandemic, we will need to avoid past assumptions and pitfalls, and focus on the evidence, even if it means taking a moment to stop and wait for the science to catch up.
This is what happened this week.
Investigation
New research shows disproportionate rate of coronavirus deaths in contaminated areas
A new peer-reviewed study conducted by both ProPublica and SUNY found that there were more coronavirus-related deaths in areas with high industrial air pollution.
(Lylla Younes and Sara Sneath / ProPublica)
The Sturgis Biker Rally did not cause 266,796 COVID-19 cases
This is a good analysis of a study modeling virus transmission that received a lot of attention this week. It delves into exactly why the numbers that catch the study’s attention deserve a skeptical look.
(Jennifer Beam Dowd / Board)
As states lift restrictions on restaurants, a CDC report links dining out to increased risk of COVID-19
People who tested positive for the coronavirus were more likely to have gone out to eat than people who did not, according to a new report from the Centers for Disease Control and Prevention. The study surveyed 314 people in various states and did not distinguish between dining indoors or outdoors.
(Erika Edwards / NBC News)
Development
A third of Americans could reject a Covid-19 vaccine. How fucked up are we?
Once we receive the COVID-19 vaccine, it will only help slow the spread of the disease if people actually take it. Right now, people in the United States are skeptical.
(Brian Resnick / Vox)
Pharmaceutical companies sign vaccine safety pledge
People’s skepticism about the vaccine development and approval process led several companies to sign a pledge promising to put safety first.
(Mary Beth Griggs / The edge)
China injects hundreds of thousands of Covid-19 experimental vaccines
Meanwhile, in China, hundreds of thousands of people received experimental vaccines, according to a new report in The Wall Street Journal. These vaccines have not yet completed phase three trials.
(Chao Deng / The Wall Street Journal)
8,000 jumbo jets needed to deliver coronavirus vaccines globally, IATA warns
Once a vaccine is developed, it has to travel from production facilities to population centers. That will require a lot of logistical power, including air power. To illustrate the challenge, a trade group calculated the amount of cargo space it would take to transport a single-dose vaccine to 7.8 billion people. They came up with 8,000 jets. Some important notes: this is all hypothetical, it is still early, and vaccines could also travel by land or sea.
(Holly Ellyatt / CNBC)
Perspectives
How many survivors of September 11 have died from COVID-19? At least 42, and probably many more
Yesterday, on the 19th anniversary of the September 11 attacks, a non-profit news organization called The city reported on the dozens of people who survived the 9/11 attacks, only to die of COVID-19. More than 1,300 survivors contracted the disease.
This story is part of “Missing Them”, an effort by The city recognize and remember all the people in New York City who died from COVID-19.
(Ashley Rodríguez and Beatriz Muylaert / The city)
More than numbers
For the more than 28,287,928 people worldwide who have tested positive, may your road to recovery be smooth.
To the families and friends of the 911,591 people who have died around the world, 192,616 of those living in the US, their loved ones have not been forgotten.
Thank you for joining us this week and staying safe, everyone.
Update September 12, 10:12 am ET: Adds AstraZeneca has resumed clinical trials of its vaccine in the UK
