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AstraZeneca is in a clinical hold pattern



A large vaccine study was canceled this week after a participant developed severe neurological symptoms. It was one of the first known bumps on the road for the high profile vaccine candidate being developed by AstraZeneca and Oxford University.

The hiatus on a promising vaccine candidate can be harrowing, especially during a deadly pandemic. But it’s not unexpected, and that’s exactly what large-scale clinical trials are for. In clinical trials, researchers carefully monitor patients for any adverse reactions to the drug or treatment. If something goes wrong, they can pause, research, and then move on once it̵

7;s safe to do so.

“You take a group of 30,000 people and observe them for two or three months. It’s likely someone has a disease you weren’t expecting,” said Francis Collins, director of the National Institutes of Health. said NBC. “And until you are sure it was unrelated to the study and you need to put it on clinical hold.”

The hold was first reported by STATwho later found the stop triggered when a patient was hospitalized in the UK with severe neurological symptoms. The symptoms were apparently similar to those in people with transverse myelitis, a type of inflammation of the spinal cord. The patient – who is expected to recover – appears to have received the vaccine as part of the study, but that doesn’t mean the vaccine caused the disease.

During a conversation with investors, Pascal Soriot, head of AstraZeneca, said that according to data it was actually the second clinical interruption of the study STAT. The first break was reportedly caused by another person who started experiencing neurological symptoms. In this case, they were diagnosed with multiple sclerosis, which had nothing to do with the vaccine.

To find out what happened in this new case, researchers need to examine the data, a process that can take some time. In the meantime, other studies are looking for evidence of similar symptoms that may have appeared during their tests.

This is also normal. We cannot skip the steps of the research process if we are to get a safe and effective vaccine. It’s also quite common, even on attempts that have already made it through several smaller rounds of testing.

But you don’t have to take my word for it. Back in 2017, the Food and Drug Administration published a report that selected 22 different case studies showing that a promising drug, treatment, or vaccine candidate simply failed to make that final cut. The therapies were ineffective in 14 cases. In one thing it was unsafe. In seven cases, both were unsure and not effective. These were all equipment, drugs, and vaccines that had done great 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 guesswork can be unreliable without confirmation of clinical evidence.”

In developing a vaccine to fight this pandemic, we need to avoid previous guesswork and pitfalls and focus on the evidence – even if it takes a moment to stop and wait for science to catch up.

Here’s what happened this week.

research

New research shows a disproportionate rate of coronavirus deaths in polluted areas
A new peer-reviewed study by both ProPublica and SUNY found there were more coronavirus-related deaths in areas with high levels of industrial air pollution.
(Lylla Younes and Sara Sneath / ProPublica)

The Sturgis Biker Rally did not cause 266,796 cases of COVID-19
This is good analysis of a study modeling virus transmission that received a lot of attention this week. It examines exactly why the attention-grabbing numbers from the study are worth a skeptical look.
(Jennifer Beam Dowd / slate)

As states lift restaurant restrictions, the CDC report links eating to an increased risk of COVID-19
People who tested positive for the coronavirus were more likely to eat than people who didn’t, according to a new report from the Centers for Disease Control and Prevention. The study interviewed 314 people in multiple states and made no distinction between indoor and outdoor dining.
(Erika Edwards / NBC News)

development

A third of Americans could oppose a Covid-19 vaccine. How screwed are we?
Once we get a COVID-19 vaccine, it will only help contain the spread of disease if people actually take it. Right now people in the US are skeptical.
(Brian Resnick / Vox)

Pharmaceutical companies sign security pledges for vaccines
People’s skepticism about the vaccine development and approval process led several companies to sign a pledge that promises safety comes first.
(Mary Beth Griggs / The edge)

China injects hundreds of thousands of experimental Covid-19 vaccines
In China, hundreds of thousands of people received in The Wall Street Journal. These vaccines have not yet completed phase 3 trials.
(Chao Deng / The Wall Street Journal)

According to IATA, 8,000 jumbo jets are required worldwide to deliver coronavirus vaccines worldwide
After a vaccine is developed, it has to travel from the manufacturing facilities to the population centers. That takes a lot of logistical energy, including air power. To illustrate the challenge, a trade group calculated the amount of cargo space it would take to carry a single-dose vaccine to 7.8 billion people. They came with 8,000 jets. A few important notes: this is all hypothetical, it’s early days, and vaccines could potentially travel by land or water as well.
(Holly Ellyatt / CNBC)

Perspectives

How many 9/11 survivors died of COVID-19? At least 42 – and probably a lot more
Yesterday, on the 19th anniversary of the 9/11 attacks, a nonprofit news organization called The town reported 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 town To recognize and remember everyone in New York City who has died of COVID-19.
(Ashley Rodriguez and Beatriz Muylaert / The town)

More than numbers

For the 28,287,928+ people worldwide who tested positive, your journey to recovery can be a smooth one.

To the families and friends of 9111,591 people worldwide – 192,616 in the US – loved ones will not be forgotten.

Thank you for joining us this week and for being all safe.


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