AstraZeneca resumes clinical trials of coronavirus vaccine

A major vaccine trial was canceled this week after participants experienced severe neurological symptoms. This was one of the first known bumps on the path of highly advertised vaccine candidates developed by AstraZeneca and the University of Oxford.

AstraZeneca said it resumed Phase 3 trials on Saturday Only in the UK after being confirmed to be safe by UK drug regulators. The company was unable to reveal medical information in a blog post, only stating that “the standard review process caused a voluntary suspension,” and worked with health authorities in other countries for other clinical trials. He added that he was determining when the trial would resume.

Putting a pause on a promising vaccine candidate can be jarring, especially during a deadly pandemic. But that’s not unexpected, it’s just for large clinical trials. In clinical trials, researchers carefully monitor patients for all sorts of adverse reactions to drugs or treatments. If something goes wrong, they can pause and investigate, and if there are no problems, they can safely continue working.

“You take any group of 30,000 people and observe them during the two or three months, it’s likely that someone has an illness you didn’t expect.” National Health Study Francis Collins, the director of the office, Told NBC.. “And until I was convinced that it wasn’t relevant to the trial and needed to put the clinical trial on hold.”

Hold is First reported STAT, later It was found that the arrest was triggered when a British patient was hospitalized with severe neurological symptoms. Symptoms were clearly similar to those seen in humans Transverse myelitis, A type of inflammation of the spinal cord. The patient-expected to recover-seems to have 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’s head Pascal Soriot said this was actually the second clinical hold in the clinical trial, by STAT.. The first pause was reported to have been caused by another person who caused the neurological symptoms, in which case he was diagnosed with multiple sclerosis unrelated to the vaccine.

Researchers need to dig into the data to understand what happened in this new case. It may take some time.. Meanwhile, other trials are looking for evidence of similar symptoms that may have occurred during the test.

Again, this is normal. we You cannot skip steps in the research process If you want to get a safe and effective vaccine. This is also fairly common, even for trials that have already been successful in multiple small rounds of testing.

But you don’t have to take my word. In 2017, the Food and Drug Administration We chose 22 different case studies It shows when a promising drug, treatment, or vaccine candidate did not make that final cut. In 14 cases, treatment was ineffective. For one thing, it wasn’t safe. And in seven cases, neither was safe And It has no effect. All of these are devices, drugs, and vaccines that have been successful in the lab, and some have also been approved to treat other conditions. However, the human body is complicated. And, as the FDA’s report points out, this sample of failed tests shows “how logical estimates can be unreliable without supporting clinical evidence.” ..

When developing a vaccine to combat this pandemic, it is necessary to avoid past estimates and pitfalls and focus on the evidence. Even if that means pausing and waiting for science to catch up.

Other events this week include:

the study

New study shows disproportionate rate of coronavirus death in contaminated areas
Ah New peer-reviewed study Both ProPublica SUNY has found that coronavirus-related deaths are high in areas with high industrial air pollution.
(Lira Younes and Sarah Nice / ProPublica)

Sturgis Biker Rally did not cause 266,796 cases of COVID-19
This is an excellent analysis of a study that modeled a viral infection that attracted attention this week. Dig into exactly why the numbers that draw attention from research are worth a skeptical look.
(Jennifer Beam Daud / slate)

When the state lifts restaurant restrictions, CDC reports associate eating out with an increased risk of COVID-19
People who are positive for the coronavirus are more likely to eat out than those who are not. New report from Centers for Disease Control and Prevention.. The survey included 314 people across several states and did not distinguish between indoor and outdoor diets.
(Erica Edwards / NBC News)

development of

One-third of Americans may reject the Covid-19 vaccine. How screwed are we?
Once you have the COVID-19 vaccine, it will help control the spread of the disease only if people actually get it. Currently, Americans are skeptical.
(Brian Resnick / Vox)

Pharmaceutical company signs vaccine safety pledge
People’s skepticism about the vaccine development and approval process has prompted some companies to sign a pledge that promises to put safety first.
(Mary Beth Griggs / brink)

China injects hundreds of Covid-19 vaccines
Meanwhile, in China, hundreds of thousands have been vaccinated with vaccines. The Wall Street Journal.. These vaccines have not yet completed Phase 3 trials.
(Chaoden / The Wall Street Journal)

IATA warns 8,000 jumbo jets needed to deliver coronavirus vaccine worldwide
After the vaccine is developed, it must reach the center of population from the production facility. It will require a lot of logistical support, including air power. To illustrate the challenge, industry groups have calculated the amount of cargo space required to transport a single-dose vaccine to 7.8 billion people. They came up with 8,000 jets. Some important notes: This is all a hypothesis, still in its infancy, and vaccines may also pass by land or sea.
(Holly Elaiat / CNBC)

Outlook

How many 9/11 survivors died from COVID-19? At least 42 — and maybe more
Yesterday, on the 19th anniversary of the 9/11 attacks city He reported on dozens of people who survived the 9/11 attacks but died in COVID-19. More than 1,300 survivors have the disease.

This story is part of “Missing Them” city Recognize and remember everyone in New York City who died of COVID-19.
(Ashley Rodriguez and Beatrice Murat / city)

More than a number

For more than 28,287,928 people worldwide who test positive, the road to recovery is on track.

For the 911,591 family and friends who died in the world (192,616 in the United States), their loved ones will never be forgotten.

Thank you for joining us this week.

Updated to 10:12 AM ET on September 12th: Added that AstraZeneca has resumed clinical trials of vaccines in the UK