AstraZeneca coronovirus vaccine begins clinical trials, but only in the UK


This week a major vaccine trial stopped after a participant experienced severe neurological symptoms. It was one of the first known bumps in the road to a highly touted vaccine candidate, which is being developed by AstraZeneca and the University of Oxford.

AstraZeneca said the trial began in three phases on Saturday in the UK itself, after confirmation from the UK’s Medicine Health Regulatory Authority that it was safe to do so. The company said in a blog post that it could not reveal any medical information, only stating that “the standard review process has started a voluntary standoff,” with health officials in other countries linking it Was working so that it could be determined that other clinical trials could resume.

Stopping a promising vaccine candidate can be a shock, especially during a deadly epidemic. But this is not unexpected, and is exactly the same as there are large-scale clinical trials. In clinical trials, researchers carefully monitor patients for bad reactions to any form of medication or treatment. If something goes wrong, they can stop, check, and then keep going once it’s safe to do so.

“You take any group of 30,000 people, and you see them over the course of two or three months, it’s likely that someone is expected to have the disease,” said Francis Collins, head of the National Institutes of Health, to NBC Told. “And until you are sure that it was not attached to the test, and you need to keep it in clinical hold.”

First reported picket STAT, Which later revealed that a patient was hospitalized in the United Kingdom with severe neurological symptoms. The symptoms were clearly similar to those with transverse myelitis, a type of spinal inflammation. The patient – who is expected to recover – apparently received the vaccine as part of the trial, but this does not mean that the vaccine caused the disease.

During a call with investors, AstraZeneca chief Pascal Soriot said it was, in fact, the second clinical hold on the trial according to him. STAT. The first stop was allegedly caused by a different person who came down with neurological symptoms – but in that case, he was diagnosed with multiple sclerosis, something that was vaccine-related.

To find out what happened in this new case, researchers have to dig into the data, a process that can take some time. Meanwhile, other tests are looking for evidence of similar symptoms that may have cropped up during their tests.

Again, this is normal. If we want to have a safe and effective vaccine, we cannot skip the steps of the research process. This is a very common thing, even for tests that have already made it through many, short rounds.

But you don’t have to take my word for it. In 2017, the Food and Drug Administration came out with a report that featured 22 different case studies when a promising drug, treatment, or vaccine candidate just didn’t make that final cut. In 14 cases, treatments were not effective. In one, it was unsafe. And in seven cases, they were both vulnerable And Not impressive These were all devices, drugs, and vaccines that performed well in the lab, and some were also approved to treat other conditions. But the human body is complex. And as stated in the FDA report, this sample of unsuccessful tests shows “how logical inferences can be unreliable without corroborating clinical evidence.”

In developing a vaccine to fight this epidemic, we have to avoid past projections and pitfalls, and focus on the evidence – even if it means taking a moment to stop and wait for science to catch up .

What else has happened this week.

The research

New research shows disproportion of coronavirus deaths in polluted areas
A new peer was reviewed by both ProPublica And SUNY found that more coronovirus-related deaths occurred in areas with high industrial air pollution.
(Lyla Younis and Sara Sneth / ProPublica)

Sturgis biker rally did not cause 266,796 cases of COVID-19
This is a good analysis of a study modeling virus transmission that received a ton of attention this week. It is worth doubting the number that actually drew attention from the study.
(Jennifer Beam / Dowd Slate)

As states lift restaurant restrictions, CDC report increases food exposure by increasing risk of COVID-19
According to a new report by the Center for Disease Control and Prevention, people who had a positive test for coronovirus went out to eat compared to those who did not. The study surveyed 314 people in several states and did not differentiate between indoor or outdoor food.
(Erica Edwards / NBC News)

development

A third of Americans refuse the Kovid-19 vaccine. How useless are we?
Once we get a COVID-19 vaccine, it will only help prevent the spread of the disease if people actually take it. Right now, people in America have doubts.
(Brian Resnick / Vowel)

Pharmaceutical companies sign vaccine safety pledge
People’s skepticism about the vaccine development and approval process prompted many companies to sign a promise promising safety first.
(Mary Beth Griggs / The ledge)

China injects hundreds of thousands with experimental Kovid-19 vaccines
Meanwhile, in China, thousands of people received experimental vaccines, according to a new report Wall Street Journal. These vaccines have not yet completed phase three trials.
(Chao Deng / Wall Street Journal)

8,000 jumbo jets need to deliver coronavirus vaccines globally, IATA warns
Once a vaccine is developed, it has to be transported from production facilities to population centers. This requires a lot of logical power including air power. To illustrate the challenge, a trade group calculated the amount of cargo space that would be required to transport a single-dose vaccine to 7.8 billion people. They came with 8,000 jets. Some important notes: This is all fictional, still early days, and vaccines can potentially travel by land or sea.
(Holy Eliot / Cnbc)

Perspective

How many 9/11 survivors have died of COVID-19? At least 42 – and possibly much more
Yesterday, on the 19th anniversary of the 9/11 attacks, a non-profit news organization called city On the dozens of survivors of the 9/11 attacks, only COVID-19 was reported dead. More than 1,300 survivors contracted the disease.

This story is an attempt by “Missing Them” city Recognizing and remembering every person in New York City who died of COVID-19.
(Ashley Rodriguez and Beatriz Mulert / city)

Over number

With over 28,287,928 people who have tested positive worldwide, the road to recovery can be easy.

For the families and friends of the 911,591 people who died worldwide – 192,616 in the US – your loved ones are not forgotten.

Thanks for joining us this week, and be safe, everyone.

Update September 12, 10:12 am: Adds that AstraZeneca has resumed clinical trials of its vaccine in the UK