AstraZeneca is pausing the trial after an unexplained illness in a volunteer, a standard procedure in trials

4 years ago 295
5 hr 18 min ago

AstraZeneca pauses coronavirus vaccine trial after unexplained illness in volunteer

From CNN's Maggie Fox

A man receives an injection as UCLA and AstraZeneca begin phase three trials in a potential COVID-19 vaccine. A man receives an injection as UCLA and AstraZeneca begin phase three trials in a potential COVID-19 vaccine. The Lundquist Institute/FILE

Drug giant AstraZeneca said Tuesday it had paused a trial of its coronavirus vaccine because of an unexplained illness in one of the volunteers.

It’s a standard precaution in vaccine trials, meant to ensure experimental vaccines don’t cause serious reactions among volunteers.

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data,” the company said in a statement sent to CNN.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the statement added. 

“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”

Earlier Tuesday, AstraZeneca joined eight other companies in signing a pledge promising they would not seek premature government approval for any coronavirus vaccine. They promised they would wait until they had adequate data showing any potential vaccine worked safely to prevent infection.

The AstraZeneca vaccine is one of three coronavirus vaccines in late-stage, Phase 3 trials in the US.

It was not immediately clear if the pause involved only US trial sites or all of the company’s trial sites around the world. A Data and Safety Monitoring Board usually monitors trials for adverse events and can order a pause or halt to a trial, but AstraZeneca did not say who had stopped the trial.

An AstraZeneca spokesperson later said the illness affected a participant in Britain, but said all of the company’s trials of the vaccine globally would be paused.

5 hr 58 min ago

UK's Boris Johnson will lower limits on social gatherings to control coronavirus spread

From CNN’s Zahid Mahmood

British Prime Minister Boris Johnson leaves Downing Street on September 8, in London.British Prime Minister Boris Johnson leaves Downing Street on September 8, in London. Leon Neal/Getty Images

British Prime Minister Boris Johnson will announce new measures on Wednesday to reduce the number of people legally allowed to socially gather from 30 to six in England to control the coronavirus spread.

The new lower limit, due to take effect starting Monday, will make it easier for police to identify and disperse illegal gatherings of more than six people unless it meets one of the exemptions.

Exemptions include, a household or support bubble larger than six, if gatherings are for work or education purposes, weddings, funerals, or organized team sports.

“We need to act now to stop the virus spreading. So we are simplifying and strengthening the rules on social contact – making them easier to understand and for the police to enforce,” Johnson said in a statement.

“It is absolutely critical that people now abide by these rules and remember the basics – washing your hands, covering your face, keeping space from others, and getting a test if you have symptoms.”

The statement added the new measures are supported by the government, Chief Medical Officer Chris Whitty and Chief Scientific Adviser Patrick Vallance after the UK has seen the number of daily coronavirus cases rise to almost 3,000.

On Tuesday, Britain recorded an increase of 2,460 new coronavirus cases in the past 24 hours, bringing the total number of cases to 352,560.

6 hr 28 min ago

Colorado governor announces partnership with Apple and Google to allow Covid-19 exposure notifications

From CNN's Gisela Crespo

Gov. Jared PolisGov. Jared Polis Colorado Governor's office

Colorado will launch a partnership with Apple and Google to allow for Covid-19 exposure notifications on cellphones for contact tracing in an effort to slow the spread of the virus, Gov. Jared Polis announced Tuesday.

"We want to use every tool in the toolbox to contain the virus and limit community spread," Polis said during a news briefing.

The technology, called EN Express Opportunity, will roll out at the end of September. It will be available for iOS users who opt-in to use the service, and for Android users as an app.  

Using Bluetooth technology, the service or app will exchange anonymous tokens between phones of people who've been within a certain distance of each other, according to Sarah Tuneberg, director of the Colorado Coronavirus Innovation Response Team.

If a person using the service or app has been near someone who tests positive for coronavirus, the person will receive a push notification about exposure to the virus. People who are using the service and test positive for the virus need to report it. 

Both Polis and Tuneberg both emphasized no personal information is obtained from users.  

"Data security and privacy are of the utmost importance to us. This is a completely anonymized service that contains no personal health information," Tuneberg said.

7 hr 10 min ago

University of Iowa athletics resumes voluntary and mandatory workouts

From CNN's Kevin Dotson

The University of Iowa Athletics Department has announced it is resuming voluntary and mandatory student-athlete workouts.

Eight days ago, the university had halted all sports programs after reporting 93 positive Covid-19 tests within the athletics community. In the most recent testing period of Aug. 31-Sept. 6, Iowa reports 21 positive tests and 276 that were negative.

As a member of the Big 10 football conference, Iowa’s fall football season was postponed last month by the conference’s Council of Presidents and Chancellors, which cited health and safety concerns related to coronavirus.

7 hr 18 min ago

University of Tennessee is having a "significant issue" with Covid-19 stemming from fraternities

From CNN's Elizabeth Hartfield

University of Tennessee Chancellor Donde Plowman gives a Covid-19 update via a Zoom call on Tuesday.University of Tennessee Chancellor Donde Plowman gives a Covid-19 update via a Zoom call on Tuesday. University of Tennessee

The University of Tennessee is having a “significant issue” with a small portion of its study body, particularly fraternities, in combating the spread of Covid-19 on campus, University Chancellor Donde Plowman said Tuesday in her coronavirus livestream. 

Plowman detailed the disturbing reports of irresponsible behaviors that had been reported stemming from the fraternities. 

“Fraternities leaders communicating to houses how to have parties and avoid being caught, avoid the police. Stories of a fraternity renting space off campus to have their party, crammed with lots of people in close quarters. Telling fraternity members not to get tested or how to get tested so the results aren’t shared with the university,” Plowman said. 

What the numbers look like: The school reported 600 active Covid-19 cases, 592 of which are among students, eight are among employees, and a total of 2,112 people— 1,939 of whom are students — are now in quarantine or in isolation. 

“Our case counts are going up way too fast and we will need more drastic measures to stop the upward trajectory,” Plowman said, adding that the school will need more isolation spaces over time, and is in the process of creating more of that space. 

Plowman said that the school was considering a range of options for enforcement, and that “everything is on the table at this point.” She promised additional announcements on specifics in the days ahead. 

8 hr 20 min ago

Coronavirus has disrupted care for other diseases globally, Fauci says

From CNN's Naomi Thomas

Dr. Anthony Fauci speaks remotely during the Research! America 2020 Summit.Dr. Anthony Fauci speaks remotely during the Research! America 2020 Summit. Research! America

Covid-19 has interfered with care and prevention efforts for other diseases around the world, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Tuesday.

“Unfortunately, it’s been disruptive across the board, not only in the United States but globally,” Fauci said during the Research! America 2020 Summit.

People are missing screening for things “that you need to pay attention to,” such as breast cancer and prostate cancer. And they’re missing follow-up appointments for other conditions. 

“You can wind up getting into a situation where diseases that have nothing to do with Covid, diseases of different types, infection, cancer, autoimmune, inflammatory, they might get neglected and routine checkups that you would need tend to get neglected,” he said.

Fauci said that it is known in the HIV community that disruption of services and availability of drugs can really be a problem.

“Bottom line is, it’s quite disruptive and has deleterious effects on how we handle other diseases,” he said.

8 hr 50 min ago

More than half a million US children have been diagnosed with Covid-19

From CNN’s Jen Christensen

More than 513,000 US children have been diagnosed with Covid-19, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The groups found that 70,630 new child cases were reported from Aug. 20 through Sept. 3. This is a 16% increase in child cases over two weeks, bringing up the total to at least 513,415 cases, the groups said in their weekly report on pediatric coronavirus cases.

“These numbers are a chilling reminder of why we need to take this virus seriously,” said American Academy of Pediatrics President Dr. Sally Goza. “While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities,” she added.

“A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities.” 

Children represent nearly 10% of all reported cases in the US, according to the report. The child cases are likely underreported because the tally relies on state data that is inconsistently collected.

“This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors,�� said Dr. Sean O’Leary, the vice chair of the AAP Committee on Infectious Diseases. 

“Now we are heading into flu season. We must take this seriously and implement the public health measures we know can help. That includes wearing masks, avoiding large crowds, and maintaining social distance. In addition, it will be really important for everyone to get an influenza vaccine this year. These measures will help protect everyone, including children.” 

8 hr 58 min ago

Fauci says vaccine unlikely to be ready by Election Day

From CNN's Lauren Mascarenhas

A lab technician sorts blood samples as part of a Covid-19 vaccine study in Hollywood, Florida.A lab technician sorts blood samples as part of a Covid-19 vaccine study in Hollywood, Florida. Chandan Khanna/AFP/Getty Images

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Tuesday he is cautiously optimistic that a vaccine will be proven safe and effective by the end of the year. But he said that’s unlikely to happen by Election Day. 

President Trump has said he thinks a Covid-19 vaccine could be ready by Election Day, Nov. 3, but Fauci said this is unlikely.

“The only way you can see that scenario come true, is if there are so many infections in the clinical trial sites that you get an efficacy answer sooner than you would have projected,” Fauci said during an event sponsored by Research! America.

“It's unlikely that we'll have a definitive answer at that time,” he added. “More likely by the end of the year.”

There are currently three vaccine candidates in large-scale, Phase Three clinical trials in the US.

“You have a lot of candidates in play, which really is the reason why we're optimistic that we will be successful with one or more, and that will likely start taking place by the end of the calendar year 2020,” said Fauci.

9 hr 2 min ago

We should continue to encourage people to get the flu vaccine, Fauci says

From CNN’s Naomi Thomas

A man gets a flu shot at a health facility in Washington, DC, in January.A man gets a flu shot at a health facility in Washington, DC, in January. Eva Hambach/AFP/Getty Images

People can hope for a mild flu season like that just experienced in the southern hemisphere, but they need to get vaccinated, too, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Tuesday.

“One of the things we can say is that we should continue to encourage people to get vaccinated with the influenza vaccine,” Fauci said during an event sponsored by Research! America. 

Australia had “one of the lowest rates of influenza infection in memory,” Fauci said. “If we can do that, I think that would be very favorable,” he added.

“If what happened in the southern hemisphere happens here, that would be a very good and favorable thing,” Fauci added. 

Mask use, social distancing and hand washing have not only helped prevent the spread of coronavirus, but they likely helped stop the spread of flu, too, he said.

If the US does have what Fauci calls a “full-blown” flu season without getting control over the coronavirus, doctors, hospitals and others will struggle to tell the two infections apart. Plus, the sheer number of sick people could overwhelm the healthcare system.

“That’s the reason why, when you have two coexisting infections during the winter months, it becomes problematic,” he said. 

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