December 11 coronavirus news

By Julia Hollingsworth, Brett McKeehan, Nada Bashir, Eoin McSweeney, Hannah Strange and Meg Wagner, CNN

Updated 11:38 PM ET, Sun December 13, 2020
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4:11 a.m. ET, December 11, 2020

US FDA likely to recommend against Pfizer vaccine for pregnant women, committee member says

From CNN Health’s Shelby Lin Erdman

Dr. Paul Offit.
Dr. Paul Offit. Source: CNN

The US Food and Drug Administration is likely to recommend against giving pregnant women the upcoming Pfizer vaccine, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee said Thursday.

Dr. Paul Offit's comments came after the committee voted to recommend the vaccine for an emergency use authorization (EUA).

“I think the recommendation will be that pregnant women not receive this vaccine until we know more,” Offit told CNN’s Wolf Blitze

.

“However, as shown in this trial, whenever you do any sort of large clinical trial, invariably you do get pregnant women because women don't find out they're pregnant until after they've gotten one or two doses. So, there were about two dozen women in this trial that were pregnant and there doesn't appear to be any harmful effects on them, but their babies haven’t been born yet to find out

Offit said this will also happen when the vaccine rolls out to health care workers and people in long-term care facilities. Some of those vaccinated will invariably include pregnant women.

The committee voted 17-4, with one abstention, in favor of recommending the FDA grant Pfizer an EUA. The FDA will now decide whether to accept the recommendation but has signaled that it will issue the EUA for the vaccine.

4:03 a.m. ET, December 11, 2020

Singapore to lift border restrictions for travelers from Taiwan next week

From CNN's Akanksha Sharma

Visitors walk through a terminal of the Changi International Airport in Singapore, on December 7.
Visitors walk through a terminal of the Changi International Airport in Singapore, on December 7. Roslan Rahman/AFP/Getty Images

Singapore will welcome travelers from Taiwan beginning December 18, according to a press release from Singapore's Civil Aviation Authority.

Visitors from Taiwan can apply for a single-entry "Air Travel Pass" to enter Singapore on or after next Friday.

Travelers must have stayed in Taiwan for 14 consecutive days prior to departure.

Visitors will be required to take a Covid-19 PCR test upon arrival. If negative, they will be allowed to move freely throughout Singapore without serving a stay-at-home notice, the aviation authority added.

"Taiwan has a comprehensive public health surveillance system and has displayed successful control over the spread of the Covid-19 virus. Over the past 28 days, Taiwan has zero local Covid-19 cases. The risk of importation from Taiwan is low," the press release said.

3:55 a.m. ET, December 11, 2020

Paradigm RE, LLC warned over fraudulent Covid-19 product

From CNN Health’s Jen Christensen

The US Food and Drug Administration and the Federal Trade Commission said Thursday they had warned Paradigm RE, LLC for selling unapproved products that claim to mitigate, prevent, treat, diagnose or cure Covid-19.

The FDA said it considers the product, which the company sells under the name “Thymosin Alpha 1,” an unapproved new drug sold in violation of US law. It is also misbranded.

The company’s website implies Thymosin Alpha 1 was tested in government-designated treatment centers and helps with treatment. The website claims “the findings were that there was a significant reduction of mortality in the 28-day variation” because it improved oxygen levels in the bloodstream and reduced lung injury, according to the FDA.

The FDA asked the company to stop selling the product immediately and gave it 48 hours to email the government and describe what specific steps it took to correct violations. 

3:06 a.m. ET, December 11, 2020

Germany records its deadliest day of the Covid-19 pandemic

From CNN’s Fred Pleitgen and Claudia Otto in Berlin

A sign reminding people that masks are required in Hof, Bavaria is seen in front of the St. Marien church on December 10.
A sign reminding people that masks are required in Hof, Bavaria is seen in front of the St. Marien church on December 10. Nicolas Armer/picture alliance/Getty Images

Germany on Friday announced it had recorded 598 coronavirus fatalities in the previous 24 hours, according to data from the Robert Koch Institute, the country's center for disease control.

It was Germany's highest single-day coronavirus death toll since the pandemic began.

The nation also registered a record 29,875 new confirmed infections on Friday -- roughly 6,000 more than the day before. 

German lawmakers will meet in the coming days to tighten lockdown measures in a bid to get the surge in infections under control.

According to Johns Hopkins University, there are now 1,287,092 confirmed coronavirus infections in Germany, including 21,064 related deaths.

2:04 a.m. ET, December 11, 2020

Actor Thomas "Tiny" Lister Jr. dies at 62 after experiencing Covid-19 symptoms 

From CNN's Sarah Moon

Thomas "Tiny" Lister Jr. attends the premiere of "Sister" during the 2014 Tribeca Film Festival on April 25, 2014 in New York City.
Thomas "Tiny" Lister Jr. attends the premiere of "Sister" during the 2014 Tribeca Film Festival on April 25, 2014 in New York City. Taylor Hill/FilmMagic/Getty Images

Actor and wrestler Thomas Lister Jr., also known as “Tiny,” was found dead in his home on Thursday after experiencing Covid-19 symptoms, his manager Cindy Cowan confirmed to CNN.

According to Cowan, the 62-year-old actor started feeling sick last Thursday, but his symptoms “got really bad, really quick.”

He couldn’t breathe and felt very weak, she said. “It literally went so fast," Cowan added.

Lister was supposed to visit a set for a new movie on Sunday, however he called Friday to cancel because he was feeling too weak and had a hard time breathing, according to Cowan.  

“Tiny doesn’t miss movies; he took it very seriously,” said Cowan.

The actor then canceled plans for a panel scheduled on Wednesday for a TV festival via Zoom, according to Cowan. Calls to Lister also went unanswered.

According to a press release from the Los Angeles County Sheriff’s Department, deputies responded to Lister’s Marina del Rey home on Thursday afternoon when “friends and business associates of Mr. Lister hadn’t heard from him since the night before and were concerned about his wellbeing.”

When deputies entered the home, they found Lister dead. 

“Mr. Lister’s death appears to be of natural causes but will ultimately be determined by the Office of Medical Examiner-Coroner,” the sheriff’s department said. 

The death is still under investigation, according to the release. 

Lister was best known for his role as Deebo in the “Friday” movie franchise alongside rapper Ice Cube. He also appeared with Hulk Hogan in the World Wrestling Entertainment movie “No Holds Barred.”

1:24 a.m. ET, December 11, 2020

Business travel could bounce back in 2022, Emirates president says

From CNN's John Defterios and Stephanie Bailey

Tonnes of medical equipment and coronavirus testing kits provided by the World Health Orgnization are pictured passing by an Emirates airlines Airbus A380-861, at the al-Maktum International airport in Dubai on March 2.
Tonnes of medical equipment and coronavirus testing kits provided by the World Health Orgnization are pictured passing by an Emirates airlines Airbus A380-861, at the al-Maktum International airport in Dubai on March 2. Karim Sahib/AFP/Getty Images

Few sectors have been hit as hard by the coronavirus pandemic as the aviation industry. 

Last month, the International Air Transport Association forecast the crisis will cost airlines $157 billion this year and next -- and the sector has already cut tens of thousands of jobs

But Tim Clark, president of the Emirates airline, sees reason to be optimistic. He thinks business travel could bounce back in 2022.

Clark recently spoke with CNN's John Defterios about the recovery of business travel and Emirates' imminent role as a distribution center for future Covid-19 vaccines. 

Here's what he had to say on when business travel will get back to normal:

"What has happened as a result of being locked down, as a result of having to engage in (online communication) networks, whether it be Zoom or (Microsoft) Teams, I saw it in the mid '90s, when we digitized the global economy and all these tools came to market. The digital world ruled, the age of information came along, and everybody said, 'you know what's going to happen? We're not really going to travel anymore,'" Clark said. 
"The converse happened. Between 1995, and 2015 to 2018, the demand for business travel grew exponentially. The more they (people) interacted, the more they traveled. As we get back to normal, as the economy is strengthened, as cash starts flowing back into the businesses that have been affected, we'll start to see business travel bounce back, and we'll see it grow. It will not slow down."

Read more here.

12:04 a.m. ET, December 11, 2020

Australian Covid-19 vaccine trials ended after test subjects return false positive HIV results

From CNN's Ben Westcott, Angus Watson and Pauline Lockwood

Australian Prime Minister Scott Morrison
Australian Prime Minister Scott Morrison

An Australian-produced coronavirus vaccine candidate has been scrapped after trial participants returned false positive test results for HIV, developers announced Friday.

The inoculation, which had yet to progress beyond Phase 1 trials, was being jointly developed by the University of Queensland and Australian biotech company CSL.

Australia had hoped the vaccine would be available by mid-2021.

In a statement, CSL said no serious adverse effects had been reported in the 216 trial participants, and the vaccine was shown to have a "strong safety profile." However trial data revealed that antibodies generated by the vaccine interfered with HIV diagnosis and led to false positives on some HIV tests, CSL said.

If the vaccine was rolled out nationally, CSL said it could undermine public health in Australia by causing a wave of false positive HIV tests in the community.

"Follow-up tests confirmed that there is no HIV virus present, just a false positive on certain HIV tests. There is no possibility the vaccine causes infection," the statement added.

Australian Prime Minister Scott Morrison told reporters Friday that the vaccine "will no longer feature as part of the country's vaccine plan." Australia had pre-emptively ordered 51 million doses of the CSL vaccine in October.

Morrison said Australia had backed four vaccines that showed promise but "at no stage ... believed that all four of those vaccines would likely get through that process."

Read more about the vaccine here.

12:04 a.m. ET, December 11, 2020

US could be back to normal by next summer or fall, Fauci says -- provided everybody gets vaccinated

From CNN Health’s Shelby Lin Erdman

The United States could be back to normal by next summer or early fall if everyone gets a Covid-19 vaccine, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, predicted Thursday.

"It depends how quickly and how many people want to get vaccinated," Fauci told CNN’s Chris Cuomo.  
"If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality reasonably quickly into the summer and certainly into the fall." 

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted to recommend emergency-use authorization (EUA) for Pfizer’s Covid-19 vaccine Thursday. The FDA is expected to approve an EUA for the vaccine in the next couple of days.

"My hope and my projection is that if we get people vaccinated en masse so that we get that large percentage of the population, as we get into the fall, we can get real comfort about people being in schools, safe in school," Fauci said. 
"That's what I hope and project we would do if we get everybody vaccinated."
8:17 a.m. ET, December 11, 2020

US FDA calls committee vote "an important step"

From CNN’s Jen Christensen

Stephen Hahn testifies during a US Senate Health, Education, Labor, and Pensions Committee hearing to examine Covid-19 in Washington DC, on September 23.
Stephen Hahn testifies during a US Senate Health, Education, Labor, and Pensions Committee hearing to examine Covid-19 in Washington DC, on September 23. Graeme Jennings/Pool/AFP/Getty Images

The US Food and Drug Administration said Thursday’s vote by its vaccine advisers to recommend emergency use authorization of the Pfizer Covid-19 vaccine was an “important step” in the review process.

The FDA said its Vaccines and Related Biological Products Advisory Committee, made up of independent scientists and public health experts, provided “valuable advice and input” for the agency to help make its decision.

“Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the agency said in a statement.

“In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect,” FDA Commissioner Dr. Stephen Hahn said in the statement.

“The whole of the FDA — myself included — remains committed to keeping the public informed about the evaluation of the data of a potential Covid-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves.”