November 18 coronavirus news

By Nectar Gan, Adam Renton, Mike Hayes, Melissa Macaya and Meg Wagner, CNN

Updated 12:00 a.m. ET, November 19, 2020
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10:55 a.m. ET, November 18, 2020

Pfizer and BioNTech say final analysis shows coronavirus vaccine is 95% effective with no safety concerns

From CNN's Maggie Fox and Amanda Sealy

A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday.

The company counted 170 cases of coronavirus infection among volunteers who took part in the trial. It said 162 infections were in people who got placebo, or plain saline, shots, while eight cases were in participants who got the actual vaccine. That works out to an efficacy of 95%, Pfizer said.

The data show Pfizer's initial claim of a better than 90% efficacy -- a claim that stunned and pleased health officials and vaccine developers last week -- holds up.

"Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%," Pfizer and its German partner BioNTech said in a joint statement.

"There were 10 severe cases of Covid-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group." BNT162b2 is the experimental name for the vaccine.

An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said.

"The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2," the companies said. Older adults tended to have fewer adverse events and those they had were milder.

Pfizer said it will seek US Food and Drug Administration emergency use authorization "within days."

Read the full story here.

CNN's Sanjay Gupta explains Pfizer's 95% effectiveness rate:

6:15 a.m. ET, November 18, 2020

UK's 'Test and Trace' chief self-isolating after being pinged by her own app

From CNN's Sharon Braithwaite, in Pisa, Italy

Dido Harding, head of the NHS Test and Trace program, is seen walking in London on November 9.
Dido Harding, head of the NHS Test and Trace program, is seen walking in London on November 9. Tolga Akmen,AFP/Getty Images

The head of the UK government's 'Test and Trace' program has been told to self isolate by the app that she is responsible for.

Dido Harding tweeted a screenshot of the notification on Wednesday, adding: "Nothing like personal experience of your own products ....got this overnight. Feeling well. Many hours of Zoom ahead,"

Harding will be in self-isolation until 26th November. She follows British Prime Minister Boris Johnson who is also self-isolating after getting the same message.

The app has a notification feature which alerts the user if s/he's been near another app user who tests positive for coronavirus, if the user's local area (postcode district) has a changed risk status, or if the user has visited a venue which later reports an outbreak while s/he was there, the UK government says on its website.

People in England and Wales were encouraged to download the NHS COVID-19 app when it was launched. There were teething issues with the app, which included it failing to alert people to their need to self isolate.

5:25 a.m. ET, November 18, 2020

Iraq's Erbil governor dies from coronavirus

From CNN’s Muwafaq Mohamed and Aqeel Naijm in Baghdad

The governor of Erbil, capital of the semiautonomous Kurdistan region in northern Iraq, died Wednesday from coronavirus complications, a spokesman for the region's health ministry, Aso Hweizi, told CNN.

Firsat Sofi was infected more than three weeks ago and was transferred for treatment in Turkey, Hweizi said.

Erbil alone recorded 156 cases and nine deaths on Tuesday, the health ministry said. The total number of cases recorded across Iraq that day was 2,961, with 40 deaths.

Iraq is the second worst-hit country in the Middle East with a total of 524,503 recorded cases, according to government data.

4:33 a.m. ET, November 18, 2020

With possible vaccine on the horizon, US is likely in "last big surge" of the pandemic's toughest phase

From CNN's Christina Maxouris

A medical staff member treats a coronavirus patient in the Covid-19 intensive care unit at the United Memorial Medical Center in Houston, Texas on November 14.
A medical staff member treats a coronavirus patient in the Covid-19 intensive care unit at the United Memorial Medical Center in Houston, Texas on November 14. Go Nakamura/Getty Images

The United States is likely in the "last big surge" before a possible Covid-19 vaccine can start to offer help in the coming months, one expert says. But for now, the country is continuing to set grim case and hospitalization records and the pandemic shows no signs of slowing down.

"The months ahead are going to look better than the weeks ahead," former US Food and Drug Administration commissioner Dr. Mark McClellan said at a Tuesday event hosted by Duke University.
"Things are going to start gradually getting better," he said. "Won't be past this for still months to come. But it will start getting better by early 2021," he said, with the help of a vaccine.

His projection comes at the heels of more good news out of vaccine trials -- with Moderna announcing this week its vaccine is more than 94% effective and Pfizer's CEO saying the company is preparing to file for emergency use authorization for their own vaccine.

But it also comes amid a scary time for the country. For at least 15 days straight, the US has reported more than 100,000 daily infections. About 76,830 people are hospitalized with the virus nationwide, according to the COVID Tracking Project. That's the highest number since the pandemic's start. And each day, hundreds of Americans continue to lose their battle against Covid-19, with at least 11 days this month topping a 1,000 daily death toll.

Read the full story:

2:53 a.m. ET, November 18, 2020

Japan reports nearly 1,700 new Covid-19 cases

From CNN's Yoko Wakatsuki in Tokyo

Commuters, mostly wearing face masks, walk through Shinagawa train station on November 18 in Tokyo, Japan.
Commuters, mostly wearing face masks, walk through Shinagawa train station on November 18 in Tokyo, Japan. Carl Court/Getty Images

Japan reported 1,694 new Covid-19 cases for Tuesday, its third highest single-day jump since the pandemic began. 

The country's daily new cases dipped below 1,000 for the first time in over a week on Monday, but they rose back up on Tuesday, according to the Health Ministry.

The total number of confirmed cases nationwide stands at 121,529, including 1,926 deaths.

Capital spike: Tokyo reported 493 new Covid-19 infections on Wednesday, the highest daily increase in cases for Japan’s capital since the pandemic began. 

The last peak was recorded on Aug. 1 with 472 new cases, according to Tokyo’s Metropolitan Government.

1:55 a.m. ET, November 18, 2020

Fauci wishes he had pushed harder on coronavirus testing early in pandemic

From CNN Health’s Maggie Fox

Dr. Anthony Fauci testifies at a hearing of the Senate Health, Education, Labor and Pensions Committee on September 23 in Washington, DC.
Dr. Anthony Fauci testifies at a hearing of the Senate Health, Education, Labor and Pensions Committee on September 23 in Washington, DC. Alex Edelman/Pool/Getty Images

If there’s one thing he regrets about the pandemic, the US' top infectious disease expert Dr. Anthony Fauci says he wishes he had pushed harder for broader testing early on.

Fauci, who was an early member of the White House coronavirus task force, said he knew the pandemic would be bad when it was clear community spread was happening back in the late winter.

“I thought we should be flooding the system with testing. There weren’t enough tests then,” Fauci said in an interview with STAT News Tuesday.
“It never became a reality because we never really had enough tests to do the tests that you had to do,” added Fauci, who is director of the National Institute of Allergy and Infectious Diseases.

Importance of testing: Testing is the first step for contact tracing -- a tried and true public health approach that involves identifying cases quickly, isolating and treating those people, identifying their contacts and testing them to see if they need to be isolated or quarantined.

“But deep down perhaps I should have been much more vocal about saying we have really, absolutely, got to do that,’” Fauci said. “I saw that it went nowhere and maybe I should have kept pushing the envelope on that.”

Testing is important because otherwise cases spread silently, Fauci noted. “What is going on now that you don’t recognize becomes a case a few weeks later,” he said.

“That becomes a hospitalization a few weeks later. That becomes intensive care a few days later. That becomes death a few weeks later.”

Fauci said he was hesitant to talk about his regrets for fear his statements would be taken out of context as sound-bites.

1:28 a.m. ET, November 18, 2020

US reports more than 161,000 new Covid-19 cases

From CNN's Tina Burnside 

The United States reported 161,934 new coronavirus infections and 1,707 new fatalities on Tuesday, according to Johns Hopkins University.

The country has now reported a total of at least 11,357,322 cases and 248,672 deaths, according to the university's tally.

The totals include cases from all 50 states, the District of Columbia and other US territories, as well as repatriated cases. 

CNN is tracking US cases:

1:06 a.m. ET, November 18, 2020

FDA authorizes first rapid Covid-19 self-test for home diagnosis

From CNN Health’s Shelby Lin Erdman

A sign for the Food And Drug Administration is seen outside of its headquarters on July 20 in White Oak, Maryland.
A sign for the Food And Drug Administration is seen outside of its headquarters on July 20 in White Oak, Maryland. Sarah Silbiger/Getty Images

The US Food and Drug Administration (FDA) has issued an emergency use authorization for the first self-test for Covid-19 that can provide rapid results at home.

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test available by prescription for self-diagnosis of the coronavirus, the agency said Tuesday.

It uses a molecular amplification technology to search for signs of the coronavirus’s genetic material.

How does it work? The kit includes a sterile swab, a sample vial, a test unit, batteries and a plastic disposal bag.

A user first needs to self-collect a nasal swab sample and insert it into the vial, which then enters the test unit where it is analyzed. The results are displayed on the test unit by a color change in the LED indicators, according to the FDA.

Who can use it? The new test is authorized for people aged 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider.

It is also authorized for use in point-of-care settings, such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said.

“While Covid-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Dr. Stephen Hahn said in a statement.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn added.
12:53 a.m. ET, November 18, 2020

Washington State sees new daily high in Covid-19 cases

From CNN’s Andy Rose

Metro buses in Seattle post signs saying masks are required on November 12.
Metro buses in Seattle post signs saying masks are required on November 12. Elaine Thompson/AP

The state of Washington reported 2,677 new coronavirus cases Tuesday, a new single-day high, according to its health department.

Following the release of the latest numbers, Gov. Jay Inslee said on Twitter: “We need everyone doing their part to stop this virus.”

 

Washington has recorded a total of 131,444 Covid-19 cases and 2,571 deaths. Currently, 9,573 patients are hospitalized.

Note: These numbers were released by the Washington state Department of Health and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.