December 9 coronavirus news

By Ben Westcott, Adam Renton, Eoin McSweeney, Nada Bashir, Mike Hayes, Meg Wagner and Melissa Macaya, CNN

Updated 12:00 a.m. ET, December 10, 2020
66 Posts
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7:40 p.m. ET, December 9, 2020

FDA authorizes first over-the-counter, non-prescription Covid-19 test system for home use

From CNN’s Shelby Lin Erdman

Source: LabCorp
Source: LabCorp

The US Food and Drug Administration has granted an emergency use authorization for the first non-prescription, over-the-counter Covid-19 test kit for at home use. 

The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone age 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday. The samples are then sent to a LabCorp facility for testing. 

Positive or invalid results are delivered back to the consumer by phone or through a health care provider. Users will be notified by email or through an online portal if results are negative.

“While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing,” Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.

The kit can help individuals understand their Covid-19 status and make decisions about when self-isolation or quarantine may be necessary, the FDA said. It can also help with health care decisions after discussions with providers.

“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities,” Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a statement. 

The new kit is now available through the Pixel by LabCorp website and may soon be available in stores, the company said in a news release.  

After buying the test, users register the kit on the website and follow the included instructions.

“Test results are securely delivered to the consumer via the Pixel by LabCorp portal,” LabCorp said. “A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions.”

The company emphasized in its news release that the new Covid-19 at-home testing kit is not a substitute for a doctor’s visit.

7:24 p.m. ET, December 9, 2020

North Dakota extends orders requiring face coverings and limiting capacity at restaurants

From CNN’s Jennifer Henderson

A digital highway sign encourages drivers to wear a mask in Fargo, North Dakota, on Wednesday, October 14.
A digital highway sign encourages drivers to wear a mask in Fargo, North Dakota, on Wednesday, October 14. Dan Koeck/Bloomberg via Getty Images

North Dakota extended two orders today that require face coverings and limit capacity at bars, restaurants and events, Gov. Doug Burgum announced during a news conference today.

The order requiring face coverings to be worn in indoor businesses and public settings, and outdoor public settings where physically distancing isn’t possible has been extended until 12:01 a.m. local time on Jan. 18, Burgum said. Jan. 18 was chosen to allow a 14-day incubation period after Christmas and New Year's Day, he added. 

The amended order limiting capacity at bars and restaurants to 50% and closing in-person service between 10 p.m. and 4 a.m. has been extended until 8 a.m. on Jan. 8, Burgum said. Event venues remain limited to 25% of their normal capacity, he added. 

Burgum will also allow the four-week pause on K-12 extracurricular activities and competitions expire on Dec. 13. 

North Dakota reported 4,286 new cases of Covid-19 in the past seven days and 102 deaths from Covid-19, the governor said.  

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

6:20 p.m. ET, December 9, 2020

Democratic senator: "We are not going home" until deal on Covid stimulus bill is reached

From CNN's Leinz Vales

In this February 5 file photo, Sen. Joe Manchin speaks with reporters on Capitol Hill in Washington.
In this February 5 file photo, Sen. Joe Manchin speaks with reporters on Capitol Hill in Washington. Patrick Semansky/AP

Democratic Sen. Joe Manchin said Wednesday that Congress is "not going to fail" in getting a Covid stimulus bill passed.

"We're not going home until we do get one," Manchin told CNN's Wolf Blitzer. "Remember, this is called a Covid emergency relief package. It's not called a do all, end all package. This is called what Joe Biden has said, this is a down payment on what is needed."

Manchin is a member of a bipartisan group of lawmakers that proposed a coronavirus emergency relief framework aimed at helping Americans affected by the pandemic. 

On CNN's "The Situation Room," the West Virginia senator went on to lay out some of the stumbling blocks to an agreement. 

Liability Protection:

"I don't think there's a Democrat or a Republican believes that anyone in a small business should be sued out of existence. But on the other hand, you have to have a safe workplace. You have to have worker conditions that are safe. You can't throw the baby out with the bath water and say you get total amnesty, anything you want to do. We think there's a way. We have all of our lawyers working. That should be done."

Funding state and local governments:

"A lot of my Republican friends don't think the state and locals need anything. The only thing I've said, this is based on need. We're not sending money for the sake of sending money. We're saying, show us your need. This is what you qualify for. But you're not going to be able to spend it or use it if you don't have a loss of revenue, excessive Covid expenses."

Watch the moment below:

6:09 p.m. ET, December 9, 2020

Kentucky reports sixth day of declining Covid-19 positivity rate

From CNN’s Rebekah Riess

Kentucky Gov. Andy Beshear announced today, that while Covid-19 numbers in the state are still “alarmingly high,” Wednesday was the state’s sixth straight day with a declining positivity rate, a release from the governor’s office said.

The governor linked the declining positivity rate to Kentucky’s “ongoing sacrifices” and his recent executive orders to mitigate spread.

“We continue to see some promising trends in our Covid-19 numbers. They are still far too high, but given that we were experiencing exponential growth before we took those difficult steps, this is evidence that we may not just be slowing down that growth, we may even be plateauing our cases,” Beshear said.

Kentucky reported 3,481 new cases of Covid-19 Wednesday, for a total of 209,136 cases. At least 16 new Covid-19-related deaths were also reported, bringing the total to 2,118. 

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

5:36 p.m. ET, December 9, 2020

Covid-19 cases and hospitalizations in California are at all-time highs

From CNN's Cheri Mossburg

California broke Covid-19 records Wednesday as it recorded its highest number of cases in a single day and increased hospitalizations and intensive care admissions.

The state added 30,851 new confirmed cases Wednesday, about 800 more than the previous record set Sunday. The steep climb in infections brings California’s total to more than 1.4 million cases, according to data from California Department of Public Health.

Hospitalizations are at an all-time high with nearly 12,000 people receiving in-patient treatment. More than 2,600 of those patients have been admitted to intensive care units – another record number.

Available ICU beds in all of California have also dipped, according to state data. Several hospitals in the San Joaquin Valley have completely run out of ICU beds as has San Jose Regional Medical Center in the Bay Area. 

That limited capacity of ICU beds has triggered regional stay-at-home orders affecting about 27 million residents in Central and Southern California.

5:34 p.m. ET, December 9, 2020

Mississippi governor signs new executive order that limits gatherings

From CNN’s Jamiel Lynch

Gov. Tate Reeves adjusts his face mask as he prepares to leave his Covid-19 press briefing on Wednesday, August 5, in Jackson, Mississippi.
Gov. Tate Reeves adjusts his face mask as he prepares to leave his Covid-19 press briefing on Wednesday, August 5, in Jackson, Mississippi. Rogelio V. Solis/AP

Mississippi Gov. Tate Reeves signed a new executive order on Wednesday that adds stricter limitations on indoor and outdoor gatherings and adds more counties to the state’s mask mandate list.

The new order limits indoor crowds to no more than 10, and outdoor crowds no more than 50. 

Face coverings are required in schools statewide.

There are 61 of the state’s 82 counties under a mandatory mask mandate, according to a release from Reeves’ office. 

On Wednesday, the state reported an additional 2,746 Covid-19 cases and 24 deaths.

Since the start of the pandemic, the state has reported 170,672 cases and 4,041 deaths. 

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

4:43 p.m. ET, December 9, 2020

Johnson & Johnson says it's reducing the size of its phase 3 Covid-19 vaccine trial  

From CNN's Jen Christensen

Johnson & Johnson said it will cut the size of its Covid-19 vaccine trial because the virus is so widespread.

The trial initially planned to recruit 60,000 volunteers.

“Given the high incidence of Covid-19 among the general population, we expect that approximately 40,000 participants will generate the data needed to determine the safety and efficacy of our investigational Covid-19 vaccine candidate,” spokesperson Lisa Cannellos told CNN over email. “We continue to anticipate that interim data from the ENSEMBLE trial will be available by the end of January. If the vaccine is safe and effective, an emergency use authorization application could be submitted to the FDA in February. Other health regulatory applications around the world would be made in parallel.” 

Moncef Slaoui, of Operation Warp Speed, said Wednesday that the trial may have enough participants by the end of the week.

“We have already recruited more than 38,000 subjects in the study,” Slaoui said at a news briefing. “With J&J we decided to cap the recruitment to around 40,000 subjects, which will happen by the end of this week or in the next two or three days.” 

Slaoui said that he thought if the data showed that the vaccine worked, an emergency use authorization from the Food and Drug Administration would be “hopefully approved swiftly.” 

 

4:16 p.m. ET, December 9, 2020

US has a "moral responsibility" to help make sure the vaccine is fairly distributed, Fauci says

From CNN's Jacqueline Howard

Dr. Anthony Fauci, the nation's top infectious disease expert, said that he believes the United States has a "moral responsibility" to ensure equitable distribution of a Covid-19 vaccine around the world. 

"There are countries on our globe that have different resources and different capabilities of responding to epidemics and pandemics that are common to all of us," Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN Wednesday during a Harvard T.H. Chan School of Public Health virtual event.

While speaking, Fauci emphasized that he was giving his personal opinion and not speaking on behalf of the United States.

Fauci's comments were made a day after President Trump signed an executive order aimed at prioritizing the shipment of the coronavirus vaccine to Americans before other nations.

"We have a moral responsibility as a rich country, along with other rich countries, to make sure that when we have the facilities and the capabilities – be it life-saving drugs for HIV, life-saving preventions for HIV, or a vaccine for Covid-19 – that as a global community, we do everything we can to make sure that there is the equitable distribution of those countermeasures throughout the world," Fauci said. "I think we all need to pull together as a global community to make sure that there’s equitable distribution."

4:01 p.m. ET, December 9, 2020

Fauci says Covid-19 vaccine allergic reactions are concerning, but are likely "unusual and rare"

From CNN's Jacqueline Howard

A phial of the Pfizer/BioNTech Covid-19 vaccine concentrate is diluted with 1.8ml sodium chloride ready for use at Guy's Hospital in London on December 8.
A phial of the Pfizer/BioNTech Covid-19 vaccine concentrate is diluted with 1.8ml sodium chloride ready for use at Guy's Hospital in London on December 8. Victoria Jones/AFP/Getty Images

While the significant allergic reactions that two health care workers in the United Kingdom experienced after receiving Pfizer's Covid-19 vaccine are of concern, Dr. Anthony Fauci said on Wednesday that such a reaction is likely "unusual and rare."

The UK's Medicines and Healthcare products Regulatory Agency said on Wednesday it was "fully investigating" those two cases.

"It obviously, Sanjay, is of some concern because there are people who have what’s called allergic diathesis or tendencies to get allergic reactions," Fauci, director of the US National Institute of Allergy and Infectious Diseases, told CNN's Dr. Sanjay Gupta during a Harvard T.H. Chan School of Public Health virtual event on Wednesday. 

Yet "it likely is an unusual and rare effect but clearly everyone now is aware of that and will be looking at that -- and particularly taking care of people who do have underlying allergic phenomenon, that they may be cautious about vaccination or at least be prepared to respond with some sort of anecdote to the reaction," Fauci said.

Fauci added: "If I were a person that had an underlying allergic tendency, I might want to be prepared that I might get a reaction and therefore be ready to treat it."