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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5:58 p.m. ET, December 11, 2020

Los Angeles County is on track for "catastrophic suffering and death," health director warns

From CNN's Jon Passantino

Health care administers COVID-19 tests at Long Beach City College-Veterans Memorial Stadium in Long Beach, California, on Wednesday, December 9.
Health care administers COVID-19 tests at Long Beach City College-Veterans Memorial Stadium in Long Beach, California, on Wednesday, December 9. Allen J. Schaben/Los Angeles Times/Getty Images

Los Angeles County has recorded a record number of new Covid-19 cases for a second straight day, raising the total number of residents in the nation's most populous county who have tested positive to more than a half-million, in what health officials called "uncharted territory."

"We're on a very dangerous track to see unprecedented and catastrophic suffering and death here in L.A. County if we can't stop the surge," Public Health Director Dr. Barbara Ferrer said.

The Los Angeles County Department of Public Health reported 13,815 new cases of Covid-19 Friday, raising the countywide total to 501,635 cases. Another 50 deaths linked to complications from the coronavirus were also reported, for a total of 8,199 fatalities.

"These numbers are overwhelming," Ferrer said. "We have doubled the number of new cases in about 10 days."

Los Angeles County reported 12,819 cases Thursday, the previous record high in a dramatic surge of new infections sending a rising number of new patients to hospitals.

Ferrer warned the unprecedented number of new cases in Los Angeles County is putting "extraordinary stress" on the health care system, and pleaded with the public to "stay home as much as possible.

Covid-19 restrictions: L.A. County's 10 million residents are under a nightly curfew and Gov. Gavin Newsom's stay-at-home order after the region's intensive care unit capacity plunged below 15% and continues to quickly dwindle.

In Southern California, just 6.2% ICU capacity remained Friday. The dire situation comes just days before the county expects to receive an initial shipment of 82,875 doses of Pfizer’s Covid-19 vaccine early next week.

"I want to sound an alarm that we've been sounding for the last month," Ferrer said. "In L.A. County we're in uncharted territory at this point. We're seeing daily numbers of cases and hospitalizations that we have not experienced and frankly did not anticipate."

6:16 p.m. ET, December 11, 2020

Operation Warp Speed leader urges Americans hesitant about getting a Covid-19 vaccine "to keep an open mind"

From CNN's Shelby Lin Erdman

Moncef Slaoui, the chief adviser for the Defense Department's Project Warp Speed, speaks during an Operation Warp Speed vaccine summit at the White House in Washington, DC, on Tuesday, Dec. 8.
Moncef Slaoui, the chief adviser for the Defense Department's Project Warp Speed, speaks during an Operation Warp Speed vaccine summit at the White House in Washington, DC, on Tuesday, Dec. 8. Al Drago/Bloomberg via Getty Images

Operation Warp Speed Chief Adviser Moncef Slaoui is urging Americans to keep an “open mind” about the upcoming coronavirus vaccine.

Slaoui said he is aware some Americans are worried about getting a new vaccine. 

“I would say two words: keep an open mind and transparency,” Slaoui told CNN. “The ask from people is please keep an open mind. The ask from us, from the FDA, from all those involved is 100% transparency of the data of everything, every single thing that we look into."

As the government and Pfizer prepare to roll out a Covid-19 vaccine, there is concern about vaccine hesitancy among some Americans, including minority communities. 

Slaoui emphasized that the experts reviewing the data on the Pfizer vaccine have concluded that the shot has “exceptional efficacy” and an “excellent safety profile that is comparable to many approved vaccines.”

More context: In terms of getting a stronger message out to hesitant Americans, Slaoui said experts had been unable to talk about the specifics of the data before the information was public.

“Now that that is the case, we have to go out there and engage with all of the leadership at all levels in our communities to help explain the features of the vaccine, its performance, and hopefully engage with people and convince them," Slaoui said. “Frankly, we couldn't do it effectively before because we couldn't be very specific.”

The US Food and Drug Administration is expected to grant an emergency use authorization for Pfizer’s vaccine within days.

Watch:

 

5:38 p.m. ET, December 11, 2020

Pfizer and FDA in negotiations before coronavirus vaccine authorization

From CNN’s Elizabeth Cohen

The Food And Drug Administration headquarters on July 20, in White Oak, Maryland.
The Food And Drug Administration headquarters on July 20, in White Oak, Maryland. Sarah Silbiger/Getty Images

Pfizer and the US Food and Drug Administration are “negotiating” what information should be on the label for the company’s coronavirus vaccine, considering two people in the UK had adverse reactions to the shots this week, according to the acting chairman of an FDA vaccine advisory committee. 

“They’re going back and forth about what wording should be on the label – that’s what’s happening right now,” said Dr. Arnold Monto, acting chairman of the FDA’s Vaccines and Related Biological Products Advisory Committee, which voted Thursday to recommend authorization of the vaccine. 

Monto also said the FDA and Pfizer are negotiating whether there should be special information on the label about 16 and 17 year olds, since relatively few people that age were included in Pfizer’s clinical trials. 

“I think they’re going to issue the authorization down to age 16 – that’s pretty clear – but I don’t know if they’re going to require that the label say that the data for people that age is not as extensive,” said Monto, a professor at the University of Michigan School of Public Health. 

He said these and other issues are being discussed before the agency issues an emergency use authorization for the vaccine. 

“They want to move as fast as they can, but they have to get all these things decided before the vaccine can be approved,” he said.
5:12 p.m. ET, December 11, 2020

US buys 100 million more doses of Moderna's coronavirus vaccine

From CNN's Maggie Fox

Nurse Kathe Olmstead prepares a syringe containing a Covid-19 vaccine,developed by the National Institutes of Health and Moderna on July 27 in Binghamton, New York.
Nurse Kathe Olmstead prepares a syringe containing a Covid-19 vaccine,developed by the National Institutes of Health and Moderna on July 27 in Binghamton, New York. Hans Pennink/AP

The federal government plans to buy 100 million more doses of coronavirus vaccine from Moderna, the Health and Human Services Department said Friday.

“The purchase announced today brings the total doses of mRNA-1273 owned by the federal government to 200 million. Moderna began manufacturing the first 100 million doses while clinical trials were getting underway,” HHS said in a statement.

The US Food and Drug Administration is expected to issue emergency use authorization for Pfizer/BioNTech’s coronavirus vaccine at any moment, and the federal government has denied reports it turned down an opportunity to buy 100 million extra doses of Pfizer’s vaccine last summer. Vaccine advisers to the FDA will meet next week to discuss an emergency use authorization for Moderna’s vaccine.

“If authorized by the US Food and Drug Administration for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans,” HHS said.  

Both Moderna’s and Pfizer’s vaccines have been shown to be about 95% effective in preventing symptomatic infections. Moderna’s vaccine does not need to be kept as cold as Pfizer’s does during shipment and storage.

5:31 p.m. ET, December 11, 2020

CDC held extra meeting Thursday night to discuss allergic reactions to Pfizer vaccine

From CNN’s Maggie Fox

Erik S Lesser/EPA-EFE/Shutterstock
Erik S Lesser/EPA-EFE/Shutterstock

The Centers for Disease Control and Prevention called a meeting of experts Thursday night to discuss reports of allergic reactions to Pfizer/BioNTech’s coronavirus vaccine, an expert told a meeting of vaccine advisers Friday.

“Last night, CDC convened an external group with experience in vaccine safety, immunology, and allergy to collate expert knowledge regarding possible cases,” the CDC’s Dr. Sara Oliver told a meeting of the Advisory Committee on Immunization Practices. ACIP was meeting to discuss the vaccine ahead of an expected emergency use authorization from the US Food and Drug Administration.

“The FDA is obtaining more data from the UK regulatory authorities and will consider if additional information would need to be included in an EUA regarding this issue.” 

British health officials have started vaccinating people there with Pfizer’s vaccine and reported at least two allergic reactions. Members of ACIP expressed some concern about the reports, as did members of the FDA’s Vaccines and Related Biological Products Advisory Committee, although the committee nonetheless voted to recommend that the FDA authorize the vaccine for use in the US. An EUA from the FDA is expected imminently.

 

5:30 p.m. ET, December 11, 2020

CDC advisers expect FDA authorization of Pfizer's coronavirus vaccine before Saturday morning

From CNN's Maggie Fox

A member of staff holds a phial of the Pfizer-BioNTech Covid-19 vaccine at a vaccination health center on December 8 in Cardiff, England.
A member of staff holds a phial of the Pfizer-BioNTech Covid-19 vaccine at a vaccination health center on December 8 in Cardiff, England. Justin Tallis/Pool/Getty Images

Vaccine advisers to the US Centers for Disease Control and Prevention expect the US Food and Drug Administration to issue an emergency use authorization for Pfizer and BioNTech’s coronavirus vaccine before Saturday morning, the CDC’s Dr. Amanda Cohn said Friday. 

The Advisory Committee on Immunization Practices met Friday and plans another meeting as soon as the FDA issues an EUA for the vaccine. The meeting will be held Saturday if the FDA issues the EUA before 10 a.m. ET Saturday, Cohn told the committee as it wound up Friday’s meeting. 

“We do anticipate that it is likely,” she said.

ACIP will advise the CDC about whether Americans should receive the vaccine under an FDA EUA.

3:36 p.m. ET, December 11, 2020

South Carolina reports its highest daily number of new Covid-19 cases ever 

From CNN’s Natasha Chen

South Carolina announced that it had its highest number of new cases of Covid-19 on Friday.  

“One week ago, today, South Carolina announced its highest number of new cases of Covid-19. Today, we eclipse that number by more than 700,” South Carolina’s Department of Health and Environmental Control wrote in a news release on Friday afternoon.   

South Carolina announced a total of 3,217 confirmed and probable cases of Covid-19 on Friday and 47 additional deaths, bringing the statewide total to 4,673 deaths and 245,200 cases.   

“South Carolina, like many other states, is currently experiencing a worsening of this pandemic,” said Dr. Brannon Traxler, DHEC Interim Public Health Director. “While the arriving vaccine is the light at the end of the tunnel, it will be months before there is enough vaccine available for everyone. It is incumbent upon all of us to continue to take actions aimed at saving lives.” 

South Carolina health officials are urging residents to do their part to help take the recommended actions and precautions to slow the spread. 

“No one else should have to die at the hands of this silent killer,” said Dr. Linda Bell, state epidemiologist. “It is within all of our powers to stop Covid-19. As we each wait patiently for our turn to receive the Covid-19 vaccines, let’s keep doing our part by wearing our masks and practicing social distancing.” 

3:03 p.m. ET, December 11, 2020

White House official told FDA head vaccine must be authorized today or he needs to resign, sources say 

From CNN's Kaitlan Collins, Kevin Liptak and Jim Acosta

White House Chief of Staff Mark Meadows attends a luncheon on Capitol Hill on October 21 in Washington, DC.
White House Chief of Staff Mark Meadows attends a luncheon on Capitol Hill on October 21 in Washington, DC. Stefani Reynolds/Getty Images

White House chief of staff Mark Meadows told Food and Drug Administration commissioner Stephen Hahn that he needed to have the Pfizer coronavirus vaccine emergency use authorized by the end of the day and if not, he needs to resign, an administration official and a source familiar with the situation told CNN.

A White House official said they do not comment on private conversations but the chief “regularly requests updates on the progress toward a vaccine."

The two men had a call this morning.

Another person familiar also said the chief of staff communicated to Hahn this morning that the vaccine needed to be authorized by the end of today. This person said Trump has been venting about Hahn since the UK vaccine was rolled out earlier this week. 

Hahn disputed the episode above. 

“This is an untrue representation of the phone call with the chief of staff. The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning," Hahn said in a statement to CNN.

The Washington Post first reported the conversation between Dr. Hahn and the White House chief of staff. 

2:44 p.m. ET, December 11, 2020

Vaccine reaction among UK health workers with allergies happened "within minutes," Pfizer says

From CNN's Jacquelne Howard

The adverse reactions that occurred among two health care workers in the United Kingdom after receiving the Pfizer/BioNTech coronavirus vaccine happened "within minutes," a representative for Pfizer said on Friday.

The health care workers, who both have a significant history of allergic reactions, have since recovered. 

"Both of the women had their reactions started within minutes," Dr. Susan Mather, senior director of safety surveillance and risk management at Pfizer, told the US Centers for Disease Control and Prevention's Advisory Community on Immunization Practices on Friday. "So, about two minutes, and the other one just said within minutes."

The Advisory Committee on Immunization Practices convened a half-day meeting Friday to discuss the Pfizer/BioNTech Covid-19 vaccine and then, in a follow-up meeting, will vote on whether any groups should not receive the vaccine.

Following the two cases in the United Kingdom, UK health authorities gave precautionary advice that people with a significant history of allergic reactions should not be given the vaccine.