December 11 coronavirus news | CNN

December 11 coronavirus news

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Dr. Fauci explains importance of vaccine approval process
02:19 - Source: CNN

What you need to know

  • The US Food and Drug Administration’s advisory committee recommended the agency grant emergency-use authorization to Pfizer’s coronavirus vaccine. A US Centers for Disease Control and Prevention committee is meeting this weekend to consider if the vaccine should be offered to the American public.
  • Health experts are warning it’s likely the US won’t see any meaningful, widespread impacts from vaccinations until well into 2021.
  • Canada granted emergency approval for the vaccine after health officials determined it met safety, efficacy and quality requirements.
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South Korea reports its highest daily rise in coronavirus cases since the start of pandemic 

Containers to be used as a ward to treat people infected with the coronavirus are set up on the grounds of the Seoul Medical Center in Seoul, South Korea on Thursday, December 10.

South Korea reported 950 new coronavirus cases on Saturday – the most infections in a single day since the beginning of the pandemic, the Korea Disease Control and Prevention Agency (KDCA) said in a press release.

Of those, 928 confirmed cases are local infections, while 22 are imported. 

The Seoul Metropolitan Area accounts for the majority of the total with a record 669 new cases, the KDCA said.

Meanwhile, three more cases have been linked to the church cluster in Daegu city, according to the local government’s press release on Saturday.

There have now been 32 cases linked to the church cluster, where contact tracers said members of the choir didn’t wear masks and parishioners shared snacks.

Earlier this year, the Daegu branch of the Shincheonji religious group became one of the country’s biggest single clusters, linked to more than 5,200 cases.

The country has recorded 41,736 cases in total so far.

South Korea’s related death toll also increased by six on Saturday, bringing total fatalities to 578.

Pfizer vaccine EUA "a monumental moment" for US, health expert says

CNN medical analyst Dr. Leana Wen.

The US Food and Drug Administration’s approval of an emergency use authorization for Pfizer’s Covid-19 vaccine is “really a monumental moment,” Dr. Leana Wen, a CNN medical analyst and emergency room physician, said Friday. 

“I think it’s really amazing,” Wen, the former Baltimore health commissioner, told CNN’s Chris Cuomo.

“We also need to make sure that every safeguard was followed, and that’s what all these scientists and all these committees are here to do,” she added.

FDA vaccine advisers met Thursday and voted to recommend an EUA for the vaccine. Now the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Saturday. 

The CDC committee must vote to recommend the vaccine, and the agency must accept that recommendation, in order for vaccinations to begin.

US CDC vaccine advisers meeting Saturday

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting will now begin at 11 a.m. ET Saturday, according to an update on the CDC’s website.

The meeting was previously scheduled for Sunday.

Following the US Food and Drug Administration’s emergency use authorization of Pfizer and BioNTech’s coronavirus vaccine, the CDC committee must vote to recommend it. The CDC must then accept that recommendation for vaccinations to begin.

The vote is expected to take place about 2:30 p.m. ET Saturday.

US FDA chief calls Pfizer Covid-19 vaccine EUA a "significant milestone" in pandemic fight

Stephen Hahn testifies at a hearing of the Senate Health, Education, Labor and Pensions Committee on September 23, in Washington D.C.

The US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine is a “significant milestone” in fighting a pandemic that has killed nearly 300,000 Americans, FDA Commissioner Dr. Stephen Hahn said Friday.

“The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” Hahn said in a statement.

The emergency use authorization allows the Pfizer-BioNTech Covid-19 vaccine to be distributed in the US, the FDA said in a news release.

It’s not an FDA approval, but the EUA “holds the promise to alter the course of this pandemic in the United States,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” Marks said.

US FDA issues emergency use authorization for Pfizer/BioNTech’s Covid-19 vaccine

A member of staff uses a needle and a vial of Pfizer-BioNTech Covid-19 vaccine to prepare a dose at a vaccination health center on December 8, in Cardiff, UK.

The US Food and Drug Administration has authorized Pfizer and BioNTech’s coronavirus vaccine for emergency use.

A Pfizer spokesperson confirmed to CNN on Friday that an EUA had been granted, following the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee.

On Thursday, 17 committee members voted to recommend the FDA issue an EUA for the vaccine. Four voted no and one abstained.

FAA urges all US airports to be ready for vaccine deliveries

FAA chief Steve Dickson answers questions about his test flight of a Boeing 737 MAX during a press conference after landing at Boeing Field on September 30 in Seattle.

The US Federal Aviation Administration is urging airports nationwide to be ready for flights carrying the coronavirus vaccine even if the airport is not scheduled to receive it.  

The agency told airports “to ensure they are fully prepared for aircraft carrying Covid-19 vaccines.”

FAA Administrator Steve Dickson directed airports to ensure delivery trucks have priority access to the airfield, and that adequate security is in place for vaccine shipments.

On Thursday, the FAA told CNN it would direct air traffic controllers to give priority clearance to flights carrying the vaccine. The agency said the flights will be monitored from its command center in Warrenton, Virginia, outside Washington, D.C.

Covid-19 patients account for an increasing share of people hospitalized in the US

Health care worker Demetra Ransom comforts a patient in the Covid-19 ward at United Memorial Medical Center in Houston, Texas, on December 4.

Newly released data from the US Department of Health and Human Services (HHS) shows more than 85% of hospitals nationwide had more patients with Covid-19 last week than they did a month ago.

Overall, about 1 in 5 hospital inpatients were confirmed to have Covid-19 last week – nearly double from a month earlier. 

Among America’s 10 largest cities, the share of hospital patients with Covid-19 ranged from about 9% in New York to 23% in Chicago. 

They are: New York, 9%; Los Angeles, 16%; Chicago, 23%; Houston, 11%; Phoenix, 22%; Philadelphia, 22%; San Antonio, 16%; San Diego, 16%; Dallas, 20%; San Jose, 19%.

But in smaller cities the situation can be even worse. In El Paso, Texas, for example, more than 50% of patients in city hospitals were confirmed to have Covid-19 – nearly double the national average for the seven-day period between November 27 and December 3. 

HHS had previously reported Covid-19 hospitalization data at the state level, but this dataset – released Monday – is the first from the national government to report local, facility-level data.

US hits record number of Covid-19 hospitalizations

Medics transfer a patient at Coral Gables Hospital where coronavirus patients are treated in Miami, Florida, on December 10.

The United States reported 108,044 Covid-19 hospitalizations on Friday, setting a new record high since the pandemic began, according to the Covid Tracking Project (CTP).

This is the tenth consecutive day that the US has remained above 100,000 hospitalizations.

 According to CTP data, the highest hospitalization numbers are…

  1. Dec. 11: 108,044
  2. Dec. 10: 107,258
  3. Dec. 9: 106,705
  4. Dec. 8: 104,590
  5. Dec. 7: 102,148

Trump signs stopgap funding bill to avert shutdown at midnight

U.S. President Donald Trump arrives during an Operation Warp Speed vaccine summit at the White House in Washington, D.C., on Tuesday, December 8.

President Trump has signed a one-week stopgap funding bill by voice vote to avert a government shutdown at midnight.

The bill was passed by the Senate earlier Friday. 

Some background: The short-term spending bill would extend government funding by a week to Dec. 18 and is aimed at giving lawmakers more time to reach an agreement on Covid relief and broader funding legislation for a new fiscal year. It passed the House earlier this week.

So far, however, stimulus talks remain at an impasse over critical sticking points, creating uncertainty over whether an agreement can be reached.

Lawmakers now have just one additional week to work out thorny issues that are currently holding up an agreement or potentially witness the collapse of the talks.

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

Health care administers COVID-19 tests at Long Beach City College-Veterans Memorial Stadium in Long Beach, California, on Wednesday, December 9.

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.”

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.”

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

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.

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. 

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.

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01:15 - Source: cnn

Pfizer and FDA in negotiations before coronavirus vaccine authorization

The Food And Drug Administration headquarters on July 20, in White Oak, Maryland.

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. 

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

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.

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.

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.

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

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.

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

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.

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.

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

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

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.” 

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

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 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. 

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

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

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. 

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.

WHO releases an updated checklist to help support school re-openings as Covid-19 cases surge

Children arrive for class on the first day of school reopening on December 7 in New York.

In preparation for the surge of positive Covid-19 cases, the World Health Organization released an updated checklist on Friday to help school administrators in re-opening schools.

“Prolonged school closures are being presenting an unprecedented challenge to children’s education, health and well-being,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus said during a virtual WHO briefing. “Today, WHO has released a new checklist to support schools in reopening and in preparing for resurgence of Covid-19 and similar public health crisis.”

The checklist encourages a continued practice of public health safety measures including wearing a mask, social distancing, washing hands, sanitation and isolation.

Ghebreyesus said the checklist includes 38 suggested measures including reorganizing the layout of desks or changing school schedules to stagger breaks in between class.

Senate passes stop-gap bill to avert shutdown hours before midnight deadline

After a series of last-minute holdups, the Senate just passed a one-week stop-gap funding bill by voice vote to avert a government shutdown at midnight tonight. The bill will next go to President Trump for his signature.

The short-term spending bill would extend government funding by a week to Dec. 18 and is aimed at giving lawmakers more time to reach an agreement on Covid relief and broader funding legislation for a new fiscal year. It passed the House earlier this week.

The Senate needed to pass the short-term government funding bill sometime during the day Friday ahead of the funding expiration deadline to avert a shutdown, but lawmakers have been dealing with a series of holdups that had thrown a timeline for a vote into question.

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