November 9 coronavirus news

By Emma Reynolds, Zamira Rahim, Jenni Marsh, Joshua Berlinger and Stephanie Halasz, CNN

Updated 1:41 a.m. ET, November 10, 2020
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6:51 p.m. ET, November 9, 2020

FDA gives emergency authorization to Eli Lilly's monoclonal antibody treatment for coronavirus

From CNN Health’s Maggie Fox

The US Food and Drug Administration said Monday it had issued an emergency use authorization for Eli Lilly and Co’s investigational monoclonal antibody therapy bamlanivimab to treat mild to moderate coronavirus infections in adults and children.

"Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus' attachment and entry into human cells," the FDA said in a statement.

"The FDA's emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients," Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in the statement. "We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available."

Road to authorization: The FDA authorization was based on a study published in the New England Journal of Medicine in October. It found that the treatment seemed to lower the risk of hospitalization and ease some symptoms in a small number of patients with mild to moderate case Covid-19.

The Phase 2 trial involved 452 patients, some of whom received the treatment and some of whom received a placebo.

Only 1.6% of patients who received the treatment had to be hospitalized or seek care at the emergency room. For patients who got the placebo, the rate of hospitalization was 6.3%. 

Eli Lilly announced it had struck a $375 million deal with the government for 300,000 vials of the antibody treatment, pending emergency use authorization, to be delivered in the two months after.

The company said it planned to have 100,000 doses ready to ship within days and would manufacture a million doses by the end of 2020. The treatment would be provided to patients at no cost.

The FDA said that based on its review of the evidence available, it was "reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19" and that "the known and potential benefits outweigh the known and potential risks for the drug.”

6:45 p.m. ET, November 9, 2020

Fauci says he has "no intention of leaving" role as NIAID director

From CNN Health’s Lauren Mascarenhas

Dr. Anthony Fauci.
Dr. Anthony Fauci. Source: CNN

Dr. Anthony Fauci said Monday that he plans to remain in his role as director of the National Institute of Allergy and Infectious Diseases through the remainder of the Trump administration and into President-elect Joe Biden’s administration.

"I have no intention of leaving," Fauci told CNN’s Wolf Blitzer. "This is an important job. I've been doing it now for a very long time. I've been doing it under six presidents."

"It's an important job, and my goal is to serve the American public, no matter what the administration is," he added.

Fauci warned that the United States was in a "serious situation" with cases exceeding 100,000 a day, but said the country "can turn it around."

"Unfortunately, we predicted it when we were talking about the fact that as we enter into the coolest season of the fall and the upcoming coldest season of the winter, that you're going to start seeing more indoor activity, and we never got down to a good baseline," said Fauci, the nation's top infectious disease expert.

He said "help is on the way with a vaccine," following the announcement by Pfizer on Monday that early data shows its vaccine is 90% effective.

"The bottom line is as a vaccine, it's more than 90% effective, which is extraordinary and will play a major role in what the outcome of this is going to be," Fauci told Blitzer.

The Data and Safety Monitoring Board, an independent group that monitors vaccine trials, "has ... told us that we now have a vaccine that is more than 90% effective," said Fauci.

"Obviously, we need to go over the details of the data, but this is a highly reputable company that has extensive experience in the development of countermeasures, including vaccines," Fauci said.

He said there were still questions about how long the vaccine would protect people for, and how effective it is in the elderly versus younger people, but that it was "good news" both in the immediate term and for other vaccines from companies such as Moderna, which work along similar lines.

He emphasized, though, that while Americans should feel good about the news, no one should let their guard down yet.

"We know there's light at the end of the tunnel, but that doesn't mean that we're going to give up the important public health measures that we continually still have to do every single day," said Fauci.

6:39 p.m. ET, November 9, 2020

Every county in Ohio "feeling the brunt of rising Covid-19 hospitalizations"

From CNN’s Jennifer Henderson

A Medical Worker in full PPE prepares to conduct Covid-19 tests on patients at The Ohio State East Hospital on July 31 in Columbus, Ohio.
A Medical Worker in full PPE prepares to conduct Covid-19 tests on patients at The Ohio State East Hospital on July 31 in Columbus, Ohio. Matthew Hatcher/Getty Images

Ohio is seeing "an unprecedented spike in hospitalization, and it is impacting all areas of the state," Bruce Vanderhoff, incoming chief medical officer at the Ohio Department of Health said in a news conference on Monday.  

Vanderhoff said waves of the virus in the spring and summer were much smaller and everyone was able to pull together and reduce spread and avoiding overwhelming hospitals.

While Ohio has more PPE and capacity than they did in the spring, cases are surging and the demands on staffing are increasing. "Every county in the state is feeling the brunt of rising Covid-19 hospitalizations," he said. 

"If we don't control the spread of the virus and our case numbers, we won't be able to continue caring for the acutely ill without postponing important, but less urgent care," Vanderhoff said. "We anticipate that this kind of shift could happen in a matter of weeks if trends don't change."

In the spring, Governor Mike DeWine worked with the Ohio Hospital Association to create a comprehensive statewide public health system, bringing together hospitals and healthcare providers to support each other during the pandemic.

Ohio is not the only state in which hospitals are under increased pressure.

Connecticut Governor Ned Lamont said on Monday that hospitalizations there had doubled in the past few weeks. Fatalities have also been increasing monthly for the past three months.

But Lamont said that hospital capacity was not an issue at this time and that only 50% of the ICU is currently in use. 

6:10 p.m. ET, November 9, 2020

SEC football programs forced to change plans due to Covid-19

From CNN's David Close

An 'SEC' logo is seen on an end zone pylon before the Missouri Tigers take on the Auburn Tigers during the SEC Championship Game at Georgia Dome on December 7, 2013 in Atlanta, Georgia.
An 'SEC' logo is seen on an end zone pylon before the Missouri Tigers take on the Auburn Tigers during the SEC Championship Game at Georgia Dome on December 7, 2013 in Atlanta, Georgia. Mike Ehrmann/Getty Images

Saturday’s college football game between Auburn and Mississippi State has been postponed due to Covid-19 cases within Mississippi State’s program.

The Southeastern Conference (SEC) announced the Bulldogs have had positive tests and are subsequently quarantining. 

The game has been tentatively rescheduled for December 12. 

Louisiana State's head football coach Ed Orgeron admitted on Monday that several of the team's players, including starters, have Covid and are quarantining.

When asked about the status of Saturday’s game against Alabama, Orgeron said it was "very fluid right now."

No. 5 Texas A&M were forced to halt their football activities on Monday after receiving multiple positive coronavirus tests. 

6:10 p.m. ET, November 9, 2020

US reported record 74,000 new Covid-19 cases among children last week

From CNN Health’s Jen Christensen

There were nearly 74,000 new cases of Covid-19 among children in the US in the week ending November 5 -- the highest weekly increase since the pandemic began, according to the American Academy of Pediatrics. 

Children account for more than 11% of all coronavirus cases in the US. There has been a 17% increase in Covid-19 cases among children over the past two weeks.

The AAP said 73,883 new cases among children 17 and under were reported from October 29 to November 5, with about 927,518 children infected in the US in total. More than 10 million people have been infected in the US.

Severe illness and deaths from Covid-19 are still rare among children.

As of November 5, children represented between 1% and 3.4% of total hospitalizations, depending on the state. Between 0.6% and 6.4% of all child cases resulted in hospitalization and in states that reported the information, up to 0.13% of children with Covid-19 died. Sixteen states reported no child deaths.  

The count is not complete, because not all states report data in the same way. These numbers come from 49 states, New York City, the District of Columbia, Puerto Rico and Guam. A smaller subset of states report information about hospitalizations and deaths by age. 

The AAP said there was an "urgent need" to collect more data on the longer-term impact of Covid-19 on children, including the ways in which the virus may hurt children physically and emotionally over time.

5:30 p.m. ET, November 9, 2020

Vaccine maker Novavax gets FDA fast-track for experimental coronavirus shot

From CNN Health’s Maggie Fox

Vaccine maker Novavax said Monday it had won fast-track designation for its experimental coronavirus vaccine from the US Food and Drug Administration – something that could help speed regulatory approval or emergency use authorization.

"Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November," the company said in a statement.

That would make it the fifth coronavirus vaccine to enter late-stage clinical trials in the US. Vaccines being made by Moderna and Pfizer have also received FDA fast-track designation.

The Maryland-based company has been awarded $1.6 billion from the federal government’s Operation Warp Speed to help it run clinical trials of the vaccine.

Like several other experimental coronavirus vaccines, Novavax’s would require two doses. It hopes deliver 100 million doses by the end of this year.

Novavax's vaccine is made by growing synthetic versions of the coronavirus spike protein in armyworm moth cells. The vaccine combines these particles with the company’s adjuvant -- a plant-based compound that helps boost the immune response to the vaccine.

5:16 p.m. ET, November 9, 2020

California hospitalizations rise by more than 25% as governor warns people are "letting their guard down"

From CNN's Cheri Mossburg

Coronavirus rates are rising quickly in California with cases, positivity rate, hospitalizations, and the number of people in intensive care all climbing.

Hospitalizations are up 28.6% over the past two weeks and the number of patients in ICU has increased 27.3% over the past three weeks, Governor Gavin Newsom announced Monday.

The positivity rate has gone up significantly in that time frame, from a low of 2.5% on October 19 to 3.7% today.

Newsom said the reason for the increase was obvious. 

"People are letting their guard down by taking their masks off. They're starting to get together, outside of their household cohorts. They're starting to see businesses reopen, and we're starting to get to see more people mixing," he said. "As it gets colder, we'll see more still."

Testing for coronavirus is also climbing in California, with 194,000 tests conducted on Sunday. 

"We anticipated seeing more cases with increased testing, but the positivity rate is a better indicator of what’s actually happening," Newsom said.

Newsom said he expects an announcement on Tuesday that some counties will move backwards in the state's tier system. For some areas, that could include closing some non-essential business and reinstituting stricter health orders.

5:03 p.m. ET, November 9, 2020

Michigan State basketball coach Tom Izzo tests positive for Covid-19

From CNN's Jabari Jackson

In this Jan. 12, 2020, file photo, Michigan State coach Tom Izzo gestures during the second half of the team's NCAA college basketball game against Purdue in West Lafayette, Indiana
In this Jan. 12, 2020, file photo, Michigan State coach Tom Izzo gestures during the second half of the team's NCAA college basketball game against Purdue in West Lafayette, Indiana Michael Conroy/AP

Michigan State's men's basketball coach Tom Izzo tested positive for coronavirus Monday morning, he said in a statement.

Izzo said he had "some minor symptoms," but remained in good health.

"I've been extremely diligent for many months now, wearing my mask in public and around the office, while adhering to social distancing guidelines," said the National Basketball Hall of Famer. 
"I've been racking my brain, trying to figure out if there was a time where I let my guard down for just an instance. And while I haven't identified any area of exposure, what I have determined is that this shows the power of the virus.
"You'd be hard pressed to find a coach who's taken more precautions than I have, following all the protocols put in place by our medical team, and yet I still contracted the virus."

Izzo said technology would allow him to stay connected with his staff and players, and he would be following advice from medical staff, and taking all the steps necessary to return as soon as possible. 

He said he was "proof that no one is immune," but urged people to listen to experts and take steps to reduce their chances of contracting the virus.

4:55 p.m. ET, November 9, 2020

Pfizer vaccine "not a magic bullet," emergency physician cautions

From CNN's Lauren Mascarenhas

A health worker wearing a protective mask works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, on Wednesday, September 9.
A health worker wearing a protective mask works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, on Wednesday, September 9. Eva Marie Uzcategui/Bloomberg via Getty Images

Despite promising early results from Pfizer’s trials, the coronavirus vaccine is "not a magic bullet," Dr. Leana Wen, emergency physician and CNN medical analyst, said Monday.

The drugmaker announced Monday that its vaccine appears to be more than 90% effective, based on early data. Wen said that efficacy figure refers to the vaccine's ability to prevent any Covid-19 infection, as opposed to severe infection from the virus.

"I think what most of us care about is the endpoint of preventing severe infection – preventing somebody from getting very ill, from being hospitalized, from dying – and we just don't have those data yet," Wen told CNN’s Brianna Keilar.

Wen said she hopes Pfizer will make its data publicly available. The company is expected to do so when it applies to the US Food and Drug Administration for emergency use authorization.

"What we do know is that if you get the vaccine, it appears that you have a much lower likelihood of getting infected with Covid-19, but we don't know whether getting this vaccine prevents you from the severe illness, and we also don't know whether this vaccination will reduce the risk of your transmitting Covid-19 to others," Wen added. 

Wen added that "there is a long road between actually getting the vaccine approved and getting it distributed to hundreds of millions of Americans," emphasizing the importance of basic public health measures in the meantime.