FDA Approves Eli Lilly Antibody Drug For Emergency Use; COVID-19 Outbreak Interrupts SEC Football Schedule: Live Updates

FDA Approves Eli Lilly Antibody Drug For Emergency Use; COVID-19 Outbreak Interrupts SEC Football Schedule: Live Updates

Tyler Durden

Mon, 11/09/2020 – 19:15

Summary:

  • SEC forced to change up schedule due to virus
  • Eli Lilly’s antibody Bamlanivimab granted EUA by FDA
  • Dr. Fauci says he wants to stay in current role
  • Cali hospitalizations spike
  • California gov hints at more restrictions
  • Trump campaign advisor David Bossie tests positive
  • Illinois reports 10k+ new cases for fourth day
  • Hospitalizations climb in the mountain west
  • Deaths drop in Illinois
  • Nebraska issues mask order
  • US cases top 10 million
  • Italy tightens restrictions
  • Joe Biden warns of “dark winter”, unveils task force members
  • NJ imposes new restrictions
  • NYC on verge of 2nd wave, mayor says
  • Shanghai reports first case in months
  • US hospitalizations back to July highs
  • Ukrainian president tests positive
  • Dr. Fauci hails Pfizer-BioNTech news

* * *

Update (1900ET): In yet another critical update involving a closely watched COVID-19 vaccine or therapeutic, the FDA on Monday granted emergency-use approval for Eli Lilly’s Bamlanivimab, an antibody therapy that has shown to be somewhat effective in treating mild-to-moderate COVID-19.

Eli Lilly’s shares popped in after-hours trading on the news, which comes after a spectacular trading session where early reports about the Pfizer-BioNTech vaccine candidate helped spark a massive shift back into value.

It’s also another surprisingly timed development that again hints at some level of coordination in Monday’s post-election deluge of positive headlines about COVID-19 vaccines and treatments. Aside from the Pfizer news, the FDA also granted fast-track designation to Novavax’s vaccine candidate, as the company’s project is set to become the fifth to enter Phase 3 clinical trials in the US.

The treatment gives doctors an important alternative to treating high-risk patients before they become seriousl ill. These types of treatments are also being studied as short-term treatments that could be given to people – say, a nurse – who was potentially exposed to the virus.

In other news, a COVID-19 outbreak has impacted the SEC’s season schedule, now that Saturday’s game between Auburn and Mississippi State has been postponed due to COVID-19 outbreaks, with other games likely to be impacted by isolated campus outbreaks.

* * *

Update (1800ET): Seaking on – where else? – CNN Monday evening, Dr. Anthony Fauci one again chimed in to praise today’s Pfizer-BioNTech research, claiming we “would be giving vaccine to people very likely before the end of the year.”

The findings from the trials of the mRNA vector vaccine bode well for other vaccine projects in the works, Dr. Fauci said. He also threw in a few supportive comments about his favorite Biotech company, Moderna (a company that received $1 billion upfront from the federal government to run its trials).

“This shows that the mRNA platform actually does work. And there’s another vaccine candidate, Moderna, that’s using the same platform,” Fauci told CNN in a telephone interview.

Later this evening, Dr. Fauci spoke to another reporter, offering praise for Biden’s still-vaguely defined plan, and affirming that he would like to stay on in his current role in the new administration.

In some other troubling news from Monday afternoon, California saw its hospitalizations due to COVID-19 spiked 28.6% over the past two weeks.

* * *

Update (1520ET): California Gov. Gavin Newsom has just become the latest governor to hint at, or announce, more COVID-19-related restrictions in the neaer future.

* * *

Update (1450ET): Trump campaign senior outside advisor David Bossie has reportedly tested positive for COVID-19, joining Mark Meadows and Ben Carson in the growing number of TrumpWorld figures testing positive for the virus.

* * *

Update (1430ET): After the US topped 10 million confirmed cases on Monday…

…we’ve gotten some mixed news out of the mountain west and midwest. Wyoming reported a new record hospitaliztions Monday, while warning that 17 of 19 ICU beds at the state medical center were full. In neighboring Montana, 470 virus-linked hospitalizations were reported on Monday, a third of the total since March. 7 of 10 large hospitals in the state reported limited availability for emergency beds.

Meanwhile, Nebraska has joined Utah in issuing a mandatory mask order. Nebraska Gov. Pete Ricketts announced the new health order Monday including a requirement that masks be worn when people are in close contact for at least 15 minutes at usinesses in the state, according to reports in the Nebraska local press. The reports come after the governor’s owne chief spokesman criticized the

Illinois, meanwhile, saw daily deaths decline day over day, from 42 on Sunday to just 14 on Monday, while it exceeded 10k new COVID-19 cases for the fourth straight day.

* * *

Update (1330ET): Italy’s Health Minister has tightened coronavirus restrictions on six new parts of the country, bumping up the Province of Bolzano to a “red zone”, while the regions of Abruzzo, Umbria, Tuscany, Liguria, Basilicata became orange zones. The news, which comes via Italy’s ANSA newswire, comes as Reuters publishes a story noting Italians’ reluctance to abide by restrictions on movement and business like they did in the spring, when the nation “stoically accepted” a massively restrictive lockdown to beat back one of the first major outbreaks in Europe.

Last week, Italy became the sixth country to top 40k COVID-19 deaths (confirmed deaths, at least). Northern Italy, including Lombardy and Piedmont, have been hit by the most restrictive measures involving bars, restaurants and shops (they’re in so-called “red zones”). PM Giuseppe Conte has been slowly tightening restrictions to different degrees nationwide.

Italy, like the US and many other European countries, is seeing an alarming surge in hospitalizations as well, as some scientists warn about the second wave of the virus overwhelming the health-care system.

Unlike the first time around, protests against the new measures have been widespread across the worst-hit areas of the Italian peninsula.

Meanwhile, in the US, Johns Hopkins just confirmed that the total case count has passed the 10 million mark, as expected, meaning the US currently accounts for roughly 20% of the global confirmed COVID-19 tally.

* * *

Update (1200ET): After spending the morning with the co-chairs of his newly announced coronavirus task force, Joe Biden delivered an update where he expanded on his statement from earlier, warning Americans about the “dark winter” ahead’, as he prepares to impose mandatory mask-wearing and social distancing rules.

“There’s a need for bold action to fight this pandemic. We’re still facing a very dark winter…infection rates are going up, hospitalizations are going up, deaths are going up,” Biden said during the video briefing, after which he did not take questions.

Biden also laid out his 13-member advisory panel, which is made up of doctors and other “health experts”, including Dr. Rick Bright, a former top vaccine official who was fired from the Trump administration, as a member of his COVID-19 advisory panel, which he announced on Monday.

Biden’s task force will have three co-chairs: Vivek H. Murthy, surgeon general during the Obama administration; David Kessler, Food and Drug Administration commissioner under Presidents George H.W. Bush and Bill Clinton; and Marcella Nunez-Smith, associate dean for health equity research at the Yale School of Medicine. Murthy and Kessler have briefed Biden for months on the pandemic.

As the Washington Post pointed out, Biden’s picks for the panel intend to communicate to the public that he’s embracing a “science-backed” approach, which essentially means doubling down on economically harmful restrictions on business and movement, in addition to the social distancing, as New Jersey showed us earlier.

Other members include (text per WaPo):

Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

Atul Gawande, a surgeon at Brigham and Women’s Hospital and a professor at Harvard Medical School who is a prolific author.

Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Eric Goosby, global AIDS coordinator under President Barack Obama and professor of medicine at the University of California at San Francisco School of Medicine.

Celine R. Gounder, clinical assistant professor of medicine and infectious diseases at New York University’s Grossman School of Medicine.

Julie Morita, executive vice president of the Robert Wood Johnson Foundation, a philanthropy focused on health issues.

Loyce Pace, president and executive director of the Global Health Council, a U.S.-based nonprofit organization dedicated to global health issues.

Robert Rodriguez, professor of emergency medicine at the UCSF School of Medicine.

Rebecca Katz, director of the Center for Global Health Science and Security at Georgetown University Medical Center, and Beth Cameron, director for global health security and biodefense on the White House National Security Council during the Obama administration, are serving as advisers to the transition task force.

Biden also plans on working closely with local officials, calling both Republican and Democratic governors to get their input.

We imagine NJ’s Phil Murphy and NY’s Andrew Cuomo will have quit a bit of input.

Biden’s comments come as US cases have soared to new daily records in recent days, including the 128,000 cases reported on Saturday, a daily record.

* * *

Update (1110ET): Phil Murphy just announced that among the latest  batch of restrictions to slow the spread of COVID-19 in the Garden State, will be an order barring indoor dining between 2200 and 0500, a strategy that has also been implemented in Asia and Europe.

Importantly, the halt comes just after the FDA approved more rapid antigen tests for COVID-19. Manufacturers and many scientists argue the tests could be used by restaurants to safely serve customers, since they’re cheap (only a few dollars per customer).

Of course, most family restaurants in the state won’t be impacted, it’s the nightlife industry, which, in theory, leads to more spread, that will suffer the bulk of the impact.

It’s notable in that the bounce-back in restaurant spending was a major contributor to last quarter’s GDP print. NJ is officially back ahead of the pack in its efforts to curb the latest round of the virus.

* * *

Monday’s torrent of optimistic vaccine-related news, sparked early this morning by a WSJ report previewing the first batch of results from the Pfizer-BioNTech COVID vaccine candidate, has, predictably, been followed by a statement from the Biden campaign (which, curiously, got a preview of the results around the same time as Pfizer’s own top executives, and possibly even before the sitting president himself) warning Americans that masks remain the best tool to prevent spread of the virus.

It began Sunday evening, when Utah Gov. Gary Herbert declared a state of emergency and ordered a statewide mask mandate, blaming a surge in coronavirus hospitalizations that he said was threatening hospital capacity, CBS News reported.

Herbert and the Utah Department of Health issued executive and public health orders requiring residents to wear face coverings in public, at work and when they are within 6 feet of people who don’t live in their households. Herbert, a Republican, had resisted a statewide mandate, even as several counties in the state went ahead with more restrictive mask rules. But apparently the election results, combined with the latest data, have been convincing enough to sway them.

Across the US, hospitalizations have returned to their highs from late July, with 56,768 patients in the hospital, 11,108 of those in the ICU and 2,959 on ventilators.

On Monday morning, New Jersey Governor Phil Murphy suggested that he would revive some restrictions in the wake of the state reporting about 5,000 new COVID-19 cases in two days.

New restrictions might impact the state’s bars, restaurants and indoor youth sports may be reined in, Murphy said on CNBC’s “Squawk Box.” Though notably the limits wouldn’t be extended to include college sports as part of measures he said would likely be announced Monday.

“If you sit at a bar there’s a much higher likelihood of a transmission,” he said.

Across the river in NYC, Mayor Bill de Blasio warned that the city was coming “dangerously close” to a second wave. His warning comes as cases and hospitalizations rise, and the city health department, which has caught a lot of flack for its dysfunctional relationship with city hall (or rather, city hall has caught flack for its dysfunctional relationship with the health department, and decisions to delegate tasks like organizing the city’s contact tracing effort to others outside the department) releases a “real time” breakdown of zip-code by zip-code data.

While daily case numbers remain uncomfortably elevated, and deaths and hospitalizations continue to climb, the number of confirmed cases is currently at 50,550,062, while 1,258,321 deaths have been recorded.

Here’s some more COVID-19 news from Monday morning and overnight:

Ukrainian President Volodymyr Zelenskiy says he tested positive for Covid-19 and is self-isolating. Zelenskiy is feeling fine and will continue to work remotely, according to a statement from his office (Source: Bloomberg).

Anthony Fauci, the U.S. government’s top infectious-disease expert, said the Covid-19 vaccine being developed by Pfizer will have a “major impact” on the battle against the coronavirus. The efficacy of the Pfizer drug candidate being over 90% “is just extraordinary,” Fauci said Monday on a call with reporters. Separately, he said Moderna may have similar results to the Pfizer vaccine because it is also based on mRNA technology (Source: Bloomberg).

Shanghai reported a single domestic case of Covid-19 on Monday, according to the municipal government. The confirmed case works as a porter at Shanghai Pudong International Airport. The Chinese financial hub hasn’t reported any local cases in months, although it has seen a steady stream of imported cases (Source: Bloomberg).

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Author: Tyler Durden

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