Live Covid-19 Global News: Eli Lilly, Pfizer and Ben Carson – The New York Times
Heres what you need to know:A researcher with Eli Lilly tests possible coronavirus antibodies in a laboratory in Indianapolis earlier this year.Credit...David Morrison/Eli Lilly, via Associated Press
The Food and Drug Administration has granted emergency authorization of a Covid-19 treatment made by Eli Lilly that was given to Chris Christie, the former New Jersey governor, when he was infected with the coronavirus.
The authorization, announced on Monday, applies only to people newly infected with the virus, and the agency said it should not be used in hospitalized patients. The treatment is approved for people 12 and older, who have tested positive, and who are at risk for developing a severe form of Covid-19 or being hospitalized for the condition. That includes people who are over 65 and obese, the agency said a key group that early studies have shown can benefit the most from the treatment.
Eli Lilly said that its treatment, called bamlanivimab, should be administered as soon as possible after a positive test, and within 10 days of developing symptoms.
Its a great day for science and medicine sort of a feat of whats possible, said Dr. Daniel M. Skovronsky, the chief scientific officer of Eli Lilly. The company and its collaborators, including the National Institutes of Health, he said, were able to create a new drug, manufacture it, test it in clinical trials, and get it authorized for use in just seven months.
In October, the company announced that it had reached a $375 million deal to sell 300,000 doses of the treatment to the U.S. government. Eli Lilly said Monday that it will begin shipping the treatment immediately to AmerisourceBergen, a national distributor, which will then distribute it on behalf of the federal government.
The treatment consists of a single powerful antibody that is believed to keep the infection in check, and has been shown in early studies to reduce emergency room visits and hospitalizations in patients who get the drug early in the course of their disease. It is similar to the treatment that President Trump received, made by the Westchester biotech company Regeneron, which is a cocktail of two antibodies. Regeneron has also applied for emergency authorization.
Mr. Christie disclosed this fall that he had received the Lilly treatment on an emergency basis after he was infected with the virus.
Eli Lillys authorization raised immediate questions about who would get access to the treatments, which must be infused in a clinic or hospital. The company has said it expects to have enough to treat one million people by the end of the year. That means, even in the best case scenario, there wont be nearly enough to curb a virus that is now infecting an average of over 111,000 people a day in the United States.
Its kind of the best times for these therapies to enter, because they can have an impact, said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Its also the worst time because we dont have enough doses, and its going to add to the backlog of testing.
By Monday evening, over 100,000 new U.S. cases had been recorded for the sixth consecutive day and more than 59,000 Covid-19 patients were hospitalized, nearing a record. Seven states and Guam set daily records for new cases.
At least three people who attended an election party at the White House last week, including the housing secretary and President Trumps chief of staff, have tested positive for the coronavirus. Several hundred people gathered at the event in the East Room for several hours, many of them not wearing masks as they mingled and watched election returns.
Ben Carson, the secretary of housing and urban development, tested positive for the coronavirus on Monday, according to a spokesman for the agency. He is the latest in a long list of administration officials, including Mr. Trump, to contract the virus.
He is in good spirits and feels fortunate to have access to effective therapeutics, which aid and markedly speed his recovery, Coalter Baker, the agencys deputy chief of staff, said in an email. Mr. Baker did not specify which treatments Mr. Carson had received or would receive.
Another is David Bossie, an adviser Mr. Trump recently appointed to be the face of his efforts to contest vote tabulations in states like Nevada and Georgia, two people familiar with the diagnosis said on Monday. Mr. Bossie tested positive on Sunday and told campaign officials of the result.
The third person from the election party is Mr. Trumps chief of staff, Mark Meadows, who tested positive for the virus the day after the election, aides said, although Mr. Meadows tried to keep it quiet.
President-elect Joseph R. Biden Jr. made an urgent plea on Monday for Americans to wear masks to slow the spread of the virus, declaring that a mask is not a political statement. He said the pandemic would be his top priority when he replaces Mr. Trump on Jan. 20.
With the world anxiously awaiting any positive news about a pandemic that has killed more than 1.2 million people, the drug maker Pfizer announced on Monday that its coronavirus vaccine appeared to be robustly effective, based on an early analysis of trial results.
Mr. Carson, a neurosurgeon who ran unsuccessfully for the Republican presidential nomination in 2016, has defended Mr. Trumps response to the virus and is a member of the White House virus task force.
At 69, Mr. Carson is at an elevated risk for complications. He is also a cancer survivor, having undergone surgery in 2002 for an aggressive form of prostate cancer.
I really came down with symptoms yesterday. Fever of 101. Chills. Muscle cramps. Respiratory issues and fatigue, Mr. Carson told The Washington Post.
According to Armstrong Williams, a friend and personal adviser to Mr. Carson, the secretary felt ill over the weekend and was examined and tested early Monday at Walter Reed National Military Medical Center.
I was just on the phone with him, Mr. Williams said in an interview at midday on Monday. He said he was feeling pretty bad over the last couple of days, but he was feeling a lot better now. Carsons going to live. Carsons going to be OK.
Some patients who seem to fare well in the first week after diagnosis become seriously ill in the second week.
Mr. Carsons wife, Candy, accompanied him to Walter Reed and was tested, but the results were not back yet, Mr. Williams said. It was not clear which kind of test each had taken.
The secretary was one of several hundred people at the White House party, according people with knowledge of the situation. But Mr. Williams said that Mr. Carson thinks he caught the virus before then, while campaigning for Mr. Trump by bus before Election Day. It was not immediately clear why Mr. Carson thinks so.
Five other White House aides and a Trump campaign adviser also tested positive in the days before and after Election Day, people familiar with the diagnoses told The Times on Friday.
President-elect Joseph R. Biden Jr. named Dr. Rick Bright, a former top vaccine official in the Trump administration who submitted a whistle-blower complaint to Congress, as a member of a Covid-19 panel to advise him during the transition, officials announced Monday.
Dr. Bright, who was ousted as the head of a federal medical research agency, told lawmakers that officials in the government had failed to heed his warnings about acquiring masks and other supplies. He said that Americans died from the virus because of the Trump administrations failure to act.
Lives were endangered, and I believe lives were lost, Dr. Bright, the former director of the Department of Health and Human Servicess Biomedical Advanced Research and Development Authority, told a House subcommittee in May.
Mr. Bidens decision to put Dr. Bright on his advisory panel is intended to send a signal that the incoming administration intends to confront the virus which is surging across the country in a very different way than President Trump, who sought to largely push responsibility onto states.
In a statement on Monday, Mr. Biden said the advisory board will help him shape his approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.
After meeting with the board on Monday, Mr. Biden urged all Americans to wear a mask and vowed to make defeating the pandemic his No. 1 priority when he takes office on Jan. 20.
It doesnt matter your party, your point of view. We can save tens of thousands of lives if everyone would just wear a mask for the next few months, Mr. Biden said.
On Sunday, the nation surpassed 10 million cases and sank deeper into the grip of what could become the worst chapter yet of the pandemic.
The rate of new cases is soaring: The seven-day average of new cases across the United States rose to more than 111,000 a day, as of Sunday. With 29 states setting weekly case records, the virus is surging in more than half the country. Nationwide, hospitalizations have nearly doubled since mid-September, and deaths are slowly increasing again.
The nations worsening outlook comes at an extremely difficult juncture: Mr. Trump, who remains in office until January, is openly at odds with his own coronavirus advisers, and winter, when infections are only expected to spread faster, is coming.
The three co-chairs of Mr. Bidens virus advisory board are: Dr. Vivek H. Murthy, a former surgeon general, who has been a key Biden adviser for months and is expected to take a major public role; Dr. David A. Kessler, a former commissioner of the Food and Drug Administration who worked closely with Dr. Anthony S. Fauci, the nations top epidemiologist, to speed development and approval of HIV drugs; and Dr. Marcella Nunez-Smith, an associate professor of medicine and epidemiology at Yale University.
The 13-member panel will also include Dr. Ezekiel J. Emanuel, an oncologist and the chair of the department of medical ethics and health policy at the University of Pennsylvania. Dr. Emanuel is the brother of Rahm Emanuel, who served as White House chief of staff under former President Barack Obama and as the mayor of Chicago. Dr. Emanuel has been a high-profile advocate of a more aggressive approach to the virus.
The other members of the panel are: Dr. Atul Gawande, a professor of surgery at Brigham and Womens Hospital; Dr. Celine Gounder, a clinical assistant professor at the N.Y.U. Grossman School of Medicine; Dr. Julie Morita, the executive vice president of the Robert Wood Johnson Foundation; Dr. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota; Ms. Loyce Pace, the executive director and president of the Global Health Council; Dr. Luciana Borio, a National Security Council aide under Mr. Trump and acting chief F.D.A. scientist under Mr. Obama; and Dr. Robert Rodriguez and Dr. Eric Goosby of the University of California, San Francisco School of Medicine.
And Dr. Fauci said on Monday that he would stay at his post atop the National Institute of Allergy and Infectious Diseases after Mr. Bidens inauguration, telling CNN that he has no intention of leaving.
Ive been doing it working in public health under six presidents, Dr. Fauci said. Its an important job and my goal is to serve the American public no matter what the administration is.
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transcript
Unfortunately were also dealing with an immense challenge this morning because we see the presence of the coronavirus in the city and its trying to reassert itself. And we have to do everything in our power while were waiting for that help from the federal government to finally come, we need to do everything in our power to stop the coronavirus from reasserting in New York City. We have to stop a second wave from happening here. It is getting dangerously close. Ive been telling you for weeks that we had the ability to stop a second wave. And for weeks, actually, our numbers were higher than we wanted, but they had leveled off. Now, unfortunately, were seeing a real growth in the positivity rate in the city. And that is dangerous. So we have one last chance to stop a second wave. Its as simple as this. This is my message to all New Yorkers today: We can stop a second wave if we act immediately. But we have one last chance. So the more that people wear masks, practice social distancing, all those basics, the more were able to fight back that second wave. So I cant give you a timeline. It will actually depend on how people respond to your reporting and everything else we put out there. If they take decisive action, it can make a huge difference. But it is important, I think, to lay out the danger in terms of new restrictions because I think it will make it very visual, very real to people what were up against. God forbid this continued and we had a full-blown second wave, it means a lot more restrictions. It means, unfortunately, it could mean even having to shut down parts of our economy again, which would be horrible for this city, horrible for the livelihoods of people.
As coronavirus cases have surged to records across the United States, Gov. Philip D. Murphy of New Jersey laid out new restrictions for the state on Monday, calling for restaurants and nightclubs to shut down indoor service at 10 p.m. starting Thursday, and saying that no one may be seated directly at the bar.
High school sports teams are not permitted to participate in out-of-state tournaments, but college athletes may still travel.
Mr. Murphy said he would continue to consider additional targeted restrictions on nonessential businesses.
New Jerseys seven-day average of coronavirus cases now exceeds 2,000 infections a day, or 24 per 100,000 people, the highest rate since May. Last week, the average rate of positive tests, a key indicator of a states control of the virus, reached 6 percent. Hospitalizations have also been rising, though death rates have not spiked.
Mr. Murphy, a Democrat, said in interview on CNBCs Squawk Box on Monday that the new rules would be designed to shave at the edges, without imposing a full lockdown.
The new limits on businesses comes about two weeks after Newark, the states largest city, took similar action on its own to confront a hot spot centered in the Ironbound neighborhood, one of the states most thriving restaurant districts.
And in the New York City area, officials had also hoped to keep the outbreak at bay and press ahead with its slow but steady recovery from the dark days of spring. But now, its forecast is turning more alarming, too.
The number of new cases is swiftly rising, with more than 1,000 cases identified in New York City four days in a row this past week, or 12 per 100,000 people, a level that last occurred in May, according to a New York Times database.
Though new restrictions would be up to the governor, city health officials and Mayor Bill de Blasios aides have been discussing whether new citywide restrictions should be imposed, including a broader shutdown of nonessential businesses if the citywide seven-day average rate of positive virus test results climbs, and stays, above 3 percent. The figure was 2.21 percent, according to the citys health department.
Hospitalizations and death rates are a small fraction of what they were at the height of the pandemic, and case count comparisons can be tricky, given that much more testing is occurring now. Around the state, the daily average of new cases for the last seven days was 2,757, or 14 per 100,000 people as of Sunday, according to the Times database.
Whats more, the positivity rate in New York City is still well below that in neighboring states.
Mr. de Blasio said on Monday that now, unfortunately, we are seeing a real growth in the positivity rate in the city, and that is dangerous.
He added, This is my message to all New Yorkers: We can stop a second wave if we act immediately, but we have one last chance and everyone has to be a part of it.
The citys contact tracing program has disclosed few details about which trends and patterns are contributing to transmission. But one city health official, who spoke on condition of anonymity to share details from internal discussions, said clusters had been traced to workplaces, including construction sites and offices.
The mayor said that further lockdowns were possible should New York City not regain control of the virus.
God forbid this continued and we had a full-blown second wave, he said. It means a lot more restrictions. Unfortunately, it could mean even having to shut down parts of our economy again.
It could also mean having to close schools, he said.
The mayor has previously said that he favored halting indoor dining if the seven-day positivity rate reached 2 percent a threshold that has already been crossed without his taking any action. On Monday, the mayor would only say that it was time to re-evaluate the wisdom of allowing limited indoor dining.
At his own news conference, Gov. Andrew M. Cuomo said the so-called red zone covering parts of Brooklyn was being downgraded to orange, which allows for less severe restrictions. Parts of Erie, Monroe and Onondaga counties would face greater restrictions, though, he said.
This is going to be the constant for the foreseeable future, Mr. Cuomo said, of his whack-a-mole approach to battling the virus. Every couple of days well say, This place became a microcluster, this place is no longer a microcluster.
The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.
Pfizer, which developed the vaccine with the German drug maker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts.
Pfizer said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said.
Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said.
Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. Still, Pfizer is the first company to announce positive results from a late-stage vaccine trial.
Eleven vaccines are in late-stage trials, including four in the United States. Pfizers progress could bode well for Modernas vaccine, which uses similar technology.
The news comes just days after Joseph R. Biden Jr. clinched a victory over President Trump in the presidential election. Mr. Trump had repeatedly hinted a vaccine would be ready before Election Day, Nov. 3. This fall, Pfizers chief executive, Dr. Albert Bourla, frequently claimed that the company could have a readout by October, something that did not come to pass.
Both President Trump and President-elect Biden hailed the news on Monday.
Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans free of charge.
But in an interview, Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, sought to distance the company from Operation Warp Speed and presidential politics, noting that the company unlike the other vaccine front-runners did not take any federal money to help pay for research and development.
She said she learned of the results from the outside panel of experts shortly after 1 p.m. on Sunday, and that the timing was not influenced by the election. We have always said that science is driving how we conduct ourselves no politics, she said.
The data released by Pfizer Monday was delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.
In the wake of Joseph R. Bidens victory and the latest optimistic reports about the effectiveness of Pfizers vaccine, Gov. Andrew M. Cuomo of New York once again assailed President Trumps vaccine distribution plan, saying, We cant let this vaccination plan go forward the way the Trump administration is designing it.
The Trump administration is rolling out the vaccination plan and I believe its flawed, Mr. Cuomo, a third-term Democrat, said on ABCs Good Morning America on Monday. Theyre basically going to have the private providers do it, and thats going to leave out all sorts of communities that were left out the first time when Covid ravaged them.
Mr. Cuomos comments came even as he acknowledged that Pfizers results were great news, but some conservatives quickly accused the governor of trying to politicize the issue and hamper vaccine distribution efforts.
In a statement, Senator Ben Sasse, Republican of Nebraska, said: After this nasty virus has killed hundreds of thousands of Americans and put millions out of work, it is beyond disgusting that Governor Cuomo would use a glimmer of hope for another worn-out Trump is bad talking point. When we get a vaccine, were going to need all hands on deck distributing it as fast as possible. Shamelessly politicizing this is dangerous and stupid.
For months, Mr. Cuomo has raised concerns about the White Houses vaccination strategy, claiming that the rush to develop a vaccine has become so politicized that people might have serious trepidations about a vaccines safety. As chairman of the National Governors Association, Mr. Cuomo has accused the federal government of not providing states with sufficient answers on how governors should prepare to distribute a vaccine.
Those concerns prompted Mr. Cuomo to announce in September a state task force that is supposed to review any vaccines authorized by the federal government before theyre distributed in New York. Last month, the governor released a draft plan outlining the broad contours of how the vaccine would be distributed in New York, where up to 40 million doses could be needed for the states 19 million residents. Mr. Cuomo said priority would be given to essential workers and those considered most vulnerable.
Mr. Cuomo has also said that relying on the private sector, including pharmacies, could leave out minority communities that have already been disproportionately affected by the virus.
While the plan isnt finalized, a report released by the Department of Health and Human Services says that the most at-risk populations would indeed be prioritized in the initial phases of distribution, which will entail partnerships with local governments and public health sites, in addition to pharmacies, clinics, hospitals and nursing homes.
Ukraines president, Volodymyr Zelensky, said Monday that he has tested positive for the coronavirus, becoming the latest leader to contract the virus despite the extensive protective measures available to a head of state.
Mr. Zelensky, who is 42 and not known to have any of the underlying conditions that could put him at risk of developing severe illness from the virus, said in a post in English on Twitter that he felt good and was taking vitamins, adding, its gonna be fine!
The Ukrainian president said he intended to isolate himself but keep working. It was not clear if he had shown any symptoms. The presidents chief of staff, Andriy Yermak, has also tested positive, according to a statement he posted on Facebook minutes after the presidents tweet.
Cases have been shooting up in Ukraine. The country reported an average of 9,525 cases per day over the past seven days.
Mr. Zelensky has consistently urged Ukrainians to wear masks and to take other coronavirus precautions seriously. He often appears in public wearing a mask or on television conducting business by video conference.
Critics have, however, taken issue with a decision by his political party, which controls Parliament, to allocate more than half of a coronavirus relief fund intended for hospitals to road construction instead.
Mr. Zelensky, a former comedian, was elected president last spring and within months became entangled in an American political scandal when President Trump requested, in a telephone call, that he investigate now President-elect Joseph R. Biden Jr. and Mr. Bidens family.
Mr. Zelenskys wife, Olena Zelenska, had a mild case of Covid-19 in June. At the time, Mr. Zelensky said he isolated for a time but tested negative.
It will be a while before the University of Notre Dame knows whether the boisterous on-field celebration following the football teams double-overtime victory against top-ranked Clemson will cause a surge in students testing positive for the coronavirus.
But the school isnt waiting to react. Faculty members and administrators are already debating stronger measures to prevent the virus from spreading as students take finals and go home for Thanksgiving.
Thousands of students leapt over brick walls, dashed past overwhelmed security guards and stormed the field on Saturday, gleefully mobbing the Notre Dame players and one another for more than 15 minutes and ignoring loudspeaker announcements to retreat.
In a letter to the student body Sunday night, the Rev. John Jenkins, the president of the university, called the widespread disregard of the schools health and safety guidelines over the weekend very disappointing, and said there would be zero tolerance for noncompliance, either on campus or off. (A spokesman for the university said on Monday that Father Jenkins was not referring specifically to the football game, but to other gatherings.)
Any student who does not get tested for the coronavirus, or who leaves South Bend before the results are known, will not be allowed to graduate or register for next semesters classes, he wrote.
But Father Jenkinss credibility on campus is wearing thin. He has twice had to apologize for failing to wear a mask when he should have:posing for photos with returning students in August, and attending a White House reception where many attendees were infected, including him.
In an email Monday to the faculty and staff, Dan Lindley, an associate professor of political science, urged university leaders to lock down the campus for the rest of the semester (classes end Thursday, followed by final exams). His letter was in response to one Sunday night from the schools provost and vice president saying the school would not shut down classes.
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Live Covid-19 Global News: Eli Lilly, Pfizer and Ben Carson - The New York Times