At least 247,000 people have died from coronavirus in the U.S.

(The Washington Post, as of 3:55 p.m. Eastern)

At least 11,357,000 cases have been reported.

The disease caused by the novel coronavirus has killed at least 247,000 people in the United States since February and has enveloped nearly every part of the country.

As health officials long predicted, autumn brought soaring case counts, strained hospital capacity and increased deaths nationwide, as the virus is not only popping up in new places but also circling back to areas that once appeared to have it contained. Nearly all metrics in most of the country are trending in the wrong direction.

During an April peak, the seven-day-average U.S. death toll hit more than 2,000 per day, but cases were concentrated largely in the Northeast. During a July lull, average deaths sank to a low of 463 per day, although cases surged in the Sun Belt.

By early November, however, the country was recording more new cases than ever — well over 100,000 per day — and many states reported record-high caseloads and hospitalizations. The average U.S. deaths per day again shot past 1,000, despite improvements in treatment that make survival more likely.

In the past week in the U.S….New daily reported cases rose 26% New daily reported deaths rose 13.5% Covid related hospitalizations  rose 23.9%.

Among reported tests, the positivity rate was 10%.

The number of tests reported rose 9.6%  from the previous week.

Numbers in this article have fluctuated as testing and reporting criteria have evolved, particularly in areas that were hit early. Three spikes in the deaths chart above reflect large, one-time adjustments: In mid-April, New York City added more than 3,700 deaths. New Jersey added more than 1,800 on June 25. And in September, The Post changed its methodology for reporting deaths in New York and added a one-day increase of more than 2,700 on Sept. 18.

Health officials, including the country’s top infectious disease expert, Anthony S. Fauci, have said the virus has killed more people than official death tolls indicate.

No longer concentrated solely in a few urban areas or in nursing homes, prisons and factories, the virus seems to flourish wherever people let down their guard.

New York, which was slammed with the new disease in spring and where at least 33,000 have died, is one of several states experiencing a second or even third wave.

Sun Belt states had serious outbreaks after Memorial Day when people flocked to beaches. By late summer, parts of the Midwest were inundated. In August and September, clusters appeared in newly reopened college campuses, particularly in the Northeast and Midwest. By October, Upper Midwest, Great Plains and Western states that had previously been mostly spared were reporting major outbreaks, including MinnesotaWisconsinArkansasthe Dakotas and Alaska.

In November, most states reported record-high case counts and greater demand for hospital beds. Several set records for single-day fatalities.

In the absence of a federal plan, containment strategies vary by state and locality and have often reflected political polarization. The mounting crush of cases this fall, however, has prompted officials of both parties to tighten mask mandatesreimpose restrictions on gatherings and discourage holiday travel and gatherings to try to squelch the spread.

A majority of states and many retail chains required masks in public places by late July, and public health officials touted them as one of the easiest ways to stop the pandemic. Still, some people in even the hardest-hit areas refuse to wear them, despite evidence that they protect wearers and those around them.

People older than 65 and those with obesity and underlying health problems are the mostly likely to die from covid-19, but a large percentage of infections occur in younger, more mobile people. People younger than 40 tend to become less sick but also unknowingly may pass the disease to others around them.

The virus rarely kills children, although researchers have linked it to a mysterious and deadly inflammatory syndrome.

Outbreaks of covid-19 have hit Black, Hispanic and Native American communities particularly hard.

Sparsely populated areas don’t have the huge raw numbers that cities have reported, but some rank among the highest in deaths and cases per capita.

By late October, covid-19 had been documented in all but three U.S. counties and areas in Montana, the Dakotas and Idaho had some of the highest per capita caseloads.

People in very rural areas may be more vulnerable to covid-19 than urbanites, according to a Post analysis of CDC data.

Testing was slow to begin in the United States, and a system has yet to be standardized.

Demand has often overwhelmed testing infrastructure, muddying the ability of officials to get a true picture of the virus’s reach. In June, CDC Director Robert Redfield estimated that, based on antibody tests, the actual number of U.S. residents who had been infected by the virus was likely to be 10 times as high as the number of confirmed cases. More recently, conflicting CDC guidelines about whether people without symptoms should be tested caused confusion and inhibited contact tracing.

A sharp increase in hospitalizations in late October and November demonstrates that the virus is spreading, not just that more testing is finding more asymptomatic cases. A group of Illinois health-care workers predicted in a Nov. 10 open letter to state and Chicago officials that “Illinois will surpass its ICU bed capacity by Thanksgiving.”

Some hospitals, straining to find beds and health-care workers to handle the crush of patients, are considering unusual measures.

In North Dakota, health-care workers who test positive but have no symptoms can continue working in covid-19 wards, according to Gov. Doug Burgum (R). Some facilities in Oklahoma, Kansas and Ohio are limiting routine care and deferring non-emergency surgeries.

Not all news is bleak, however.

On Nov. 9, Pfizer announced that its promising vaccine — one of many in the works — appeared more than 90 percent effective in an ongoing trial. The same day, regulators granted emergency authorization to an antibody treatment that may keep mild illness from becoming severe.

And the next day, Fauci told CNN that the average American may have access to a vaccine by April.

What will the world look like after COVID-19?

Home | Bill Gates

Like a lot of people, I have really gotten into listening to podcasts over the last year. They’re such an immersive way to learn about the world, and I like how the format lets you dive as deep on a topic as you want. So, I was inspired to start one of my own—but I knew I couldn’t do it on my own.

I couldn’t ask for a better partner on this project than Rashida Jones. A mutual friend suggested that the two of us might have a lot to talk about, and it turned out he was right. I already knew she was a talented actor, but I was impressed by her thoughtful perspective on the world. So, we decided to start a podcast that lets us think through some of today’s most pressing problems together. In our first episode, Rashida and I explore a big question that is top of mind for many people: what will the world look like after COVID-19?

I know it’s hard to imagine right now while new cases are surging around the world, but there will come a time when the COVID-19 pandemic is behind us. I think it’s safe to assume that society will be changed forever, given how disruptive the virus has been to virtually every part of our lives.

Unfortunately, we still have a long way to go before life truly gets back to “normal.” Rashida and I were joined by Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, to discuss what to expect in the months to come. I’ve had the opportunity to work with Dr. Fauci on a number of global health issues over the years, including the quest for an HIV vaccine and cure. He’s such a quiet and unassuming guy normally, so it’s been wild to watch him become a huge celebrity.

Dr. Fauci and I are both optimistic that a vaccine will bring an end to the pandemic at some point in the near future. But what the world looks like after that is a lot less clear. I suspect that some of the digitization trends we’ve seen—especially in the areas of online learning, telemedicine, and remote work—will become a regular part of our lives. I hope this episode leaves you hopeful about the future and curious about what comes next.

Michigan, Washington order new restrictions as U.S. passes 11 million coronavirus cases

https://www.washingtonpost.com/politics/2020/11/15/incoming-biden-chief-staff-calls-seamless-transition-pandemic-surges/

Covid: Michigan and Washington State clamp down as US cases pass 11 million  mark - BBC News

Coronavirus cases reported in the United States passed 11 million on Sunday, as the nation shatters records for hospitalizations and daily new infections and as leaders turn to new, painful restrictions to stem the pandemic’s long-predicted surge.

The milestone came one week after the country hit 10 million cases, a testament to just how rapidly the virus is spreading — the first 1 million cases took more than three months. This new wave has increased covid-19 hospitalizations past the peaks seen in April and July, straining health-care systems and pushing some reluctant Republican governors to enact statewide mask mandates for the first time.

Other states are reenacting stay-at-home orders and store closures. Michigan Gov. Gretchen Whitmer (D) on Sunday announced sweeping new limits on gatherings for three-weeks — including a ban on indoor dining at restaurants and bars, and a halt to in-person classes at high schools and colleges. Washington Gov. Jay Inslee (D) also laid out a slew of new rules, which prohibit indoor social gatherings with people outside one’s household and indoor service at restaurants, bars and more.

“As hard as those first months were for our state, these next few are going to be even harder,” Whitmer said at a news conference, as health experts fear that winter weather driving people indoors will accelerate the crisis.

Inslee acknowledged that slowing the virus would come at a steep price for struggling businesses, even as the state works to distribute millions more in aid. He and Whitmer both appealed to the federal government to step in with more help. Congress remains deadlocked on a stimulus package, and President Trump — still denying his election loss — has largely tuned out the pandemic’s surge; his refusal to concede is also stalling the transition to a new administration, including the formal transfer of information on the nation’s pandemic response.

Whitmer said that Trump has “an opportunity to meet the needs of the people of this country” and emphasized the importance of his final months in office. Inslee was already looking ahead to the administration of President-elect Joe Biden.

“All of us who feel, as I do, the pain of the small-business people ought to be pounding the doors of the Congress and the new president, who I’m glad we’re going to have, to really get this job done,” Inslee said.

Washington’s restrictions are not as tough as its stay-at-home order issued in March but extend into nearly every aspect of daily life. Wedding and funeral receptions are forbidden. Religious services and in-store retail are forced to operate at reduced capacity. Even outdoor social gatherings must be kept to a maximum of five people from outside one’s household.

Inslee and other leaders in the state emphasized the need to intervene early amid spiraling statistics, even as Washington posts some of the lowest numbers for new coronavirus infections in the country. The number of hospital patients with covid-19 recently rose about 40 percent in a week, officials said, and Seattle’s mayor said that nearly a fifth of the city’s cases have come just in the past two weeks.

Clint Wallace, an ICU nurse in Spokane, joined Inslee at Sunday’s news conference to plead with residents for their help. He called the ICU “as busy as I’ve seen it.”

“We are exhausted,” Wallace said of health-care workers around the state.

State and local officials nationwide are reinstating restrictions to fight the virus. New Mexico and Oregon on Friday ordered extensive new statewide shutdowns, while the Navajo Nation — devastated early on by the virus — reissued its stay-at-home order for at least three weeks. The Navajo Nation said cases threaten to swamp the health system on the southwestern reservation without immediate action.

North Dakota Gov. Doug Burgum (R) on Friday issued a statewide mask mandate and new capacity limits on businesses, less than a week after Utah Gov. Gary R. Herbert (R) announced a similar mask order in the face of overwhelmed hospitals warning that they might have to ration care.

“Our situation has changed, and we must change with it,” Burgum said in a late-night video message.

But state rules are just one piece of the puzzle, and some leaders are looking to Congress and the incoming president to take stronger action.

Ron Klain, Joe Biden’s incoming chief of staff, said Sunday it’s critical for the president-elect’s transition team to start working with Trump administration officials to ensure “nothing drops in this change of power” that could imperil the distribution of a potential coronavirus vaccine.

“Joe Biden is going to become president of the United States in the midst of an ongoing crisis. That has to be a seamless transition,” Klain said on NBC News’s “Meet the Press.”

President Trump’s White House is blocking the administration from formally cooperating with Biden, forcing the president-elect’s transition team to continue preparations with recently departed government officials and other experts. That means Biden’s team has not heard from Trump’s about vaccine development and other work to combat the pandemic.

A health expert on Biden’s covid-19 advisory board said there’s “a lot of information that needs to be transmitted. It can’t wait until the last minute.”

It is in the nation’s interest that the transition team get the threat assessments that the team knows about, understand the vaccine distribution plans, need to know where the stockpiles are, what the status is of masks and gloves,” said Atul Gawande, a surgeon at Brigham and Women’s Hospital and a professor at Harvard Medical School, on ABC News’s “This Week.”

Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, compared the process Sunday to “passing a baton in a race.”

“I’ve been through multiple transitions now, having served six presidents for 36 years, and it’s very clear that transition process that we go through … is really important in a smooth handing over of the information,” Fauci said on CNN’s “State of the Union.”

“Of course it would be better if we could start working with them,” he added when asked whether working with Biden’s team would serve the public interest.

On “Meet the Press,” Klain said there is “not that much Joe Biden can do right now to change things,” because he is not yet president.

“Right now we have a crisis that’s getting worse,” Klain said. “We had never had a day with 100,000 cases in a single day until last week. By next week, we may see 200,000 cases in a single day.”

Biden’s Panel Outlines Proactive Pandemic Response as COVID-19 Toll Soars

Essential Coverage

On the morning of November 7, major news networks starting with CNN called the presidential election for Joe Biden. Although the election has yet to be officially certified, Biden and Vice President-elect Kamala Harris have wasted no time preparing their response to the rapidly worsening coronavirus pandemic.

Over the past week, the US has averaged more than 150,000 new COVID-19 cases per day, an increase of 81% from the average on November 1. The US had a record 181,200 new reported cases on November 13. Over 11 million Americans have been infected, and the nation is nearing a grim milestone of 250,000 deaths. Experts warn that the worst is yet to come. As temperatures drop and family-centric holidays approach, people are likely to spend more time socializing indoors with non-household members, increasing the risk for COVID-19 transmission.

Mitigating the spread of the coronavirus and preventing more deaths are top priorities for the incoming Biden-Harris administration. Biden’s campaign team published a seven-point plan to beat COVID-19, and on November 9, the Biden-Harris transition team named a COVID-19 Advisory Council tasked with guiding the federal response to the pandemic immediately after the inauguration.

The council “will be consulting with state and local officials to gauge public-health steps needed to bring the virus under control,” Evan Halper and Noam Levey reported in the Los Angeles Times. “The board will also focus on racial and ethnic disparities in how, where, and how quickly the virus is spreading.”

Innovative Plan: Tell the Truth

The Biden-Harris plan sets a new tone for the nation’s coronavirus response, using federal powers and leadership to centralize the acquisition and distribution of personal protective equipment (PPE), along with the coordination of testing and contact tracing, instead of leaving those vital resources to be led in 50 different ways by state governors. It emphasizes evidence-based guidance and empowers public health officials and scientists to guide and revise the nation’s reopening strategy as the pandemic evolves.

You’ll immediately see a change of tone, a change in communication,” Ezekiel Emanuel, MD, PhD, the vice provost for global initiatives at the University of Pennsylvania, told Politico. “This is the stuff of real leadership: telling the truth, modeling the right behaviors like wearing a mask, only having small crowds, putting the scientists out there.”

The first priority in the plan is to ensure that all Americans have access to regular, reliable, and free coronavirus testing. Rapid testing is vital for identifying, isolating, and treating new cases of COVID-19, but the US has been crippled by continuing test shortages and long lag times before results are reported. Biden plans to double the number of drive-through testing sites while scaling up next-generation solutions like home tests.

Contact tracing goes hand-in-hand with testing in the public health response to COVID-19, and the plan would establish a US Public Health Job Corps to train and mobilize 100,000 Americans to perform culturally competent contact tracing in communities most affected by COVID-19.

The second priority is to fix the nation’s PPE problems. N95 masks, gloves, gowns, and other PPE used by health care staff are still in short supply. AARP reported that one in four nursing homes ran short of PPE between August 24 and September 20. (Nursing homes continue to be a hot spot for coronavirus transmission.) Biden would use the Defense Production Act to increase production of PPE and distribute the supply to states instead of leaving states to fend for themselves.

For the third priority, Biden would tap the nation’s wealth of science experts to provide clear public guidance on how communities should navigate the pandemic. The US Centers for Disease Control and Prevention (CDC) would lead this effort, with an emphasis on helping communities determine when it is safe to reopen schools and various types of businesses.

Navigating Hurdles to Safe, Effective, Accepted Vaccine

Although the pharmaceutical company Pfizer announced on November 9 that its coronavirus vaccine trial showed positive early results, the road to vaccinating all Americans is tortuous. Pfizer still needs to seek emergency use authorization from the Food and Drug Administration (FDA) and ramp up vaccine production to meet the global need. In the meantime, Biden plans to invest $25 billion in a vaccine manufacturing and distribution plan that ensures every American can get vaccinated for free. This fourth priority would make the vaccine accessible to all people and communities regardless of income or any other factor.

The fifth priority is to protect Americans who are at high risk of getting seriously ill or dying from COVID-19. This includes people over 65, nursing home residents, and people living in neighborhoods with higher rates of COVID-19. Biden would establish a COVID-19 Racial and Ethnic Disparities Task Force (PDF) to report on disparities in COVID-19 infection, hospitalization, and death rates, as well as to provide recommendations to Congress and the Federal Emergency Management Agency on how best to distribute resources and relief funds to combat these disparities. The plan also calls for strengthening the Affordable Care Act to ensure that during the pandemic, Americans have health insurance coverage.

During the presidential campaign, Biden called for a national mask mandate based on the growing body of evidence that mask-wearing can considerably reduce the transmission of respiratory viruses like the one that causes COVID-19. Biden plans to coordinate with governors and mayors to convince Americans to wear a mask when they are around people outside their household. Currently, 34 states and the District of Columbia mandate face masks in public, but there is no nationwide requirement.

Finally, the plan takes the long view on pandemic threats by rebuilding and reinvesting in defenses that will help the world predict and prevent future pandemics. The Biden administration has declared that the US will rejoin the World Health Organization, restore the White House National Security Council Directorate for Global Health Security and Biodefense, which was eliminated by the Trump administration in 2018, and shore up CDC’s global corps of disease detectives.

Public Health Experts at the Helm

The newly announced COVID-19 Advisory Council is a who’s who of public health experts, former government officials, and doctors, including several from California. The panel currently comprises 13 members, but Biden has said it may be expanded.

The three cochairs of the advisory board are former surgeon general Vivek Murthy, MD; former FDA commissioner David Kessler, MD, a UCSF professor of pediatrics, and of epidemiology and biostatistics; and Marcella Nunez-Smith, MD, MPH, an associate professor of internal medicine, public health, and management at Yale University whose research focuses on health disparities.

The other members appointed so far include:

  • Luciana Borio, MD, vice president at the venture capital firm In-Q-It. Borio served in multiple leadership roles in the Trump and Obama administrations in the National Security Council and FDA.
  • Rick Bright, PhD, director of the Biomedical Advanced Research and Development Authority under Trump and Obama. Bright resigned from the government in October after being removed from his vaccine development role by President Trump.
  • Ezekiel Emanuel, MD, PhD, the vice provost for global initiatives at the University of Pennsylvania. Emanuel served in the Obama administration as special advisor for health policy to Peter Orszag, PhD, the former director of the Office of Management and Budget.
  • Atul Gawande, MD, MPH, a professor at Harvard Medical School and the Harvard T.H. Chan School of Public Health. Gawande is a staff writer covering health and medicine at the New Yorker and served in the Clinton administration as senior adviser in the Department of Health and Human Services.
  • Eric Goosby, MD, a professor of medicine at UCSF. Goosby, an expert on HIV/AIDS, led policy work in this field under Clinton and Obama.
  • Celine Gounder, MD, a clinical assistant professor of internal medicine and infectious diseases at New York University.
  • Julie Morita, MD, executive vice president of the Robert Wood Johnson Foundation and former commissioner of the Chicago Department of Public Health.
  • Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
  • Loyce Pace, MPH, president and executive director of the Global Health Council.
  • Robert Rodriguez, MD, a professor of emergency medicine at UCSF.

What do Pfizer’s and Moderna’s COVID-19 vaccine announcements mean for you?

https://www.politifact.com/article/2020/nov/12/what-does-pfizers-covid-19-announcement-mean-you/

COVID vaccine: What the second shot in the Moderna trial was like

IF YOUR TIME IS SHORT

  • If all goes according to plan, health care workers and individuals at high risk for severe illness from COVID-19 could be vaccinated as early as December.
  • Experts predict that the broader public could start being vaccinated in April.
  • The distribution of the vaccine could present some challenges for state and federal governments. That or any other unexpected events could delay the vaccine’s distribution.

When drugmaker Pfizer announced that its new vaccine was highly effective at preventing COVID-19, it raised hopes that the coronavirus pandemic could be nearing its end. 

In a Nov. 9 press release, the company and its partner BioNTech claimed that an early analysis of clinical trial data found that inoculated individuals experienced 90% fewer cases of symptomatic COVID-19 than those who had received a placebo. 

These results surpassed expectations. For months, experts have warned that a new vaccine might only be 60% effective. If Pfizer’s analysis is accurate — and it has yet to produce official scientific documentation —  the new vaccine would offer a level of protection equal to that of highly effective vaccines for diseases such as measles

Experts told us that Pfizer’s announcement is cause for optimism. However, the country, and the world, still have a way to go before coronavirus vaccines become available to ordinary Americans. 

Here’s what we know about when the vaccine might be distributed and what that process could look like. What’s next for Pfizer’s vaccine?

If the information in the press release is accurate, Pfizer will likely be the first company to come up with a vaccine that meets the Food and Drug Administration’s requirements for distribution. 

To get approval from the FDA, Pfizer has to gather two months of safety data on clinical trial participants to gauge whether the treatment has any negative side effects. The company will reach the two-month benchmark in the third week of November. Barring any unexpected developments, it will then submit its vaccine to the FDA for emergency use authorization, a special provision allowing the use of an unapproved product during a state of emergency.  

After Pfizer submits its data to the FDA, the agency will analyze it to see if it’s sufficient to begin distribution. After approval from the FDA, the vaccine would be assessed by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The Advisory Committee will then issue a recommendation to the CDC, which will make the final ruling about whether to distribute the vaccine.  

This might sound intricate, but James Blumenstock, the chief program officer for health security at the Association of State and Territorial Health Officials, said that the vaccine could probably be approved by the FDA and the CDC in a matter of days rather than weeks. 

“Both agencies are standing ready and will give these requests and this assessment the highest level of priority just for expediency’s sake,” he said. 

What this means is that high-priority Americans, such as health care workers, could be vaccinated as early as December. What a vaccine rollout might look like.

Pfizer predicts that it will be able to manufacture only 50 million doses for global consumption by the end of the year, enough to vaccinate 25 million people. (The world’s population is about 7.8 billion.)

With a limited number of doses available, the eventual rollout of a vaccine would likely consist of two phases. During the first phase, U.S. health care workers, emergency responders and individuals at higher risk of severe illness would be eligible for vaccination. If all goes according to plan, the first phase will commence sometime in December. 

During the second phase, the vaccine would become available to the broader public. Most experts told us that they expect the second phase to start sometime in April, although the date would vary depending on Pfizer’s vaccine production rates and whether other companies get their vaccines greenlit by the FDA and CDC. The state of other vaccines

As of early July, there were roughly 160 vaccine projects under way worldwide, according to the World Health Organization

Pfizer’s announcement bodes well for other vaccine candidates, said Matthew B. Laurens, an associate professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. 

Pfizer’s vaccine uses genetic material, known as mRNA, that provides the instructions for a body to produce coronavirus proteins, known as antigens, in the hope that these could prime the human immune system to fight the virus. The biotechnology company Moderna is also manufacturing a vaccine that uses mRNA and is set to receive trial data by the end of November. 

Other companies in the United States and Europe producing a vaccine include Novavax, which plans to start clinical trials in the U.S. and Mexico by the end of November; Johnson & Johnson, which recently resumed testing its vaccine candidate after a brief pause; and AstraZeneca, which expects to have clinical trial data by the end of the year. 

The more companies there are that are able to produce a vaccine, the quicker the vaccine will become widely available, experts say.

Vaccine presents potential distribution hurdles

The CDC will be in charge of the distribution process, with involvement from the U.S. Defense Department, said Dr. Litjen Tan, chief strategy officer for the Immunization Action Coalition, which distributes information about vaccines to try to increase vaccination rates. 

Vaccines would be manufactured and then transported to states, which will then pass the vaccine on to providers, such as hospitals. The McKesson Corp., which has received a federal contract to distribute the treatment, will assist pharmaceutical companies and the government with the shipping process. 

Shipping the doses will present some challenges. Pfizer’s vaccine has complex and ultra-cold storage requirements that many hospitals, particularly those in hard-to-reach areas, won’t be able to meet. 

The cold chain requirement “is an issue for Pfizer, but manufacturing and distribution are issues for all vaccines,” said Robert Finberg, a physician and infectious disease specialist at the University of Massachusetts Medical Center.

To surmount this hurdle, Pfizer plans to transport the vaccine in thermal shippers that can keep the vaccine at the necessary temperature of minus 70 degrees Celsius for about two weeks. However, the shippers themselves present additional problems for distribution, Tan said. Each shipment consists of five trays containing 975 doses of vaccine, and reducing the size of the shipment could dramatically raise the cost of distribution. 

As a result, the states might initially prioritize shipping the vaccine to major hospitals rather than rural hospitals that service fewer patients in order to avoid waste. 

Blumenstock told us that state and federal governments are working hard to make sure that all regions of the U.S. receive proportionate amounts of vaccine. However, he acknowledged that hospitals in remote areas that don’t service many patients could initially take longer to get the vaccine than a well-trafficked hospital in a heavily populated area.

“Outskirt hospitals won’t be ignored or marginalized, even if it takes more time and effort to get them the vaccine,” he said. “One of the primary principles will be equitable distribution, even when that means you need to take extraordinary measures for logistics, transportation, and handling.” 

Overall, experts said that Pfizer’s announcement is a significant step forward. “I’m optimistic that we have a vaccine that’s safe and effective,” said Tan. “And I’m glad that what we’re dealing with now is the problem of how to get it to the public.”

Moderna’s coronavirus vaccine found to be nearly 95 percent effective in a preliminary analysis

Moderna says its COVID-19 vaccine is 94.5 percent effective | US & Canada |  Al Jazeera

Biotechnology firm Moderna announced Monday that a preliminary analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases — a striking initial result that leaves the United States with the prospect that two coronavirus vaccines could be available on a limited basis by the end of the year.

The news comes a week after pharmaceutical giant Pfizer and its German partner BioNTech lifted the stock market and people’s hopes with the news that their coronavirus vaccine was more than 90 percent effective. The announcement sent stocks up again, with the Dow Jones industrial average and S&P 500 up about 1 percent in midmorning trading. Moderna’s share price rose more than 6 percent.

At a briefing Monday, government officials predicted that if the two vaccines receive a regulatory greenlight, the first shots could be given in December, with enough to vaccinate 20 million people that month — and more becoming available into 2021 as production ramps up and other vaccine candidates may be successful.

“It’s extremely good news. If you look at the data, the numbers speak for themselves,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, who was one of three people briefed on the data by an independent committee Sunday morning. “I describe myself as a realist, but I’m fundamentally a cautious optimist. I felt we’d likely get something less than this. … I said certainly a 90-plus-percent effective vaccine is possible, but I wasn’t counting on it.”

Moderna’s vaccine, co-developed with Fauci’s institute, is being tested in 30,000 people. Half received two doses of the vaccine, and half received a placebo. To test how well the vaccine works, physicians closely monitored cases of covid-19 to see whether they predominantly occurred in people who received the placebo.

Of the 95 cases of covid-19, the disease caused by the virus, 90 were in the group that received the placebo. There were 11 severe cases reported — all in people who received the placebo. With cases of covid-19 confined almost exclusively to trial participants receiving a placebo, that sends a strong signal that the vaccine is effective at thwarting the virus.

The data have not yet been published or peer reviewed, and the overall effectiveness of the vaccine may change as the study continues. But Fauci said the data on severe cases was “quite impressive” and effectively answers a question that has lingered: whether a vaccine measured by its success in preventing any case of covid-19 can prevent the most urgent cases, too.

An independent data committee, convened by the National Institutes of Health, analyzed the results Sunday morning. Stéphane Bancel, chief executive of Moderna, said in an interview that he spent the morning trying to distract himself from wondering about the results by working at his home in Boston, but instead he found himself constantly checking his phone and email. When he learned the results later in the morning, the evidence that the vaccine prevented severe disease stood out as most consequential.

“In this pandemic, what has been awful from a public health standpoint, an economic standpoint, is the worry people have to get so sick they have to go to the hospital — so sick they have to get to the ICU and have a high risk of dying,” Bancel said. “If a [vaccine] could prevent 95 percent of people to not get disease, but to not get severe disease, that would be a game-changer: the impact on hospitals, the impact on people’s psyche and the impact on deaths.”

Many questions about details remain. How long will the protection last? Will results be similar across all subgroups? Does the vaccine decrease the infectiousness of the virus in people without symptoms?

But the early successes show the power and speed of a new vaccine technology never before used in an approved medical product that delivers a strip of genetic material called messenger RNA to teach the body to defend against the virus. The messenger RNA carries the blueprint for the distinctive spike protein that dots the outside of the coronavirus, instructions that the body’s cells follow to build the spike protein.

“It is extremely encouraging,” said Stanley Plotkin, inventor of the rubella vaccine. “This and the earlier result shows that the platform really works, and this bodes very well for other diseases, where this platform could be used — and considering the speed with which the platform was put into operation. It’s an excellent result.”

Moderna has committed to completing its trial before applying for emergency-use authorization — which means waiting until there are 151 cases of covid-19 in the study. A previous projection showed that the trial might end sometime early next year, but it is instead expected to reach its endpoint in seven to 10 days, Bancel said, because of surging coronavirus cases in the United States. The explosion of virus cases translates into an expedited ability to ascertain whether a vaccine works.

The company will have enough safety data to support an application shortly before Thanksgiving. Bancel anticipates a vaccine might begin to become available to those at high risk in the second half of December.

Unlike Pfizer, which invested $2 billion of its own money in researching and developing a vaccine, Moderna is part of Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing upfront funding to companies and helping coordinate the trials. Moderna received nearly $1 billion from the U.S. government to support research and development. The companies both have contracts to sell 100 million doses to the U.S. government.

Moderna projects it can produce 20 million doses by the end of the year — enough for 10 million people to get both shots. The company aims to produce at least 500 million doses next year, with the possibility of scaling up to 1 billion doses depending on the availability of raw materials.

The side effects of the two-dose vaccine were mostly mild or moderate, including pain at the injection site, fatigue, headache and muscle pain, according to the company’s news release.

Regulators at the Food and Drug Administration must review the evidence for the Moderna and Pfizer vaccines, but the robust early indication of success suggests both vaccines might become available to high-risk populations before the end of this year.

Fauci predicted that people such as health-care workers or people with conditions that raise their risk of developing severe disease could begin receiving doses before the end of the year. It could take about four months to vaccinate people in high-risk groups, and in April, the vaccine could expand to the rest of the population.

The two successes could have ripple effects that influence the ongoing trials and in future coronavirus vaccine trials. People currently in the Moderna and Pfizer trials do not know whether they received the real vaccine or placebo, and at some point, those who received a placebo may be crossed over to receive the real thing. But the decision to do that will mean a loss of follow-up and valuable data.

“Given these products will be given to potentially billions of people, you have to be careful to make sure they’re safe and effective, and there’s no easy way around that issue,” said Ira Longini, a biostatistics expert at the University of Florida, who said a year of follow-up on participants would be ideal.

The focus on vaccines will now shift to the daunting logistics of manufacturing and distribution.

The Pfizer vaccine requires ultracold storage conditions — minus 70 degrees Celsius — not widely available in typical vaccination settings. The company has been working to overcome that limitation.

Moderna announced Monday that its vaccine can be stable at refrigerator temperatures for a month and frozen for up to six months. It will not require dilution at the point of care, unlike the Pfizer vaccine.

Cartoon – State of the Union on Covid

Hands on Wisconsin: Listen to doctors about COVID-19, not politicians |  Opinion | Cartoon | madison.com

Biden’s 7 point plan for the pandemic

https://www.beckershospitalreview.com/hospital-management-administration/biden-s-plan-for-the-pandemic-7-things-to-know.html?utm_medium=email

Trump's And Biden's Coronavirus Plans: Vaccines, Testing : NPR

President-elect Joe Biden and Vice President-elect Kamala Harris have released a seven-point plan regarding the COVID-19 pandemic.

The Biden administration’s seven pandemic plans:

1. Ensure all Americans have access to regular, reliable and free testing by doubling the number of drive-thru testing sites, investing in next-generation testing, developing a pandemic testing board to produce and distribute tests, and establishing a U.S. Public Health Jobs Corps.

2. Provide all states, cities, tribes and territories with critical supplies. Efforts will include full use of the Defense Production Act, building American-sourced and manufactured capabilities. 

3. Provide clear, consistent and evidence-based guidance for how communities should navigate the pandemic. Planned resources will be tailored to the needs of schools, small businesses and families.

4. Plan for effective and equitable distribution of treatments and vaccines. The administration intends to invest in a $25 billion manufacturing and distribution plan to guarantee every American can receive the vaccine for free. The administration also said it will work to ensure that politics won’t play a role in determining the safety and efficacy of vaccines.   

5. Protect older Americans and other high-risk groups. Efforts will include establishing a COVID-19 racial and ethnic disparities task force and a nationwide pandemic dashboard that can be checked in real-time to gauge local transmission.

6. Rebuild and expand defenses to prevent and mitigate pandemic threats, including the restoration of the White House National Security Council Directorate for Global Health Security and Biodefense and the nation’s membership with the World Health Organization.

7. Implement nationwide mask mandates.

What healthcare executives can expect under Biden presidency

https://www.beckershospitalreview.com/hospital-management-administration/pwc-what-healthcare-executives-can-expect-under-biden-presidency.html?utm_medium=email

https://www.pwc.com/us/Biden2020healthagenda

President-elect Joe Biden’s healthcare agenda: building on the ACA, value-based care, and bringing down drug prices.

In many ways, Joe Biden is promising a return to the Obama administration’s approach to healthcare:

  • Building on the Affordable Care Act (ACA) through incremental expansions in government-subsidized coverage
  • Continuing CMS’ progress toward value-based care
  • Bringing down drug prices
  • Supporting modernization of the FDA

Bolder ideas, such as developing a public option, resolving “surprise billing,” allowing for negotiation of drug prices by Medicare, handing power to a third party to help set prices for some life sciences products, and raising the corporate tax rate, could be more challenging to achieve without overwhelming majorities in both the House and the Senate.

Biden is likely to mount an intensified federal response to the COVID-19 pandemic, enlisting the Defense Production Act to compel companies to produce large quantities of tests and personal protective equipment as well as supporting ongoing deregulation around telehealth. The Biden administration also will likely return to global partnerships and groups such as the World Health Organization, especially in the area of vaccine development, production and distribution.

What can health industry executives expect from Biden’s healthcare proposals?

Broadly, healthcare executives can expect an administration with an expansionary agenda, looking to patch gaps in coverage for Americans, scrutinize proposed healthcare mergers and acquisitions more aggressively and use more of the government’s power to address the pandemic. Executives also can expect, in the event the ACA is struck down, moves by the Biden administration and Democratic lawmakers to develop a replacement. Healthcare executives should scenario plan for this unlikely yet potentially highly disruptive event, and plan for an administration marked by more certainty and continuity with the Obama years.

All healthcare organizations should prepare for the possibility that millions more Americans could gain insurance under Biden. His proposals, if enacted, would mean coverage for 97% of Americans, according to his campaign website. This could mean millions of new ACA customers for payers selling plans on the exchanges, millions of new Medicaid beneficiaries for managed care organizations, millions of newly insured patients for providers, and millions of covered customers for pharmaceutical and life sciences companies. The surge in insured consumers could mirror the swift uptake in the years following the passage of the ACA.

Biden’s plan to address the COVID-19 pandemic

Biden is expected to draw on his experience from H1N1 and the Ebola outbreaks to address the COVID-19 pandemic with a more active role for the federal government, which many Americans support. These actions could shore up the nation’s response in which the federal government largely served in a support role to local, state and private efforts.

Three notable exceptions have been the substantial federal funding for development of vaccines against the SARS-CoV-2 virus, Congress’ aid packages and the rapid deregulatory actions taken by the FDA and CMS to clear a path for medical products to be enlisted for the pandemic and for providers, in particular, to be able to respond to it.

Implications of Biden’s 2020 health agenda on healthcare payers, providers and pharmaceutical and life sciences companies

The US health system has been slowly transforming for years into a New Health Economy that is more consumer-oriented, digital, virtual, open to new players from outside the industry and focused on wellness and prevention.  The COVID-19 pandemic has accelerated some of those trends.  Once the dust from the election settles, companies that have invested in capabilities for growth and are moving forcefully toward the New Health Economy stand to gain disproportionately.

Shortages of clinicians and foreign medical students may continue to be an issue for a while

The Trump administration made limiting the flow of immigrants to the US a priority. The associated policy changes have the potential to exacerbate shortages of physicians, nurses and other healthcare workers, including medical students. These consequences have been aggravated by the pandemic, which dramatically curtailed travel into the US.

  • Healthcare organizations, especially rural ones heavily dependent on foreign-born employees, may find themselves competing fiercely for workers, paying higher salaries and having to rethink the structure of their workforces.
  • Providers should consider reengineering primary care teams to reflect the patients’ health status and preferences, along with the realities of the workforce on the ground and new opportunities in remote care.

Focus on modernizing the supply chain

Biden and lawmakers from both parties have been raising questions about life sciences’ supply chains. This focus has only intensified because of the pandemic and resulting shortages of personal protective equipment (PPE), pharmaceuticals, diagnostic tests and other medical products.

  • Investment in advanced analytics and cybersecurity could allow manufacturers to avoid disruptive stockouts and shortages, and deliver on the promise of the right treatment to the right patient at the right time in the right place.

Drug pricing needs a long-term strategy

Presidents and lawmakers have been talking about drug prices for decades; few truly meaningful actions have been implemented. Biden has made drug pricing reform a priority.

  • Drug manufacturers may need to start looking past the next quarter to create a new pricing strategy that maximizes access in local markets through the use of data and analytics to engage in more value-based pricing arrangements.
  • New financing models may help patients get access to drugs, such as subscription models that provide unlimited access to a therapy at a flat rate.
  • Companies that prepare now to establish performance metrics and data analytics tools to track patient outcomes will be well prepared to offer payers more sustainable payment models, such as mortgage or payment over time contracts, avoiding the sticker shock that comes with these treatments and improving uptake at launch.
  • Pharmaceutical and life sciences companies will likely have to continue to offer tools for consumers like co-pay calculators and use the contracting process where possible to minimize out-of-pocket costs, which can improve adherence rates and health outcomes.

View interoperability as an opportunity to embrace, not a threat to avoid or ignore

While the pandemic delayed many of the federal interoperability rule deadlines, payers and providers should use the extra time to plan strategically for an interoperable future.

  • Payers should review business partnerships in this new regulatory environment.
  • Digital health companies and new entrants may help organizations take advantage of the opportunities that achieving interoperability may present.
  • Companies should consider the legal risks and take steps to protect their reputations and relationships with customers by thinking through issues of consent and data privacy.

Health organizations should review their policies and consider whether they offer protections for customers under the new processes and what data security risks may emerge. They should also consider whether business associate agreements are due in more situations.

Plan for revitalized ACA exchanges and a booming Medicare Advantage market

The pandemic has thrown millions out of work, generating many new customers for ACA plans just as the incoming Biden administration plans to enrich subsidies, making more generous plans within reach of more Americans.

  • Payers in this market should consider how and where to expand their membership and appeal to those newly eligible for Medicare. Payers not in this market should consider partnerships or acquisitions as a quick way to enter the market, with the creation of a new Medicare Advantage plan as a slower but possibly less capital-intensive entry into this market.
  • Payers and health systems should use this opportunity to design more tailored plan options and consumer experiences to enhance margins and improve health outcomes.
  • Payers with cash from deferred care and low utilization due to the pandemic could turn to vertical integration with providers as a means of investing that cash in a manner that helps struggling providers in the short term while positioning payers to improve care and reduce its cost in the long term.
  • Under the Trump administration, the FDA has approved historic numbers of generic drugs, with the aim of making more affordable pharmaceuticals available to consumers. Despite increased FDA generics approvals, generics dispensed remain high but flat, according to HRI analysis of FDA data.
  • Pharmaceutical company stocks, on average, have climbed under the Trump administration, with a few notable dips due to presidential speeches criticizing the industry and the pandemic.
  • Providers have faced some revenue cuts, particularly in the 340B program, and many entered the pandemic in a relatively weak liquidity position.  The pandemic has led to layoffs, pay cuts and even closures. HRI expects consolidation as the pandemic continues to curb the flow of patients seeking care in emergency departments, orthopedic surgeons’ offices, dermatology suites and more.

Lawmakers and politicians often use bold language, and propose bold solutions to problems, but the government and the industry itself resists sudden, dramatic change, even in the face of sudden, dramatic events such as a global pandemic. One notable exception to this would be a decision by the US Supreme Court to strike down the ACA, an event that would generate a great deal of uncertainty and disruption for Americans, the US health industry and employers.

2021 Healthcare Reform

Healthcare Reform in the US Should Be Left to a Panel of Healthcare MBAs -  The Leader Newspaper

After an exhausting and contentious election campaign, and a vote count that was prolonged by enormous voter turnout and record-breaking use of early and mail-in voting, the major news networks have now made their calls. Joseph R. Biden, Jr. will be the 46th President of the United States, and Kamala D. Harris will be the first woman, and first person of color, to become Vice President. Securing an electoral victory by achieving razor-thin victories in a number of battleground states, President-elect Biden received the largest number of votes of any candidate in American history. Although the Trump campaign vowed to pursue legal challenges to the validity of the election, Biden’s win appeared to be secure.

The election results came in the midst of a dramatic acceleration of the coronavirus pandemic. Over the last week, the average number of new cases per day in the US surpassed 96,000, up 54 percent from just two weeks earlier. On Friday the nation recorded a pandemic-high 132,700 new cases, along with at least 1,220 COVID deaths. Hospitalizations were up in most states, hospital bed and workforce capacity are strained, and public health experts warned that the coming weeks and months will bring even worse news. Unsurprisingly, the pandemic was a top issue on the minds of votersAccording to exit polls, however, the electorate was deeply divided on the issue: 82 percent of Biden voters cited the pandemic itself as one of the most important issues in determining their vote, with only 14 percent of Trump voters agreeing. Conversely, 82 percent of Trump voters said the economy was the most important issue on their minds, as opposed to Biden voters, only 17 percent of whom listed the economy as their top issue. Based on that data, it appears that at least one important split among the electorate was “lives” versus “livelihoods”—whether the pandemic response, or its impact on the economy, was of greatest concern.

In the coming weeks, attention is likely to turn in earnest to addressing both aspects of the issue during the lame duck period. Senate Majority Leader Mitch McConnell (R-KY) has signaled that he intends to resume negotiations on a stimulus package with Democrats in the House, whose majority was diminished in the election. At this writing, it appears likely that control of the Senate will come down to the results of two runoff elections in Georgia, and McConnell will undoubtedly want to make the case that Senate Republicans have taken decisive action to bolster the economic recovery. It’s also possible that, as part of the Trump administration’s Operation Warp Speed, a coronavirus vaccine will be granted approval by the end of the year. Health officials at both federal and state levels must continue to work closely together to tackle the complex logistics of distributing and administering the vaccine, and it will be critical for the incoming administration to seek ways to collaborate with the Trump team to ensure a smooth transition of this vital work.

The outcome of the Senate runoffs in Georgia will determine whether the Biden administration must work with divided Congress, or an evenly split Senate in which Vice President-elect Kamala Harris casts the deciding vote. In either case, given the political realities underscored by the electoral result, it’s very unlikely than any of the more sweeping proposals in the Biden campaign platform—lowering the eligibility age for Medicare, establishing a government-run “public option” insurance plan, extending premium subsidies to middle-income workers—will advance very far. Rather, as we’ve discussed before, we’d expect a Biden administration’s first actions to focus on an enhanced federal response to managing the pandemic, including issuing a national mask mandate, enhancing efforts to augment and coordinate personal protective equipment (PPE) supply, and rejoining the World Health Organization.

As we look to the next two years, most healthcare policy changes are likely to come in the form of regulatory reform, such as reversing waivers for Medicaid programs to establish work requirements and withdrawing flexibility for short-term plans that fail to comply with the Affordable Care Act (ACA). Other Trump-era regulatory changes might continue. There’s broad bipartisan support for efforts to make value-based Medicare payment reforms more successful, to increase price transparency, and to address the issues of surprise billing and the cost of prescription drugs. But even in if Democrats beat the odds and win back control of the Senate, we believe the Biden administration will have other legislative priorities that will supersede any attempt to dramatically overhaul healthcare coverage—voting reforms, climate change legislation, immigration reform, and long-overdue infrastructure investments.

Unless, that is, the Supreme Court throws a spanner in the works by overturning the ACA. Should the Court rule that the individual mandate is not severable from the rest of the law, and that the entire ACA is unconstitutional, the new administration would be forced to take quick action to protect coverage and insurance protections for millions of Americans. In that event, healthcare would rocket to the top of the agenda. Either the Biden team would be forced to find a compromise solution that could pass a divided Congress, or (if Harris is the tie-breaking vote) find a way to use the budget reconciliation process to address coverage. That potential drama lies months in the future, as we won’t know the outcome of the case until next spring. We’ll monitor the oral arguments in the ACA case closely, and let you know what we hear, and what we think it means for the future of the case.

In the coming weeks, we’ll be watching for answers to some of the big healthcare questions that lie ahead: How will the Trump administration handle the worsening pandemic situation in the 75 days between now and Inauguration Day? Will any new stimulus package include additional economic relief for healthcare providers? When and how will a COVID vaccine become widely available? And perhaps most importantly, what toll will the “third wave” of the pandemic take on a nation already exhausted by a difficult year, and a bitter political fight? Surely one reason to be optimistic is that, having turned out to vote in the largest numbers in a century, Americans are more engaged than ever in finding a way forward amid the problems that confront us. Let’s hope our political leaders from across the ideological spectrum will rise to the occasion, and meet this difficult moment with positive, constructive solutions.