California To Receive 327,000 Doses Of Pfizer Coronavirus Vaccine In December

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Source: San Francisco Chronicle, by Catherine Ho

California will receive 327,000 doses of the first coronavirus vaccine in mid-December, Gov. Gavin Newsom said during a news briefing Monday.

It will be the state’s first tranche of coronavirus vaccines, developed by Pfizer and the German firm BioNTech. Pfizer applied for Food and Drug Administration authorization last month and is widely expected to receive approval in December.

The 327,000 doses will go to health care workers, but the state’s vaccine committee is still determining which health care workers will go first, Newsom said. There are about 2.4 million health care workers in California, so the first round of vaccine distribution will not provide enough doses for all of them.

Details about which health care workers will get priority for the first doses will be announced this week, he said.

If the state hews closely to recommendations from the influential National Academies of Sciences, Engineering and Medicine, it will be health care workers at hospitals, nursing homes and in-home care, and first responders. The state’s Community Vaccine Advisory Committee met Monday and decided to recommend that the first phase of vaccine distribution go to health care workers and residents of long-term care facilities.

The Pfizer vaccine is administered in two doses, given 21 days apart. The first 327,000 doses will go to 327,000 health care workers for their first round of injections. The state is slated to receive additional vaccines for the second injection soon after that. It’s unclear how long immunity from the vaccines may last, and whether people would have to get inoculated once or routinely.

Most Americans will probably not be able to get vaccinated until 2021 because there will be very limited numbers of doses at first, and they will be allocated based on order of priority. After health care workers, the next groups likely will be residents of skilled-nursing facilities and essential workers, such as people who work in agriculture, utilities and transportation.

The general population will be able to walk into a CVS or Walgreens and get vaccinated by April or May, Dr. Anthony Fauci predicted in a conversation with Facebook founder Mark Zuckerberg on Monday. Vaccines are also expected then to be available at doctors’ offices and clinics.

“The challenge is going to be to convince people to get vaccinated,” the nation’s top infectious disease expert said, adding that if 75% to 85% of the population gets vaccinated by the end of the second quarter of 2021, the U.S. will effectively suppress the pandemic. “If you want to be part of the solution, get vaccinated. Say, ‘I’m not going to be part of the stepping-stone of getting the virus to other people. I’m going to be a dead end to the virus.’”

So far, only two vaccine developers, Pfizer and Moderna, have applied for, or expressed intentions to apply for, FDA authorization. An FDA committee plans to meet Dec. 10 to discuss Pfizer’s application and Dec. 17 to discuss Moderna’s.

Operation Warp Speed officials have said doses of the Pfizer vaccine will begin shipping within 24 hours of receiving FDA authorization.

The distribution of the Pfizer vaccine is expected to be more complicated than other vaccines because it must be kept at minus-94 degrees Fahrenheit since it contains fragile genetic material. In preparation, many hospitals and state health departments have bought special ultra-low-temperature freezers to store and transport the Pfizer vaccines. And Pfizer has designed shipping units with dry ice that can keep the vaccines very cold.

One Seat, Competing Pressures as Newsom Considers Senate Pick

Alex Padilla, right, California’s secretary of state, is considered the front-runner as Gov. Gavin Newsom, left, ponders contenders to replace Vice President-elect Kamala Harris in the Senate.

Source: The New York Times, by Shawn Hubler and Alexander Burns

Since Gavin Newsom’s days as a young upstart running for mayor of San Francisco through more than two decades of public life, Alex Padilla has been a stalwart ally.

As president of the Los Angeles City Council, Mr. Padilla introduced Mr. Newsom to important local labor and Latino leaders. As a state senator, Mr. Padilla chaired Mr. Newsom’s short-lived first campaign for governor. And as California secretary of state, Mr. Padilla conferred a key early endorsement that helped Mr. Newsom win the governor’s seat in 2018.

Now Mr. Newsom is in a position to return the favor: He must appoint someone to fill the soon-to-be-vacant U.S. Senate seat of Vice President-elect Kamala Harris. Though many names have been floated to succeed Ms. Harris, Mr. Padilla has emerged as the front-runner, according to more than a half-dozen advisers, political consultants and fellow lawmakers familiar with the governor’s thinking.

Yet nearly a month after Ms. Harris’s election, Mr. Newsom has not yet named a successor — and the pressure is mounting.

“Look, all roads lead to Alex Padilla,” said Nathalie Rayes, president of the Latino Victory Fund, which has waged a “Pick Padilla” campaign since August. “I think the longer he waits — well, I would have done this a long time ago, but I’m not the governor of California.”

Since President-elect Joseph R. Biden Jr. chose Ms. Harris as his running mate in August, the question of her successor has been a matter of high-stakes speculation. Mr. Newsom faces extraordinary crosscurrents of factional rivalry and identity politics in a state where the Democratic Party is thoroughly defined by both.

He has spoken about the Senate appointment not as a political bauble that he is eager to dispense, but as a burdensome task that is likelier to generate grudges than personal gratitude and popular excitement. That sense of looming peril has only deepened in recent days, following news that Mr. Newsom breached his own administration’s public-health guidance to attend an extravagant birthday gathering at the French Laundry restaurant for a longtime political adviser.

Critics have seized on the faux pas, adding to the challenges Mr. Newsom already has as his state grapples with a terrifying surge of Covid-19, ongoing problems in its unemployment benefits system and an imminent loss of the federal stimulus funds that underwrote temporary shelter for tens of thousands of homeless people during the pandemic.

Asked last week about the Senate appointment, Mr. Newsom sidestepped.

“That determination has not yet been made,” he said, speaking from his home, where he was in quarantine after three of his four children were revealed to have been in contact with a California Highway Patrol officer who later tested positive for Covid-19.

He said he hadn’t laid out a timeline for the decision, beyond that it must be made before Jan. 20, when Ms. Harris is sworn in as vice president. But, he added, “progress has been made.”

The uncertainty has made room for lobbying by an array of aspirants and their political proxies. During some weeks it has seemed that the list of candidates for the post has continued to grow rather than narrowing toward an eventual selection.

Democratic leaders have sought to tug Mr. Newsom in different directions, playing on what they see as his short- and long-term political aspirations. Some argue that he must appoint a Black candidate if he hopes to prevail someday in a Democratic presidential primary, others that he must name a Latino to win a comfortable re-election in 2022, still others that Ms. Harris must be replaced by another woman or that he must placate progressives if he wants to govern successfully in an ongoing fiscal crunch.

This is in addition to the hard fundamentals of campaigning statewide in California, which both the governor and Senator Harris’s successor will have to do in 2022, when their terms end. California, the most populous state, has myriad subcultures — north and south, coastal and inland — and primary campaigns alone can cost millions of dollars.

Though Republicans are less than a quarter of registered voters in the state, another third or so of the electorate has no party preference and turnout drops in off-year elections. Whomever Mr. Newsom appoints will need not only experience but the cash, the campaign operation and the charisma to turn out Democrats from the Mexican border to the Oregon state line.

Mr. Newsom has held conversations with a few potential appointees, though he does not appear to have conducted formal interviews for the job, people familiar with the process said.

Mr. Padilla, 47, has emerged as the favorite of Latino lawmakers, advocacy groups and a number of labor officials, and his circle of political advisers overlaps significantly with Mr. Newsom’s. The middle son of Mexican-born parents — a short-order cook from Jalisco and a housekeeper from Chihuahua — Mr. Padilla worked his way through the Massachusetts Institute of Technology, earning a degree in 1994 in mechanical engineering.

He and his siblings still live within five miles of the house where they grew up in Pacoima, Calif., in the San Fernando Valley. His original plan, he says, was to work in aerospace but the anti-immigrant politics that swept California in the early 1990s propelled him instead to political activism.

“That really was a wake-up call,” he said last week, chopping onions for pumpkin chili as he spoke from his home. Relatives chattered in the background; he and his wife, Angela, have three children and his mother-in-law lives with them. “I knew I’d have to do my part or our community would continue to be scapegoated.”

After his graduation, he worked in the office of Senator Dianne Feinstein. By 1999, he was a 26-year-old city councilman representing his old neighborhood. By 2001, he was the youngest-ever City Council president of Los Angeles.

In the State Senate, where he spent eight years, Mr. Padilla chaired Mr. Newsom’s 2009 bid for governor before Jerry Brown got into the race and Mr. Newsom dropped out, running for lieutenant governor instead.

In 2014, Mr. Padilla ran for the secretary of state’s office on a promise to register a million new California voters. As a result of legislation he pushed that registers Californians to vote when they get a driver’s license, the state has added more than 4 million.

Exit polls showed that a third of California’s electorate this year was Latino, a group that makes up 40 percent of the state’s population. Yet the state has never elected a Latino senator or governor. Mr. Newsom helped ensure that lockout continued in the 2018 elections, when he trounced one of the state’s most prominent Latino Democrats, former Los Angeles Mayor Antonio Villaraigosa, in a primary election.

“There’s been a failure by both political parties to champion the needs of a growing electorate,” said Sonja Diaz, director of the Latino Policy and Politics Initiative at the University of California, Los Angeles. Choosing a Latino for one of the nation’s most powerful posts, she added, would help reverse that.

But other Latino candidates also have supporters. California Attorney General Xavier Becerra, 62, has run and won statewide and has represented Los Angeles in Congress; his name also has come up as a potential member of the Biden cabinet.

And Mayor Robert Garcia of Long Beach, the city’s first openly gay mayor, has an enthusiastic base. In addition to leading what would be the biggest city in many other states, Mr. Garcia’s history-making personal biography and charisma have earned him attention in the national Democratic Party.

On Wednesday, Mr. Garcia — who has been a backer since 2009 of Gov. Newsom — said addressing a coronavirus surge hammering Los Angeles County is his top priority at the moment and would not speak at length about the Senate vacancy.

“Anybody would be honored to serve their country in that way,” Mr. Garcia, 42, said “But I’m going to support whoever the governor selects.”

Should Mr. Newsom elevate a statewide officer like Mr. Padilla or Mr. Becerra to the Senate, it would also create a new vacancy for him to fill — potentially furnishing him with a consolation prize for a person or group disappointed by his Senate decision.

Still, active campaigns are underway to urge Mr. Newsom to replace Ms. Harris with a woman, particularly a Black woman. Led by longtime state Democrats like Willie Brown and groups of high-dollar female donors, they note that when Ms. Harris resigns and assumes her new office, the Senate will once again have no Black female members. The number of women of color in the chamber would drop by a quarter to just three: Tammy Duckworth of Illinois, Mazie Hirono of Hawaii and Catherine Cortez-Masto of Nevada.

At least two Black women in California’s House delegation are pursuing the appointment: Representatives Barbara Lee, 74, and Karen Bass, 67, though Ms. Lee is seen as mounting the far more determined campaign for the job. Ms. Bass, who was vetted for the vice presidency last summer, is under consideration for potential cabinet jobs in the Biden administration as well.

Neither endorsed the governor during the 2018 Democratic primary. But both women are highly regarded on the left, as is a third member of the House delegation who is interested in joining the Senate, Representative Ro Khanna, 44, a former co-chairman of the Bernie Sanders presidential campaign.

Asian-American leaders in the state have also encouraged Mr. Newsom to consider choosing a member of the increasingly organized community, such as Mr. Khanna or Representative Judy Chu, who chairs the Asian Pacific American Caucus in the House.

Another prominent progressive, Representative Katie Porter of Orange County, is seen as a probable candidate for the Senate at some point, but perhaps more likely to seek the seat currently held by Ms. Feinstein, who is 87 and announced this week she was stepping down as the top Democrat on the Senate Judiciary Committee.

There are practical reasons, however, why it may make sense for Mr. Newsom to avoid an appointment from the House. Democrats are expected to hold only a tiny majority in the chamber in January and that number could shave down even further if lawmakers accept appointments for jobs in the Biden administration.

Some Democrats have also suggested a long shot option that Mr. Newsom could appoint a distinguished figure in the late stages of their public life, who would serve out the remaining two years of Ms. Harris’s term without seeking re-election — someone like Dolores Huerta, the civil rights leader and labor organizer, who is 90, or Mr. Brown, who is 82.

For the moment, Mr. Padilla downplayed the urgency of Mr. Newsom’s decision.

“He’s a deliberate person with tons on his plate,” said Mr. Padilla. “There are wildfires. There’s Covid. He has a budget due in January. This is just one more significant item.”

But Ms. Rayes of the Latino Victory Fund was less patient.

“I know other people have their favorites, and I guess he’s just really feeling the pressure,” she said. “But it would be easier to just come out with it.”

Moderna Says New Data Shows COVID Vaccine Is More Than 94% Effective, Plans To Ask FDA For Emergency Clearance Later Monday

Source: CNBC, by Berkeley Lovelace Jr

Moderna said Monday it will request emergency clearance from the Food and Drug Administration for its coronavirus vaccine after new data confirms the vaccine is more than 94% effective in preventing Covid-19 and was safe.

Moderna will be the second drugmaker to seek emergency use from the FDA after Pfizer, another front-runner in the Covid-19 vaccine race, applied for the same authorization on Nov. 20. The announcement means some Americans could get the first doses of Moderna’s two-dose vaccine within a few weeks.

The new analysis from Moderna evaluated 196 confirmed Covid infections among the late-stage trial’s 30,000 participants. The company said 185 cases of Covid were observed in the placebo group versus 11 cases observed in the group that received its vaccine. That resulted in an estimated vaccine efficacy of 94.1%, the company said.

The company released on Nov. 16 an early analysis of its phase three trial based on just 95 Covid-19 cases that showed its vaccine was at least 94% effective. Monday’s data provides a more complete picture of the vaccine’s effectiveness.

It also appears to prevent volunteers from getting severely sick from the virus. Of the 30 severe cases of Covid-19 in the trial, none were in the group that received the vaccine, Moderna said. Additionally, there was one Covid-19-related death in the study that occurred in the placebo group, according to the company.

Shares of Moderna were up more than 16% in afternoon trading Monday.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stephane Bancel said in a statement.

Moderna said the vaccine’s effectiveness was consistent across age, race and gender. The 196 confirmed cases included 33 adults over the age of 65 and 42 people from Black, Latino and other diverse communities. The vaccine was also well tolerated with the most common side effects being fatigue, muscle pain, headache and pain at the injection site, the company said.

Bancel told CNBC on Monday that the company expects to test the vaccine on children between the ages of 11 and 17 later this year. But testing on children under the age of 11 won’t begin until sometime next year, he added. “For younger children, you have to go down in age very slowly and you have to start at a lower dose to make sure it is safe,” he said during an interview on “Squawk Box.”

Emergency use authorization means the FDA will allow some adults to receive the vaccine as the agency continues to evaluate data. It isn’t the same as a full approval, which can typically take months. The FDA granted emergency clearance for Gilead Sciences’ remdesivir in May before giving full approval in late October.

Moderna’s results come as drugmakers and public health officials race to deliver a safe and effective vaccine to help bring an end to the pandemic, which has killed at least 1.45 million people worldwide as of Sunday evening, according to data compiled by Johns Hopkins University. A vaccine is also seen by investors as a way to get the global economy back on track after the virus wreaked havoc on nearly every country.

World Health Organization Director-General Tedros Adhanom Ghebreyesus said later Monday that he is hopeful the vaccines in development as well as “existing tools,” like social distancing, could bring an end to the pandemic. In the meantime, he urged the public not to travel for the holidays as Covid-19 cases and deaths rise.

“This is no time for complacency with the holiday season approaching in many cultures and countries,” he said during a news conference from the agency’s Geneva headquarters. “We all want to be together with the people we love during festive periods. But being with family and friends is not worth putting them or yourself at risk.”

The FDA’s review of Moderna’s vaccine is expected to take a few weeks. The agency will likely schedule an advisory committee meeting to review the vaccine on Dec. 17, Moderna said. It has already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency.

Federal agencies are already sending vaccination plans around to staff. Five agencies have started telling employees they could receive Pfizer’s or Moderna’s Covid-19 vaccine in as little as eight weeks, a person with firsthand knowledge of those plans told CNBC on Nov. 20.

Health and Human Services Secretary Alex Azar told CNBC on Nov. 16 that the FDA would move “as quickly as possible” to clear Pfizer’s and Moderna’s vaccines for emergency use. Between Moderna and Pfizer, Azar told CNBC there will be roughly 40 million doses of vaccine available by the end of this year, enough to inoculate about 20 million people since both vaccines require two shots, he said at the time.

Moderna’s initial results released earlier this month were based on the first interim efficacy analysis conducted by an external and independent data monitoring committee from the phase three clinical trial. The independent group of experts oversees U.S. clinical trials to ensure the safety of participants.

Public health officials and medical experts note it remains unclear how long the vaccines will provide immunity and whether or how often people may need periodic booster shots. Moderna’s vaccine, like Pfizer’s, uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response.

Cambridge, Massachusetts-based Moderna has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at negative 4 degrees Fahrenheit. By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

Moderna told investors on Oct. 29 that it was “actively preparing” for the global launch of its potential vaccine after completing enrollment in its late-stage trial a week earlier. In August, Moderna said it was charging between $32 and $37 per dose for its vaccine for some customers, under cheaper “pandemic pricing.” The company said it was in discussion for larger volume agreements that will have a lower price.

Insurers Will Be Financially ‘Unscathed’ By COVID-19 But Must Adapt To Industry Evolution

Hospital finance

Source: Fierce Healthcare, by Paige Minemyer

While insurers are set to weather COVID-19’s financial storm, an inability to keep up with how the pandemic is changing healthcare will be credit-negative in the long term, according to a new report from Moody’s Investors Service.

The coronavirus pandemic has put a spotlight on chronic conditions, the need for continued investment in telehealth and virtual care and the drive toward value-based care, according to the report.

Health plans that are able to adapt to these changing trends are far better positioned for long-term success, Moody’s said.

“The ability or inability of our rated health insurers to adapt to these changes in the next three to five years will be an important driver of credit strength,” the analysts said. “Health insurers that successfully adapt will boost their credit strength through lower medical cost trends than their peers.”

Insurers have consistently reported strong financial performance through the pandemic, especially as care utilization dropped significantly in the first half of the year. Moody’s said 2020 earnings are likely to be on par with expectations for the year without COVID-19 in the mix, leaving them largely “unscathed.”

Costly conditions like diabetes, hypertension and cardiovascular disease were on the rise prior to the pandemic, but the vulnerability of these patients to COVID-19 puts greater emphasis on offering interventions to manage their conditions, Moody’s said.

Chronic conditions like these account for 90% of health spending, Moody’s said.

“Managing co-morbidities is already a long-term challenge for health insurers,” the analysts wrote. “While an increased focus on co-morbidities could result in beneficial early intervention in some cases, it could also result in additional complex care, leading to pressure on health insurers to help contain costs, potentially at the expense of margins.”

The increase in telehealth use that accompanied the pandemic could prove to be a valuable tailwind in addressing these costs, Moody’s said.

The long-term challenge for payers, however, is determining the correct reimbursement levers and investing in converting provider networks to offer these services, according to the report. These investments will be key in driving virtual care from a largely urgent-care-focused service to providing more primary services.

Telehealth is also proving to be a valuable tool to reach patients in rural areas and to offer behavioral health care, Moody’s said.

“Insurers that succeed in better using the potential of telehealth will have a cost advantage over time,” the analysts said.

The continued push for value-based care “ties it all together,” according to the report. Such arrangements are critical to coordinating care for patients with chronic conditions, and, while adoption has been slow, the pandemic has underscored the merit of such agreements.

For one, providers in value-based arrangements were better positioned to handle the sharp decline in service use and elective procedures, according to the report.

“Providers on value-based care contracts were much less impacted, as they continued to receive their capitated payments during the crisis,” the analysts wrote. “This will likely accelerate the adoption of full risk value-based care, and to the extent, this helps control healthcare costs, it would be a credit positive for the industry.”

Bipartisan Group Of Senators Unveils $908 Billion Stimulus Plan, Aiming To Break Partisan Logjam

Bipartisan members of the Senate and House announce coronavirus relief legislation framework at news conference on Capitol Hill in Washington

Source: The Washington Post, by Seung Min Kim, Jeff Stein and Mike DeBonis

A bipartisan group of senators introduced a stimulus proposal worth about $908 billion on Tuesday, aiming to break a months-long partisan impasse over providing emergency federal relief to the U.S. economy.

Congress has faced increasing pressure to approve additional economic relief since talks between the White House and House Democrats collapsed, first over the summer and then again in the fall ahead of the Nov. 3 presidential election.

With negotiations among congressional leaders at a standstill, senators in both parties have worked together for weeks on a proposal that could break the logjam. Several centrist lawmakers in the Senate — including Sens. Joe Manchin III (D-W.Va.), Mark R. Warner (D-Va.), Bill Cassidy (R-La.), Mitt Romney (R-Utah) and Susan Collins (R-Maine) — held a news conference Tuesday morning to push their proposal as a template for legislation that could pass Congress as the economy faces increasing strain from a winter surge in coronavirus cases.

“Our action to provide emergency relief is needed now more than ever before. The people need to know we are not going to leave until we get something accomplished,” Manchin said, flanked by about half a dozen lawmakers at the Capitol. “I’m committed to seeing this through.”

The plan circulated by the bipartisan group is light on details but seeks to reach a middle ground on numerous contentious economic issues.

It would provide $300 a week in federal unemployment benefits for four months — a lower amount than the $600 per week Democrats sought, while still offering substantial relief to tens of millions of jobless Americans. The agreement includes $160 billion in funding for state and local governments, a key Democratic priority opposed by most Republicans, as well as a temporary moratorium on some coronavirus-related lawsuits against firms and other entities — a key Republican priority that most Democrats oppose. The measure also includes funding for small businesses, schools, health care, transit authorities and student loans, among other measures.

Aides close to the effort described details as fluid and subject to change.

The effort still faces enormous hurdles, and most congressional aides are skeptical that the push will succeed. President Trump’s negotiators have remained at odds for months with House Speaker Nancy Pelosi (D-Calif.) over multiple critical aspects of stimulus legislation, while Senate Republicans led by Majority Leader Mitch McConnell (R-Ky.) were broadly uncomfortable with the amount of spending the White House pushed at times.

But the substantive efforts at a compromise in the Senate reflect growing agitation from influential senators against the hard-line stances of their respective leaders, who have struggled to reach another round of coronavirus relief aid even as the economy continues to suffer under the weight of the pandemic.

McConnell and Senate Minority Leader Charles E. Schumer (D-N.Y.) have traded barbs, with McConnell on Monday accusing Democrats of “all-or-nothing obstruction.” Schumer said in a floor speech that “both sides must give,” but also trashed McConnell for advancing a GOP wish list in stimulus talks.

Some lawmakers have hoped that elements of a bipartisan stimulus deal could be added to the spending bill required to avoid a Dec. 11 government shutdown, although that could complicate the must-pass legislation.

Treasury Secretary Steven Mnuchin said he was scheduled to talk to Pelosi on Tuesday afternoon. They are expected to discuss both the must-pass government spending bill and stimulus efforts.

“I had a conversation yesterday afternoon as well as this morning with Mitch McConnell, Kevin McCarthy, myself and Mark Meadows. I spoke to the president this morning and updated him. … I’ll be speaking to Speaker Pelosi this afternoon about the government funding. … We all believe there should be targeted fiscal response,” said Mnuchin, who was testifying on Capitol Hill with Federal Reserve Chair Jerome H. Powell.

Pressed on the coronavirus relief package, Mnuchin said he would review it. “I do think that more fiscal response is needed. I think what’s more important is what we can pass quickly on a bipartisan basis to target the most difficult parts of the economy,” he said.

Sen. Richard J. Durbin (Ill.), the second-highest-ranking Senate Democrat, was involved in the discussions but ultimately did not appear with lawmakers at the Tuesday news conference. In a floor speech, Durbin cited disagreements with the group’s decisions, arguing that it should have excluded the liability shield, but said: “I’m still willing to work on it. … Let us not make the best the enemy of the good.”

Durbin called for the legislation to come to the Senate floor, despite his reservations.

“I’m not happy with a lot of these figures,” he said. “But that’s what it’s all about, in this world of the United States Congress: You come together, willing to sit down and listen to the other side and, if necessary, compromise.”

Economists have warned of devastating consequences for the economy and millions of Americans if no stimulus deal is passed. A number of relief programs are set to expire at the end of the year. Twelve million Americans are on pace to lose their jobless benefits, and protections for renters and student borrowers are also set to expire along with a federal paid family leave program.

The White House has largely abandoned its aggressive push for stimulus since Trump lost the Nov. 3 presidential election. It is also unclear whether President-elect Joe Biden will push Democrats to accept a smaller package, although some of his economic advisers have been adamant that a stimulus deal must be passed quickly even if it is smaller than what Democrats prefer.

The bipartisan agreement includes about $288 billion in funding for small businesses, including through the Paycheck Protection Program and other aid. It also includes $45 billion for transportation agencies; $82 billion for education; $26 billion in nutrition assistance; and $16 billion in health care, including to help with coronavirus testing and tracing, and vaccine distribution.

The effort was expected to leave out a second round of $1,200 stimulus payments, as a way to bring down its overall cost, even though Trump and Pelosi support it.

The measure faced early opposition from both flanks, with liberals opposed to the liability shield and conservatives opposed to spending more money to help the economy. Rep. Rashida Tlaib (D-Mich.), a member of the Congressional Progressive Caucus, criticized the proposal for leaving out another round of $1,200 stimulus checks. Jason Pye, vice president of legislative affairs for the conservative group FreedomWorks, said conservative GOP senators probably would reject the measure because of its cost. Sens. Mike Lee (R-Utah) and Rand Paul (R-Ky.) are among those who have resisted another spending package.

“Anything that adds to the deficit is a non-starter,” Pye said.

At the news conference, Romney stressed that he is a deficit hawk and that the proposal costs far less than the $1.8 trillion that White House officials pushed earlier. He also said the legislation would be partly funded by more than $500 billion in unspent money from the Cares Act, reducing the amount of new spending.

Sara Nelson, president of the Association of Flight Attendants, spoke positively of the bipartisan effort and urged lawmakers to quickly approve emergency financial help.

“More will be needed later, but immediate relief is needed now,” she said. “That’s what the senators are talking about. We cannot wait.”

OSHA Let Employers Decide Whether to Report Health Care Worker Deaths. Many Didn’t.

Source: Kaiser Health News, by Aneri Pattani and Robert Lewis and Christina Jewett

As Walter Veal cared for residents at the Ludeman Developmental Center in suburban Chicago, he saw the potential future of his grandson, who has autism.

So he took it on himself not just to bathe and feed the residents, which was part of the job, but also to cut their hair, run to the store to buy their favorite body wash and barbecue for them on holidays.

“They were his second family,” said his wife, Carlene Veal.

Even after COVID-19 struck in mid-March and cases began spreading through the government-run facility, which serves nearly 350 adults with developmental disabilities, Walter was determined to go to work, Carlene said.

Staff members were struggling to acquire masks and other personal protective equipment at the time, many asking family members for donations and wearing rain ponchos sent by professional baseball teams.

All Walter had was a pair of gloves, Carlene said.

By mid-May, rumors of some sick residents and staffers had turned into 274 confirmed positive COVID tests, according to the Illinois Department of Human Services COVID tracking site. On May 16, Walter, 53, died of the virus. Three of his colleagues had already passed, according to interviews with Ludeman workers, the deceased employees’ families and union officials.

State and federal laws say facilities like Ludeman are required to alert Occupational Safety and Health Administration officials about work-related employee deaths within eight hours. But facility officials did not deem the first staff death on April 13 work-related, so they did not report it. They made the same decision about the second and third deaths. And Walter’s.

It’s a pattern that’s emerged across the nation, according to a KHN review of hundreds of worker deaths detailed by family members, colleagues and local, state and federal records.

Workplace safety regulators have taken a lenient stance toward employers during the pandemic, giving them broad discretion to decide internally whether to report worker deaths. As a result, scores of deaths were not reported to occupational safety officials from the earliest days of the pandemic through late October.

KHN examined more than 240 deaths of health care workers profiled for the Lost on the Frontline project and found that employers did not report more than one-third of them to a state or federal OSHA office, many based on internal decisions that the deaths were not work-related — conclusions that were not independently reviewed.

Work-safety advocates say OSHA investigations into staff deaths can help officials pinpoint problems before they endanger other employees as well as patients or residents. Yet, throughout the pandemic, health care staff deaths have steadily climbed. Thorough reviews could have also prompted the Department of Labor, which oversees OSHA, to urge the White House to address chronic protective gear shortages or sharpen guidance to help keep workers safe.

Since no public agency releases the names of health care workers who die of COVID-19, a team of reporters building the Lost on the Frontline database has scoured local news stories, GoFundMe campaigns, and obituary and social media sites to identify nearly 1,400 possible cases. More than 260 fatalities have been vetted with families, employers and public records.

For this investigation, journalists examined worker deaths at more than 100 health care facilities where OSHA records showed no fatality investigation was underway.

At Ludeman, the circumstances surrounding the April 13 worker death might have shed light on the hazards facing Veal. But no state work safety officials showed up to inspect — because the Department of Human Services, which operates Ludeman and employs the staff, said it did not report any of the four deaths there to Illinois OSHA.

The department said “it could not determine the employees contracted COVID-19 at the workplace” — despite its being the site of one of the largest U.S. outbreaks. Since Veal’s death in May, dozens more workers have tested positive for COVID-19, according to DHS’ COVID tracking site.

OSHA inspectors monitor local news media and sometimes will open investigations even without an employer’s fatality report. Through Nov. 5, federal OSHA offices issued 63 citations to facilities for failing to report a death. And when inspectors do show up, they often force improvements — requiring more protective equipment for workers and better training on how to use it, files reviewed by KHN show.

Still, many deaths receive little or no scrutiny from work-safety authorities. In California, public health officials have documented about 200 health care worker deaths. Yet the state’s OSHA office received only 75 fatality reports at health care facilities through Oct. 26, Cal/OSHA records show.

Nursing homes, which are under strict Medicare requirements, reported more than 1,000 staff deaths through mid-October, but only about 350 deaths of long-term care facility workers appear to have been reported to OSHA, agency records show.

Workers whose deaths went unreported include some who took painstaking precautions to avoid getting sick and passing the virus to family members: One California lab technician stayed in a hotel during the workweek. An Arizona nursing home worker wore a mask for family movie nights. A Nevada nurse told his brother he didn’t have adequate PPE. Nevada OSHA confirmed to KHN that his death was not reported to the agency and that officials would investigate.

KHN asked health care employers why they chose not to report fatalities. Some cited the lack of proof that a worker was exposed on-site, even in workplaces that reported a COVID outbreak. Others cited privacy concerns and gave no explanation. Still others ignored requests for comment or simply said they had followed government policies.

“It is so disrespectful of the agencies and the employers to shunt these cases aside and not do everything possible to investigate the exposures,” said Peg Seminario, a retired union health and safety director who co-authored a study on OSHA oversight with scholars from Harvard’s T.H. Chan School of Public Health.

A Department of Labor spokesperson said in a statement that an employer must report a fatality within eight hours of knowing the employee died and after determining the cause of death was a work-related case of COVID-19.

The department said employers also are bound to report a COVID death if it comes within 30 days of a workplace incident — meaning exposure to COVID-19.

Yet pinpointing exposure to an invisible virus can be difficult, with high rates of pre-symptomatic and asymptomatic transmission and spread of the virus just as prevalent inside a hospital COVID unit as out.

Those challenges, plus May guidance from OSHA, gave employers latitude to decide behind closed doors whether to report a case. So it’s no surprise that cases are going unreported, said Eric Frumin, who has testified to Congress on worker safety and is health and safety director for Change to Win, a partnership of seven unions.

“Why would an employer report unless they feel for some reason they’re socially responsible?” Frumin said. “Nobody’s holding them to account.”

Downside of Discretion

OSHA’s guidance to employers offered pointers on how to decide whether a COVID death is work-related. It would be if a cluster of infections arose at one site where employees work closely together “and there is no alternative explanation.” If a worker had close contact with someone outside of work infected with the virus, it might not have been work-related, the guidance says.

Ultimately, the memo says, if an employer can’t determine that a worker “more likely than not” got sick on the job, “the employer does not need to record that.”

In mid-March, the union that represented Paul Odighizuwa, a food service worker at Oregon Health & Science University, raised concerns with university management about the virus possibly spreading through the Food and Nutrition Services Department.

Workers there — those taking meal orders, preparing food, picking up trays for patient rooms and washing dishes — were unable to keep their distance from one another, said Michael Stewart, vice president of the American Federation of State, County and Municipal Employees Local 328, which represents about 7,000 workers at OHSU. Stewart said the union warned administrators they were endangering people’s lives.

Soon the virus tore through the department, Stewart said. At least 11 workers in food service got the virus, the union said. Odighizuwa, 61, a pillar of the local Nigerian community, died on May 12.

OHSU did not report the death to the state’s OSHA and defended the decision, saying it “was determined not to be work-related,” according to a statement from Tamara Hargens-Bradley, OHSU’s interim senior director of strategic communications.

She said the determination was made “[b]ased on the information gathered by OHSU’s Occupational Health team,” but she declined to provide details, citing privacy issues.

Stewart blasted OHSU’s response. When there’s an outbreak in a department, he said, it should be presumed that’s where a worker caught the virus.

“We have to do better going forward,” Stewart said. “We have to learn from this.” Without an investigation from an outside regulator like OSHA, he doubts that will happen.

Stacy Daugherty heard that Oasis Pavilion Nursing and Rehabilitation Center in Casa Grande, Arizona, was taking strict precautions as COVID-19 surged in the facility and in Pinal County, almost halfway between Phoenix and Tucson.

Her father, a certified nursing assistant there, was also extra cautious: He believed that if he got the virus, “he wouldn’t make it,” Daugherty said.

Mark Daugherty, a father of five, confided in his youngest son when he fell ill in May that he believed he contracted the coronavirus at work, his daughter said in a message to KHN.

Early in June, the facility filed its first public report on COVID cases to Medicare authorities: Twenty-three residents and eight staff members had fallen ill. It was one of the largest outbreaks in the state. (Medicare requires nursing homes to report staff deaths each week in a process unrelated to OSHA.)

By then, Daugherty, 60, was fighting for his life, his absence felt by the residents who enjoyed his banjo, accordion and piano performances. But the country’s occupational safety watchdog wasn’t called in to figure out whether Daugherty, who died June 19, was exposed to the virus at work. His employer did not report his death to OSHA.

“We don’t know where Mark might have contracted COVID 19 from, since the virus was widespread throughout the community at that time. Therefore there was no need to report to OSHA or any other regulatory agencies,” Oasis Pavilion’s administrator, Kenneth Opara, wrote in an email to KHN.

Since then, 15 additional staffers have tested positive and the facility suspects a dozen more have had the virus, according to Medicare records.

Gaps in the Law

If Oasis Pavilion needed another reason not to report Daugherty’s death, it might have had one. OSHA requires notice of a death only within 30 days of a work-related incident. Daugherty, like many others, clung to life for weeks before he died.

That is one loophole — among others — in work-safety laws that experts say could use a second look in the time of COVID-19.

In addition, federal OSHA rules don’t apply to about 8 million public employees. Only government workers in states with their own state OSHA agency are covered. In other words, in about half the country if a government employee dies on the job — such as a nurse at a public hospital in Florida, or a paramedic at a fire department in Texas — there’s no requirement to report it and no one to look into it.

So there was little chance anyone from OSHA would investigate the deaths of two health workers early this year at Central State Hospital in Georgia — a state-run psychiatric facility in a state without its own worker-safety agency.

On March 24, a manager at the facility had warned staff they “must not wear articles of clothing, including Personal Protective Equipment” that violate the dress code, according to an email KHN obtained through a public records request.

Three days later, what had started as a low-grade illness for Mark DeLong, a licensed practical nurse at the facility, got serious. His cough was so severe late on March 27 that he called 911 — and handed the phone to his wife, Jan, because he could barely speak, she said.

She went to visit him in the hospital the next day, fully expecting a pleasant visit with her karaoke partner. “By the time I got there it was too late,” she said. DeLong, 53 “had passed.”

She learned after his death that he’d had COVID-19.

Back at the hospital, workers had been frustrated with the early directive that employees should not wear their own PPE.

Bruce Davis had asked his supervisors if he could wear his own mask but was told no because it wasn’t part of the approved uniform, according to his wife, Gwendolyn Davis. “He told me ‘They don’t care,’” she said.

Two days after DeLong’s death, the directive was walked back and employees and contractors were informed they could “continue and are authorized to wear Personal Protective Gear,” according to a March 30 email from administrators. But Davis, a Pentecostal pastor and nursing assistant supervisor, was already sick. Davis worked at the hospital for 27 years and saw little distinction between the love he preached at the altar and his service to the patients he bathed, fed and cared for, his wife said.

Sick with the virus, Davis died April 11.

At the time, 24 of Central State’s staffers had tested positive, according to the Georgia Department of Behavioral Health and Developmental Disabilities, which runs the facility. To date, nearly 100 staffers and 33 patients at Central State have gotten the virus, according to figures from the state agency.

“I don’t think they knew what was going on either,” Jan DeLong said. “Somebody needs to check into it.”

In response to questions from KHN, a spokesperson for the department provided a prepared statement: “There was never a ban on commercially available personal protective equipment, even if the situation did not call for its use according to guidelines issued by the Centers for Disease Control and Prevention and the Georgia Department of Public Health at the time.”

KHN reviewed more than a dozen other health worker deaths at state or local government workplaces in states like Texas, Florida and Missouri that went unreported to OSHA for the same reason — the facilities were run by government agencies in a state without its own worker safety agency.

Inside Ludeman

In mid-March, staff members at the Ludeman Developmental Center were desperate for PPE. The facility was running low on everything from gloves and gowns to hand sanitizer, according to interviews with current and former workers, families of deceased workers, and union officials.

Due to a national shortage at the time, surgical masks went only to staffers working with known positive cases, said Anne Irving, regional director for AFSCME Council 31, the union that represents Ludeman employees.

Residents in the Village of Park Forest, Illinois, where the facility is located, tried to help by sewing masks or pivoting their businesses to produce face shields and hand sanitizer, said Mayor Jonathan Vanderbilt. But providing enough supplies for more than 900 Ludeman employees proved difficult.

Michelle Abernathy, 52, a newly appointed unit director, bought her own gloves at Costco. In late March, a resident on Abernathy’s unit showed symptoms, said Torrence Jones, her fiancé who also works at the facility. Then Abernathy developed a fever.

When she died on April 13 — the first known Ludeman staff member lost to the pandemic — the Illinois Department of Human Services, which runs Ludeman, made no report to safety regulators. After seeing media reports, Illinois OSHA sent the agency questions about Abernathy’s daily duties and working conditions. Based on DHS’ responses and subsequent phone calls, state OSHA officials determined Abernathy’s death was “not work-related.”

Barbara Abernathy, Michelle’s mom, doesn’t buy it. “Michelle was basically a hermit,” she said, going only from work to home. She couldn’t have gotten the virus anywhere else, she said. In response to OSHA’s inquiry for evidence that the exposure was not related to her workplace, her employer wrote “N/A,” according to documents reviewed by KHN.

Two weeks after Abernathy’s passing, two more employees died: Cephus Lee, 59, and Jose Veloz III, 52. Both worked in support services, boxing food and delivering it to the 40 buildings on campus. Their deaths were not reported to Illinois OSHA.

Veloz was meticulous at home, having groceries delivered and wiping down each item before bringing it inside, said his son, Joseph Ricketts.

But work was another story. Maintaining social distance in the food prep area was difficult, and there was little information on who had been infected or exposed to the virus, according to his son.

“No matter what my dad did, he was screwed,” Ricketts said. Adding, he thought Ludeman did not do what it should have done to protect his dad on the job.

A March 27 complaint to Illinois OSHA said it took a week for staff to be notified about multiple employees who tested positive, according to documents obtained by the Documenting COVID-19 project at the Brown Institute for Media Innovation and shared with KHN. An early April complaint was more frank: “Lives are endangered,” it said.

That’s how Rose Banks felt when managers insisted she go to work, even though she was sick and awaiting a test result, she said. Her husband, also a Ludeman employee, had already tested positive a week earlier.

Banks said she was angry about coming in sick, worried she might infect co-workers and residents. After spending a full day at the facility, she said, she came home to a phone call saying her test was positive. She’s currently on medical leave.

With some Ludeman staff assigned to different homes each shift, the virus quickly traveled across campus. By mid-May, 76 staff and 198 residents had tested positive, according to DHS’ COVID tracking site.

Carlene Veal said her husband, Walter, was tested at the facility in late April. But by the time he got the results weeks later, she said, he was already dying.

Carlene can still picture the last time she saw Walter, her high school sweetheart and a man she called her “superhero” for 35 years of marriage and raising four kids together. He was lying on a gurney in their driveway with an oxygen mask on his face, she said. He pulled the mask down to say “I love you” one last time before the ambulance pulled away.

The Illinois Department of Human Services said that, since the beginning of the pandemic, it has implemented many new protocols to mitigate the outbreak at Ludeman, working as quickly as possible based on what was known about the virus at the time. It has created an emergency staffing plan, identified negative-airflow spaces to isolate sick individuals and made “extensive efforts” to procure more PPE, and it is testing all staffers and residents regularly.

“We were deeply saddened to lose four colleagues who worked at Ludeman Developmental Center and succumbed to the virus,” the agency said in a statement. “We are committed to complying with and following all health and safety guidelines for COVID-19.”

The number of new cases at Ludeman has remained low for several months now, according to DHS’ COVID tracking site.

But that does little to console the families of those who have died.

When a Ludeman supervisor called Barbara Abernathy in June to express condolences and ask if there was anything they could do, Abernathy didn’t know how to respond.

“There was nothing they could do for me now,” she said. “They hadn’t done what they needed to do before.”

Newsom Threatens ‘Drastic’ New Lockdown Order

This photo from video provided by the Office of the Governor shows California Gov. Gavin Newsom during a virtual briefing from his home in Sacramento, Calif., Monday, Nov. 30, 2020. 

Source: Fox News, by Bradford Betz

California Gov. Gavin Newsom on Monday said a “drastic” new lockdown order might be necessary if coronavirus cases in the state continue to surge to their highest levels since the start of the pandemic.

The Democratic governor made the remarks during a press conference after the Thanksgiving holiday weekend, during which some 50 million people were expected to have traveled despite tightening restrictions. Health officials have warned that more cases are likely to prop up as a result of holiday gatherings.

Newsom said officials are considering stay-home orders for areas with the highest case rates as it tries to head off concerns that severe coronavirus cases could triple hospitalizations and overwhelm intensive care beds.

“The red flags are flying in terms of the trajectory in our projections of growth,” said Gov. Gavin Newsom. “If these trends continue, we’re going to have to take much more dramatic, arguably drastic, action.”

In the past two weeks, hospitalizations have increased by 89%. As of Monday, nearly 7,800 coronavirus patients were hospitalized. About 12% of Californians testing positive are likely to need hospital care within the next two to three weeks.

“Current projections show hospitalizations could increase two to three times the current amount in one month,” Newsom said.

The biggest concern is intensive care cases, which have increased by 67% in the past two weeks. If that continues, it would push ICU beds to 112% of capacity by mid-December.

That statistic is likely to drive state-mandated stay-at-home orders in 51 of California’s 58 counties that already are seeing the most restrictions on business activities, said Dr. Mark Ghaly, the state’s secretary of health and human services.

Now Comes The Hardest Part: Getting A Coronavirus Vaccine From Loading Dock To Upper Arm

Pfizer coronavirus vaccine 95% effective, company says - The Washington Post

Source: The Washington Post, by Lena H. Sun and Frances Stead Sellers

Riverside Health System in Virginia has ordered a specialized freezer for each of its five hospitals to keep precious vials of coronavirus vaccine as cold as a deep Antarctic freeze.

Public health officials in Nashville and Baltimore are revamping routine flu clinics to test delivery methods for coronavirus vaccinations.

And in Maine, top health official Nirav Shah spends sleepless nights devising drive-through immunization facilities where vaccinators won’t have to wear winter parkas in addition to their personal protective gear.

Shah’s solution? Fire stations and carwashes.

Those venues are heated “so you have shelter from the snow and cold,” he said. “We haven’t inked any of those agreements yet, but that’s where our head is at.”

Buoyed by promising results from major clinical trials of three coronavirus vaccines, public health officials are preparing for the daunting task ahead of delivering those shots to tens of millions of Americans. On Monday, a third pharmaceutical company announced positive results from late-stage trials of a coronavirus vaccine, saying that its candidate is up to 90 percent effective.

The vaccines need to be distributed across 50 states, plus U.S. territories, that have different demographics and shifting needs. The leading products must be stored at different temperatures and have different minimum orders, with each requiring two shots though the three vaccines don’t all share the same schedule.

Complicating matters: A final decision on who is eligible to get the early doses must wait for a federal advisory group’s recommendations. That can’t happen until regulators authorize the new vaccines. And once set in motion, the distribution — from loading dock to upper arm — has to be accomplished equitably and with as few handoffs as possible because it’s all being done amid a pandemic.

The stakes are enormous. The massive undertaking to immunize most of the population requires extraordinary communication, planning and coordination. Federal, state and local officials are working with hospitals and pharmacies, suppliers of dry ice, gloves and vials, and carriers such as UPS and FedEx. A successful operation could transform the health and economic well-being of society, in the United States and overseas.

“There are a million moving parts,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute. “The system is complex to start with, [and] it is being modified to mount an immunization campaign of historic proportions,” he said, warning that while “expectations are sky high,” there are pitfalls at every step.

Officials are wrestling with how to ensure vulnerable populations receive the vaccine. Almost certainly at the front of the line: about 21 million front-line health-care workers. Next up are likely to be other essential workers, many of whom come from Black, Latino and Asian communities hard hit because of socioeconomic factors. Many can’t work from home, don’t have transportation and live in crowded housing.

“It’s like treating an individual patient while rebuilding the entire health-care system,” said Alfred Sommer, former dean of the Johns Hopkins Bloomberg School of Public Health, who was part of the team that vanquished smallpox four decades ago. Challenges will crop up, he said, such as immunizing disadvantaged communities. “Even with special outreach programs, it will not be easy with the vaccines ready for approval.”

Further complicating the logistics: the continued intrusion of politics. The Trump administration has not given information about vaccine distribution to the Biden transition team, President-elect Joe Biden’s chief of staff, Ron Klain, said in an interview Sunday on ABC’s “This Week,” adding to the potential for disruption.

“I have faith that the incoming administration will not completely upend the thousands of man and woman hours of work we’ve put in,” said Cindy Williams, vice president of the Riverside Health System and a member of Virginia’s coronavirus advisory committee. “Creating additional chaos as we’re managing this is really a bad idea.”

Once the vaccines are authorized by the Food and Drug Administration, doses will be allocated to each state according to population, with some held in reserve in case of loss or theft. Within 24 hours of FDA action, doses will be “prepositioned” at key sites designated by each state where vaccines will be administered to the first priority groups.

U.S. government officials anticipate having 40 million doses of vaccines from pharmaceutical giant Pfizer and biotech firm Moderna by the end of the year, enough to vaccinate 20 million people, a small fraction of the U.S. population of 330 million. (The United States will receive about half of Pfizer’s 50 million doses globally.) Government officials say it will be April before most people could get vaccinated.

The good news from AstraZeneca, manufacturer of the third vaccine, which is easier to store and transport, means the company will also apply for regulatory approval in the United States.

Americans will receive coronavirus vaccines free. The federal government is paying for much of the delivery and vaccine administration costs. But state officials are asking Congress for at least $8 billion for vaccination efforts; to date, $200 million in federal funds has been sent to state, territorial and local jurisdictions.

The vials will be sent first to large hospitals and other sites where mass immunization clinics can take place. But even that first step presents daunting travel, storage and handling requirements.

The Pfizer vaccine will be shipped to sites selected by states in GPS-tracked, suitcase-sized “shippers” with 50 pounds of dry ice pellets, and must be kept at minus-70 Celsius. Upon arrival, the dry ice must be refreshed, or the vials of vaccine must be transferred to ultralow-temperature freezers. The specifications are exacting if the vials stay in the shippers: The container cannot be opened more than twice a day, the dry ice must be replenished every five days, and the contents must be used within 15 days. The vials can stay at refrigerator temperature for five days before their contents degrade.

The Moderna vaccine is less demanding, with a storage temperature of minus-20 Celsius, which is the same for many medications.

The shipments need to be coordinated with kits of syringes, needles, face masks and other ancillary supplies.

From there, every state, territory and each of six major metropolitan areas is responsible for its own deployments. States are in varying stages of preparation. Many have designated large hospital systems to be the first places to receive vaccine. Maine, for example, has chosen five hospitals with ultracold freezers to receive its first doses, and each has a plan to reach into the community. But just in case, the state bought an ultracold freezer for its public health emergency warehouse that can store more than 200,000 doses.

Maine has held meetings with transportation officials and the National Guard to work through worst-case scenarios, Shah said. If there’s a flood or loss of power, a backup generator for the freezer would kick in. If shots are transported during a blizzard, the vaccine convoy could follow 30 minutes behind a salt truck.

The Centers for Disease Control and Prevention has told states they don’t need to buy specialized freezers because immunizations in the earliest phases will focus on sites that can vaccinate as many people as possible and will be able to handle the cold chain requirements, even without freezers.

But at the Henry Ford Health System in Detroit, Northwell Health in New York and Riverside in Virginia, officials bought them anyway, executives said on a conference call Thursday about vaccine distribution organized by Premier, the group purchasing organization and supply consultancy for 4,100 hospitals. The executives’ assumption was that early public vaccination clinics will be most efficiently done on the campuses of hospitals with ultracold freezers.

Among them is Riverside Shore Memorial Hospital on Virginia’s Eastern Shore, a medically underserved and rural community that includes poultry and agricultural workers who did not have health insurance until the state recently expanded Medicaid, said Williams, of Riverside Health. It is one of three major health-care providers for the community, and the only one with an ultracold freezer.

Clinicians will need to be trained to administer the vaccines, which have different protocols. The Pfizer version must be diluted before the shot is given — inverting the vial 10 times “gently,” according to the Pfizer instructions. In contrast, the Moderna vaccine does not require on-site mixing and should not be shaken.

To start with, vaccination efforts may favor urban areas. That’s because the vaccines will arrive in big batches: For Pfizer, the minimum order is 975 doses. Moderna’s smallest batch is 100 doses.

In Alaska, “you’re not going to have 900 people within 1,000 square miles,” said Danny Staley, a senior vice president at the Association of State and Territorial Health Officials. “You’re wanting to do that at a mass vaccination clinic, where we know people can use it so we don’t waste it,” he said.

“The most disadvantaging issue is the minimum order,” said Ann Lewandowski, program manager for the Southern Wisconsin Immunization Consortium, a group of 42 rural hospitals in Wisconsin. None has the resources to purchase a special freezer, which can cost $12,000 to $15,000 and might be needed for only a year until vaccines are developed that don’t require such frigid temperatures.

Identifying enough health-care workers to be immunized is also challenging for rural hospitals that may have only 20 nurses and 20 doctors. “You would need to reach out to pharmacists, reach out to dentists and all these other professionals, but 975 is really an impossible goal,” Lewandowski said.

On a recent call, a Pfizer representative told Lewandowski the company hopes to send out smaller batches of 125 doses by April. But even that creates logistical challenges because the vials need to be coordinated with the ancillary kits, which are equipped for 100 doses.

Health-care personnel from rural hospitals may have to drive to get their shots at larger hubs in Madison, Milwaukee or Eau Claire, Lewandowski said. That could pose a barrier for staffers already stretched thin caring for patients with covid-19, the illness caused by the coronavirus.

“These are health-care workers who are taking risks to serve the state in our time of need, and it’s not fair to discriminate against them simply because they live in a geographically challenged place,” Lewandowski said.

A Pfizer spokeswoman said the company is working on a smaller pack size that will be ready the first three months of 2021.

Final recommendations on who gets the first shots will come from an independent committee on immunizations that advises the CDC. There is broad agreement that health-care workers will be first, and will include clinicians, custodial staff, home health aides, pharmacists, paramedics and staff in long-term care facilities, according to discussions Monday during a meeting of the Advisory Committee on Immunization Practices. That first group may also include about three million long-term care residents.

Jose Romero, a pediatric infectious-diseases specialist who chairs the immunization panel, said “essential workers” are likely to be high on the list. That might include people who stock supermarket shelves or pick vegetables, many of whom belong to communities of color devastated by covid-19.

“That is part of the equity question we are trying to solve,” Romero said in an interview.

That assumes priority groups are willing to take the first shots. Health officials say they are increasingly worried about staffers who say they won’t take the vaccine, according to internal surveys and conversations with clinicians.

“When it comes to this vaccine, what I’m hearing from colleagues … is that their confidence is lacking,” Pamela G. Rockwell, a physician representing the American Academy of Family Physicians, said during last month’s meeting of the federal immunization advisory committee.

“I’m already won over,” she said. “We need to win over a lot of primary care physicians … We need to do this right and get our patients convinced that this is safe so we can save our country.”

Federal health officials are also concerned.

“I am worried that people are going to equate the complicated storage and handling as somehow more reason to be hesitant about the vaccine, when in fact, it has nothing to do with how well the vaccines work,” said a senior federal health official involved in distribution with the Defense Department and private industry. The official spoke on the condition of anonymity because they were not authorized to speak publicly on the record.

At Riverside, a survey last month of about 1,000 employees, most in nursing and administrative positions, found about a third said they would take the vaccine, another third said they would not, and the remainder wanted more data on safety and efficacy. A separate poll of physicians found nearly half would not take the vaccine. The surveys were conducted before reports about the vaccines’ effectiveness, and acceptance is likely to increase, said Riverside’s Williams.

Patients will be more likely to be vaccinated if they ask their doctors if they’re willing to be vaccinated and the physician says yes, she said.

Saad B. Omer, an epidemiologist and infectious-diseases expert who directs the Yale Institute for Global Health, has done extensive studies about the political and social factors influencing trust in vaccines. What he sees now is not “your run-of-the-mill vaccine hesitancy.” President Trump’s actions fueled mistrust in science, he said.

But health-care personnel can be persuaded. Strong endorsements from a trusted person, such as Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, can make a huge difference, according to a study Omer conducted recently.

Experts who study vaccine hesitancy say promotional campaigns that use social media and increase community engagement with trusted leaders will be key to encouraging use of a new vaccine.

Adam Abadir, director of communications at the Baltimore City Health Department, said the city’s health officials had been using routine flu clinics to hone strategies such as tailored social media campaigns and outreach through pastors and other trusted community members.

“We now have partners in place who can deliver the messages,” Abadir said, even though he doesn’t yet know what those messages will say.

In Nashville, the annual “Flulapalooza” mass vaccination event at Vanderbilt University Medical Center — last year, they managed 15,000 shots on site in one day — was modified as Flula-2-uza to test strategies for the coronavirus, which may involve reversing their strategy and venturing out to remote workers.

The new vaccines are likely to produce more unpleasant side-effects than a flu shot, potentially leading recipients to need a day or two off work.

“Any group of individuals that work together, we can’t vaccinate them all at the same time,” said Thomas Talbot, chief hospital epidemiologist at Vanderbilt, which will likely be among the first sites to receive the Pfizer vaccine and is looking at how to stagger immunizations to minimize the impact on departments.

In Baltimore, a mobile flu clinic in a predominantly Latino community drew more than 150 people on a recent stormy morning to a school parking lot, where a team of Spanish-speaking officials were working with next year in mind.

Drive-through vaccination isn’t viable for people in the city who lack transportation, said Rebecca Dineen, assistant commissioner for the city’s Bureau of Maternal and Child Health. So the health department is pushing hard to foster links in public housing and with neighborhood leaders who will be key to coronavirus distribution.

“You don’t need a fancy innovative approach,” Dineen said. “A lot of it is really knowing your people.”

Shah, in Maine, is hoping that beyond cultivating relationships with pharmacies and physicians offices, fire stations and carwashes will be all the innovation he needs.

“We think the fire departments are a pretty good source for sites because there are so many, many small towns in Maine,” he said.

EMS clinicians can be vaccinators there or at carwashes.

“People trust them,” he said. “And trust matters a lot.”

Newsom: Up To 2.4 Million California Health Care Workers Could Get Coronavirus Vaccines As Soon As December

Newsom: Up to 2.4 million California health care workers could get  coronavirus vaccines as soon as December - SFChronicle.comSource: San Francisco Chronicle, by Catherine Ho

California could start administering coronavirus vaccines to as many as 2.4 million of the state’s highest-priority health care workers in early December, Gov. Gavin Newsom said Monday.

The state is making vaccine distribution plans around the estimated assumption that the first vaccines will be authorized by the FDA in early December. That first approval will likely be for the vaccine made by Pfizer and German firm BioNTech, followed by the vaccine made by Moderna. Federal health officials have said states will begin receiving doses within 24 hours after the first vaccine receives FDA authorization.

“We’re waiting for FDA approval of at least one or more vaccines to occur in a number of weeks,” Newsom said. “We’re currently calendaring early December. … For planning purposes, we’re anticipating that FDA approval in early December. That hopefully will be Pfizer and Moderna.”

Pfizer said it submitted its application for FDA authorization Friday. Both Pfizer and Moderna recently shared Phase 3 clinical trial data indicating their vaccines are about 95% effective. AstraZeneca on Monday also shared early data showing its vaccine is 70% effective on average — 62% effective under one dosing scheme, and 90% effective under another dosing scheme.

However, depending on how many doses of the first vaccines are made available, there may not be enough doses for all 2.4 million California health care workers at first, Newsom said. Members of the state’s vaccination committees are working on a plan to divide those health care workers into subsets based on priority. That plan may be shared publicly as soon as the end of November.

“We begin with a framework of scarcity,” he said.

Newsom cautioned that mass vaccination will not likely occur until spring or summer 2021, reiterating previous estimated timelines made by state and federal officials regarding when most Americans will be able to get vaccinated.

Newsom said California has identified the need to buy 16 ultra-cold freezers and 61 smaller freezers to help transport and store the Pfizer vaccine, which must be kept at minus 70 degrees Celsius, or minus 94 degrees Fahrenheit. Some California hospitals have gone ahead and bought their own ultra freezers, and Pfizer plans to ship its vaccine in special containers equipped with dry ice. Newsom said the state’s freezers will supplement those efforts, and will likely be placed in regions that may struggle on their own to obtain such specialized freezers.

Moderna’s vaccine does not need freezers quite that cold. Its vaccine is kept at minus 20 degrees Celsius, and more hospitals and clinics have access to freezers that can accommodate that temperature. Moderna will work with McKesson, the Texas-based pharmaceutical distributor that until recently was headquartered in San Francisco, to distribute its vaccine.

In terms of cost, Newsom said the U.S. Centers for Disease Control and Prevention has committed $28 million to California for the first phase of vaccine distribution. The state has distributed $16 million so far — $10 million for planning and $6 million for staffing, Newsom said. He called the federal funding “inadequate,” and said the second round of funding “needs to be substantially greater.”

It’s unclear how much it would cost to distribute coronavirus vaccines in California. Newsom said he is working with House Speaker Nancy Pelosi, Minority Leader Kevin McCarthy and Vice President-elect Kamala Harris to seek more federal funding for vaccine distribution.

Trump’s New Drug-Pricing Plan Overhauls Outpatient Drug Pay Starting Jan. 1

White House expands international reference pricing to pharmacy drugs

Source: Modern Healthcare, by Rachel Cohrs

The Trump administration is trying to overhaul some providers’ payments for outpatient drugs in six weeks as it makes a last-ditch attempt to finalize drug-pricing policies that have languished in regulatory limbo.

A model through the Center for Medicare and Medicare Innovation announced Friday would require mandatory participation from healthcare providers starting Jan. 1, 2021, though there are several categories of exceptions. The model would change providers’ payment for administering drugs from a percentage of a drug’s average sales price to a flat fee and tie reimbursement to prices charged in foreign countries.

Providers have already sounded the alarm about reimbursement cuts.

“Hospitals will have to absorb losses while drug companies are free to continue their trend of charging exorbitant prices. This will put hospitals in the terrible position of having to divert resources from other patient care simply to buy the drug therapies they need for their patients,” said American Hospital Association Executive Vice President Tom Nickels.

Most-favored nation model

The Trump administration’s international reference pricing plan is limited to setting reimbursement for outpatient drugs. The model is supposed to begin on Jan. 1, 2021, which gives providers only six weeks to prepare.

Instead of paying drugs’ average sales price, Medicare will now also factor in a “most-favored nation” price determined by finding the lowest price a drugmaker offers in certain OECD member countries. The international price would carry heavier weight in the formula over a four-year phase-in period.

Hospitals questioned the rule’s legality and warned it could harm healthcare providers.

“We urge the Administration to withdraw this rule immediately and replace it with a serious effort at drug pricing reform,” Nickels said.

Providers are now paid a percentage of a drug’s average sales price to administer Part B drugs, which some have criticized as incentivizing high drug prices. The model would replace this method with a flat add-on fee.

The administration estimated the rule could save the federal government and beneficiaries more than $80 billion over seven years, but some of the savings will come from reduced beneficiary access. If drugmakers don’t lower their prices, then some providers may choose to not administer certain drugs at a loss, thus reducing access.

“Eligible providers and suppliers will need to decide if the difference between the amount that Medicare will pay and the price that they must pay to purchase the drugs would allow them to continue offering the drugs,” the final rule states.

Community oncologists were displeased with the changes, and called the model “brazen and unhinged.”

“Rather than give community oncology providers the support they need during this third wave of the pandemic, as they struggle to keep their facilities and staff COVID-19 free while treating cancer patients, the Trump Administration is essentially throwing these providers under the bus,” Community Oncology Alliance Executive Director Ted Okon said.

Participation would be mandatory for healthcare providers with some exceptions, including cancer hospitals, children’s hospitals, ambulatory surgical centers, critical-access hospitals, rural health clinics, federally qualified health centers, and Indian Health Service facilities.

Some providers may also be able to apply for exceptions from the model due to financial hardship, said Manatt, Phelps & Phillips Senior Advisor Ian Spatz.

Capitol Street Managing Director Ipsita Smolinski said the rule is likely to be challenged by drugmakers and providers because it is nationwide and mandatory.

“The MFN rule does not fit with the parameters of the CMS innovation center: to be a limited pilot that will be tested and expanded if it works, and restricted or discontinued if it doesn’t work,” Smolinski said.

The model says that it will eventually include the top 50 drugs that make up the most Medicare Part B spending.

Drugmakers are likely to sue to stop the actions, and Trump admitted as much during a speech on Friday.

“I presume they’ll sue, and it is a suit that they should never be able to win,” Trump said.

The most-favored nation policy could also be vulnerable on regulatory grounds because the administration skipped straight from a regulatory draft to an interim final rule, even though an intermediate proposal was under White House review for more than a year. Legally, an agency has to find that it has “good cause” to issue a final rule without first publishing a proposed rule.

“PhRMA is considering all options to stop this unlawful onslaught on medical progress and maintain our ability to win the fight against COVID-19,” said Pharmaceutical Research and Manufacturers of America President and CEO Stephen Ubl.

President-Elect Joe Biden has not expressly endorsed international reference pricing plan like Trump is proposing, but Biden has advocated for an independent board to assess fair prices for drugs without competition. Those assessments would include pricing data from other countries.

“I hope they have the courage to keep it, because the powerful drug lobby, Big Pharma, is putting pressure on people like you wouldn’t believe,” Trump said Friday, though he has not conceded that he lost the election.

Friday was the last business day the Trump administration had to ensure the regulations it is issuing take effect before Inauguration Day.

Drug rebate reform

The Trump administration also moved forward with a policy prohibiting pharmacy benefit managers frfom retaining rebates paid by drugmakers. This rule applies to the Medicare Part D program.

Insurers and pharmacy benefit managers have balked at the policy, as it would expose the amounts of rebates they receive from drugmakers and redistribute money they use to keep premiums steady.

The final rule would go into effect in 2022.

Drugmakers support and have actively lobbied for rebate reform, but pharmacy benefit managers said they would sue to stop the rule from taking effect.

“PCMA will explore all possible litigation options to stop the rule from taking effect and destabilizing the Medicare Part D program that millions of beneficiaries rely on,” said Pharmaceutical Care Management Association President and CEO JC Scott.

America’s Health Insurance Plans also criticized the proposed rebate reform and said it would take action to try to reverse the policy.

Congress could also gain scored savings from trying to stop the policy, Spatz said.

Last Updated 12/02/2020

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