POST 82. December 3, 2020. CORONAVIRIUS. The NBA jumped to the front of the line for Coronavirus testing….while front line nurses often are still waiting. Who will similarly “hijack” the vaccine?

With CDC guidelines approved, states establish their own vaccine distribution plans.

The federal Centers for Disease Control and Prevention have sent $200 million to the states for the effort (vaccine implementation), with another $140 million promised in December…Health departments have asked Congress for at least $8.4 billion more..

‘The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is formally recommending that 21 million health care workers and 3 million older adults living in long-term care facilities (plus the people caring for them) be first in line for COVID-19 vaccinations, which could begin within weeks…

The committee did not consider a third major contributor to COVID-19 cases, prisons and jails, as a priority for vaccinations. The Marshall Project says prisons and jails have counted 197,000 COVID-19 cases  — among both prisoners and staff — and 1,400 deaths.

The ACIP has been wrestling with a central, strategic issue that may play out differently around the country. One vaccination strategy is to protect the most vulnerable populations, which would put people in nursing homes, health care workers and people with other health issues (including smokers and people with morbid obesity) at the top of the list. Another strategy would be to stop the spread of the virus first, which would put people in places like jails, prisons, nursing homes and homeless shelters and essential workers — like taxi and Uber drivers and store clerks who come in contact with lots of people every day — higher on the priority list.

The ACIP’s recommendation is that the “health care worker” designation includes people who have direct patient contact, and people who work with infectious materials, such as lab work, and also hospital food services and medical aides. Committee members were especially concerned that lower-wage health care workers be given priority consideration because COVID-19 rates are higher among lower-wage workers than higher-paid health care workers.

After health care workers and people living in long-term facilities, the next priority, referred to as Group 1B, will be “essential workers,” which would still have to be defined but would likely include police and other emergency workers, as well as people who work in essential services like utility companies, grocery stores and so on.

The third priority group (Group 1C) will be people with other health issues that place them at higher risk.

The fourth priority (Group 1D) will be 53 million Americans who are 65 years old and older but not suffering from other serious health issues.” (A)

“Health care workers. Essential workers. Nursing home residents. New Yorkers who live in the hardest-hit neighborhoods.

These are among the different groups that the public health authorities in New York want to prioritize for coronavirus vaccination.

On Wednesday, Gov. Andrew M. Cuomo said that the state would receive its first batch of the vaccine — 170,000 doses from the drug maker Pfizer — on Dec. 15, pending federal approval.

New York City expected to have received around 480,000 doses by the beginning of January, a spokesman for Mayor Bill de Blasio said on Wednesday. Bill Neidhardt, the spokesman, said about roughly half would be Pfizer’s vaccine and half would be from Moderna, another drug maker….

While the C.D.C. will offer a broad framework for which groups to prioritize, there is considerable room for New York State and New York City to make their own decisions.

Hospitals are already preparing to receive their first shipments, even if they don’t know how many doses they will get. Northwell Health, the state’s largest hospital system, was told it would receive 48 hours’ notice before its first allotment of the Pfizer vaccine shipped from a distribution center in Michigan, according to Onisis Stefas, the hospital system’s chief pharmacy officer.

The vaccine would arrive in a suitcase-sized box, packed with dry ice. Inside, a smaller box would contain the frozen vaccine vials.

There was so much uncertainty that Dr. Stefas said he was unsure whether to use those doses quickly, or reserve half to use as the second dose.

Who will get the vaccine first?

An advisory committee to the C.D.C. on Tuesday recommended that the first people to receive the vaccine should be health care workers, along with nursing home residents and staff.

Mr. Neidhardt, the spokesman for the mayor, said the 480,000 expected doses would be given to health care personnel performing high-risk activities, like working on coronavirus floors at hospitals, and people living and working in nursing homes.

“It’s important to protect health care workers so they can continue to go to work and take care of the sick,” said Jessica Justman, an epidemiology professor at Columbia University’s Mailman School of Public Health.

Nursing home residents are being prioritized for a different reason: They are at high risk of dying from the coronavirus. Residents and staff of long-term care facilities have made up about 40 percent of the deaths attributed to the virus in the United States.

On Wednesday, Mr. Cuomo and his aides said the first shipments of the vaccine would go to nursing home residents and staff, as well as frontline health care workers. (A second dose of the Pfizer vaccine and initial shipments of the Moderna vaccine would arrive later in December, the governor’s office said.)

There are about 85,000 residents of nursing homes, according to the governor’s office, and the state has told the C.D.C. that there are more than “800,000 critical health care workers.” That includes home health care aides and staff members in hospitals, nursing homes and ambulance companies. In all, that is more than 4 percent of the state’s population.

There is likely some overlap between the 480,000 doses New York City expects to receive and the 170,000 doses Mr. Cuomo described Wednesday.

Getting through the high-priority groups could take some time, experts said. Hospitals are already deciding which employees are eligible to be vaccinated once the first shipments come in.

Mount Sinai Health System, for example, will include some janitors and food delivery personnel who work in the emergency department and intensive care units among the health care workers slated to receive some of the earliest vaccines, said Susan Mashni, the chief pharmacy officer of the system.

Who is after that?

New York State has told the C.D.C. that the next groups to be “targeted” for the vaccine will be “other frontline essential workers, medically high risk individuals and individuals over 65.”

In a draft plan that the state released publicly in October, more than a dozen categories of people were put in one of five priority groups. Grocery store workers were ahead of “individuals under 65 with high-risk comorbidities,” who were in turn ahead of certain groups of essential workers.

Mr. Cuomo has also been expressing concern that low-income and minority areas could be underserved by the vaccines, a point he reiterated on Wednesday, saying the federal vaccination plan “overlooks the Black, brown, and poor communities.”

A draft plan that New York City filed with the C.D.C. raised the possibility that race would factor into the city’s vaccination plans. Black and Hispanic New Yorkers have died of the virus at a disproportionate rate. The draft stated that “vaccine planning and allocation decisions must be made through an anti-racist and intersectional lens.”

What that means in practice remains unclear. One city official, speaking on condition of anonymity because the plans were still evolving, said that there had been some discussion about prioritizing residents of some 27 neighborhoods that had been disproportionately hard hit in the spring. Many of those neighborhoods have predominately Black or Hispanic residents, the official said.

But the official added that the plans largely depended on how much of the vaccine the city received in the coming months.

In the past, the city has released lists of neighborhoods it has deemed particularly hard-hit.” (B)

“The first COVID vaccines are expected to arrive in New Jersey within days — even before the vaccine is authorized for use by the federal government. Six hospitals have been selected to receive the super-cold cases of frozen vaccine as part of a dry run by Operation Warp Speed.

“They’re checking their own logistics and want to check their plan” before full-scale distribution gets underway once the vaccines are authorized by the federal Food and Drug Administration, said Regina Foley, Hackensack Meridian Health’s vaccine czar.

The six hospitals — Hackensack University Medical Center, Morristown Medical Center, University Hospital in Newark, Robert Wood Johnson University Hospital in New Brunswick, AtlantiCare Regional Medical Center in Atlantic City and Cooper University Hospital in Camden — all have Arctic-level subzero freezers ready to receive the shipments. 

“When we talk about light at the end of the tunnel, this is real,” Gov. Phil Murphy said Wednesday. No details were provided about the amount or dates of the shipments.

Positioning the vaccine in advance of its authorization allows the government “to test the delivery and storage systems,” said Donna Leusner, a spokeswoman for the state health department. Hospitals receiving the shipments have freezers that can maintain temperatures of –94 degrees Fahrenheit. Hackensack Meridian recently bought four of the freezers, and Atlantic Health two. 

The state Health Department is finalizing its vaccine distribution plan this week. Its goal is to inoculate 70% of the adult population, or 4.7 million people, in six months. The governor said he expects everyone in the state who wants a vaccine will be able to get one by April and May. 

Hospitals receiving the “pre-position” shipments won’t actually use the vaccine until the FDA issues an Emergency Use Authorization. 

The agency is meeting on Dec. 10 to consider an application from Pfizer to authorize its vaccine and on Dec. 17 to consider an application from Moderna. Clinical trials have shown both vaccines have an efficacy rate of around 95%.  

Once authorized, the vaccines will be given to two top priority groups first: nursing home staff and residents, and health care workers who face potential exposure to COVID patients or infectious materials on the job. 

Two shots are required to be effective. Pfizer’s must be spaced three weeks apart, and Moderna’s four weeks apart. 

How COVID vaccine will be distributed

Hospitals will follow state guidelines on distribution, they said. They expect to vaccinate “patient-facing” staff first. The vaccines are voluntary — no one is required to get one. They are not recommended for pregnant women, because they have not been tested in that group. 

One issue that health care institutions face is scheduling the vaccine. Results from early clinical trials of the vaccines showed that a significant percentage of recipients — perhaps as many as one-third — developed mild side effects such as headaches, low-grade fevers, muscle aches or fatigue, most commonly after the second shot. 

While the side effects are minor and should not discourage anyone from receiving the shot, “We don’t want anyone working who doesn’t feel well,” said Dr. Jan Schwarz-Miller, the chief medical and academic officer for Atlantic Health system. Staggered schedules should be used to vaccinate the staff, so that an entire shift or unit is not affected by potential absences.

The eligible staff for the first tranche of vaccines includes about 26,000 employees of Hackensack Meridian Health system’s hospitals from Pascack Valley Medical Center in the north to Ocean Medical Center in the south, Foley said. The priority list includes not only nurses, doctors, and respiratory therapists, but environmental services and dietary workers, who clean rooms and deliver meals to patients. 

Atlantic Health System, with five hospitals in Summit, Pompton Plains, Newton and Hackettstown as well as Morristown, also hopes to immunize nearly all of its 23,000 staff members, said Schwarz-Miller.

Nursing home residents and staffs will receive the vaccines through CVS or Walgreens, two national retail pharmacy chains that have partnered with the federal Department of Health and Human Services. 

The pharmacies will make three separate visits to the nursing homes to make sure everyone is vaccinated, according to the plan presented to the national Advisory Committee on Immunization Practices on Tuesday.” (J)

“Doses of Pfizer’s coronavirus vaccine, the first expected to gain federal approval, could arrive in Massachusetts in mid to late December. Hospitals should expect 975 doses in each cooler, identify their first 975 frontline staff who will receive it and then the next 975. Hospitals that don’t have super cold (-80 degrees Celsius) freezers should get in touch with their local dry ice supplier ASAP.

That’s some of the latest guidance from the state Department of Public Health as Massachusetts and communities around the world prepare for an historic coronavirus vaccination campaign. The DPH instructions apply to phase one, which is expected to include vaccines produced by both Pfizer and Cambridge-based Moderna, although Moderna has not yet filed for federal approval.

Hospital leaders say federal officials have suggested a wide range of estimated doses that may come to Massachusetts, between 200,000 and 700,000, depending on when the Moderna vaccine is approved.

The first doses may be limited to hospitals and long-term care facilities. The state’s interim plan says other essential workers might be included in the initial offering of vaccines, but there’s no mention of the other workers in this update. Some community health workers, teachers and EMTs say they should be on the list for early vaccines as well.

The CDC, in partnership with CVS and Walgreens, is managing vaccination of staff and patients at long-term care facilities. The DPH guidance for hospitals says priority should be given to health care personnel in direct or indirect contact with COVID-19 patients or infected materials. That includes doctors, nurses, radiology technicians, the people who disinfect rooms and cafeteria staff.

Even on the current high end of vaccine projections — 700,000 — there would not be enough doses for all those hospital employees, estimated to number about 350,000, and the thousands of employees and residents of nursing homes and other long-term care facilities. Both the Pfizer and Moderna vaccines are delivered as two shots administered several weeks apart. So 700,000 doses would cover 350,000 people. Hospitals say coronavirus vaccination will not be required for staff, at least not until there is enough for all health care workers.

Both the Pfizer and Moderna vaccines will come with the needles, face shields and other items used to give the shots. The Pfizer vaccine can either be stored in specialized freezers or kept in the coolers it arrives in, as long as the container is not opened more than twice a day for no more than three minutes each time and is repacked with dry ice every five days.

There’s concern that some Pfizer vaccines may be thrown out if they aren’t used quickly enough or if the hospitals don’t use all 975 doses. That’s less of a concern with Moderna’s vaccine, which DPH says will be shipped in 100-dose packages, can be stored in standard hospital freezers and does not need to be reconstituted with a liquid before administering.”  (C)

“Which Virginians will receive the first vaccinations?

Phase I

In the first wave, once it receives approval, Virginia will receive 70,000 doses of Pfizer’s vaccine.

Approval and distribution could begin as early as mid-December, said Northam.

Both Pfizer and Moderna vaccines require two doses, about two weeks apart. It’s expected that the second 70,000 doses of Pfizer’s vaccine will be ready in time for people’s second doses.

Health care workers and residents of long-term care facilities have been identified on a federal level as the top-priority groups to receive the vaccine.

The decisions for who goes first will be based upon medical ethics and protocols created by the Virginia Hospital and Health Association and the Virginia Disaster Medical Advisory Committee.

That group contains about 500,000 Virginians, according to Northam.

Phase II

Following them comes critical infrastructure staff, adults with high-risk medical conditions and adults ages 65 and older.

Phase III

After that group comes the general public, a group that shouldn’t expect the be eligible anytime soon.

“It will be a ways before we get to the general public,” said Dr. Daniel Carey, Virginia’s Secretary of Health and Human Resources, during Wednesday’s news conference.

How will the COVID-19 vaccine be distributed?

VDH has been working with hospitals, long-term care facilities and community providers for months in preparation for a vaccine distribution plan.

Along with administering the vaccine, these organizations will work with VDH on the following pieces of updating management information system:

Vaccine allocation

Vaccine ordering/tracking

Clinic operations (including appointment scheduling and recording of doses administered)

Tracking of doses administred

The vaccine will be administered by hospital systems or facilities equipped with ultra-cold storage facilities, which exist within each region of Virginia.

The state has also partnered with CVS and Walgreens, as well as other pharmacies, and medical offices for vaccine and distribution.” (G)

“Wisconsin ready to distribute vaccines.

State health officials have been working with partners at the federal and local levels, and are ready to distribute vaccines pending regulatory approval, Goodsitt said.

Wisconsin’s plan will be implemented in partnership with the state’s 97 local health departments and tribal jurisdictions, as well as health care providers, pharmacies, community-based organizations and other public agencies, she said.

More than 1,100 providers and 485 organizations have submitted forms to become vaccine providers, Goodsitt said Wednesday.

Two companies, Pfizer and Moderna, already have applied for emergency use authorization from the U.S. Food and Drug Administration for their vaccines. More companies are expected to apply in the coming months.

Once vaccines arrive, the first to be inoculated will be health care workers who have treated or been exposed to COVID-19 patients, residents of long-term care or assisted living facilities, people over age 65, and some essential workers under the DHS plan. Those groups are considered to be priority “Phase 1 populations” by the state.

If there aren’t enough doses for all frontline workers and first responders, state officials will follow guidance provided by the Advisory Committee on Immunization Practices and State Disaster Medical Committee, Goodsitt said.

The second phase will include all those from Phase 1 who have yet to be vaccinated, along with “other critical populations to be determined.” The state expects a larger number of doses to be available, likely enough to meet demand.

Wisconsin plans to take part in a program that will pair long-term care and assisted living facilities with specific pharmacies. Residents would be vaccinated where they live.

Vaccine distribution points would include health care providers and pharmacies, Goodsitt said.

Enrolled vaccine providers will order the COVID-19 vaccine from their state immunization program’s allocation, and the vaccine will then ship from the CDC’s distributor directly to the provider, the DHS plan says.

The minimum order for the Moderna vaccine is expected to be 100 doses, while Pfizer’s minimum is 975, Goodsitt said. Vaccines will be shipped with the supplies needed to administer the vaccine, including needles, syringes, and some PPE.

The state also plans to track COVID-19 vaccinations through the Wisconsin Immunization registry, an information system that can track doses administered, to whom, and where.

With the prospect that a coronavirus vaccine will become available for emergency use as soon as next month, states and cities are warning that distributing the shots to an anxious public could be hindered by inadequate technology, severe funding shortfalls and a lack of trained personnel.

While the Trump administration has showered billions of dollars on the companies developing the vaccines, it has left the logistics of inoculating and tracking as many as 20 million people by year’s end — and many tens of millions more next year — largely to local governments without providing enough money, officials in several localities and public health experts involved in the preparations said in interviews.

Public health departments, already strained by a pandemic that has overrun hospitals and drained budgets, are racing to expand online systems to track and share information about who has been vaccinated; to recruit and train hundreds of thousands of doctors, nurses and pharmacists to give people the shot and collect data about everyone who gets it; to find safe locations for mass vaccination events; and to convince the public of the importance of getting immunized.

The federal Centers for Disease Control and Prevention have sent $200 million to the states for the effort, with another $140 million promised in December, but state and local officials said that was billions of dollars short of what would be needed to carry out their complex plans.

“We absolutely do not have enough to pull this off successfully,” said Dr. Thomas E. Dobbs III, the state health officer of Mississippi. “This is going to be a phenomenal logistical feat, to vaccinate everybody in the country. We absolutely have zero margin for failure. We really have to get this right.”

Health departments have asked Congress for at least $8.4 billion more for “a timely, comprehensive, and equitable vaccine distribution campaign”; the C.D.C. director, Dr. Robert R. Redfield, has said that at least $6 billion is needed. But negotiations for further funding are caught up in the stalemate between House Democrats and the Trump administration over the coronavirus stimulus bill.

“Much of the discussion around vaccine priority has focused on minimizing the number of Covid-19 deaths and cases, but those will not be the only two factors in play. Dr. Anthony S. Fauci, the nation’s top infectious disease expert, said on NPR in November that the priority list will be graded according not only to risk but to the degree to which certain people, like teachers and child-care providers, are deemed “important to society.”

How one measures importance to society is, of course, a very thorny question. The National Academies framework, for its part, suggests that people should have higher priority “to the extent that societal function and other individuals’ lives and livelihood depend on them directly and would be imperiled if they fell ill.” In other words, economic and quality of life concerns will be part of the equation.

But state officials may come to different conclusions about where the right balance lies between those concerns and the need to contain the virus. In New York, for example, Gov. Andrew Cuomo announced that, in contrast to the National Academies plan, the state would prioritize teachers, transit workers and grocery store workers before the 65 and older age group. That may not minimize the number of lives lost to the virus, but it could presumably do more to relieve the strain so many parents, children and workers are facing.” (D)

“The first rigorously tested coronavirus vaccine was given a green light for use on Wednesday in Britain. Doses of the vaccine, made by the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected starting next week, the government said.

In leaping ahead of the United States to allow mass inoculations, Britain added to the pressure on American drug regulators, who were summoned to the White House on Tuesday by President Trump’s chief of staff to explain why they were not ready to do the same.

Why did Britain authorize a vaccine before the U.S.?,

The two countries vet vaccines differently.

Rather than accepting the findings of vaccine makers, American regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, said on Tuesday that the F.D.A. “is one of the few regulatory agencies in the world that actually looks at the raw data.”” (E)

“…..when it comes to coronavirus testing, this is a nation of haves and have-nots.

Among the haves are professional and college athletes. That’s been true, and a subject of fierce debate, since at least March, when entire rosters of NBA teams got tested for the virus before many Americans could access tests. As sports lurched back to life over the summer, health experts debated the ethics of entire leagues jumping to the front of the testing line. But ultimately the leagues, with billions of revenue dollars at stake, contracted with private labs to pay for the best and fastest tests available — a luxury many hospitals and other healthcare providers, reeling from the pandemic, can’t afford.

From Nov. 8 to 14, the NFL administered 43,148 tests to 7,856 players, coaches and employees. Major college football programs supply dozens of tests each day, an attempt — futile as it has been — to maintain health and prevent schedule interruptions. Major League Soccer administered nearly 5,000 tests last week, and Major League Baseball conducted some 170,000 tests during its truncated season.

Sandoval, meanwhile, is a 58-year-old front-line worker who regularly treats patients either suspected or confirmed to have been infected by the coronavirus. In eight months, she has never been tested. She says her employer, California Pacific Medical Center, refuses to provide testing for its medical staff even after possible exposure.

Watching sports, then, no longer represents an escape from reality for Sandoval. Instead, she says, it’s a signal of what the nation prioritizes.

“There’s an endless supply in the sports world,” she says of coronavirus tests. “You’re throwing your arms up. I like sports as much as the next person. But the disparity between who gets tested and who doesn’t, it doesn’t make any sense.”

This month, registered nurses gathered in Los Angeles to protest the fact that UCLA’s athletic department conducted 1,248 tests in a single week while health-care workers at UCLA hospitals were denied testing. Last week National Nurses United, the country’s largest nursing union, released the results of a survey of more than 15,000 members. About two-thirds reported they had never been tested.

Since August, when NFL training camps opened, the nation’s most popular and powerful sports league — one that generates more than $15 billion in annual revenue — has conducted roughly 645,000 coronavirus tests.

“These athletes and teams have a stockpile of covid testing, enough to test them at will,” says Michelle Gutierrez Vo, another registered nurse and sports fan in California. “And it’s painful to watch. It seemed like nobody else mattered or their lives are more important than ours.”

Months into the pandemic, and with vaccines nearing distribution, testing in the United States remains something of a luxury. Testing sites are crowded, and some patients still report waiting days for results. Sandoval said nurses who suspect they’ve been exposed are expected to seek out a testing site on their own, at their expense, and take unpaid time while they wait for results — in effect choosing between their paycheck and their health and potentially that of others.” (F)

_____________________________________

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