
Cartoon – The Right Vaccine



As President Trump pushes the possibility of a vaccine this year, the C.D.C. has outlined technical scenarios to state public health officials for an unidentified Vaccine A and Vaccine B.
The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November.
The new C.D.C. guidance is the latest sign of an accelerating race for a vaccine to ease a pandemic that has killed more than 184,000 Americans. The documents were sent out on the same day that President Trump told the nation in his speech to the Republican National Convention that a vaccine might arrive before the end of the year.
Over the past week, both Dr. Anthony S. Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, who heads the Food and Drug Administration, have said in interviews with news organizations that a vaccine may be available for certain groups before clinical trials have been completed, if the data is overwhelmingly positive.
Public health experts agree that agencies at all levels of government should urgently prepare for what will eventually be a vast, complex effort to vaccinate hundreds of millions of Americans. But the possibility of a rollout in late October or early November has heightened concerns that the Trump administration is seeking to rush the distribution of a vaccine — or simply to hype that one is possible — before Election Day on Nov. 3.
For an administration that has struggled with the logistical challenges of containing the coronavirus, the distribution of millions of vaccines that must be stored in subzero temperatures and provided first to high-risk groups through America’s flawed, fragmented health care system would be a daunting challenge. Even the C.D.C.’s guidance acknowledged that its plan was hypothetical and based on the need to immediately begin organizing the gigantic effort that would be required if the F.D.A. were to allow the use of a vaccine or two this year.
The C.D.C. plans lay out technical specifications for two candidates described as Vaccine A and Vaccine B, including requirements for shipping, mixing, storage and administration. The details seem to match the products developed by Pfizer and Moderna, which are the furthest along in late-stage clinical trials. On Aug. 20, Pfizer said it was “on track” for seeking government review “as early as October 2020.”

Credit…
“This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications,” said Saskia Popescu, an infection prevention epidemiologist based in Arizona. “It’s hard not to see this as a push for a pre-election vaccine.”
Three documents were sent to public health officials in all states and territories as well as officials in New York, Chicago, Philadelphia, Houston and San Antonio on Aug. 27. They outlined detailed scenarios for distributing two unidentified vaccine candidates, each requiring two doses a few weeks apart, at hospitals, mobile clinics and other facilities offering easy access to the first targeted recipients.
The guidance noted that health care professionals, including long-term care employees, would be among the first to receive the product, along with other essential workers and national security employees. People 65 or older, as well as Native Americans and those who are from “racial and ethnic minority populations” or incarcerated — all communities known to be at greater risk of contracting the virus and experiencing severe disease — were also prioritized in the documents.
That’s a positive development, “so it doesn’t just all wind up in high-income, affluent suburbs,” said Dr. Cedric Dark, an emergency medicine physician at Baylor College of Medicine in Texas.
The C.D.C. noted in its guidance that “limited Covid-19 vaccine doses may be available by early November 2020.” The documents were dispatched the same day that Dr. Robert Redfield, director of the C.D.C., sent a letter to governors asking them to prepare vaccine distribution sites by Nov. 1, as McClatchy reported.
The agency also said its plans were as yet hypothetical, noting, “The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” A C.D.C. spokeswoman confirmed that the documents were sent but declined to comment further.
Many of the details listed for the two vaccines — including required storage temperature, the number of days needed between doses, and the type of medical center that can accommodate the product’s storage — match what Pfizer and Moderna have said about their products, which are based on so-called mRNA technology. Neither company responded to requests for comment.
The scenarios, which assume that the two vaccines will demonstrate sufficient safety and effectiveness for an emergency authorization from the F.D.A. by the end of October, noted that Vaccine A, which seems to match Pfizer’s, would have about two million doses ready within this time frame, and that Vaccine B, whose description matches Moderna’s, would have about one million doses ready, with tens of millions of doses of each vaccine ready by the end of the year. Although it’s possible that some promising preliminary data may emerge by the end of October, experts are skeptical.
“The timeline that’s reported seems a bit ambitious to me,” Dr. Dark said. “October’s like 30 days away.”
Trials that test a vaccine’s effectiveness can take years to yield reliable results. It’s possible to draw conclusions sooner “if there is an overwhelming effect” in which vaccinated people appear to be far better protected from disease, said Padmini Pillai, a vaccine researcher and immunologist at M.I.T.
But there can be significant risks in approving a vaccine for broad use in the public before Phase 3 clinical trials involving tens of thousand of participants are completed. Rare but dangerous side effects may only surface over time, after such large numbers of people have received the vaccine.
And data gathered early in a trial might not hold true months down the line. Researchers also need time to test large numbers of people from a variety of backgrounds to determine how well the vaccine works in different populations — including the vulnerable communities identified in the guidelines.
Should any of these snags occur, Dr. Pillai said, “all of this together could diminish public trust in the vaccine.”
James S. Blumenstock, senior vice president of pandemic response and recovery at the Association of State and Territorial Health Officials, confirmed that the three C.D.C. documents were sent to all state and territorial health departments last week. “It is now the time to enhance organizational structure and involve all partners in this planning process going forward,” he said.
Lisa Stromme, a spokeswoman for the Washington State Department of Health, said that her state’s health officials were still at “a very early stage in a planning process,” but were already working toward developing infrastructure that would accommodate the assumptions laid out by the C.D.C.
The C.D.C. documents said that public health administrators should review lessons learned from the 2009 H1N1 pandemic vaccination campaign, which did not have enough doses at the beginning to meet demand.
“It’s good to have a plan out for hospitals and health care systems to prepare” for a potential rollout, said Dr. Taison Bell, a pulmonary and critical care physician at the University of Virginia. But Dr. Bell added that he was concerned that the timeline outlined in the documents “is incredibly ambitious and makes me worry that the administration will prioritize this arbitrary deadline rather than maintaining diligence with following the science.”
The technical comparison of Vaccine A and Vaccine B has some echoes of what was discussed at an Aug. 26 meeting of the Advisory Committee on Immunization Practices of the C.D.C. At the meeting, Dr. Kathleen Dooling, a C.D.C. medical officer, laid out three scenarios: Vaccine A, or the Pfizer vaccine, is approved, Vaccine B, the Moderna vaccine, is approved, or both. The requirement that Pfizer’s vaccine be stored at minus 70 degrees Celsius would mean that it couldn’t be administered at most small sites, she said. The C.D.C. documents noted that orders of Vaccine A would go “to large administration sites only.” The Moderna vaccine requires storage at minus 20 degrees Celsius.
The C.D.C. documents said the vaccine would be free to patients, but that providers might not be reimbursed for administrative costs if the vaccine was given an emergency authorization, rather than a standard approval.
Experts worry that the process is unlikely to go off without a hitch, given the last-minute scramble and the mixed messaging so far. “I think distribution is going to be very tricky for the vaccine, particularly if there is a cold storage requirement,” Dr. Bell said.
There are also likely to be challenges administering both doses of the proposed vaccines, which must be given weeks apart, Dr. Dark said. “How are you going to make sure people get both?”

Those on the front lines of the fight against the novel coronavirus worry about keeping themselves, their families and their patients safe.
This story is part of a series examining the state of healthcare six months into the public health emergency declared for COVID-19.
There’s no end in sight for the country as it grapples with another surge of COVID-19 cases.
That’s especially true for nurses seeking the reprieve of their hospitals returning to normal operations sometime this year. Many in the South and West are now treating ICUs full of COVID-19 patients they hoped would never arrive in their states, largely spared from spring’s first wave.
And like many other essential workers, those in healthcare are falling ill and dying from COVID-19. The total number of nurses stricken by the virus is still unclear, though the Centers for Disease Control and Prevention has reported 106,180 cases and 552 deaths among healthcare workers. That’s almost certainly an undercount.
National Nurses United, the country’s largest nurses union, told Healthcare Dive it has counted 165 nurse deaths from COVID-19 and an additional 1,060 healthcare worker deaths.
Safety concerns have ignited union activity among healthcare workers during the pandemic, and also given them an opportunity to punctuate labor issues that aren’t new, like nurse-patient ratios, adequate pay and racial equality.
At the same time, the hospitals they work for are facing some of their worst years yet financially, after months of delayed elective procedures and depleted volumes that analysts predict will continue through the year. Many have instituted furloughs and layoffs or other workforce reduction measures.
Healthcare Dive had in-depth conversations with three nurses to get a clearer picture of how they’re faring amid the once-in-a-century pandemic. Here’s what they said.
Elizabeth Lalasz has worked at John H. Stroger Hospital in Chicago for the past 10 years. Her hospital is a safety net facility, catering to those who are “Black, Latinx, the homeless, inmates,” Lalasz told Healthcare Dive. “People who don’t actually receive the kind of healthcare they should in this country.”
Data from the CDC show racial and ethnic minority groups are at increased risk of getting COVID-19 or experiencing severe illness, regardless of age, due to long-standing systemic health and social inequities.
CDC data reveal that Black people are five times more likely to contract the virus than white people.
This spring Lalasz treated inmates from the Cook County Jail, an epicenter in the city and also the country. “That population gradually decreased, and then we just had COVID patients, many of them Latinx families,” she said.

Once Chicago’s curve began to flatten and the hospital could take non-COVID patients, those coming in for treatment were desperately sick. They’d been delaying care for non-COVID conditions, worried a trip to the hospital could risk infection.
A Kaiser Family Foundation poll conducted in May found that 48% of Americans said they or a family member had skipped or delayed medical care because of the pandemic. And 11% said the person’s condition worsened as a result of the delayed care.
When patients do come into Lalasz’s hospital, many have “chest pain, then they also have diabetes, asthma, hypertension and obesity, it just adds up,” she said.
“So now we’re also treating people who’ve been delaying care. But after the recent southern state surges, the hospital census started going down again,” she said.
Amy Arlund works the night shift at Kaiser Fresno as an ICU nurse, which she’s done for the past two decades.
She’s also on the hospital’s infection control committee, where for years she’s fought to control the spread of clostridium difficile colitis, or C. diff., in her facility. The highly infectious disease can live on surfaces outside the body for months or sometimes years.
The measures Arlund developed to control C. diff served as her litmus test, as “the top, most stringent protocols we could adhere to,” when coronavirus patients arrived at her hospital, she told Healthcare Dive.
But when COVID-19 cases surged in northern states this spring, “it’s like all those really strict isolation protocols that prior to COVID showing up would be disciplinable offenses were gone,” Arlund said.
Widespread personal protective equipment shortages at the start of the pandemic led the CDC and the Occupational Safety and Health Administration to change their longstanding guidance on when to use N95 respirator masks, which have long been the industry standard when dealing with novel infectious diseases.
The CDC also issued guidance for N95 respirator reuse, an entirely new concept to nurses like Arlund who say those changes go against everything they learned in school.
“I think the biggest change is we always relied on science, and we have always relied heavily on infection control protocols to guide our practice,” Arlund said. “Now infection control is out of control, we can no longer rely on the information and resources we always have.”

The CDC says experts are still learning how the coronavirus spreads, though person-to-person transmission is most common, while the World Health Organization recently acknowledged that it wouldn’t rule out airborne transmission of the virus.
In Arlund’s ICU, she’s taken care of dozens of COVID positive patients and patients ruled out for coronavirus, she said. After a first wave in the beginning of April, cases dropped, but are now rising again.
Other changing guidance weighing heavily on nurses is how to effectively treat coronavirus patients.
“Are we doing remdesivir this week or are we going back to the hydroxychloroquine, or giving them convalescent plasma?”Arlund said. “Next week I’m going to be giving them some kind of lavender enema, who knows.”
Erik Andrews, a rapid response nurse at Riverside Community Hospital in California, has treated coronavirus patients since the pandemic started earlier this year. He likens ventilating them to diffusing a bomb.
“These types of procedures generate a lot of aerosols, you have to do everything in perfectly stepwise fashion, otherwise you’re going to endanger yourself and endanger your colleagues,” Andrews, who’s been at Riverside for the past 13 years, told Healthcare Dive.
He and about 600 other nurses at the hospital went on strike for 10 days this summer after a staffing agreement between the hospital and its owner, HCA Healthcare, and SEIU Local 121RN, the union representing RCH nurses, ended without a renewal.
The nurses said it would lead to too few nurses treating too many patients during a pandemic. Insufficient PPE and recycling of single-use PPE were also putting nurses and patients at risk, the union said, and another reason for the strike.
But rapidly changing guidance around PPE use and generally inconsistent information from public officials are now making the nurses at his hospital feel apathetic.
“Unfortunately I feel like in the past few weeks it’s gotten to the point where you have to remind people about putting on their respirator instead of face mask, so people haven’t gotten lax, but definitely kind of become desensitized compared to when we first started,” Andrews said.

With two children at home, Andrews slept in a trailer in his driveway for 12 weeks when he first started treating coronavirus patients. The trailer is still there, just in case, but after testing negative twice he felt he couldn’t spend any more time away from his family.
He still worries though, especially about his coworkers’ families. Some coworkers he’s known for over a decade, including one staff member who died from COVID-19 related complications.
“It’s people you know and you know that their families worry about them every day,” he said. “So to know that they’ve had to deal with that loss is pretty horrifying, and to know that could happen to my family too.”
U.S. advisory group lays out detailed recommendations on how to prioritize Covid-19 vaccine

A new report that aims to prioritize groups to receive Covid-19 vaccine lays out detailed recommendations on who should be at the front of the line, starting with health care workers in high-risk settings, followed by adults of any age who have medical conditions that put them at significantly higher risk of having severe disease.
Also toward the front of the line would be older adults living in long-term care homes or other crowded settings.
The draft report, which runs 114 pages, was released Tuesday by the National Academies of Sciences, Engineering, and Medicine, which was tasked with the work by Francis Collins, director of the National Institutes of Health, and Robert Redfield, director of the Centers for Disease Control and Prevention.
A virtual public meeting on the recommendations will be held Wednesday afternoon, and the committee’s final report will be submitted later in September.
When Covid-19 vaccines are approved for use, initial supplies will be tight — potentially in the tens of millions of doses. Most of the vaccines under development will require two doses per person: a priming dose followed by a booster either three or four weeks later.
The report suggests that a second phase of vaccinations should involve critical risk workers — people in industries essential to the functioning of society — as well as teachers and school staff; people of all ages with an underlying health problem that increases the risk of severe Covid-19; all older adults not vaccinated in the first phase; people in homeless shelters and group homes, and prisons; and staff working in these facilities.
Young adults, children, and workers in essential industries not vaccinated previously would make up the third priority group. Remaining Americans who were not vaccinated in the first three groups would be offered vaccine during a fourth and final phase.
The report is meant to serve as a guide for more detailed prioritization plans on the order in which Americans will be offered vaccine. That more granular work is already being conducted by the Advisory Committee on Immunization Practices, an expert panel that crafts vaccination guidance for the CDC, and by state, local, and tribal health authorities, who must identify the actual people in their regions who fall into the priority groups.
There has been discussion of prioritizing people of color, who have been disproportionately badly hit in this pandemic. But the report does not recommend that Black, Hispanic, Latinx people, or American Indians or Alaskan natives be treated as a distinct priority group.
The committee suggested that there does not appear to be a biological reason for why these communities are more seriously affected by the pandemic. Instead, it argues, the high rates of infections and deaths in these communities are due to systemic racism that leads to higher levels of poor health and socioeconomic factors such as working in jobs that cannot be done from home or living in crowded settings.
The report therefore prioritized other factors — people with underlying medical problems, people living in crowded environments, for instance — rather than creating priority categories for racial or ethnic groups.
The ACIP’s recommendations will go to the CDC. It remains unclear, however, whether the CDC, Operation Warp Speed — the task force set up to fast-track development of Covid-19 vaccines, drugs and diagnostics — or the White House will make the final determinations on who will be vaccinated first.
The task of determining who should be at the front of the vaccines line is not an easy one, and must be made without key pieces of information. It’s not yet known how many vaccines will prove to be successful, when they will be approved for use and in what quantities. Critically, some vaccines may prove to be more effective in key groups — the elderly, for instance — than others. Knowing that in advance could influence the recommendations, but people working on the priority groups cannot wait for that information to become available.
Initial discussions suggest large numbers of Americans would qualify as members of priority groups, a reality that will likely require additional tough decisions to be made.
CDC estimates that there are between 17 million and 20 million health care workers in the country, and roughly 100 million people with medical conditions that put them at increased risk of severe illness if they contract Covid-19. There are roughly 53 million Americans aged 65 and older and 100 million people in jobs designated as essential services. There is some overlap among these groups — health workers, for instance, are also essential workers.
A report released last month by the Johns Hopkins Center for Health Security recommended dividing priority groups into two tiers, with health workers and others essential to the Covid-19 response in the first tier and other health workers in the second.
In that report, people at greatest risk and their caregivers, and workers most essential to maintaining core societal functions would also be designated to be in the first tier.