Virus World

The Trump administration moved on Tuesday to accelerate vaccinations of Americans against COVID-19, releasing the rest of the doses it had been keeping in reserve and recommending states immediately open inoculations to those aged 65 and over.  Federal and state health officials have scrambled in recent days to step up vaccination programs that had given shots to only 9.3 million Americans as coronavirus infections remain at record highs in many U.S. states nearly two weeks into the new year. Many U.S. states had strict rules in place giving shots to healthcare workers and nursing home residents first, telling “non-essential workers” they might wait months for their turn. “We’ve already distributed more vaccine than we have healthcare workers and people in nursing homes,” U.S. Health and Human Services Secretary Alex Azar told ABC News. “We’ve got to get to more channels of administration.” Roughly 27.5 million doses have been distributed by the U.S. government to states so far, according to the U.S. Centers for Disease Control and Prevention.Azar said the outgoing administration, which had been keeping doses in reserve to make sure that all those who got a first inoculation receive their second shot on schedule, was now confident enough in the supply chain to release that stockpile. 

Last week, a spokesman for Joe Biden said the president-elect, who takes office on Jan. 20, would release more of the reserved doses. The pace of vaccinations has risen to 700,000 a day nationwide and was expected to hit 1 million a day within 10 days, officials said. “Michigan and states across the country remain ready to get more shots in arms, which is why the Trump Administration’s decision to grant our request and release millions of doses of the vaccine is so crucial,” Michigan Governor Gretchen Whitmer said in a statement. Whitmer, who had backed the lower vaccination age, is seeking permission from the U.S. government to purchase 100,000 vaccine doses directly from manufacturer Pfizer Inc.  The U.S. Food and Drug Administration has authorized the vaccine from Pfizer and partner BioNTech SE and a second vaccine from Moderna Inc for emergency use. As of Monday night, the United States had reported a total of 22.5 million coronavirus infections and 376,188 deaths during the pandemic, the most of any country. Nearly 130,000 Americans were hospitalized with COVID-19 at midnight on Monday.

GRIM SCENES AT CALIFORNIA HOSPITAL

A Reuters tally has shown that the number of COVID-19 patients requiring hospitalization may have leveled off, at least temporarily, although public health officials warn that further spread may still be seen from holiday gatherings. California Health and Human Services Secretary Dr. Mark Ghaly cited several promising trends in COVID metrics statewide in recent days, including a slowing in confirmed daily case numbers and a leveling off in positive tests. The number of new COVID hospitalizations statewide has fallen to about 2,500 admissions a day over the past two days from a daily average of about 3,500 admissions in previous days. Ghaly called that “the biggest signal to me that things are beginning to flatten and potentially improve."  Despite the encouraging statistics, staff at Providence St. Mary Medical Center in Apple Valley, California, said that the situation was grim. “Where in the beginning we were overloaded with a lot of patients - we still have a lot of patients - but now it seems like they’re sicker than they’ve ever been before,” said Mary Mendy, executive director of acute care services at the hospital some 90 miles northeast of Los Angeles.  “And every day there’s Code Blues on the floor and more and more patients are updated to ICU. It’s devastating,” Mendy said. The latest surge has potentially been compounded by a more infectious variant of the virus first seen in the UK and now found in at least 10 U.S. states - California, Florida, New York, Colorado, Georgia, Indiana, Connecticut, Minnesota, Pennsylvania and Texas.

The panel says adults aged 75 and older, as well as frontline essential workers, be designated as the second priority group. n expert panel that advises the Centers for Disease Control and Prevention recommended Sunday that adults aged 75 and older, as well as frontline essential workers, be designated as the second priority group to be vaccinated against Covid-19. The Advisory Committee on Immunization Practices also voted to recommend that the third stage of the national vaccination program should focus on adults 65 to 74, people 16 to 64 years old with high-risk medical conditions, and essential workers not included in the second phase of vaccination. The committee defined frontline essential workers as first responders, teachers and other education workers including day care workers, food and agriculture workers, correctional facility staff, postal workers, public transit workers, and people who work in manufacturing and in grocery stores. The vote came after hours of data presentations and debate, and pleas from members of the public to move up individual groups in the priority listing. “I voted for this recommendation because in my opinion, it follows the evidence about the risk from coronavirus and the ethical principles that we have developed on ACIP to maximize the benefits and minimize harms, promote justice, and to minimize health inequities,” said Peter Szilagyi, a pediatrician at UCLA.  “We are trying to thread the needle here.”

Szilagyi and multiple members of the committee said the work to decide who gets priority access to Covid-19 vaccines has been agonizing.   “This is without a doubt the hardest vote that I have taken in my 6 1/2 years on this committee,” said chair Jose Romero, secretary of health for Arkansas.  The committee voted 13 to 1 to approve the groups to be included in Phase 1b and Phase 1c of the vaccination program. Phase 1a, which is currently ongoing, gives top priority to health care workers and residents and staff of nursing homes. The lone dissenter, Henry Bernstein, a pediatrician and professor at the Zucker School of Medicine at Hofstra/Northwell, said he felt that adults aged 65 and older should have been in Phase 1b. The toll the virus takes on people 65 to 74 is not substantially different from its impact on people 75 and older, he argued. The ACIP recommendations now go to CDC Director Robert Redfield, who must sign off on them in order for them to become CDC guidance. However, state and local health authorities make the final decisions on how to roll out vaccination in their locales. At the end of Sunday’s meeting it was announced that more than half a million people in the country have already been vaccinated with the Pfizer Covid-19 vaccine. Moderna’s vaccine, which was given an emergency use authorization Friday evening by the Food and Drug Administration, will begin to be rolled out this week. 

The ACIP’s Covid vaccines work group, which proposed the priority groups, explained it was trying to balance the prevention of illness and death with trying to maintain societal functioning as well as equity. Frontline essential workers are in jobs where they cannot work from home; they may not even be able to practice social distancing because of the demands of their work. Previously the committee had talked about putting all essential workers ahead of seniors — an idea which drew pushback from Health and Human Services Secretary Alex Azar, among others.  But the entire essential workers group, which is based on a list drawn up by a division of the Department of Homeland Security, represents about 87 million people — too big a group at a time when vaccine supplies are scarce. Essential workers who will have to wait for Phase 1c for vaccine include people who maintain water and wastewater systems, people who work in the IT and communications sector, members of the media, and public safety workers.  Operation Warp Speed, the federal government’s program to fast-track vaccine production, estimates there will be enough vaccine to vaccinate 20 million people in December, another 30 million in January, and an additional 50 million by the end of February. Phase 1a of the vaccination effort, which began last week, involves offering vaccine to 24 million people. In Phase 1b, 49 million people will be eligible to receive vaccine. Phase 1c is a much larger group, including roughly 129 million people. In total, the first three priority groups will cover 202 million people — double the number of people the country expects to have vaccine for by the end of February.....

CDC ACIP Meetings Recommendations (Nov. 23, 2020):

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-11/COVID-04-Dooling.pdf 

CDC Data on Vaccine Administration and Distribution (updated daily):

https://covid.cdc.gov/covid-data-tracker/#vaccinations

Margaret Keenan, 90, given approved vaccine to start mass immunisation programme. A 90-year-old woman has become the first patient in the world to receive the Pfizer Covid-19 vaccine after its approval in the UK, where the NHS has launched its biggest vaccine campaign. Margaret Keenan received the jab at about 6.45am in Coventry, marking the start of a historic mass vaccination programme. The vaccines will be administered at 50 hospital hubs around the country, with patients aged 80 and over who are either already attending hospital as an outpatient or are being discharged home after a hospital stay, being first in line. Keenan, known as Maggie, received the injection from the nurse May Parsons at University hospital and said it was a “privilege”. The former jewellery shop assistant who retired four years ago turns 91 next week.

“I feel so privileged to be the first person vaccinated against Covid-19, it’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year,” said Keenan, who has a daughter, a son and four grandchildren. She is originally from Enniskillen, Northern Ireland, but has lived in Coventry for more than 60 years. “I can’t thank May and the NHS staff enough who have looked after me tremendously, and my advice to anyone offered the vaccine is to take it – if I can have it at 90 then you can have it too,” she said. Parsons said it was a “huge honour” to be the first in the country to deliver the vaccine to a patient. “I’m just glad that I’m able to play a part in this historic day. The last few months have been tough for all of us working in the NHS, but now it feels like there is light at the end of the tunnel,” said Parsons, who is originally from the Philippines and has worked in the NHS for the last 24 years.

Boris Johnson said: “Thank you to our NHS, to all of the scientists who worked so hard to develop this vaccine, to all the volunteers – and to everyone who has been following the rules to protect others.” The prime minister added: “We will beat this together.” Matt Hancock said he felt emotional watching the video of Keenan receiving the vaccine and hailed the moment as “a triumph of science and human ingenuity”. Several million further doses will be arriving in the UK this month, the health secretary told Sky News, although he declined to give an exact figure, saying it depended on the manufacturing and transportation processes. “We have a high degree of confidence in the delivery that will come next week.” He said the government hoped to start providing the vaccine in care homes before Christmas, and that coronavirus restrictions could be lifted in the spring, once enough people who were vulnerable to Covid-19 had been vaccinated. However, he said people should continue to obey the coronavirus restrictions: “We’ve got to stick together and we’ve got to follow the rules … It is no good everybody relaxing now – we’ve got to hold firm until the vaccination programme has reached enough vulnerable people so that we don’t have people dying from coronavirus in the number that we do today.”....

“Anything that’s seen as lifesaving, life-preserving, and that's in short supply creates black markets,” said one ethicist. Bill Lang didn’t get much of a break over Thanksgiving. Almost every day last week, the medical director at a high-end concierge medical practice, WorldClinic, heard from clients asking when a Covid-19 vaccine would be available. Two patients even texted on Thanksgiving day. “Since then, I’ve had at least three texts or calls every day just asking, ‘When do you think I can get a vaccine?’” said Lang, who is based in Washington, but also speaks with patients across the U.S. and internationally. Athletes, politicians, and other wealthy or well-connected people have managed to get special treatment throughout the pandemic, including preferential access to testing and unapproved therapies. Early access to coronavirus vaccines is likely to be no different, medical experts and ethicists told STAT. It could happen in any number of ways, they said: fudging the definition of “essential workers” or “high-risk” conditions, lobbying by influential industries, physicians caving to pressure to keep their patients happy, and even through outright bribery or theft. The worst attempts to nefariously procure a vaccine may come a few months into distribution, once vaccines are available that don’t require ultra-cold storage and local pharmacies and physician practices get allotments. “There absolutely will be a black market,” said bioethicist Arthur Caplan of New York University. “Anything that’s seen as lifesaving, life-preserving, and that’s in short supply creates black markets.”

At WorldClinic, which charges members $10,000 to $250,000 a year for 24/7 care, no patients have asked for special treatment and the clinic would not undermine its integrity by trying to secure vaccines unethically, said Lang, who was a White House physician during both the Bush and Clinton administrations. “The optics of trying to jump the line would be so bad, they don’t want to do that.” But within the broader system, he added, some people will inevitably cut in line. “Essential workers” are expected to receive early access to the vaccine, and the definition of this category is open to interpretation by state health departments, creating a means for influential industries to lobby for priority. “The devil’s going to be in the details of how the state runs their program,” Lang said he tells his patients. Members of the Advisory Committee on Immunization Practices (ACIP), the federal panel recommending how to distribute the vaccines, want to prioritize essential workers to help ensure people of color, who are often the hardest hit by the virus, get early access. But the predominantly white workers in the financial services industry are also considered essential, according to guidance from the Cybersecurity and Infrastructure Security Agency, which was referenced by ACIP, as well as executive orders from several states including New York, Illinois, Colorado, and California. Public-facing bank tellers face contagion risks in their work, but aren’t the only financial services employees included. “It was left a little bit nebulous but basically covered people who oil the movement of money, so exchanges, trading floors, trading operations, and people who keep money moving at the retail [banking] level,” said Lang. “They’re defined very broadly in New York and Illinois, because that’s where so many of our financial services industries are based.”

The concept of “essential workers” has already been tested during the pandemic, when Florida declared that World Wrestling Entertainment (WWE) met the definition and could remain open during lockdown. The chairman of WWE, Vince McMahon, is friends with President Trump, while his wife, Linda McMahon, served in the administration and is chair of a pro-Trump super PAC. Neither WWE nor Florida’s health department responded to requests for comment about whether WWE would be considered essential for the vaccine rollout. Other powerful industries might be tempted to follow this example. The potential of industry lobbyists “redefining what an essential worker is is a very strong possibility,” said Glenn Ellis, a visiting scholar at the National Center for Bioethics in Research and Health care at Tuskegee University and a narrative bioethics fellow at Harvard Medical School. Prioritizing essential workers is intended to give early vaccine access to those who provide a critical societal function and cannot socially distance easily, the Colorado health department said in a statement that acknowledged it can be difficult to write airtight rules. “Given the thousands of different job descriptions in the state, it is impossible to come up with a complete list for every occupation for a specific vaccine phase. Vaccine providers will need to use their best judgment about which patients may qualify for vaccination during this phase.”  The California health department confirmed financial services employees, including those needed to “maintain orderly market operations,” will have early access to the vaccine as essential workers, as will people in the news media, such as reporters. State health departments in New York and Illinois did not respond to requests for comment about whether those in financial services would receive a vaccine early.

Another opening that could be exploited to skip the line involves high-risk medical conditions that warrant early access to the vaccine. Smokers are within this group, according to ACIP, and people with conditions such as moderate-to-severe asthma and high blood pressure could also be included.  This leaves room for a doctor to, for example, portray a patient’s mild asthma as severe enough to justify early access to a vaccine, said Jonathan Cushing, head of major projects of the health initiative at Transparency International, a nonprofit focused on global corruption. The profit motives within U.S. health care make it particularly susceptible to such distortions, he said: “It’s a market-based economy. You as a doctor want to keep your clients coming back.” Given the need to protect patient privacy, Lang said he doesn’t expect immunization sites to demand documentation of health risk factors. Instead, they will likely either ask patients to state that they have one of the relevant conditions, without disclosing details, or require physician certification, he said: “A lot of that is left to a doctor’s judgment.”  Exaggerating sickness is not a new phenomenon in the U.S. medical system. Insurance companies have portrayed Medicare patients as sicker than they really are, so as to receive higher government payouts. Similarly, physicians to wealthy patients could “make sure they’re among the first to get the vaccines by fudging it in a way that would enable their clients to cut in line” said Wendell Potter, former head of corporate communications at Cigna and current head of the nonprofit Center for Health and Democracy.....

A C.D.C. advisory panel will decide on its recommendations on Tuesday afternoon. Here’s what we expect, along with answers to other questions about the new shot. After months of deliberation and debate, a panel of independent experts advising the Centers for Disease Control and Prevention is set to decide on Tuesday which Americans it will recommend to get the coronavirus vaccine first, while supply is still short. The panel, the Advisory Committee on Immunization Practices, will vote in a public meeting on Tuesday afternoon, and it is expected to advise that health care workers be first in line, along with residents of nursing homes and other long-term care facilities. If the C.D.C. director, Dr. Robert R. Redfield, approves the recommendations, they will be shared with states, which are preparing to receive their first vaccine shipments as soon as mid-December, if the Food and Drug Administration approves an application for emergency use of a vaccine developed by Pfizer. States don’t have to follow the C.D.C.’s recommendations, but most probably will, said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies. The committee will meet again soon to vote on which groups should be next to receive priority. Here are answers to some common questions about the vaccine and its distribution.

This article was originally published on Undark. Read the original article. If the book of nature is written in the language of mathematics, as Galileo once declared, the covid-19 pandemic has brought that truth home for the world’s mathematicians, who have been galvanized by the rapid spread of the coronavirus. So far this year, they have been involved in everything from revealing how contagious the novel coronavirus is, how far we should stand from each other, how long an infected person might shed the virus, how a single strain spread from Europe to New York and then burst across America, and how to “flatten the curve” to save hundreds of thousands of lives. Modeling also helped persuade the Centers for Disease Control and Prevention that the virus can be airborne and transmitted by aerosols that stay aloft for hours. And at the moment many are grappling with a particularly urgent—and thorny—area of research: modeling the optimal rollout of a vaccine. Because vaccine supply will be limited at first, the decisions about who gets those first doses could save tens of thousands of lives. This is critical now that promising early results are coming in about two vaccine candidates—one from Pfizer and BioNTech and one from Moderna—that may be highly effective and for which the companies may apply for emergency authorization from the Food and Drug Administration. But figuring out how to allocate vaccines—there are close to 50 in clinical trials on humans—to the right groups at the right time is “a very complex problem,” says Eva Lee, director of the Center for Operations Research in Medicine and Health Care at the Georgia Institute of Technology. Lee has modeled dispensing strategies for vaccines and medical supplies for Zika, Ebola, and influenza, and is now working on covid-19. The coronavirus is “so infectious and so much more deadly than influenza,” she says. “We have never been challenged like that by a virus.”

Howard Forman, a public health professor at Yale University, says the last time we did “mass vaccination with completely new vaccines” was with smallpox and polio. “We are treading into an area we are not used to,” he says: all the other vaccines of the last decades have either been tested for years or were introduced very slowly. Because covid-19 is especially lethal for those over 65 and those with other health problems such as obesity, diabetes, or asthma, and yet is spread rapidly and widely by healthy young adults who are more likely to recover, mathematicians are faced with two conflicting priorities when modeling for vaccines: Should they prevent deaths or slow transmission? The consensus among most modelers is that if the main goal is to slash mortality rates, officials must prioritize vaccinating those who are older, and if they want to slow transmission, they must target younger adults. “Almost no matter what, you get the same answer,” says Harvard epidemiologist Marc Lipsitch. Vaccinate the elderly first to prevent deaths, he says, and then move on to other, healthier groups or the general population. One recent study modeled how covid-19 is likely to spread in six countries—the US, India, Spain, Zimbabwe, Brazil, and Belgium—and concluded that if the primary goal is to reduce mortality rates, adults over 60 should be prioritized for direct vaccination. The study, whose authors include Lipsitch as well as Daniel Larremore and Kate Bubar of the University of Colorado Boulder, has been published as a preprint, meaning it has not yet been peer-reviewed. Of course, when considering covid-19's outsizeimpact on minorities —especially Black and Latino communities—additional considerations for prioritization come into play. Most modelers agree that “everything is changing with coronavirus at the speed of light,” as applied mathematician Laura Matrajt, a research associate at the Fred Hutchinson Cancer Research Center in Seattle, put it in an email. That includes our understanding of how the virus spreads, how it attacks the body, how having another disease at the same time might raise the risk, and what leads to superspreader events.

So far, the research has yielded some surprising results. While children are usually prioritized for flu vaccine, for example, experts say the very young should be a lower priority for covid-19 vaccines in the United States, because thus far young adults have been primary drivers of transmission. (This is not necessarily true across the globe; in India, for instance, where multiple generations often live together in smaller spaces, new research shows both children and young adults are spreading much of the virus in the two states studied.) In addition, several models suggest that significant headway can be made against the pandemic even with lower deployment of a vaccine that is only partly effective. And several others emphasize the importance of local infection and transmission rates. According to Lee, whose early assessments of the pandemic’s origin, virulence, and probable global trajectory proved to be strikingly accurate, New York could potentially contain the virus if about 40% of the population were vaccinated, because local transmission of the virus is fairly low (a positivity rate of a little below 3% as of November 16), and around 20% have already been infected. “The higher the fraction of people in the population who already have antibodies, the more bang for your buck,” says Larremore, because you can prioritize giving vaccines to those who don’t have antibodies. All these findings are important because “at the end of the day, you will never have enough vaccines for the entire population,” says Lee—and not all Americans will take it. In fact, the World Health Organization recently predicted that healthy young adults may not even be able to get a vaccine until 2022, after the elderly, health-care workers, and other high-risk groups are vaccinated.....

Limited initial supply of SARS-CoV-2 vaccine raises the question of how to prioritize available doses. Here, we used a mathematical model to compare five age-stratified prioritization strategies. A highly effective transmission-blocking vaccine prioritized to adults ages 20-49 years minimized cumulative incidence, but mortality and years of life lost were minimized in most scenarios when the vaccine was prioritized to adults over 60 years old. Use of individual-level serological tests to redirect doses to seronegative individuals improved the marginal impact of each dose while partially addressing existing inequities in COVID-19 impact. While maximum impact prioritization strategies were broadly consistent across countries, transmission rates, vaccination rollout speeds, and estimates of naturally acquired immunity, this framework can be used to compare impacts of prioritization strategies across contexts.

Available in medRxiv (Dec. 7, 2020):

 https://doi.org/10.1101/2020.09.08.20190629

Health care systems in California, Illinois, Wisconsin, and Kansas expect to still be giving staff their first shots in mid-January. Hospitals across the United States are preparing for a Covid-19 vaccine distribution timeline that’s well behind official government targets as they face ongoing confusion about the process for inoculating frontline employees.  Leaders of Operation Warp Speed have repeatedly said they are on track to vaccinate 20 million people in December, enough for nearly all the health care workers and long-term care residents who are first in line to get a vaccine. But those involved in vaccine planning at four health care systems, in California, Illinois, Wisconsin, and Kansas, told STAT they expect to still be giving staff their first shots in mid-January. These workers would then receive their second vaccine dose three to four weeks later, depending on the vaccine, and would receive the full immunization effects a week after that, in mid-February. With hospitals across the U.S. filling up, as numerous states set daily records for Covid cases, federal officials have pledged a massive distribution push within days of the expected FDA approval this month of the first two vaccines. Moncef Slaoui, head of Operation Warp Speed, said in a briefing last week he was confident “we will be able to distribute … enough vaccine to immunize 20 million people in the U.S. in December.” But on the ground, the reality is murkier. “We’re not going to get 300 doses [immediately] for a hospital that has 300 employees,” said Pat Schou, director of the Illinois Critical Access Hospital Network, which works with 57 critical access rural hospitals. “I think it’s going to take a couple months. By mid-February, I would hope that we would have almost all our health care workers and EMS and be moving into long-term care. I think that’s the best we can hope for.”

Wisconsin’s health department recently released prioritization plans for those within the first tier of vaccination. “If we were able to [vaccinate] all almost immediately, I’m not sure they would have gone to that trouble,” said Tim Size, executive director of Rural Wisconsin Health Cooperative. These delayed expectations reflect the basic questions and concerns that many of the first Covid-19 vaccination sites still have about a process due to start in a matter of weeks. “We don’t know a lot yet,” said Dave Dobosenski, chief executive of St. Croix Regional Medical Center in Wisconsin, a state with one of the highest case rates in the country. “We’re craving to get some information here to understand what we’re doing.” The biggest questions among health care systems include when they will receive their vaccines, and how many. But there are also logistical hurdles, including not wasting unused doses, not leaving patients unattended while staff are vaccinated, and not having workers take sick days all at once when they experience expected side effects of the vaccines, including fatigue and fever. 

Even when health care providers have information, it can frequently change. Houston Methodist Hospital was originally told it was a “pre-position” vaccine site, due to receive the vaccine five to seven days ahead of other providers in the state, said chief executive Roberta Schwartz. But the vaccine will no longer be going to pre-positioned sites first, said Texas health department spokesperson Chris Van Deusen. Schwartz said she was most recently told to expect a delivery on Dec. 12 or 13. “If you asked me that tomorrow, I’ll give you another day,” she added. Sanford Health, with hospitals in North Dakota, South Dakota, Minnesota, and Iowa, has received an estimate of how many vaccines it will first receive from only one of those states, said Jesse Breidenbach, senior executive director of pharmacy support services. That delivery would be sufficient to cover the majority of staff who have volunteered to take the vaccine in that state....

A federal advisory committee to the Centers for Disease Control and Prevention voted Tuesday to recommend who should get COVID-19 vaccines first once one is authorized for use. The 14 voting members of the Advisory Committee on Immunization Practices, along with representatives from federal science agencies and the health care industry, voted during an emergency meeting online to recommend that the first COVID-19 vaccines should go to health care workers and residents of long-term care facilities, including nursing homes and assisted living. The CDC estimates that most people in these high-priority groups could be fully vaccinated by early next year if the Food and Drug Administration authorizes a vaccine by mid-December, as is currently anticipated. But because supplies will be short in the first few weeks after that authorization, individual health care and long-term care facilities will likely need to determine their own priority schedules for vaccination once they've obtained the vaccine. Long-term care facilities include nursing homes, assisted living and other residential facilities. The CDC estimates that 48 million doses will be needed to vaccinate these groups, which account for about 24 million people. It's anticipated that as many as 40 million doses could be available by the end of December, with 5 million to 10 million available each week afterward. The recommendations from the independent advisory committee now go to CDC Director Robert Redfield for final approval.

The issue of which risk groups should be prioritized for a COVID-19 vaccine has been a key topic at the group's regular public meetings over the past several months. The committee's goal is to use a COVID-19 vaccine to reduce severe illness and death from the disease and to lessen disruptions to society and the economy from the pandemic. In earlier meetings, the committee has considered four overlapping groups that might receive priority access to COVID-19 vaccines while immunizations are in short supply. The groups include health care workers and other essential workers who have a higher risk of exposure to the virus. Also included are people 65 and over and those with certain underlying medical conditions who are more likely to become severely ill if they contract COVID-19. Health care workers have long been considered to be first in line because they are exposed directly to COVID-19 through their work, and because protecting them and their patients from the virus would help reduce the spread of the coronavirus and keep the health system running. 

What's been more controversial is whether to add nursing home residents and other long-term care facility residents to the initial priority group. (Staffers at these facilities are considered health care workers.) At a public meeting last week, members of the committee agreed that the death toll in this population, a subgroup of the over-65 category, has been severe. Staff and residents at long-term care facilities represent just 6% of confirmed coronavirus cases but account for nearly 40% of COVID-19 deaths.  Still, some committee members raised concerns about giving newly authorized COVID-19 vaccines to nursing home residents. "This population is not a population that's been studied in the vaccine trials," said Dr. Robert Atmar, a professor of infectious diseases at Baylor College of Medicine, during last week's meeting. Older people who are participating in vaccine trials are generally in good health, while nursing home residents are often frail. "Coming back to the science of it, we really are not able to assess the balance of benefits and harms," he said. Another committee member worried that introducing COVID-19 vaccines first to nursing home residents could erode public confidence in the safety of the vaccines. Given the high mortality rate in long-term care facilities, it's likely that some nursing home patients who receive COVID-19 vaccines could die shortly after from other causes, said Dr. Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University Medical Center.  "I think you're going to have a very striking backlash of, 'My grandmother got the vaccine and she passed away.' They're not likely to be related, but that will become remembered," she said.

Before a COVID-19 vaccine is recommended for use among nursing home residents, Talbot suggested running a limited clinical trial in this population to gather data that would show the vaccine is safe for this group. Tuesday's vote comes in advance of a COVID-19 vaccine receiving FDA authorization. The CDC committee previously said it would wait for authorization before making vaccine recommendations. But in recent weeks, it has undergone pressure from the federal government to move faster. "We are not dependent on any delay from [the advisory committee] in terms of helping to advise states," Alex Azar, secretary of health and human services, said at a Nov. 24 press briefing, discussing his intent to move quickly with the vaccine distribution process. States will use the CDC guidance as they place orders for COVID-19 vaccine doses. Their first orders are due to the federal government Friday.

Operation Warp Speed is allocating the first batch of 6.4 million COVID vaccines to states, based on population. This circumvents a CDC advisory committee, which proposed allocation based on risk.  Once a COVID-19 vaccine is authorized by the Food and Drug Administration, allocations will be made based on the total number of adults in the state. "We wanted to keep this simple," Alex Azar, Secretary of Health and Human Services said at a media briefing Tuesday, "We thought it would be the fairest approach, and the most consistent." The allocation-by-population policy is a departure from earlier distribution plans, and it downplays the role of the Advisory Committee on Immunization Practices. The independent vaccine advisory group for the Centers for Disease Control and Prevention has proposed allocations based on high-risk groups. The CDC advisory committee had previously been central to the government's vaccine distribution plans. At a briefing on October 23, top HHS official Paul Mango told reporters that Operation Warp Speed would send vaccines out to states based on the number of people in high-risk groups, such health care workers, nursing home residents and factory workers, who had been identified by the CDC advisory committee. The committee is currently working on guidelines for prioritizing these groups, which will be finalized once a vaccine is authorized by the FDA. Operation Warp Speed officials had previously said they would wait for these guidelines to be completed.

Now government officials say that's changed. Instead of waiting for the advisory committee's recommendations, they've gone ahead and allocated the first 6.4 million doses to states, based on overall population. "I finally made the decision, late Friday night," said General Gustave Perna, head of logistics for Operation Warp Speed, at the briefing Tuesday. "So states could prioritize based on [their] amount," meaning how many doses of vaccine each state will receive. HHS Secretary Azar says the way vaccines are allocated will not change once the advisory committee makes its recommendations. "At the end of the day, that is a decision of the U.S. government's to make." He added that states would get the final say in whether to abide by the government's recommendations. Still, many states intend to follow the committee's guidance on how to prioritize limited doses, according to plans submitted to the CDC. States are currently enrolling local hospitals, doctors offices and pharmacies to be eligible to give COVID-19 shots when they're available — and providers are signing agreements saying they will follow the CDC's advisory committee guidelines. There may be valid reasons why Operation Warp Speed has changed the way it's decided to allocate vaccines — and it would be helpful for the public to see how their thinking evolved, says Dr. Grace Lee, an advisory committee member. "Transparency in the process is entwined with public trust," she says, "and that's so critical to the success of a COVID-19 vaccination program, especially in a pandemic." That's why the committee has been holding monthly public meetings where members openly air their considerations and concerns.

At one such meeting Monday, advisory committee members described the importance of prioritizing vaccines for groups that bear the highest risk burdens. "I think if we're serious about valuing equity, we need to have that baked in, early on in the vaccination program," said Dr. Beth Bell, who chairs the committee's COVID-19 vaccines workgroup. They are weighing the relative benefits and risks of vaccinating specific populations such as health care personnel and essential workers, who are more likely to be exposed to the coronavirus because of jobs requirements; and people who are older and those with underlying health conditions, who are more likely to get severely ill or die from COVID-19. At the meeting, the committee generally supported prioritizing vaccines for workers who keep our health, food and transport systems running, ahead of those with health issues. "These essential workers are out there putting themselves at risk to allow the rest of us to socially distance," Bell said. No vaccines have been authorized yet, but the FDA has set a December 10 meeting to consider the first application for a COVID-19 vaccine co-developed by drug companies Pfizer and BioNTech. If the vaccine is given the OK by the FDA, the government expects to begin vaccine distribution in mid-December.