AstraZeneca stumbles again in it its vaccine rollout

https://mailchi.mp/3e9af44fcab8/the-weekly-gist-march-26-2021?e=d1e747d2d8

U.S. Health Officials Raise Concerns Over AstraZeneca Vaccine Data - WSJ

It was a relatively quiet week on the COVID front—so quiet that President Biden held his first White House press conference last week and wasn’t asked a single question about the pandemic, which continues to be a race between vaccinations and virus variants.

Not that nothing happened this week: it was a rocky week for AstraZeneca, which was hoping to change the narrative over its vaccine, which has stumbled in its rollout in Europe, by reporting positive results from US trials.

After a press release announcing that the vaccine was found to be 79 percent effective against symptomatic COVID, an independent review board called the results into question, pointing out that the report was based on data that had not been fully updated. That earned a swift and unusual rebuke from the National Institutes of Health (NIH), forcing the company to correct its findings—to 76 percent.

A relatively minor difference, but the dust-up served to further undermine confidence in the company’s COVID jab, especially troubling in Europe where hesitancy and distribution have been a vexing problem, and concerns about blood clots associated with the AstraZeneca shot caused several countries to pause inoculations. Given the supply of already-approved vaccines from other manufacturers in the US, it’s not clear that the AstraZeneca shot will play a big role here, but it is critical in other parts of the world, especially as part of the global COVAX initiative targeted at developing countries, since the vaccine can be stored at normal refrigerator temperatures.

The company’s set-to with American regulators also highlighted another challenge that’s become common during the COVID pandemic: conducting scientific review by press release, as the global emergency has required the otherwise slow-moving research community to move at lightning pace.

Meanwhile, back at that relatively dull White House press conference, one piece of encouraging news: President Biden doubled his “first 100 days” goal for vaccinations to 200M shots, a goal that seems wholly achievable, given that 2.5M Americans are being vaccinated every day, on average.

Becerra squeaks through confirmation vote to become HHS secretary

Becerra squeaks through confirmation vote to become HHS secretary - The  Washington Post

Xavier Becerra narrowly won confirmation Thursday to lead the Department of Health and Human Services, the agency pivotal to President Biden’s urgent goal of defeating the coronavirus pandemic and expanding access to health care.

Becerra, a congressman from Los Angeles for two dozen years and then California attorney general, squeaked by on a vote of 50 to 49, the closest margin for any of the Biden cabinet members the Senate has confirmed so far.

He becomes the first Latino secretary of HHS, the largest federal department in terms of spending. The department includes agencies at the core of the federal response to the pandemic that has infected more than 29.5 million people in the United States and killed more than 535,000. They include the National Institutes of Health, the Centers for Disease Control and Prevention, the vaccine-approving Food and Drug Administration, and the Centers for Medicare and Medicaid Services, which oversees the country’s vast public insurance programs.

Sen. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, which considered the nomination, said that “after four years of going in reverse,” Becerra will make it “possible to go to drive and actually make progress for the American people, progress in terms of lowering the cost of health care.”

Republican Sen. John Barrasso (Wyo.), countered that Becerra is “an aggressive culture warrior from the radical left,” who is “out of touch with the views of the American people.” Barrasso noted that, as state attorney general, Becerra sued the Trump administration more than 150 times over immigration, environmental and health policies.

“In this time of crisis, our secretary of Health and Human Services may be the single most important member of the president’s cabinet,” Barrasso said, contending that “the president has chosen a nominee, no public health experience, extremely partisan record.”

Sen. Susan Collins (R-Maine) was the only member of the GOP to vote for Becerra’s confirmation along with a solid wall of Senate Democrats.

During his confirmation hearing last month before the Senate Finance Committee, Becerra said, “The mission of HHS — to enhance the health and well-being of all Americans — is core to who I am.”

In keeping with Biden’s emphasis on portraying his administration’s top rung as diverse and having working-class roots like his own, Becerra told the senators his immigrant parents had insurance through his father’s laborers union, making his family more fortunate when he was a boy than many of their neighbors.

As a longtime member of the House Ways and Means Committee, Becerra testified, he worked on several major pieces of health-care legislation, including the Children’s Health Insurance Program created in the late 1990s and changes to the way Medicare is run and financed, as well as the Affordable Care Act.

He did not mention that he was a longtime advocate of a single-payer health-care system, akin to the Medicare-for-all proposals backed by several Democratic candidates in last year’s presidential election, but rejected by Biden. Becerra has renounced his previous support since his nomination, echoing the president’s view that affordable insurance coverage should be widened by building upon the ACA.

Becerra, 63, became a lightning rod for conservatives immediately after Biden announced his selection in early December.

Senate Republicans targeted his defense of abortion rights. They contended he is unqualified because he is not a physician, though few HHS secretaries have had medical training. And they have denounced his previous advocacy of a larger government role in health insurance.

An undercurrent running through opposition to his nomination was Becerra’s leadership in recent years of a coalition of Democratic attorneys general fighting to preserve the ACA. Republicans, including President Donald Trump, are seeking to overturn the 2010 law in a case now before the Supreme Court.

Sen. James Inhofe (R-Okla.) lambasted Becerra, saying he has “an appalling track record disrespecting the sanctity of life. . . . He has no shame when it comes to his pro-abortion beliefs.”

Inhofe also criticized Becerra’s support last year for California’s ban on indoor worship services as part of the state’s efforts to slow the cornavirus’s spread. And the senator criticized Becerra’s position that undocumented immigrants should be allowed public benefits, such as Medicaid.

Senate Majority Leader Charles E. Schumer (D-N.Y.) said Republicans’ arguments against Becerra “almost verge on the ridiculous.”

Schumer said Republicans challenging Becerra’s qualifications for the job had embraced the nomination of Alex Azar as Trump’s second HHS secretary, though he was a pharmaceutical executive who also was an attorney and had no medical training.

In addition to working to tame the pandemic, which Biden has identified as the government’s job number one for now, Becerra will face many major decisions at the helm of the sprawling department over whether to continue or reverse policies established by the Trump administration.

CMS has already announced it was rescinding a significant Medicaid policy of the Trump era that had allowed states to require some residents to hold a job or be preparing for work to qualify for the safety-net insurance program. HHS officials are reviewing other Trump-era Medicaid policies.

Another HHS agency, the Administration for Children and Families, oversees the nation’s policies regarding welfare and unaccompanied children coming across the country’s borders — a flashpoint during the Trump administration.

The CDC, the government’s public-health agency, has been working to regain its footing and scientific moorings after repeated intrusions into its advice to the public by the Trump White House. The agency has been involved in the largest mass vaccination campaign in U.S. history to immunize the public against the coronavirus. And it is developing guidance on aspects of American life — and ongoing public safety measures — as research findings evolve for the virus and vaccine’s effects.

The FDA is in the thick of decisions about coronavirus vaccines, developed in record time, as additional manufacturers, such as AstraZeneca, have devised them and tested their safety and effectiveness. The three vaccines being given to about 2 million Americans a day — by Pfizer-BioNTech, Moderna and Johnson & Johnson — are being allowed so far for emergency use and have not yet secured full FDA approval.

Becerra almost certainly will continue to face hostility from social conservatives after his swearing in, expected Friday.

Roger Severino, who led HHS’s Office for Civil Rights during the Trump administration and created a division to promote “conscience and religious freedom,” is building an “HHS Accountability Project” within the conservative Ethics and Public Policy Center.

While at HHS, Severino tangled directly with Becerra during his tenure as attorney general of the nation’s most populous state, twice citing him in violation of federal laws for upholding California statutes involving abortion rights.

Severino said this week he believes those on the right might find common ground with Biden health officials on disability rights. But on matters of abortion and deference to religion, Severino said, “We will be watching.”

Healthcare AI investment will shift to these 5 areas in the next 2 years: survey

The COVID-19 pandemic has accelerated the pace of artificial intelligence adoption, and healthcare leaders are confident AI can help solve some of today’s toughest challenges, including COVID-19 tracking and vaccines.

The majority of healthcare and life sciences executives (82%) want to see their organizations more aggressively adopt AI technology, according to a new survey from KPMG, an audit, tax and advisory services firm.

Healthcare and life sciences (56%) business leaders report that AI initiatives have delivered more value than expected for their organizations. However, life sciences companies seem to be struggling to select the best AI technologies, according to 73% of executives.

As the U.S. continues to navigate the pandemic, life sciences business leaders are overwhelmingly confident in AI’s ability to monitor the spread of COVID-19 cases (94%), help with vaccine development (90%) and aid vaccine distribution (90%).

KPMG’s AI survey is based on feedback from 950 business or IT decision-makers across seven industries, with 100 respondents each from healthcare and life sciences companies.

Despite the optimism about the potential for AI, executives across industries believe more controls are needed and overwhelmingly believe the government has a role to play in regulating AI technology. The majority of life sciences (86%) and healthcare (84%) executives say the government should be involved in regulating AI technology.

And executives across industries are optimistic about the new administration in Washington, D.C., with the majority believing the Biden administration will do more to help advance the adoption of AI in the enterprise.

“We are seeing very high levels of support this year across all industries for more AI regulation. One reason for this may be that, as the technology advances very quickly, insiders want to avoid AI becoming the ‘Wild Wild West.’ Additionally, a more robust regulatory environment may help facilitate commerce. It can help remove unintended barriers that may be the result of other laws or regulations, or due to lack of maturity of legal and technical standards,” said Rob Dwyer, principal, advisory at KPMG, specializing in technology in government.

Healthcare and pharma companies seem to be more bullish on AI than other industries are.

The survey found half of business leaders in industrial manufacturing, retail and tech say AI is moving faster than it should in their industry. Concerns about the speed of AI adoption are particularly pronounced among small companies (63%), business leaders with high AI knowledge (51%) and Gen Z and millennial business leaders (51%).

“Leaders are experiencing COVID-19 whiplash, with AI adoption skyrocketing as a result of the pandemic. But many say it’s moving too fast. That’s probably because of current debate surrounding the ethics, governance and regulation of AI.  Many business leaders do not have a view into what their organizations are doing to control and govern AI and may fear risks are developing,” Traci Gusher, principal of artificial intelligence at KPMG, said in a statement.

Future AI investment

Healthcare organizations are ramping up their investments in AI in response to the COVID-19 pandemic. In a Deloitte survey, nearly 3 in 4 healthcare organizations said they expect to increase their AI funding, with executives citing making processes more efficient as the top outcome they are trying to achieve with AI.

Healthcare executives say current AI investments at their organizations have focused on electronic health record (EHR) management and diagnosis.

To date, the technology has proved its value in reducing errors and improving medical outcomes for patients, according to executives. Around 40% of healthcare executives said AI technology has helped with patient engagement and also to improve clinical quality. About a third of executives said AI has improved administrative efficiency. Only 18% said the technology helped uncover new revenue opportunities.

But AI investments will shift over the next two years to prioritize telemedicine (38%), robotic tasks such as process automation (37%) and delivery of patient care (36%), the survey found. Clinical trials and diagnosis rounded out the top five investment areas.

At life sciences companies, AI is primarily deployed during the drug development process to improve record-keeping and the application process, the survey found. Companies also have leveraged AI to help with clinical trial site selection.

Moving forward, pharmaceutical companies will likely focus their AI investments on discovering new revenue opportunities in the next two years, a pivot from their current strategy focusing on increasing profitability of existing products, according to the survey. About half of life sciences executives say their organizations plan to leverage AI to reduce administrative costs, analyze patient data and accelerate clinical trials.

Industry stakeholders are taking steps to advance the use of AI and machine learning in healthcare.

The Consumer Technology Association (CTA) created a working group two years ago to develop some standardization on definitions and characteristics of healthcare AI. Last year, the CTA working group developed a standard that creates a common language so industry stakeholders can better understand AI technologies. A group also recently developed a new standard to advance trust in AI solutions.

On the regulatory front, the U.S. Food and Drug Administration (FDA) last month released its first AI and machine learning action plan, a multistep approach designed to advance the agency’s management of advanced medical software. The action plan aims to force manufacturers to be more rigorous in their evaluations, according to the FDA.

A somber milestone on the path to brighter days ahead

https://mailchi.mp/05e4ff455445/the-weekly-gist-february-26-2021?e=d1e747d2d8

U.S. tops 500,000 COVID-19 deaths | PBS NewsHour

Although the nation reached a grim and long-dreaded milestone on Monday, surpassing 500,000 lives lost to COVID—more than were killed in two World Wars and the Vietnam conflict combined—the news this week was mostly good, as key indicators of the pandemic’s severity continued to rapidly improve.

Over the past two weeks, hospitalizations for COVID were down 30 percent, deaths were down 22 percent, and new cases declined by 32 percent—the lowest levels since late October. This week’s numbers declined somewhat more slowly than last week’s, leading Dr. Rachel Walensky, director of the Centers for Disease Control and Prevention, to caution people against letting their guard down just yet: “Things are tenuous. Now is not the time to relax restrictions.” Of particular concern are new variants of the coronavirus that have emerged in numerous states, including one in New York and another in California, that may be more contagious than the original virus.
 
The best news of the week was surely a report from the Food and Drug Administration (FDA) evaluating the new, single-shot COVID vaccine from Johnson & Johnson (J&J), showing it to be highly effective at preventing severe disease, hospitalization, and death caused by COVID, including variants. On Friday, a panel of outside experts met to assess whether to approve the J&J vaccine for emergency use, which would make it the third in the nation’s arsenal of COVID vaccines. If approved, the vaccine will be rolled out next week, according to the White House, with up to 4M doses available immediately.

The sooner the better: new data show that since vaccinations began in late December, new cases among nursing home residents have fallen more than 80 percent—a hopeful glimpse at the future that lies ahead for the general population once vaccines become widely available.

FDA scientists endorse J&J’s Covid vaccine, as new data shed light on efficacy


Scientists at the Food and Drug Administration said Wednesday that the single-shot Covid-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease.

Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.

Documents from the FDA scientists, as well as separate documents from Johnson & Johnson, were released ahead of a Friday meeting of an FDA advisory panel in which outside experts will discuss and then vote on the risks and benefits of the new vaccine. The panel, known as the Vaccines and Related Biological Products Advisory Committee, makes recommendations to the FDA; the agency is not required to follow them, but it generally does.

The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also does not need to be kept frozen when being shipped, as the vaccines developed by Moderna and the team of Pfizer and BioNTech do. Both of those advantages could be profound when it comes to vaccinating as many people as possible, a key step in slowing the spread of SARS-CoV-2.

Overall in the study, the vaccine reduced cases of Covid-19 that were rated as moderate to severe by 66.1% when considering cases occurring at least 28 days after vaccination. There were 193 cases that occurred at least 28 days after vaccination in the placebo group and 66 in the vaccine group. As of Feb. 5, there were seven Covid-19 related deaths in the placebo group and none in the vaccine group.

FDA researchers conducted a new analysis of how frequently volunteers in the study were hospitalized for Covid. When researchers counted cases 28 days after vaccination, there were zero hospitalizations in the vaccine arm and 16 in the placebo arm. For the full analysis set starting with the first dose, there were six hospitalizations for those who received the vaccine and 42 for those who did not.

Johnson & Johnson and the National Institutes of Health initially announced interim results of a 44,325 study testing the vaccine’s efficacy on Jan. 29. At the time, they said the 66% efficacy varied by geography. The vaccine was 72% protective in the U.S., compared to 58% in South Africa, where a new variant of SARS-CoV-2 is circulating.

In new documents, Johnson & Johnson said that in South Africa, the vaccine reduced severe or critical Covid-19 by 81.7% starting 28 days after vaccination, but that efficacy against more moderate disease was 64%. But the company said that the vaccine efficacy was not affected by the high prevalence of another variant in Brazil.

Unexpected side effects occurred at the same rate overall among volunteers who received vaccine and placebo — about 0.5%. However, some rare conditions appeared more common with the vaccine. Blood clot-related conditions occurred in 15 volunteers who received the vaccine and 10 who received placebo. Tinnitus, a ringing in the ears, occurred in six volunteers who received the vaccine and none who received placebo. The FDA said it will recommend monitoring for thromboembolic events after an EUA is granted.

Expected side effects that are related to the vaccine’s effect were common. Nearly half of volunteers reported injection site pain, 38.9% reported headache, 38.2% fatigue, and 33% reported muscle aches.

Johnson & Johnson also conducted an analysis in 2,650 volunteers looking at whether those who received the vaccine were less likely to test positive for the SARS-CoV-2 virus, which causes Covid-19, without having symptoms. There were 50 such cases in the placebo group compared to 18 among those who received the vaccine, a 65.5% reduction.

The United States has purchased 100 million doses of the vaccine, with an option to buy another 200 million doses. The agreement, announced last August, netted J&J over $1 billion in a contract with the Biomedical Advanced Research and Development Authority and the Department of Defense.

That said, the company currently has a limited number of doses to contribute to the effort to step up the country’s vaccine rollout. It will be April before J&J begins to have substantial amounts of vaccine to feed into the distribution pipeline, Moncef Slaoui, former co-chair of Operation Warp Speed, said earlier this year.

However, the company and the NIH said the vaccine was 85% effective at preventing severe disease, with no differences seen across the eight countries included in the study.

J&J is also conducting a trial in the United States of a two-dose vaccine, with the doses given eight weeks apart.The results from that 30,000 person trial are not expected until sometime in May.

The FDA documents represent the first close look at the data released Jan. 29, and are the result of a three-week effort by FDA scientists to independently evaluate the data generated in the trial. Friday’s panel will provide a deeper look at what those data actually mean.

Reversing course on Trump-era healthcare policy

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Image result for Reversing course on Trump-era healthcare policy

Ahead of a Supreme Court hearing in March to consider the legality of imposing work requirements as a condition of gaining Medicaid coverage, the Centers for Medicare and Medicaid Services (CMS) were expected to inform states on Friday of plans to rescind the controversial Trump administration policy.

Under the previous administration, ten states had applied for and were approved to use waiver authority to impose work requirements on Medicaid enrollees, and several other states were in the process of submitting applications. Critics (including us) have long held that such requirements, while nominally intended to introduce an element of “personal responsibility” to the safety-net coverage program for low-income Americans, actually serve to hinder access to care, and jeopardize the health status of already vulnerable populations; in addition, the added expense of program infrastructure often exceeds anticipated cost savings.

The policy was a favored project of former CMS administrator Seema Verma, who helped craft a similar program for the state of Indiana before joining the Trump administration. Among states granted waiver authority to impose work requirements, only Arkansas ever fully implemented the policy, before the legality of the waivers was challenged successfully in lower courts.
 
The Biden administration’s recision of work requirements is part of a broader reversal of Trump-era healthcare policies. This week the Justice Department notified the Supreme Court that it was switching sides in the closely watched case questioning the constitutionality of the Affordable Care Act (ACA), although the court has already heard the case and is expected to rule this spring. Starting Monday, the Biden team will also reopen the federal insurance marketplace for a special enrollment period, bolstering funding for outreach to ensure those eligible are aware of coverage options. And as part of its proposed COVID relief legislation, the administration plans to increase subsidies to help individuals buy coverage on the exchanges, and to increase funding to support state Medicaid programs—policies that got a boost this week from a broad coalition of healthcare industry groups, including health plans, doctors, and hospitals.

As the administration rounds out its health policy team, we’d expect a continued focus on strengthening the core pillars of the ACA, along with a greater focus on ensuring health equity and addressing disparities. Meanwhile, two key positions remain unfilled: CMS administrator and commissioner of the Food and Drug Administration (FDA). These slots will likely remain open until the looming confirmation battle over Biden’s nominee for Secretary of Health and Human Services (HHS), California Attorney General Xavier Becerra, has been settled.
 

Can Your Employer Require You to Get a COVID-19 Vaccine?

https://www.aarp.org/work/working-at-50-plus/info-2020/employer-require-covid-vaccine/

A man is about to get a vaccine

Workers have rights, but the answer is more complicated than you think.

En español | With millions of people out of work and millions of others forced to work from home, the pandemic has reshaped the nation’s labor force. And it’s not done yet. As the unemployed look ahead to getting hired and remote employees prepare for a return to the workplace, many are contemplating the same question: Could they eventually be required to get a COVID-19 vaccination if they want to keep their jobs?

The question has become more urgent since the U.S. Food and Drug Administration (FDA)  granted Pfizer and BioNTech’s coronavirus vaccine emergency use authorization on Dec. 11. The short answer: Yes. An employer can make a vaccination a requirement if you want to continue working there. But there are significant exceptions for potential concerns related to any disability you may have and for religious beliefs that prohibit vaccinations. And experts say that employers are more likely to simply encourage their workers to get immunized rather that issue a company-wide mandate.

On Dec. 16, the Equal Employment Opportunity Commission (EEOC) confirmed that a COVID-19 vaccination requirement by itself would not violate Americans with Disabilities Act (ADA). That law prohibits employers from conducting some types of medical examinations.

“If a vaccine is administered to an employee by an employer for protection against contracting COVID-19, the employer is not seeking information about an individual’s impairments or current health status and, therefore, it is not a medical examination,” the EEOC says.

But some employees may be exempted from mandatory vaccinations based on potential concerns related to any disability you may have and for religious beliefs that prohibit vaccinations. And experts say that employers are more likely to simply encourage their workers to get immunized rather that issue a company-wide mandate.

“Employment in the United States is generally ‘at will,’ which means that your employer can set working conditions,” says Dorit Reiss, a law professor at the University of California, Hastings, who specializes in legal and policy issues related to vaccines. “Certainly, employers can set health and safety work conditions, with a few limits.”

Those restrictions generally are tied to the federal Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act of 1964. If employees have medical reasons or sincerely held religious beliefs that prevent them from taking a potential coronavirus vaccine, employers could be legally required to give the workers some reasonable alternative to continue to work, Reiss says.

The EEOC guidance notes that even if an employer finds that a worker who cannot be vaccinated due to disability poses a risk to the workplace, the employer cannot exclude the employee from the job — or take any other action — unless there is no way to provide a reasonable accommodation that would reduce this risk to others.

“That might be a [wearing a] mask, a working from home, or a working separately from other people alternative. As long as it’s not too significant a barrier for the employer,” Reiss says. “If you can achieve the same level of safety as the vaccine via mask, or remote working, you can’t fire the employee. You need to give them an accommodation.”

Vaccine recommendations vs. requirements

The potential medical and religious accommodations are just two of the factors employers will have to consider when deciding whether to put a vaccination requirement in place. Experts say that given all the different concerns employers will need to balance with a potential COVID-19 vaccine, many might choose to simply recommend their workers get immunized rather than make vaccination a condition of employment.

For example, employers also need to weigh any liability issues a vaccination requirement might raise. Some federal lawmakers already have raised concerns that employers are vulnerable to lawsuits from workers and customers who might have contracted COVID-19 at the business. A mandate that all their employees get inoculated could complicate the risks for companies.

“It’s a treacherous area for employers,” says Jay Rosenlieb, an employment law attorney at the Klein DeNatale Goldner law group in California. “The reason it’s treacherous for employers is liability that arises from requiring a vaccine where the vaccine goes sideways and creates harm to the employee. That’s going to probably be a workers compensation claim against the employer. And, of course, some kind of claim against the vaccine manufacturer. There’s a lot of weighing that goes on here.”

L.J. Tan, chief strategy officer for the Immunization Action Coalition — an advocacy group that supports vaccinations — says that because potential COVID-19 vaccines are largely being developed in the same manner as earlier vaccines, researchers have the benefit of past scientific experience to better ensure that a vaccine for this coronavirus will be safe. But he noted that the speed of the development of a COVID-19 vaccine — compressed into months rather than the usual years — and the politics that have accompanied it add to the reasons employers may be unwilling to make vaccination a requirement.

“One of the challenges we’re going to be dealing with, obviously, especially now is that there is a shadow of politics over the vaccine,” Tan says. “As a result, there’s some fear about whether the vaccine can be safe, whether it can be approved appropriately. Because of that shadow, I think it’s going to be extremely difficult for an employer to make COVID-19 vaccination a condition of employment.”

Vaccine requirement more likely in health care, other high-risk jobs

The industry most likely to require COVID-19 vaccinations for workers is health care, where most employers already require workers to get a flu shot annually. In fact, interim guidance from the Centers for Disease Control and Prevention (CDC) on which groups might be among the first to have access to a coronavirus vaccine placed “healthcare personnel likely to be exposed to or treat people with COVID-19” at the top of the list.

But once enough doses of a vaccine have been produced for distribution to the broader public, some employers might start to consider a mandate.

“For example, essential workers in retail stores or in food production plants, such as a meat-packing plant, seem to be at high risk,” Reiss says. “Those employers could reasonably require [a COVID vaccination], because remember, if an employee doesn’t vaccinate, it’s not just a risk to them. It’s a risk to other employees, and — if it’s a customer-facing business — a risk to the customers. So, in high-risk places, I think it’s reasonable.”

Some companies may make inoculation voluntary but make it as easy as possible for workers to get the shot. For instance, Ford already has purchased twelve of the ultracold freezers required to store doses of Pfizer’s vaccine so it can provide the shot to employees who want it.

For those workers who might be told to get a vaccination, remember to raise any concerns you might have with your employer.

“Ask for reasonable accommodation and have a discussion with the employer as to whether there might be reasonable alternatives such as work from home or such as continued use” of personal protective equipment, Rosenlieb says.

If vaccination requirements do become more common, both workers and their employers will have to find ways to balance personal concerns with public safety.

“On one hand, [vaccine requirements] do limit the autonomy of workers that have reservations,” Reiss says. “On the other hand, they also protect workers by making the workplace safer from the disease. So, it’s not just a mandate to limit your rights. A mandate can also protect your right to a safe work environment.

Biden plans to release nearly all available vaccine doses in an attempt to speed delivery.

President-elect Joseph R. Biden Jr. plans to release nearly all available coronavirus vaccine doses “to ensure the Americans who need it most get it as soon as possible,” the Biden transition team said Friday, a move that represents a sharp break from the Trump administration’s practice of holding back some of the vaccine.

The announcement coincided with a letter from eight Democratic governors — including Andrew M. Cuomo of New York and Gretchen Whitmer of Michigan, both of whom have clashed with President Trump — imploring the current administration to release all available doses to the states as soon as possible.

“The failure to distribute these doses to states who request them is unconscionable and unacceptable,” the governors wrote in the letter, which was obtained by The New York Times and sent Friday to the secretary of health, Alex M. Azar II, and Gen. Gustave F. Perna, who is in charge of vaccine distribution. “We demand that the federal government begin distributing these reserved doses to states immediately,” the letter said.

Because both of the vaccines with emergency approval require two doses, the Trump administration has been holding back roughly half of its supply to ensure those already vaccinated receive the booster dose. The vaccine rollout has been troubled from the start.

As of Thursday, the Trump administration had shipped more than 21 million vaccine doses, and millions more were already in the federal government’s hands. Yet only 5.9 million people had received a dose. State and local public health officials, already overwhelmed with rising infections, have been struggling to administer the vaccine to hospital workers and at-risk older Americans while most people remain in the dark about when they might be protected. Mr. Biden has promised that 100 million doses of the vaccine would be administered by his first 100th day in office.

Releasing the vast majority of the vaccine doses raises the risk that second doses would not be administered on time. Officials from the Food and Drug Administration — experts whose advice Mr. Biden has pledged to follow — have spoken out strongly against changing the dosing schedule, calling such a move “premature and not rooted solidly in the available evidence.”

A transition official, speaking anonymously to provide insight into the president-elect’s thinking, said would use the Defense Production Act, if needed, to ensure that enough doses are available.

However, the official also noted that the Biden team has “faith in our manufacturers that they can produce enough vaccines to ensure people can get their second dose in a timely manner, while also getting more people their first dose.”

A spokesman for Operation Warp Speed, the Trump administration’s vaccine initiative, released a statement sharply criticizing Mr. Biden’s approach.

“If President-elect Biden is calling for the distribution of vaccines knowing that there would not be a second dose available, that decision is without science or data and is contrary to the FDA’s approved label,” said the spokesman, Michael Pratt. “If President-elect Biden is suggesting that the maximum number of doses should be made available, consistent with ensuring that a second dose of vaccine will be there when the patient shows up, then that is already happening.”

A spokesman for the transition team, T.J. Ducklo, said Mr. Biden “believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible.”

“He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” Mr. Ducklo said. “He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th.”

Dr. Leana Wen, an emergency physician and public health expert at the George Washington University School of Public Health, said she was surprised and concerned about the new strategy, which seemed to offer a solution incongruous with the biggest problems in the vaccine rollout. Distribution has sputtered in large part because of a lack of administering capacity and several logistical hurdles, rather than a severe shortage of doses.

“This is not the problem we’re trying to solve right now,” Dr. Wen said.

For such a plan to work, Dr. Wen added, the Biden administration will need to be confident in both improved distribution tactics and sufficient vaccine production, “so all who receive the first dose of the vaccine will receive the second in a timely manner.”

Should a high number of delayed second doses occur — ostensibly shirking the regimens laid out in clinical trials — “it runs the risk of substantially eroding public trust in vaccines,” Dr. Wen said. The recommended timeframe for administering the second dose for the Pfizer-BioNTech vaccine is 21 days later, and for the Moderna vaccine, 28 days.

Mr. Biden’s announcement came amid growing pressure to step up the slow pace of mass vaccinations.

Speaking at a news briefing on Friday, Dr. Stephen Hahn, the F.D.A. commissioner, urged states that have utilized only a small part of their supply to begin vaccinating lower-priority groups, while still observing government guidelines.

“We think that will go a long way toward using these vaccines appropriately and getting them into the arms of individuals,” he said.

Mr. Biden also formally announced nearly two dozen members of his National Security Council staff on Friday, including a senior official for global health threats whose office was downgraded before the coronavirus pandemic.

Among the 21 appointees is Elizabeth Cameron, who will be the council’s senior director for global health security and biodefense, the job she held until John R. Bolton, Mr. Trump’s then-national security adviser, eliminated the office in May 2018, reassigning its responsibilities elsewhere within the N.S.C. Ms. Cameron has argued publicly that the move “contributed to the federal government’s sluggish domestic response” to the pandemic, and Mr. Biden vowed as a candidate to restore the office.

‘Shkreli Awards’ Shame Healthcare Profiteers

Lown Institute berates greedy pricing, ethical lapses, wallet biopsies, and avoidable shortages.

Greedy corporations, uncaring hospitals, individual miscreants, and a task force led by Jared Kushner were dinged Tuesday in the Lown Institute‘s annual Shkreli awards, a list of the top 10 worst offenders for 2020.

Named after Martin Shkreli, the entrepreneur who unapologetically raised the price of an anti-parasitic drug by a factor of 56 in 2015 (now serving a federal prison term for unrelated crimes), the list of shame calls out what Vikas Saini, the institute’s CEO, called “pandemic profiteers.” (Lown bills itself as “a nonpartisan think tank advocating bold ideas for a just and caring system for health.”)

Topping the list was the federal government itself and Jared Kushner, President’s Trump’s son-in-law, who led a personal protective equipment (PPE) procurement task force. The effort, called Project Airbridge, was to “airlift PPE from overseas and bring it to the U.S. quickly,” which it did.

“But rather than distribute the PPE to the states, FEMA gave these supplies to six private medical supply companies to sell to the highest bidder, creating a bidding war among the states,” Saini said. Though these supplies were supposed to go to designated pandemic hotspots, “no officials from the 10 hardest hit counties” said they received PPE from Project Airbridge. In fact, federal agencies outbid states or seized supplies that states had purchased, “making it much harder and more expensive” for states to get supplies, he said.

Number two on the institute’s list: vaccine maker Moderna, which received nearly $1 billion in federal funds to develop its mRNA COVID-19 preventive. It set a price of between $32 and $37 per dose, more than the U.S. agreed to pay for other COVID vaccines. “Although the U.S. has placed an order for $1.5 billion worth of doses at a discount, a price of $15 per dose, given the upfront investment by the U.S. government, we are essentially paying for the vaccine twice,” said Lown Institute Senior Vice President Shannon Brownlee.

Webcast panelist Don Berwick, MD, former acting administrator for the Centers for Medicare & Medicaid Services, noted that a lot of work went into producing the vaccine at an impressive pace, “and if there’s not an immune breakout, we’re going to be very grateful that this happened.” But, he added, “I mean, how much money is enough? Maybe there needs to be some real sense of discipline and public spirit here that goes way beyond what any of these companies are doing.”

In third place: four California hospital systems that refused to take COVID-19 patients or delayed transfers from hospitals that were out of beds. Wall Street Journal investigation found that these refusals or delays were based on the patients’ ability to pay; many were on Medicaid or were uninsured.

“In the midst of such a pandemic, to continue that sort of behavior is mind boggling,” said Saini. “This is more than the proverbial wallet biopsy.”

The remaining seven offenders:

4. Poor nursing homes decisions, especially one by Soldiers’ Home for Veterans in western Massachusetts, that worsened an already terrible situation. At Soldiers’ Home, management decided to combine the COVID-19 unit with a dementia unit because they were low on staff, said Brownlee. That allowed the virus to spread rapidly, killing 76 residents and staff as of November. Roughly one-third of all COVID-19 deaths in the U.S. have been in long-term care facilities.

5. Pharmaceutical giants AstraZeneca, GlaxoSmithKline, Pfizer, and Johnson & Johnson, which refused to share intellectual property on COVID-19, instead deciding to “compete for their profits instead,” Saini said. The envisioned technology access pool would have made participants’ discoveries openly available “to more easily develop and distribute coronavirus treatments, vaccines, and diagnostics.”

Saini added that he was was most struck by such an attitude of “historical blindness or tone deafness” at a time when the pandemic is roiling every single country.

Berwick asked rhetorically, “What would it be like if we were a world in which a company like Pfizer or Moderna, or the next company that develops a really great breakthrough, says on behalf of the well-being of the human race, we will make this intellectual property available to anyone who wants it?”

6. Elizabeth Nabel, MD, CEO of Brigham and Women’s Hospital in Boston, because she defended high drug prices as a necessity for innovation in an op-ed, without disclosing that she sat on Moderna’s board. In that capacity, she received $487,500 in stock options and other payments in 2019. The value of those options quadrupled on the news of Moderna’s successful vaccine. She sold $8.5 million worth of stock last year, after its value nearly quadrupled. She resigned from Moderna’s board in July and, it was announced Tuesday, is leaving her CEO position to join a biotech company founded by her husband.

7. Hospitals that punished clinicians for “scaring the public,” suspending or firing them, because they “insisted on wearing N95 masks and other protective equipment in the hospital,” said Saini. Hospitals also fired or threatened to fire clinicians for speaking out on COVID-19 safety issues, such as the lack of PPE and long test turnaround times.

Webcast panelist Mona Hanna-Attisha, MD, the Flint, Michigan, pediatrician who exposed the city’s water contamination, said that healthcare workers “have really been abandoned in this administration” and that the federal Occupational Safety and Health Administration “has pretty much fallen asleep at the wheel.” She added that workers in many industries such as meatpacking and poultry processing “have suffered tremendously from not having the protections or regulations in place to protect [them].”

8. Connecticut internist Steven Murphy, MD, who ran COVID-19 testing sites for several towns, but conducted allegedly unnecessary add-ons such as screening for 20 other respiratory pathogens. He also charged insurers $480 to provide results over the phone, leading to total bills of up to $2,000 per person.

“As far as I know, having an MD is not a license to steal, and this guy seemed to think that it was,” said Brownlee.

9. Those “pandemic profiteers” who hawked fake and potentially harmful COVID-19 cures. Among them: televangelist Jim Bakker sold “Silver Solution,” containing colloidal silver, and the “MyPillow Guy,” Mike Lindell, for his boostering for oleandrin.

Colloidal silver has no known health benefits and can cause seizures and organ damage. Oleandrin is a biological extract from the oleander plant and known for its toxicity and ingesting it can be deadly,” said Saini.

Others named by the Lown Institute include Jennings Ryan Staley, MD — now under indictment — who ran the “Skinny Beach Med Spa” in San Diego which sold so-called COVID treatment packs containing hydroxychloroquine, antibiotics, Xanax, and Viagra, all for $4,000.

Berwick commented that such schemes indicate a crisis of confidence in science, adding that without facts and science to guide care, “patients get hurt, costs rise without any benefit, and confusion reigns, and COVID has made that worse right now.”

Brownlee mentioned the “huge play” that hydroxychloroquine received and the FDA’s recent record as examples of why confidence in science has eroded.

10. Two private equity-owned companies that provide physician staffing for hospitalsTeam Health and Envision, that cut doctors’ pay during the first COVID-19 wave while simultaneously spending millions on political ads to protect surprise billing practices. And the same companies also received millions in COVID relief funds under the CARES Act.

Berwick said surprise billing by itself should receive a deputy Shkreli award, “as out-of-pocket costs to patients have risen dramatically and even worse during the COVID pandemic… and Congress has failed to act. It’s time to fix this one.”

A tall order: Rolling out the COVID-19 vaccine to all

https://mailchi.mp/e38b070b8787/the-weekly-gist-december-18-2020?e=d1e747d2d8

As the first Americans receive COVID vaccines, supplies remain limited even for the highest-risk populations. And with doses now in the pipeline, states are facing more intense questions about how they will prioritize vaccine delivery across demographic and at-risk groups. The graphic above shows an estimated vaccination timeline, based on the Centers for Disease Control and Prevention’s (CDC) recommended schedule. It illustrates the relative size of different populations in each allocation phase, along with the likely difficulty of targeting them and verifying eligibility. The first phase is divided into three waves (1a, 1b, 1c) for at-risk populations and essential workers, while the second phase includes the rest of the adult population, as well as children (though pediatric clinical trials are still in early stages).
 
Unsurprisingly, the CDC recommends that those most at risk for infection and severe disease—healthcare workers and nursing home residents—receive the 20M doses available by year’s end. While most states are generally adhering to the initial recommendations on priority groups for phase 1a set by the CDC’s Advisory Committee on Immunization Practices (ACIP), several have made adjustments. At least three are including law enforcement personnel in phase 1a, and others are further categorizing healthcare workers into high-, medium-, and low-risk groups. This weekend, ACIP will reconvene to create its official recommendations for phases 1b and 1c, which include the much larger populations of adults over age 65, and those with high-risk medical conditions.

Beyond eligibility guidelines, larger questions loom. How would someone “verify” that they have a high-risk condition? Who will reach out to older Americans to let them know they are eligible, and where to access the vaccine? As vaccine rollout continues, providers should anticipate the role they will likely play in managing patients “in the queue”, documenting eligible conditions and establishing regular information channels to keep people informed about the current status of vaccine planning and access.