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.

UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions

https://www.reuters.com/article/health-coronavirus-britain-vaccine/update-5-uk-to-refine-allergy-warning-on-pfizer-vaccine-sparked-by-two-adverse-reactions-idUSL8N2IP307

UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions -  YouTube

Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.

Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.

“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.

“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”

Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.

Pfizer and BioNTech said they were supporting the MHRA’s investigation.

Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.

Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot, after the country approved the vaccine.

ALLERGIC REACTION

MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials.

Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.

However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.

Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”

“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.

The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.

In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.

The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.

However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.

“I would not have broadened to the degree they did,” he said.

“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”

No Easy Fixes for Drug Supply Chain Problems

Better leadership is needed on both ends of the chain, expert says.

The U.S. drug supply chain works well in the middle, but the beginning and end leave much room for improvement, according to Stephen Schondelmeyer, PharmD, PhD, of the University of Minnesota in Minneapolis.

“When a manufacturer imports a drug into the U.S. and sells it to wholesalers and then it goes to group purchasing organizations and through hospital institutional systems, that system works very well,” Schondelmeyer said last week at a public workshop of the National Academies of Science, Engineering, and Medicine’s Committee on Security of Medical Product Supply Chain. “But where problems occur is when the API [active pharmaceutical ingredient] is not being produced or is not available, or is not shipped to the finished dose manufacturer to make enough.” With the current “just in time” manufacturing system, “inventories may only last a month” before supplies dry up, he said.

Leadership on this issue “is certainly needed at the top, but also needed at the end,” said Schondelmeyer, who is co-principal investigator of the Resilient Drug Supply Project at the university’s Center for Infectious Disease Research and Policy.

For example, he said, “I routinely meet with groups of pharmacy directors at major hospital systems. I have heard stories from pharmacy directors … who have said they had remdesivir allocated by their state; it showed up in their hospital’s lab. Nobody in the lab knew what it was or why it arrived, and it sat there for several days before they figured out this was a drug and pharmacy should be managing this You can run a marathon, but if you don’t finish the last 200 yards, you don’t finish the marathon, and that’s what happened with remdesivir.”

“We need to be predicting not only demand changes but what things can create a supply disruption, because a lot of shortages we have are from supply disruption,” Schondelmeyer said. In the COVID-19 era, this could include unexpected political moves such as export bans — such as those recently put in place in India and the United Kingdom — which could mean that “we could find whole categories of drugs not available in the U.S., and we don’t have the capacity to replace that supply, in the short run at least,” he said.

Pharmaceuticals are a very unique market, he added. “We established a pharmaceutical market based on monopolies when drugs first come on the market, via intellectual property, and even later on, when you’re down to two or three generics they function like an oligopoly. We have a marketplace that has extreme asymmetries of information, where people selling a drug know a lot more than people buying the drug. We have to establish an infrastructure to understand the pharmaceutical market and the flow of products so we can correct the market when it’s not working.”

“Our current system of fixing drug shortages is a ‘fail and fix’ system,” he said. The list of shortages “is a list of products that have already failed. I think we should have a system that has supply chain maps that identify critical stages — even pre-API — that can suggest where we might have a failure, and do something before the failure occurs. I suggest we move from ‘fail and fix’ to ‘predict and prevent.'”

Schondelmeyer said he and his colleagues are trying to build such supply chain maps, “but really the government should be doing that … I don’t fault the FDA; the FDA may or may not be the right place to do that.” But more agencies and other players need to be involved because “no one player in the market can solve this problem alone.”

Schondelmeyer displayed percentages of various drug types that were in shortage. Among 156 “critical acute care drugs” — those that must be used within hours or days of an illness’s onset to avoid serious outcomes or death — the FDA found 25.6% were in shortage, while the American Society of Hospital Pharmacists (ASHP) found that 41.7% of them were in shortage, “and this was even before COVID-19,” he said. Among a list of 40 “critical COVID-19 drugs,” the FDA has listed 45% of them as being in shortage, while the ASHP rated 75% as being in shortage. “Most were in short supply even before COVID-19 hit,” he added. “These are alarming levels of shortage and they have persisted.”

Many people suggest that the supply chain problem can be solved by moving manufacturing for particular drug products from overseas to a U.S. plant, but that doesn’t quite solve the problem, said Schondelmeyer. “If we manufactured our entire supply of drugs in the U.S., it doesn’t solve the problem if you put all the manufacturing in one facility and it gets wiped out by a hurricane,” he said, recalling what happened when a hurricane hit Puerto Rico, the home of several medical product manufacturers. “Hospitals were scrambling to get things like normal saline. So simply bringing production back to the U.S. but concentrating it in one place doesn’t solve the problem — it just moves the problem.”

Khatereh Calleja, president and CEO of the Healthcare Supply Chain Association, agreed. “We’ve got to focus on this very issue of geographic diversity,” Calleja said. “Otherwise we’re creating a risk when we create that concentration.”

When people are discussing the supply chain, having a common language among institutions is also important, said Chris Liu, director of enterprise services for the state of Washington, “In hospitals, ‘conservation’ of PPE [personal protective equipment] means something different at every hospital you go to,” he said.

Another thing that needs to be taken on is the vulnerability of drug precursors, said James Lawler, director of international programs and innovation at the University of Nebraska’s Global Center for Health Security. “It’s one thing if the plant that makes the final small-molecule antibiotic … is in the U.S., but if all the precursor chemicals they require to synthesize that product come from overseas, you haven’t necessarily fixed your supply chain vulnerability.”

Amid a worsening pandemic, hope

https://mailchi.mp/4c1ddd69e1fc/the-weekly-gist-december-4-2020?e=d1e747d2d8

Tech pitches in to fight COVID-19 pandemic | Computerworld

We are now in uncharted and dangerous new territory in the coronavirus pandemic, with the US recording a record-high 2,800 deaths on Thursday, along with 200,000 new cases—the second highest daily total of the pandemic so far.

More than 100,000 Americans are now hospitalized with COVID-19, occupying more than 10 percent of the nation’s hospital beds, and creating capacity constraints at hospitals around the country. With the impact of Thanksgiving travel—which was the heaviest since March—yet to be seen in the numbers, and with hospitalizations and deaths lagging new case counts by several weeks (as an epidemiological rule of thumb, 1.7 percent of new cases will result in reported deaths from COVID after 22 days), we are almost certainly headed for a grim winter holiday season.
 
But the light at the end of the tunnel grew brighter this week, with the United Kingdom becoming the first Western country to approve a COVID vaccine. (China and Russia both rolled out vaccines prior to Phase 3 trials being completed.)

Doctors and hospital staff in the UK will begin to administer Pfizer’s vaccine next week, and the US Food and Drug Administration (FDA) is expected to approve the same vaccine for emergency use on or shortly after an outside panel of experts convenes on December 10th.

Moderna, whose vaccine is similar to Pfizer’s, submitted an application for emergency use this week, and it will be evaluated on December 17th.

In the meantime, a group advising the Centers for Disease Control and Prevention (CDC) held a public meeting this week to craft recommendations for which populations should be prioritized to receive the new vaccines, settling on healthcare workers and residents of long-term care facilities as first in line. While state public health officials will make the final decisions about who gets vaccinated, most are expected to follow the CDC’s guidelines. The two priority groups represent about 24M people, most of whom could be immunized by the end of this month if all goes according to plan. The end of the pandemic will not come quickly, or easily, but it will come—we are near the beginning of the end.

Biden Closes In on Top Health Leaders as Pandemic Ravages U.S.

https://www.bloomberg.com/news/articles/2020-12-02/biden-closes-in-on-top-health-leaders-as-pandemic-ravages-u-s

President-elect Joe Biden’s front-runner for secretary of Health and Human Services is New Mexico Governor Michelle Lujan Grisham, and he may announce several of his administration’s health leaders as soon as next week, according to people familiar with the matter.

The position of HHS secretary is down to two possibilities, the people said, between Lujan Grisham and former Surgeon General Vivek Murthy, a co-chair of the coronavirus advisory board Biden appointed shortly after he was elected.

Biden’s health team will assume office with the U.S. still suffering from the pandemic, as virus cases and hospitalizations soared over the past month. His health secretary is expected to have input on filling other top health posts, such as FDA commissioner and the administrator of the Centers for Medicare and Medicaid Services, the people said, so those appointments may not be announced until later.

The Health and Human Services secretary will have the tough task of rebuilding Obamacare, which Biden has promised to expand. That will be a difficult undertaking with a Republican-led Senate.

Murthy or Jeff Zients, who led the Obama administration effort to repair healthcare.gov, the faulty Obamacare website, may be named to a leadership role on the pandemic, according to the people familiar with the matter — a “Covid-19 czar.”

Mandy Cohen, the North Carolina state health secretary, is a favorite for CMS, the people said. Biden’s choices to lead the Food and Drug Administration appear narrowed down to David Kessler, a former commissioner of the agency who is another co-chair of his coronavirus advisory board, and Joshua Sharfstein, a former FDA official who is a vice dean at Johns Hopkins University’s Bloomberg School of Public Health.

Biden announced his economic team on Tuesday, a group led by Treasury Secretary-designate Janet Yellen whose top priority will be restoring jobs eliminated by the pandemic. An announcement on some of his health team could come as soon as Monday, the people said.

The people familiar with the matter asked not to be identified because talks are still ongoing and no final decision has been made. It’s not clear how many people will be announced at once, or which positions would later be filled by the health secretary once the Biden administration is in place.

Biden’s transition team did not immediately respond to a request for comment.

The U.S. recorded 158,000 new coronavirus infections on Monday and a record 205,000 cases three days earlier. Biden will take office as distribution of coronavirus vaccines ramps up, and he has warned that any delay in the transition to his administration could slow or complicate that endeavor.

Lujan Grisham is seen as having an easier path to confirmation than Murthy, who has spoken out against gun violence as a public health threat and may draw strong opposition from Senate Republicans as a result, the people familiar with the matter said.

If he isn’t nominated to lead HHS, Murthy is under consideration as Covid-19 czar or another role, including a second stint as surgeon general, the people said. Murthy talks to Biden almost every day as co-chair of his advisory board and is seen as having influential supporters.

Murthy and Zients have also represented Biden’s transition team on calls with current HHS officials, two of the people said.

Biden’s team is still discussing what the White House coronavirus task force and Operation Warp Speed — the Trump administration’s effort to fast-track vaccines — will look like under the new administration.

If Biden announces his health team next week, he may be just days ahead of the first emergency FDA approval of a coronavirus vaccine. President Donald Trump is planning a vaccine summit next week at the White House, while an FDA advisory panel is scheduled to meet on Dec. 10 to discuss the shots.

No COVID-19 vaccine, no normal life, UK minister suggests

https://www.reuters.com/article/uk-health-coronavirus-britain-vaccines/no-covid-19-vaccine-no-normal-life-uk-minister-suggests-idUSKBN28A24R?fbclid=IwAR2V5IfikBf64K7KvQwr3kr5CLwQv-4DJ-H2eXTNScN6VLhh3BPNbS-C0Tc

No COVID-19 Vaccine, No Normal Life, UK Minister Suggests | World News | US  News

People who refuse a vaccine for COVID-19 could find normal life curtailed as restaurants, bars, cinemas and sports venues could block entry to those who don’t have proof they are inoculated, Britain’s new vaccine minister said on Monday.

Several major COVID-19 vaccines have been announced in recent weeks, raising hopes that the world could soon return to some semblance of normality after the coronavirus killed 1.46 million people and wiped out a chunk of the global economy.

The British minister responsible for the vaccine rollout, Nadhim Zahawi, said getting vaccinated should be voluntary but that Google, Facebook and Twitter should do more to fact-check opposing views of vaccines.

Asked by the BBC if there would be an immunity passport, Zahawi said a person’s COVID-19 vaccine status might be included in a phone app that would inform local doctors of a person’s status.

“But also I think you’d probably find that restaurants and bars and cinemas and other venues, sports venues, will probably also use that system as they’ve done with the app,” Zahawi told the BBC.

“The sort of pressure will come both ways: from service providers – who will say ‘look, demonstrate to us that you have been vaccinated’ – but also we will make the technology as easy and accessible as possible.”

Health authorities in many countries have become increasingly concerned in recent years by the growth of anti-vaccine groups, which are especially active on social media.

Asked if it would become virtually impossible to do anything without the vaccine, Zahawi said: “I think people have to make a decision but I think you’ll probably find many service providers will want to engage in this in the way they did with the app.”

Zahawi declined to give any specific date on a vaccine rollout as none have yet been approved for public use.

The message, he said, should be that a vaccine is good for the community and the country.

Purdue Pharma pleads guilty to federal criminal charges related to nation’s opioid crisis

https://www.cnn.com/2020/11/24/us/purdue-pharma-oxycontin-guilty-plea/index.html?fbclid=IwAR2DM1jxDtKxFaCW1o-HJ45Tuh1-HOVw5DjNx_ncuhfajyjdkvP9wnMHUMg

Purdue Pharma, the maker of OxyContin, pleaded guilty Tuesday to three federal criminal charges related to the company’s role in creating the nation’s opioid crisis. Purdue Pharma board chairman Steve Miller pleaded guilty on behalf of the company during a virtual federal court hearing in front of US District Judge Madeline Cox Arleo.

The counts include one of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

The plea deal announced in October includes the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture, according to a Department of Justice press release.

The company, which declared bankruptcy last year, will be dissolved as a part of the plea agreement, and its assets will be used to create a new “public benefit company” controlled by a trust or similar entity designed for the benefit of the American public.

The Justice Department has said Purdue Pharma will function entirely in the public interest rather than to maximize profits. Its future earnings will go to paying the fines and penalties, which in turn will be used to combat the opioid crisis.

In pleading guilty to the criminal charges, the company is taking responsibility for past misconduct, Purdue Pharma said in a statement to CNN Tuesday.”Having our plea accepted in federal court, and taking responsibility for past misconduct, is an essential step to preserve billions of dollars of value for creditors and advance our goal of providing financial resources and lifesaving medicines to address the opioid crisis,” the statement said. “We continue to work tirelessly to build additional support for a proposed bankruptcy settlement, which would direct the overwhelming majority of the settlement funds to state, local and tribal governments for the purpose of abating the opioid crisis.”

According to the US Centers for Disease Control and Prevention, about 70,000 Americans died of drug overdoses in 2018, just one year of the opioid crisis, and about 70% of those deaths were caused by prescription or illicit opioids like OxyContin. In that year, an estimated 10.3 million Americans 12 and older misused opioids, including 9.9 million prescription pain reliever abusers and 808,000 heroin users, according to the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration.

The Sackler family, and other current and former employees and owners of the company, still face the possibility that federal criminal charges will be filed against them. The court did not set a date for a sentencing hearing.