Arizona TSA checkpoints close amid COVID-19 staffing issues

 Phoenix Sky Harbor International Airport will be temporarily closing several security checkpoints starting Friday due to Transportation Security Administration (TSA) staffing issues tied to the COVID-19 pandemic.

The TSA and airport said in a joint statement that the temporary closure of two security checkpoints in Terminal 4 was due to “the impacts of COVID on TSA personnel."

The Phoenix Airport said in a tweet on Thursday that TSA checkpoints B and D would be closed beginning at 4 a.m. on Friday while the other two remain open.

“Beginning at 4 a.m. Jan, 7, the B & D Security Checkpoints in Terminal 4 will be closed. A & C will remain open. Wait times for non-PreCheck passengers could be up to 30 minutes & passengers should plan their arrivals accordingly,” Phoenix Sky Harbor International Airport wrote.

The two noted that they did not anticipate impacts to Terminal 3's security checkpoint.

"We are monitoring this closely, and this situation only seems to affect Phoenix Sky Harbor for now," R. Carter Langston, TSA spokesman, said in a statement.

"Communities and transportation systems have been hard hit by increasing COVID infections, and we continue to encourage those who are ill to stay home and get tested. Compliance with the federal face mask requirement, social distancing, and checkpoint modifications remain in place for those who choose to travel," Langston added. 

Inclement weather and staffing shortages linked to the omicron variant have hurt airlines, which have had to cancel close to 20,000 flights since Christmas Eve. 

Though growing data and research suggest that the omicron variant may not be as severe as public health officials initially worried, the variant is still highly transmissible. 

Close to 3,300 TSA employees alone have been infected with COVID-19 as of Thursday, according to USA Today, which notes it accounts for 5 percent of its employees.

https://thehill.com/policy/transportation/588707-arizona-tsa-checkpoints-close-due-to-covid-19-staffing-issues

Conservative justices seem skeptical of Biden vaccine mandates

 Conservative members of the Supreme Court on Friday appeared skeptical of Biden administration policies that impose a COVID-19 vaccine-or-test requirement on broad swathes of the U.S. workforce.

During several hours of oral arguments, the court’s conservative majority posed sharp questions about whether a federal workplace law that Congress passed some five decades ago provides the legal authority for a vaccine-or-test policy affecting roughly 84 million workers at large employers.

The conservative justices also appeared wary, though slightly less so, of a separate coronavirus vaccine mandate that applies to the roughly 17 million health care workers at hospitals and other facilities that receive federal funding through the Medicare and Medicaid programs.

The tenor of Friday’s back-to-back arguments suggested a split along familiar ideological lines. Questions posed by the court’s six conservative justices reflected concerns about granular details like the efficacy of COVID-19 vaccines in preventing the spread to others, as well as broader structural issues like how public health authority fits within the country’s constitutional framework.

“It seems to me that the more and more mandates that pop up in different agencies, it's fair -- I wonder if it's not fair for us to look at [this] as a general exercise of power by the federal government and then ask the questions of, well, why doesn't Congress have a say in this, and why don't the -- why doesn't this be the primary responsibility of the states?” Chief Justice John Roberts asked the solicitor general. 

The court’s three liberals appeared primarily concerned with the public health impact that might result from blocking the administration’s policies while challenges proceed in the lower courts. 

Justice Stephen Breyer, addressing an attorney for one set of challengers to the employer vaccine-or-test mandate, said he found their request to block the policy “unbelievable” in light of the soaring infection rates amid the spread of the omicron variant. 

“How can it conceivably be in the public interest,” he asked. “You have the hospitalization figures growing by factors of 10, 10 times what it was. You have hospitalization at the record, near the record.”

https://thehill.com/regulation/court-battles/588774-conservative-justices-seem-skeptical-of-biden-vaccine-policies

Global Dementia Cases to Triple by 2050 Unless Risk Factors Cut: Gates-Backed Study

 The number of individuals over 40 with dementia will nearly triple worldwide and double in the United States by 2050 unless steps are taken to address risk factors, new research suggests.

Results from a study of 195 countries and territories estimates that by 2050, 153 million people are expected to have dementia worldwide — up from 57 million in 2019. In the United States, the number is expected to increase 100%, from an estimated 5.3 million in 2019 to 10.5 million in 2050.

The increase is largely driven by population growth and population aging, but researchers note that expanding access to education and addressing risk factors such as obesity, high blood sugar, and smoking could blunt the rise in cases.

The study, the first of its kind, predicts increases in dementia in every country included in the analysis. The sharpest rise is expected in north Africa and the Middle East (367%) and sub-Saharan Africa (357%). The smallest increases will be in high-income countries in Asia Pacific (53%) and western Europe (74%).

Although the US had the 37th lowest percentage increase across all countries considered, "this expected increase is still large and requires attention from policy and decision-makers," co-investigator Emma Nichols, MPH, a researcher with the Institute for Health Metrics and Evaluation at the University of Washington in Seattle, told Medscape Medical News.

The findings were published online today in The Lancet Public Health.

Dementia Prevalence

For the study, researchers used country-specific estimates of dementia prevalence from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 study to project dementia prevalence globally, by world region, and at the country level.

They also used information on projected trends in four important dementia risk factors (high body mass index, high fasting plasma glucose, smoking, and education) to estimate how changes in these risk factors might impact dementia prevalence between 2019 and 2050.

Despite large increases in the projected number of people living with dementia, age-standardized both-sex prevalence remained stable between 2019 and 2050, with a global percentage change of 0.1% (–7.5 to 10.8).

Dementia prevalence was higher in women than in men and increased with age, doubling about every 5 years until 85 years of age in both 2019 and 2050 (female-to-male ratio, 1.67 [1.52–1.85]).

Projected increases in cases could largely be attributed to population growth and population aging, although their relative importance varied by world region. Population growth contributed most to the increases in sub-Saharan Africa and population aging contributed most to the increases in east Asia.

Countries with the highest expected percentage change in total number of dementia cases between 2019 and 2050 were:

• Qatar (1926%)

• United Arab Emirates (1795%)

• Bahrain (1084%)

• Oman (943%)

• Saudi Arabia (898%)

• Kuwait (850%)

• Iraq (559%)

• Maldives (554%)

• Jordan (522%)

• Equatorial Guinea (498%)

Countries with the lowest expected percentage change in total number of dementia cases between 2019 and 2050:

• Japan (27%)

• Bulgaria (37%)

• Serbia (38%)

• Lithuania (44%)

• Greece (45%)

• Latvia (47%)

• Croatia (55%)

• Ukraine (55%)

• Italy (56%)

• Finland (58%)

Modifiable Risk Factors

Researchers also calculated how changes in risk factors might affect dementia prevalence. They found that improvements in global education access would reduce dementia prevalence by an estimated 6.2 million cases worldwide by 2050.

However, that decrease would be offset by expected increases in obesity, high blood sugar, and smoking, which investigators estimate will result in an additional 6.8 million dementia cases.

The projections are based on expected trends in population aging, population growth, and risk factor trajectories, but "projections could change if effective interventions for modifiable risk factors are developed and deployed," Nichols said.

In 2020, the Lancet Commission on Dementia Prevention, Intervention, and Care issued an update of its 2017 report, identifying 12 modifiable risk factors that could delay or prevent 40% of dementia cases. The risk factors were low education, hypertension, hearing impairment, smoking, midlife obesity, depression, physical inactivity, diabetes, social isolation, excessive alcohol consumption, head injury, and air pollution.

"Countries, including the US, should look to develop effective interventions for modifiable risk factors, but also should invest in the resources needed to support those with dementia and their caregivers," Nichols said.

She added that additional support for research and resources to develop therapeutic interventions is also warranted.

Oversimplifying Mechanisms?

In an accompanying commentary, Michaël Schwarzinger, MD, and Carole Dufouil, PhD, of Bordeaux University Hospital, Bordeaux, France, note that the authors' efforts to build on GBD 2019 oversimplify the underlying mechanisms that cause dementia.

The authors "provide somehow apocalyptic projections that do not factor in advisable changes in lifestyle over the lifetime," they write.

"There is a considerable and urgent need to reinforce a public health approach towards dementia to better inform the people and decision-makers about the appropriate means to delay or avoid these dire projections," the editorialists add.

The study was funded by the Bill and Melinda Gates Foundation and Gates Ventures. Nichols and the editorialists have disclosed no relevant financial relationships. Full disclosures for the other investigators are available in the original article.

Lancet Public Health. Published online January 6, 2022. Abstract, Editorial

https://www.medscape.com/viewarticle/966215

Citi To Fire All Unvaxed Unless They Comply With Mandate By Jan 14

 Citigroup has just become the first Wall Street megabank to give the anti-vaxxers among its 70K employees an ultimatum: either get vaccinated (and turn over the appropriate proper documentation), or find somewhere else to work.

As Wall Street banks struggle to find a strategy to bring workers back to the office without putting them at risk of getting COVID, the bank has decided that Citi employees who don't comply with this mandate by Jan. 14 will be placed on unpaid leave, and their last day of employment will come at the end of the month, according to a message to Citigroup staff seen by Bloomberg.

This is by far the most restrictive requirement among Wall Street firms. But whether or not it will help the financial services industry bring workers back to the office more quickly remains to be seen.

On top of this, Citi is holding bonus payments over workers' heads, saying that any employees who refuse the vaccine also won't receive bonus payments for 2021 unless they sign a legal document giving up their right to sue Citigroup, presumably for wrongful termination since the legality of employer vaccine mandates is still being chewed over by SCOTUS.

Workers who are forced out by the vaccination policy can apply for other jobs at Citi in the future, but they shouldn't bother if they don't "see the light" and get vaccinated.

"You are welcome to apply for other roles at Citi in the future as long as you are compliant with Citi’s vaccination policy," the company said in the memo.

According to Bloomberg, more than 90% of Citigroup’s staffers in the US have already been vaccinated. Any workers who haven't gotten their shots are welcome to apply for religious or medical exemptions. Although it's not clear what those applying for an exemption will do during the period between the start of the vaccine mandate, and whenever Citi finishes analyzing all the applications for an exemption.

Unsurprisingly, Citi is already facing public backlash for its decision to push out anti-vaxxers. One Twitter user questioned if Citi would take responsibility for any vaccine-induced medical issues (like the 'almost harmless' inflammation of the heart that has been associated with mRNA vaccines and younger users).

And what's next? Will Citibank extend this mandate to its vaccinated customers?

One Citi worker complained on LinkedIn that this policy feels like a huge "overreach" since most of his direct reports don't work in the same state as him.

"I’ve been sitting at home for two years now, I rarely go to the office, my direct reports are states away -- this felt like a huge overreach," said George Pagano, who spent five years in Citigroup’s operations and technology division before departing in November due to the mandate.

"When it comes to promoting the company at the expense of having to threaten to fire people the week after Christmas, it just seemed to be a bit too much."

Finally, Citi is imposing its mandate as constitutionality of vaccine mandates is still debatable. As one source told Bloomberg, most companies are waiting to see how SCOTUS rules.

"It’s extremely onerous for employers," Paul said, noting challenges in obtaining tests and tracking the data.

"Because of these burdens, there are a lot of employers that are just waiting to see what the Supreme Court does before they go ahead and roll out their plans."

While Citi's office workers must adhere to the Jan. 14 deadline, workers in the company's office branches will have a little more leeway. To try and make the mandate more palatable, Citi has taken measures including bringing in medical experts to educate staff, holding town halls with human-resources leaders and handing out prizes for vaccinated workers. It also offered paid time off for workers hoping to get the shot.

Earlier this week, Goldman Sachs became the latest Wall Street megabank to abandon its plans to return employees to its offices.

Citi has already faced legal challenges over its vaccine mandate, which it first announced back in November after President Biden called on corporations to coerce their workers into getting the jabs. Of course, the rate of vaccination will differ dramatically by state, as many workers in New York are already facing pressure from the government to get the vaccines, while workers in Florida and Texas have been afforded much more leniency.

Unfortunately, the world has learned over the last year that the vaccines aren't nearly as effective as Pfizer and Moderna (and President Biden) originally led the public to believe. So hopefully whoever came up with this idea at Citi isn't disappointed when it has no impact on the number of workers afflicted by virus.

https://www.zerohedge.com/markets/citigroup-faces-backlash-after-announcing-wall-streets-first-vaccination-mandate

Amphastar upped to Overweight from Neutral by Piper Sandler

 Target to $28 from $21

https://finviz.com/quote.ashx?t=amph

Medicare Revamp May Be Part of 'Skinny Build Back Better' Bill

 Although the prospects appear dim now for passage in Congress of the Build Back Better Act in its current form, a pared-down version may survive and is likely to include some health provisions, a policy expert said at a webinar sponsored by Avalere, a healthcare consulting firm.

"The legislation passed in the House is likely not to advance in its current form," especially after Sen. Joe Manchin (D-W.Va.) said that he wouldn't support the bill, Matt Kazan, MPP, principal at Avalere, said during Thursday's webinar. "However, right now Democrats remain very motivated to get something done, and many have already talked about a more scaled-back or 'skinny' version of that legislation. That certainly could include healthcare, so provisions like [Medicare] Part B benefit redesign, inflation rebates, even Medicare [drug price] negotiation -- those policies are certainly on the table going forward."

Even if the Build Back Better Act doesn't advance, "Democrats are still going to have to act on healthcare because of a variety of deadlines related to the Affordable Care Act (ACA)," he added.

Drug pricing policies are one area of healthcare emphasis in proposed Build Back Better Act provisions, but "there are a set of other separate drug pricing-related changes that have already been finalized or enacted, and are scheduled to be implemented over the coming months and years," said Megan Olsen, MPH, principal at Avalere. "So it's important that stakeholders are not losing sight of these upcoming changes, particularly as there could be some interesting interaction effects."

Olsen highlighted four upcoming changes:

• Removal of the 100% average manufacturer price (AMP) cap on Medicaid rebates in 2024. "This will allow Medicaid rebates for some products to exceed 100% of AMP for the drugs' cost," she said.
• Changes to the calculation of AMP and "best price" -- the requirement that drugmakers must offer their lowest price to Medicaid plans -- in the context of copay accumulators. Accumulators are health insurers' way of keeping track of the drug company coupons and copay cards that patients use to help afford their drugs; often, the insurers don't allow the value of the coupons and cards to count toward a patient's deductible. "This will require manufacturers to ensure the full value of financial assistance is going to patients; otherwise they must reflect that in the reporting of best price," she said.
• New flexibilities associated with value-based purchasing arrangements. "This will allow manufacturers to report multiple best prices in connection with a value-based purchasing arrangement, and this is intended to facilitate growth and adoption of new and innovative contracting arrangements across Medicaid and commercial markets," said Olsen. "This could be particularly interesting as we think about rare disease drugs, cell and gene therapies, and the like."
• Inclusion of U.S. territories in the Medicaid drug rebate program in 2023. "That will have some implications for manufacturer rebate liability overall," she said. "The combination of these changes with the potential for additional drug pricing changes via the Build Back Better Act certainly yield a complex outlook as we think about drug pricing moving forward."

One aspect missing from the Build Back Better Act is provisions to address prices of drugs just being launched or entering the market, said Rebecca Yip, MS, principal at Avalere. "How will the government participate in negotiating or setting these prices? I think we can anticipate the administration using CMMI [the Center for Medicare and Medicaid Innovation] as a vehicle to test out some of these models."

For example, a model might involve value-based pricing, which could be developed using an "ACA-like" entity or independent board, she said. Although Obama- and Trump-era demonstration projects along those lines were rescinded, "if and when the BBBA [Build Back Better Act] passes or some separate drug pricing package passes, we can expect the focus to turn to launch prices to round out meeting the objectives of drug pricing," said Yip.

Health equity and social determinants of health also are high priorities for the Biden administration, said Kazan. To address those issues, "Medicare Advantage does seem like a natural program that one could focus on, given its large number of low-income enrollees and large number of racial minority enrollees." The administration would have a lot of policy levers to choose from in that program, including supplemental benefits that address non-health-related factors, risk adjustment payments that vary reimbursement based on the characteristics of each enrollee, and quality ratings, he said.

However, Kazan added, "Democrats historically ... have been reluctant in the past years to give Medicare Advantage a lot of flexibility. I think the Biden administration has a really interesting choice to make as to whether or not they want to buck the previous trends and and focus on the Medicare Advantage program" as a way to improve health equity and social determinants of health.

State-level drug pricing reforms also are something to watch for in 2022, according to Olsen. "Over the past couple years we've seen states move from more drug price transparency and manufacturer reporting measures to more aggressive drug price control measures, and [they are] also looking at additional aspects of transparency, including PBM [pharmacy benefit manager] reporting requirements," she said. "I'd also look out for additional activity around drug price affordability review boards at the state level."

https://www.medpagetoday.com/practicemanagement/reimbursement/96555

Another mRNA company gets snapped up as Merck buys Exelead

The latest pharma company to make a move for an mRNA specialist is Germany’s Merck KGaA, which has offered a $780 million cash buyout to US biotech Exelead.

Unlike other recent deals however the takeover isn’t focused on adding a pipeline of mRNA candidates, as Indianapolis-based Exelead is a contract development and manufacturing organisation (CDMO) provide derives to other drugmakers.

Rather, it brings with it platform capabilities in formulations of mRNA drugs, including lipid nanoparticles used to deliver them safely to target tissues, as well as additional manufacturing capacity that will be offered to partners.

In that respect it follows a similar model to Merck’s takeover of AmpTec, another CDMO that uses a PCR platform to make mRNA drugs, for an undisclosed sum last year.

Outsourcing services are on of the pillars of Merck’s business, delivered via its process solutions unit, part of the group’s life sciences division. The unit contributed almost €3.4 billion out of Merck’s total revenues of €14.4 billion in the first nine months of 2021.

mRNA emerged as the most important new technology for the biopharma sector in 20021, as COVID-19 vaccines from Pfizer/BioNTech and Moderna – which both use lipid nanoparticles for delivery – quickly became the mainstay of many immunisation programmes around the world.

Exelead was part of that success, helping to manufacture vaccine precursors for the Pfizer/BioNTech shot Comirnaty.

The stellar success of the COVID-19 jabs – bringing in billions of dollars in revenues and profits for their developers – prompted a string of M&A and licensing deals last year, notably Sanofi’s $3.2 billion acquisition of Translate Bio and $470 million purchase of Tidal Therapeutics.

“Novel modalities, particularly mRNA, present a highly attractive business opportunity as pharma and biotech pipelines are increasingly building on them beyond COVID-19,” said Merck chief executive Belén Garijo.

Just this week Pfizer and BioNTech added an mRNA-based shingles vaccine to their ongoing alliance, which also includes new flu vaccines, and the technology is also showing promise in non-infectious disease applications including heart failure.

“The acquisition of Exelead will further enable Merck to capture the significant potential of the fast-growing market for mRNA therapies by providing leading CDMO services to our customers,” he added.

Exelead – which until 2017 was known as Sigma Tau Pharmasource – has around 200 staff members, with 50 added as a result of the Pfizer/BioNTech contract. Last year the company undertook a major expansion project, adding new formulation suites and filling lines at its main Indianapolis campus.

The deal is scheduled to close in the first quarter of this year, pending the usual closing requirements and antitrust reviews.

https://pharmaphorum.com/news/another-mrna-company-gets-snapped-up-as-merck-buys-exelead/