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Tuesday, February 2, 2021

Cultural tightness–looseness and COVID-19 cases and deaths


PDF: https://www.thelancet.com/action/showPdf?pii=S2542-5196%2820%2930301-6

Summary

Background

The COVID-19 pandemic is a global health crisis, yet certain countries have had far more success in limiting COVID-19 cases and deaths. We suggest that collective threats require a tremendous amount of coordination, and that strict adherence to social norms is a key mechanism that enables groups to do so. Here we examine how the strength of social norms—or cultural tightness–looseness—was associated with countries' success in limiting cases and deaths by October, 2020. We expected that tight cultures, which have strict norms and punishments for deviance, would have fewer cases and deaths per million as compared with loose cultures, which have weaker norms and are more permissive.

Methods

We estimated the relationship between cultural tightness–looseness and COVID-19 case and mortality rates as of Oct 16, 2020, using ordinary least squares regression. We fit a series of stepwise models to capture whether cultural tightness–looseness explained variation in case and death rates controlling for under-reporting, demographics, geopolitical factors, other cultural dimensions, and climate.

Findings

The results indicated that, compared with nations with high levels of cultural tightness, nations with high levels of cultural looseness are estimated to have had 4·99 times the number of cases (7132 per million vs 1428 per million, respectively) and 8·71 times the number of deaths (183 per million vs 21 per million, respectively), taking into account a number of controls. A formal evolutionary game theoretic model suggested that tight groups coordinate much faster and have higher survival rates than loose groups. The results suggest that tightening social norms might confer an evolutionary advantage in times of collective threat.

Interpretation

Nations that are tight and abide by strict norms have had more success than those that are looser as of the October, 2020. New interventions are needed to help countries tighten social norms as they continue to battle COVID-19 and other collective threats.

Funding

Office of Naval Research, US Navy.

Get Your Homebound Parent a COVID-19 Vaccine

 On January 9, Donna Lackner-Horn made appointments for her parents, Trudy and Werner Lackner, and an aunt and uncle, to get their COVID-19 vaccines the following week at HealthAlliance Hospital-Foxhall in Kingston, N.Y., 45 minutes from their homes in Poughkeepsie, NY. Though she needed to transport them to the vaccination site, Lackner-Horn considered herself lucky to nab the appointments since her mom, 78, and uncle, 88, are mostly homebound with chronic health issues and she couldn't find a way to get them vaccinated where they live.

"On Facebook, I follow various COVID awareness groups, but it was actually my town's supervisor who posted that the vaccines were being scheduled the next county over," says Lackner-Horn, 59, a nonprofit executive who lives in Hyde Park, NY. So, she clicked on a link in the Facebook post, which brought her to an app that allowed her to schedule all four appointments at the hospital. "It was just sheer luck I was scrolling through Facebook that day," says Lackner-Horn.

As her experience shows, getting homebound relatives vaccinated against COVID-19 isn't easy. But it's a problem a lot of caregivers will be facing: About 1.9 million adults over 65 are mostly homebound and another 5.3 million have health conditions that make leaving home difficult, according to the health policy think tank Commonwealth Fund.

There is no national plan for getting COVID-19 vaccines delivered to older homebound adults.

The phased rollout plans for the vaccines have been drawn up at the state level, and the early phases do include adults over 75 (in some cases, over 65). But it's logistically challenging to get the vaccines into homes, because the first two on the market, from Moderna and Pfizer, must be stored at ultra-cold temperatures.

How to Be Proactive for a Homebound Person's Vaccine

So, it's likely that family members or other caregivers will need to arrange for homebound people to be transported to vaccine centers, says Dr. Steven Albert, professor and chair of the University of Pittsburgh Graduate School of Public Health's department of behavioral and community health sciences.

"It is a very confusing picture right now," Albert says. "It's easy to get vaccines to nursing homes. But for every one person in a nursing home, there are probably five people in their homes with equal levels of disability who rely on a combination of family and community-based services."

So where should you start if you need to get a homebound parent vaccinated?

If they use a home health agency, calling there for guidance may lead you in the right direction. Home health aides aren't licensed to administer vaccines, but the agencies that employ them might partner with other health care providers who can bring vaccines to people's homes.

Some companies providing in-home health services are arranging transportation to COVID-19 vaccination sites for their homebound clients.

They include Landmark Health, a Huntington Beach, Calif. company that provides in-home care in 16 states. While Landmark physicians can't bring the vaccines to homes because of the cold-storage requirement, they can assist patients getting to vaccination sites, says Dr. Michael Le, chief medical officer.

"Our social workers can help them make appointments for vaccination at places that will minimize their time out of the home. They can also tap into community resources to arrange for transportation," Le says.

Alternatively, you might try the local government where your parent lives, but don't get your hopes up. Just a few local governments are beginning to arrange for COVID-19 vaccines for their homebound populations.

What Some Local Governments Are Doing

Florida's Miami-Dade County, for example, recently posted online that it started scheduling those vaccines. The Miami Beach fire department took 600 doses of the Moderna vaccine to a local apartment building for low-income older adults and the city has taken 200 older residents to a nearby medical center to get vaccinated.

According to The Orlando Sentinel, older homebound residents in the area's Seminole County can call to have a paramedic sent to them through a new, little-known program. (Florida's governor has prioritized COVID-19 vaccinations for people 65 and older but hasn't implemented a statewide plan for the homebound.)

And the township of Nutley, N.J., just announced that it will deploy medical staff from nearby RWJ Barnabas Health to bring a COVID-19 vaccine to those who are homebound due to illness or immobility.

Check with your parent's community's social media channels and local news websites.

If your parent is part of a Medicaid waiver program (state-funded providers of long-term home care), see if there's a care coordinator to call for information about a COVID-19 vaccination, Albert says.

An Expert's Advice for Family Caregivers

Le's advice for family caregivers who need to transport parents to vaccination sites: Do some research in advance to minimize the hassle. He speaks from personal experience.

When Le got his COVID-19 vaccine at a site set up by the Orange County Fire Department, he was surprised that he had to wait nearly three hours in his car just to get into the vaccination parking lot.

Bottom line: "If you're bringing your mom or dad to a vaccination site, be proactive," Le says. "If there's a line, make sure there's a way for them to be seated in the shade or to have their spot saved in line, so it's not so much of a physical struggle for them."

As for Lackner-Horn's four relatives, they got their first dose of the COVID-19 vaccine on January 12. The check-in and administrative work was "seamlessly efficient," Lackner-Horn says.

What's more, they were able to make appointments for the required second dose onsite. "They are all very pleased, and a bit elated," Lackner-Horn says. She's relieved.

PerkinElmer Q4, Full Year 2020 Results, 2021 Projections

 PerkinElmer, Inc.. (NYSE: PKI), a global leader committed to innovating for a healthier world, today reported financial results for the fourth quarter and full year ended January 3, 2021.

Fourth Quarter 2020

The Company reported GAAP earnings per share from continuing operations of $3.38, as compared to GAAP earnings per share from continuing operations of $0.58 in the fourth quarter of 2019. GAAP revenue for the quarter was $1.355 billion, as compared to $805 million in the fourth quarter of 2019. GAAP operating income from continuing operations for the quarter was $510 million, as compared to $138 million for the same period a year ago. GAAP operating profit margin was 37.7% as a percentage of revenue, as compared to 17.2% in the fourth quarter of 2019.

Adjusted earnings per share from continuing operations for the quarter was $3.96, as compared to $1.35 in the fourth quarter of 2019. Adjusted revenue for the quarter was $1.355 billion, as compared to $806 million in the fourth quarter of 2019. Adjusted operating income from continuing operations for the quarter was $571 million, as compared to $192 million for the same period a year ago. Adjusted operating profit margin was 42.2% as a percentage of adjusted revenue, as compared to 23.9% in the fourth quarter of 2019.

Full Year 2020

The Company reported GAAP earnings per share from continuing operations of $6.50, as compared to GAAP earnings per share from continuing operations of $2.04 in 2019. GAAP revenue for the year was $3.783 billion, as compared to $2.884 billion in 2019. GAAP operating income from continuing operations for the year was $979 million, as compared to $362 million in 2019. GAAP operating profit margin was 25.9% as a percentage of revenue, as compared to 12.6% in 2019.

Adjusted earnings per share from continuing operations for the year was $8.30, as compared to $4.10 in 2019. Adjusted revenue for the year was $3.784 billion, as compared to $2.884 billion in 2019. Adjusted operating income from continuing operations for the year was $1.203 billion, as compared to $596 million in 2019. Adjusted operating profit margin was 31.8% as a percentage of adjusted revenue, as compared to 20.7% in 2019.

Adjustments for the Company's non-GAAP financial measures have been noted in the attached reconciliations.

“While the fourth quarter and full year financial results are certainly impressive, we have many accomplishments beyond the headline financial numbers to be proud of,” said Prahlad Singh, president and chief executive officer of PerkinElmer. “The team’s response to the pandemic, and their resolute focus throughout 2020 to be a part of the solution, was humbling and inspiring to watch. As we look ahead, I could not be more excited about the future for PerkinElmer.”

 

Financial Overview by Reporting Segment for the Fourth Quarter and Full Year 2020

Discovery & Analytical Solutions

  • Fourth quarter 2020 revenue was $503 million, as compared to $496 million for the fourth quarter of 2019. Reported revenue increased 1% and organic revenue decreased 2% as compared to the fourth quarter of 2019. Full year 2020 revenue was $1.716 billion, as compared to $1.746 billion in 2019. Full year reported revenue decreased 2% and organic revenue decreased 4%.
  • Fourth quarter 2020 operating income from continuing operations was $73 million, as compared to $91 million for the comparable prior period. Full year 2020 operating income was $183 million, as compared to $238 million in 2019.
  • Fourth quarter 2020 adjusted operating income was $92 million, as compared to $116 million for the fourth quarter of 2019. Full year 2020 adjusted operating income was $267 million, as compared to $338 million in 2019.

Diagnostics

  • Fourth quarter 2020 revenue was $852 million, as compared to $309 million for the fourth quarter of 2019. Reported revenue increased 176% and organic revenue increased 172% as compared to the fourth quarter of 2019. Full year 2020 revenue was $2.067 billion, as compared to $1.138 billion in 2019. Full year reported revenue increased 82% and organic revenue increased 81%.
  • Fourth quarter 2020 operating income from continuing operations was $460 million, as compared to $61 million for the comparable prior period. Full year 2020 operating income was $874 million, as compared to $189 million in 2019.
  • Fourth quarter 2020 adjusted operating income was $502 million, as compared to $91 million for the fourth quarter of 2019. Full year 2020 adjusted operating income was $1.010 billion, as compared to $316 million in 2019.

Initiates Financial Guidance: First Quarter and Full Year 2021 Guidance

For the first quarter of 2021, the Company forecasts GAAP revenue of approximately $1.19 billion. GAAP earnings per share from continuing operations of at least $2.52 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of at least $3.00.

For the full year of 2021, the Company forecasts GAAP revenue of at least $4.08 billion. GAAP earnings per share from continuing operations of at least $6.73 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of at least $8.50.

Conference Call Information

The Company will discuss its fourth quarter and full year 2020 results and its outlook for business trends in a conference call on February 2, 2021 at 5:00 p.m. Eastern Time. To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 2779705.

A live audio webcast of the call will be available on the Investors section of the Company’s Web site, www.perkinelmer.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Company’s Web site for a two-week period beginning approximately two hours after the call.

https://www.biospace.com/article/releases/perkinelmer-announces-financial-results-for-the-fourth-quarter-and-full-year-of-2020/

FDA to Require Additional Study for Eagle’s Generic Vasopressin

 Eagle Pharmaceuticals is still struggling to get its generic vasopressin to market, announcing both a regulatory stall and an additional trial delay for a patent case with Endo Par Innovation Company over the drug.

Eagle received a complete response letter from the U.S. Food and Drug Administration (FDA), and after additional consultation with FDA, it has determined it will begin an additional, short-duration study by mid-March.

In the patent case, Eagle received word from the United States District Court for the District of Delaware last week its court data has been postponed to July 7, from February 1. According to the company, Endo Par has asserted claims in its patents for a vasopressin formulation with a pH between 3.7-3.9. However, Eagle says its vasopressin product would not be in that range.

Vasostrict – Endo Par’s branded version of injectable vasopressin – was approved in 2014 in hypotensive adult patients with vasodilatory shock, and works by increasing blood pressure. Vasopressin is a naturally occurring hormone and was previously marketed without FDA approval until 2011, when FDA required New Drug Applications (NDAs) from drugmakers. Endo Par was the first to win approval, and the company negotiated exclusive deals with the largest vasopressin suppliers, effectively blocking out existing competitors. At least one competitor, Fresnius SE, sued Endo over the moves but lost its case last year.

Eagle was the first of at least three companies that have submitted Abbreviated NDAs to FDA for approval of a generic vasopressin, and the complete response letter came following a priority review that was granted in November. The company said it has already met with FDA twice about the letter and “believes it can fully respond to the questions raised.” FDA and Eagle will meet again within a month.

Eagle estimates that Endo Par had over $700 million in sales for Vasostrict last year, up 20% over the previous year, and says FDA has flagged it as a COVID priority. Vasopressin has been used in adults with severe COIVD-19 with shock. If its Abbreviated NDA is approved, the company expects it will be eligible for a 180-day generic exclusivity period.

https://www.biospace.com/article/fda-to-require-additional-study-for-eagle-s-generic-vasopressin/

Vertex poised for shopping spree, still unclear just what

 After setting the tone at JP Morgan for a busy year of dealmaking, Reshma Kewalramani and her Vertex crew are giving slightly more shape to the pipeline they want to build with $6.7 billion in cash — but leaving much to be speculated.


Through it all, the freshman CEO says, Vertex will remain “a company that is about specialty markets” — and emphatically not a rare disease player.


Geoff Porges at SVB Leerink, though, sees the drive to introduce new drugs to the pipeline more driven by necessity than anything else. The company, according to him, is avoiding key questions while exposing “inconsistencies between their portfolio and their strategy.”

(T)he company’s success is catching up with them, in terms of the burden of having to diversify their business and add to their pipeline,” he wrote in a note. “Notwithstanding the company’s catchphrases of ‘cracking the biology’ and ‘pouring on the chemistry’, their most advanced program is CTX-001 which is an allogeneic stem therapy treatment for sickle cell disease and beta thalassemia. Another of their handful of clinical programs is their pancreatic islet cell transplant therapy for type I diabetes (entering clinic 1H 21).”


Rather than specifics, she offered some “color and texture” behind capital allocation: Compared to three years ago, Vertex molecules are in patients across six disease areas (up from just two, cystic fibrosis and pain) and revenue has grown from a little north of $2 billion to more than $6 billion.


As she suggested at JPM, it all backs up a search for mid-to late-stage assets alongside new tools:


I want to be very clear that the strategy is exactly the same what I outlined previously. And if I just focus in on the assets that fit our R&D strategy, we are now able to look at, for example, Phase 2 assets, assets that might be in Phase 3, and those are assets that we’re going to look at. We’re also going to continue to look at tools for our toolkit. I’m not looking at — I have no preconceived notions about the timing of a transaction and I have no preconceived notions about the dollar amount of a transaction. It has to fit our R&D strategy. It has to be transformative. We have to be able to add value. And, when we find that asset, and we have the patience and the judgment to be very thoughtful about that, we’re going to be ready to evaluate.



The execs also dodged a question on whether there is any platform tech that they don’t already have but would be interested in.


They have already dipped their toes into some of the hottest pools, including gene therapy, gene editing, mRNA, protein degradation and small molecule approaches for drugging RNA. “And you will continue to see us do deals and partnerships where there’s a particular technology that opens up a target that we think has transformational potential, and we’ll continue to do those as time goes on,” was as far as R&D chief David Altshuler was willing to go.


For now, at least.

https://endpts.com/vertex-is-poised-for-a-shopping-spree-but-its-still-unclear-just-what-might-go-into-their-basket-and-at-least-one-analyst-is-getting-impatient/

Genesis HealthCare Resident, Staff COVID-19 Vaccine Acceptance Rates

 Genesis HealthCare, (“Genesis” or “Company”) (NYSE: GEN), one of the largest post-acute care providers in the United States, announced today that 84% of its skilled nursing residents and 61% of skilled nursing staff members have been vaccinated, each receiving their first dose of the COVID-19 vaccine, through January 29, 2021. Staff vaccine acceptance rates far exceed the national average, and resident acceptance rates at Genesis skilled nursing centers were also above the national average, based on vaccine administration data in an analysis published by the Centers for Disease Control and Prevention (CDC).

On February 1, 2021, the CDC announced that “among 11,460 SNFs with at least one vaccination clinic conducted during the first month of the CDC Pharmacy Partnership for Long-Term Care Program, a median of 77.8% of residents and 37.5% of staff members received ≥1 vaccine dose through the program.”

“I am so extraordinarily proud of the progress our centers have made vaccinating both residents and staff,” states Dr. Richard Feifer, Chief Medical Officer of Genesis. “Our leadership team, clinicians, physicians and advanced practice providers have been working around the clock to educate patients, residents, staff and families about the importance of being vaccinated, and to answer every point of hesitancy or concern with a combination of compassion and factual information. These acceptance rates are a testament to the hard work and dedication our leadership and center staff have shown throughout this entire pandemic. We are not done yet, and continue our work to increase vaccination rates even higher.”

As of January 21, 2021, 100% of Genesis skilled nursing facilities received dose one of the vaccine, primarily utilizing CVS Health, our primary partner through the Pharmacy Partnership for Long Term Care program. Genesis facilities were among the first to begin vaccinations in nursing homes, beginning on December 17, 2020. After the first clinic, the pharmacists return three to four weeks later to administer the second booster shots for those who received the vaccine in round one, and will also vaccinate anyone not included in round one. The pharmacists will then return for a third time, three to four weeks after round two, to administer the final booster shots. Genesis skilled nursing facilities are approximately 67% through their second clinics.

https://www.streetinsider.com/Globe+Newswire/Genesis+HealthCare+Announces+Resident+and+Staff+COVID-19+Vaccine+Acceptance+Rates/17905589.html

COVID-19 lockdowns temporarily raised global temperatures

 The lockdowns and reduced societal activity related to the COVID-19 pandemic affected emissions of pollutants in ways that slightly warmed the planet for several months last year, according to new research led by the National Center for Atmospheric Research (NCAR).

The counterintuitive finding highlights the influence of airborne particles, or aerosols, that block incoming sunlight. When emissions of aerosols dropped last spring, more of the Sun's warmth reached the planet, especially in heavily industrialized nations, such as the United States and Russia, that normally pump high amounts of aerosols into the atmosphere.

"There was a big decline in emissions from the most polluting industries, and that had immediate, short-term effects on temperatures," said NCAR scientist Andrew Gettelman, the study's lead author. "Pollution cools the planet, so it makes sense that pollution reductions would warm the planet."

Temperatures over parts of Earth's land surface last spring were about 0.2-0.5 degrees Fahrenheit (0.1-0.3 degrees Celsius) warmer than would have been expected with prevailing weather conditions, the study found. The effect was most pronounced in regions that normally are associated with substantial emissions of aerosols, with the warming reaching about 0.7 degrees F (0.37 C) over much of the United States and Russia.

The new study highlights the complex and often conflicting influences of different types of emissions from power plants, motor vehicles, industrial facilities, and other sources. While aerosols tend to brighten clouds and reflect heat from the Sun back into space, carbon dioxide and other greenhouse gases have the opposite effect, trapping heat near the planet's surface and elevating temperatures.

Despite the short-term warming effects, Gettelman emphasized that the long-term impact of the pandemic may be to slightly slow climate change because of reduced emissions of carbon dioxide, which lingers in the atmosphere for decades and has a more gradual influence on climate. In contrast, aerosols - the focus of the new study - have a more immediate impact that fades away within a few years.

The study was published in Geophysical Research Letters. It was funded in part by the National Science Foundation, NCAR's sponsor. In addition to NCAR scientists, the study was co-authored by scientists at Oxford University, Imperial College, and the University of Leeds.

Teasing out the impacts

Although scientists have long been able to quantify the warming impacts of carbon dioxide, the climatic influence of various types of aerosols - including sulfates, nitrates, black carbon, and dust - has been more difficult to pin down. One of the major challenges for projecting the extent of future climate change is estimating the extent to which society will continue to emit aerosols in the future and the influence of the different types of aerosols on clouds and temperature.

To conduct the research, Gettelman and his co-authors used two of the world's leading climate models: the NCAR-based Community Earth System Model and a model known as ECHAM-HAMMOZ, which was developed by a consortium of European nations. They ran simulations on both models, adjusting emissions of aerosols and incorporating actual meteorological conditions in 2020, such as winds.

This approach enabled them to identify the impact of reduced emissions on temperature changes that were too small to tease out in actual observations, where they could be obscured by the variability in atmospheric conditions.

The results showed that the warming effect was strongest in the mid and upper latitudes of the Northern Hemisphere. The effect was mixed in the tropics and comparatively minor in much of the Southern Hemisphere, where aerosol emissions are not as pervasive.

Gettelman said the study will help scientists better understand the influence of various types of aerosols in different atmospheric conditions, helping to inform efforts to minimize climate change. Although the research illustrates how aerosols counter the warming influence of greenhouse gases, he emphasized that emitting more of them into the lower atmosphere is not a viable strategy for slowing climate change.

"Aerosol emissions have major health ramifications," he said. "Saying we should pollute is not practical."

###

About the article

Title: "Climate Impacts of COVID-19 Induced Emission Changes"
Authors: A. Gettelman, R. Lamboll, C. G. Bardeen, P. M. Forster, D. Watson-Parris
Journal: Geophysical Research Letters

This material is based upon work supported by the National Center for Atmospheric Research, a major facility sponsored by the National Science Foundation and managed by the University Corporation for Atmospheric Research. Any opinions, findings and conclusions or recommendations expressed in this material do not necessarily reflect the views of the National Science Foundation.

https://www.eurekalert.org/pub_releases/2021-02/ncfa-clt020221.php