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Saturday, May 1, 2021

Cities, states experiment with vax incentives

 States and cities are experimenting with offering incentives and privileges for residents to get vaccinated for COVID-19 as concerns have mounted over the slowdown in vaccinations across the U.S. 

Officials are turning to initiatives such as giving vaccine recipients payments through savings bonds, free drinks or gift cards to motivate Americans to get their COVID-19 shot. Public health and psychology experts said these programs have the potential to bring in more people willing to get the vaccine and that incentives are worth a try to close the country’s gap in vaccinations.

This week, West Virginia committed to giving those aged 16 to 35 who get the vaccine $100 in savings bonds to boost the state’s vaccination numbers. Gov. Jim Justice (R) reported on Monday that 52 percent of the eligible state population has received at least one dose and noted the cost would be “so minuscule” compared with what the state has spent and keeps spending on the pandemic.

Connecticut plans to take a different approach in launching its #CTDrinksOnUs campaign, through which vaccine recipients will be eligible for one free drink with the purchase of food between May 19 and 31 at participating locations.  

Max Reiss, the director of communications for Connecticut Gov. Ned Lamont (D), said the state’s drink program arose as officials and the restaurant industry brainstormed how to reach “herd immunity” — a point at which most of the population is immune to the virus.  

The idea for the program was not “directly linked” to the slowdown of vaccinations seen in the state and nationally, Reiss said.

When asked if the drink incentive had the ability to get the state to a herd immunity point, he responded, “We don’t think it hurts.”

“If there's an extra bonus that when you go to the restaurant, you can get a drink or a beer or a glass of wine or a soda, we think that's a nice token that you can enjoy,” he said. “And it shows that if you're vaccinated, you can do all these things safely.”

City and county governments are also exploring incentive approaches to increase vaccinations, with Chicago working on two programs in which fully vaccinated people would have special access to summer events and special offers for salon and barbershop services. On Wednesday, Harris County in Texas approved up to $250,000 to be used for gift cards, events and other incentives for vaccinated people, the Houston Chronicle reported

Starting on Monday, Detroit is offering $50 prepaid debit cards to anyone who drives another person to get their vaccination, as long as they preregister. Deputy Mayor Conrad Mallett said officials hope, through the program, that trusted voices within communities will be inspired to help other members decide to get the COVID-19 shot and therefore raise Detroit’s vaccination numbers.  

“Pushing past our inability to manage and win the argument on social media, we really had to be more inventive about how to get the attention of the greater, grander community,” he said. 

Detroit officials decided on giving the incentive to those who give their “time and effort” to help others get vaccinated instead of paying directly due to concerns about the “ethics of that.”

“Getting vaccinated is an important decision,” Mallett said. “And we didn't want to try to muddy up that decisionmaking process by trying to encourage people to do what we think is right but pay them to do it.”

The push for incentives comes as the average number of vaccines administered daily in the U.S. has been declining in recent days, which experts have attributed to a waning demand for vaccines after enthusiastic recipients have already gotten their shots.

The U.S. hit a peak in its seven-day average of daily vaccinations on April 13 with 3.38 million, but that number has since fallen to 2.63 million as of Thursday, according to Our World in Data. 

Overall, the Centers for Disease Control and Prevention reports that 55.4 percent of American adults have received at least one dose, and 39 percent are considered fully vaccinated, meaning much of the population is still particularly susceptible to contracting the virus. 

William Schaffner, a professor of infectious diseases and preventive medicine at Vanderbilt University Medical Center, said vaccinating more of the country’s population is important because it will “substantially diminish” COVID-19’s spread and the impact of variants. 

“Anything we can do to provide incentives to get more of those people vaccinated I think is a good thing,” he said. “Whether these incentives work, we'll have to wait and see. I'm sure they'll work with some people. There's no doubt about that, but whether they can really help us turn the tide remains to be seen.”

These state and local governments are taking a page out of some businesses’ playbooks, including Krispy Kreme, which offers a free doughnut every day of 2021 to Americans who prove they got their shot. 

Experts said research shows that incentives can be effective at influencing health behaviors, with Noel Brewer, a professor of health behavior at the University of North Carolina, saying incentives are expected to increase vaccinations by about 8 percent. 

“This idea of letting people choose and empowering freedom of choice could be quite appealing to people on the right and on the left, so this seems like a palatable approach,” Brewer said. 

This week in Michigan, Gov. Gretchen Whitmer (D) also unveiled a reopening plan that connects loosening COVID-19 restrictions to increased vaccination rates. Under the plan, once the state documents that 70 percent of the eligible population received at least one dose, its orders on masks and limitations for public and private gatherings would be dropped. 

Brewer said incentives are stronger when there’s “a clear contingency between an individual’s behavior and the reward,” so Michigan should expect to see “a weaker effect or maybe no effect” when compared to a direct incentive. 

Austin Baldwin, an associate professor of psychology at Southern Methodist University, said in general mandates can be “very effective,” but when it comes to vaccinations, those who are resistant or hesitant may not respond well to vaccine requirements if they're perceived as “threatening.”

“At least in the current context, incentives might be sort of a more effective approach because incentives at least sort of still value, at a psychological level, that autonomy, and people can feel like they're making that decision on their own accord,” Baldwin said.

https://thehill.com/policy/healthcare/551246-cities-states-experiment-with-incentives-for-vaccinations

Pandemic IG blasts DOJ memo, urges Congress to clarify mandate

 A watchdog seeking to provide oversight of trillions of dollars in coronavirus spending and other relief has blasted a new Justice Department memo while calling on Congress to clarify his oversight mandate.

Brian Miller, the Treasury Department’s special inspector general for pandemic recovery (SIGPR), said Friday that a decision this week by the Justice Department’s Office of Legal Counsel (OLC) has “permanently reduced oversight” of specific relief programs implemented during the coronavirus pandemic.

Miller in his quarterly report to Congress warned that his efforts have been limited after the OLC held that his oversight jurisdiction applies only to Treasury’s direct loans and the Federal Reserve’s lending programs but not to the Coronavirus Relief Fund, Payroll Support Program and Paycheck Protection Program.

The three programs were established by various acts of Congress last year to provide support to airline employees, states, cities and small businesses impacted by lockdown orders and safety restrictions amid the COVID-19 outbreak. 

Miller in his Friday report said that his office had “been met with resistance” for several months from the Treasury Department and the Treasury inspector general over his oversight on the Coronavirus Relief Fund and the Payroll Support Program. 

Miller, who was appointed by former President Trump, said his office had been tracking fraud and “double-dipping” in relief programs but that starting in the final months of the Trump administration, a turf war among the various inspector generals has eroded his oversight.

The watchdog's update was first reported by The New York Times. The Hill has reached out to the White House and Justice Department for comment on Miller's report.

“All special inspectors general share concurrent jurisdiction with their counterparts and must partner with agency inspectors general to achieve their respective statutory oversight missions,” Miller wrote Friday. “There is nothing more frustrating to achieving these missions than turf battles.”

The pandemic recovery inspector general called on Congress to pass legislation to clarify his office’s “mandate to provide oversight of the Coronavirus Relief Fund, Payroll Support Program, and other pandemic-related programs managed by the Secretary of the Treasury.” 

Miller later in the report referenced his testimony during his confirmation hearing last year before the Senate, when he “promised to be thorough and truthful in alerting Congress ‘if we find out that things are not working well in a particular area.’”

“One year later, SIGPR’s jurisdiction has come to be viewed narrowly, not expansively, and my only conclusion is that ‘things are not working well,’” he wrote Friday.

The report also contained a letter dated Tuesday from Laurie Schaffer, the Treasury Department’s principal deputy general counsel, who argued that Miller had oversight of only Treasury’s direct loans and investments in Federal Reserve facilities, with the other relief funds being tracked by other oversight bodies. 

“Treasury is dedicated to the prevention of waste, fraud and abuse, and we are committed to being responsive and helpful to S.I.G.P.R.,” Schaffer wrote.

Daniel Koffsky, deputy assistant attorney general in the Justice Department's Office of Legal Counsel, wrote in the opinion dated Thursday that his office had concluded that language in the Cares Act passed last year limited the special inspector general's oversight jurisdiction.

A Treasury official told The Hill that the programs under the Cares Act are overseen by several bodies, including the Treasury's inspector general, the Government Accountability Office and the Congressional Oversight Commission. 

In a statement to The Hill, a Treasury spokesperson said that the agency "supports strong oversight, and we will continue to make sure all of our inspectors general, congressional committees of jurisdiction, and other oversight bodies have the information they need.”

The oversight dispute comes as President Biden hopes to pass trillions of dollars in additional relief proposals, including $4 trillion on jobs and infrastructure development programs. The administration is also charged with overseeing another $1.9 trillion in coronavirus relief funds approved in March.

https://thehill.com/homenews/administration/551296-pandemic-inspector-general-blasts-doj-memo-urges-congress-to-clarify

Nobody Wants to Be Narcan'd: Drug Users' Perspectives on Naloxone

Jeffrey T. Lai, MD; Charlotte E. Goldfine, MD; Brittany P. Chapman, BSc; Melissa M. Taylor, BA; Rochelle K. Rosen, PhD; Stephanie P. Carreiro, MD; Kavita M. Babu, MD

DISCLOSURES 

Western J Emerg Med. 2021;22(2):339-345.

 

Abstract and Introduction

Abstract

Introduction: Bystander naloxone distribution is an important component of public health initiatives to decrease opioid-related deaths. While there is evidence supporting naloxone distribution programs, the effects of increasing naloxone availability on the behavior of people who use drugs have not been adequately delineated. In this study we sought to 1) evaluate whether individuals' drug use patterns have changed due to naloxone availability; and 2) explore individuals' knowledge of, access to, experiences with, and perceptions of naloxone.

Methods: We conducted a pilot study of adults presenting to the emergency department whose medical history included non-medical opioid use. Semi-structured interviews were conducted with participants and thematic analysis was used to code and analyze interview transcripts.

Results: Ten participants completed the study. All were aware of naloxone by brand name (Narcan) and had been trained in its use, and all but one had either currently or previously possessed a kit. Barriers to naloxone administration included fear of legal repercussions, not having it available, and a desire to avoid interrupting another user's "high." Of the eight participants who reported being revived with naloxone at least once during their lifetime, all described experiencing a noxious physical response and expressed a desire to avoid receiving it again. Furthermore, participants did not report increasing their use of opioids when naloxone was available.

Conclusions: Participants were accepting of and knowledgeable about naloxone, and were willing to administer naloxone to save a life. Participants tended to use opioids more cautiously when naloxone was present due to fears of experiencing precipitated withdrawal. This study provides preliminary evidence countering the unsubstantiated narrative that increased naloxone availability begets more high-risk opioid use and further supports increasing naloxone access.

https://www.medscape.com/viewarticle/949003

DexCom Drops After Revenue Guidance Misses

 Shares of DexCom  (DXCM) - Get Report slipped Friday even though the diabetes-monitoring equipment maker reported first-quarter earnings and revenue that exceeded analysts' expectations. Full-year revenue guidance, however, missed analyst estimates.

Shares of the San Diego company dropped 6.27% to $395.25 at last check.

For the quarter ended March 31, DexCom posted GAAP earnings of $40.3 million, or 41 cents a share, compared to $19.9 million, or 21 cents a share in the year-ago period. Adjusted net income stood at $32.8 million, or 33 cents a share.

Revenue for the first quarter rose 25% to $505 million.


A survey of analysts by FactSet produced consensus estimates of GAAP earnings of 29 cents a share, or an adjusted 31 cents, on revenue of $486.6 million.

For the full fiscal year, DexCom expects revenue to grow 17% to 22% to between $2.26 billion and $2.36 billion, or a midpoint of $2.31 billion. That fell short of FactSet's consensus estimate for 2021 fiscal year revenue of $2.34 billion. 

“Dexcom is off to a great start in 2021, including several key advancements of our strategic priorities in the first quarter,” DexCom's Chairman, President and Chief Executive Kevin Sayer said in a statement. 

"Based on the strength of our first-quarter results and the significant market opportunity ahead of us, we are pleased to raise our 2021 revenue guidance," Sayer added.

DexCom stock has 18 buys, 2 holds and 2 sells according to Bloomberg data.

https://www.thestreet.com/investing/dexcom-drops-as-revenue-guidance-misses

Serum Institute plans to start vaccine production outside India

 

The Serum Institute of India, which manufactures the AstraZeneca COVID-19 vaccine, is planning to start vaccine production in other countries as it struggles to meet supply commitments, its chief executive officer told The Times.

"There's going to be an announcement in the next few days," Adar Poonawalla was quoted as saying by the newspaper in an interview published on Friday.

Poonawalla said last week that the Serum Institute would be able to raise its monthly output to 100 million doses by July, later than a previous timeline of end-May. Several states in India have run out of vaccines against COVID-19.

He hoped to increase the Serum Institute's production capacity from 2.5 billion to 3 billion doses a year within six months, the Times reported, adding that he flew to London before Britain banned travellers from India eight days ago.

Coronavirus cases and deaths have surged in India as the world's second-most populous country has reported more than 300,000 new infections daily for nine consecutive days, hitting another global record of 386,452 on Friday.

The surge has led to a public health crisis and forced the government to seek oxygen, medicines and other essentials from abroad.

The nation's coronavirus cases may peak between May 3-5, according to scientists advising the government.

Some health experts said India became complacent when new cases were running at about 10,000 a day and the novel coronavirus seemed to be under control. Authorities lifted restrictions, allowing the resumption of large festivals and political rallies.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-India-s-Serum-Institute-plans-to-start-vaccine-production-outside-India-The-Tim-33126519/

CDC’s reign of error has done incalculable harm

 For 14 months, the Centers for Disease Control and Prevention has recommended draconian restrictions on Americans’ daily lives to combat the spread of COVID-19. The CDC disregarded the psychological hardships and economic losses the restrictions inflicted. Now the evidence is emerging that the restrictions were based on flimsy science or sheer guesswork.      

Last week, MIT researchers showed that the CDC’s 6-foot social-distancing rule has no basis in science. If you’re indoors, your risk is the same, whether an infected person is 3 feet away from you, 6 feet away, or even 60 feet away.  

So much for carefully standing 6 feet apart in the grocery store line. It’s a joke. On you. 

In the Proceedings of the National Academy of Sciences, the MIT researchers explained that an infected person emits the virus in an aerosol that can waft across indoor space, traveling 60 feet or more. The 6-foot rule, which restaurants, churches, schools, gyms and retailers follow, offers no protection. The key factors are whether you’re wearing a mask and how much time you spend in the space.

On Sunday, White House health guru Anthony Fauci pulled the veil off another CDC guideline: wearing masks outdoors. He admitted the risk of contracting COVID outdoors is “really, really quite low.” Scientists have known that for months because outdoor air movement will disperse the aerosol. You’d have to be talking nose-to-nose with an infected person to catch COVID outdoors.  

On Tuesday, President Biden announced that the CDC’s guidance is eliminating most outdoor masking for people who are vaccinated. Truth is, outdoor masking is ridiculous in nearly all circumstances. It’s inconsistent with what scientists have learned about how the virus spreads.

When the pandemic hit, in February 2020, scientists suspected the virus was transmitted on surfaces and through droplets emitted when people sneeze or cough. With no knowledge about COVID-19, they applied what they knew about influenza. When a person with the flu coughs, droplets land on the floor or a surface within 6 feet. That was the origin of the 6-foot rule.

It was guesswork. As former Food and Drug Administration head Scott Gottlieb says, CDC bureaucrats should disclose when they’re uncertain about the science behind a recommendation so the public can decide “how seriously we want to take it.” 

By June, “super-spreader” events showed that COVID-19 differed from flu. Though COVID can be spread on surfaces and through droplets like flu, it more often floats across indoor spaces and is blown away outdoors. 

That’s when the CDC should have reconsidered the 6-foot rule and the outdoor-masking rule. Instead, Americans are struggling to comply.   

At the Doubletree in Syracuse, hundreds of banquet department jobs depend on hosting big weddings. That’s not possible because New York state is requiring that tables be 6 feet apart, in keeping with CDC guidance.

The same 6-foot rule has been “the biggest barrier to getting kids back in school,” notes Harvard infectious disease specialist Westyn Branch-Elliman. In March, the CDC revised guidelines, but only for elementary schools. This week, as New York students return to class, the 6-foot rule is still being applied in middle and high schools, needlessly limiting capacity. 

Johns Hopkins surgeon Marty Makary faults the CDC’s “counter-science track record of being late and wrong.” 

Even less scientific than the 6-foot rule is the agency’s guidance for the fully vaccinated. The agency tells them to “continue to wear masks, maintain physical distance and practice other prevention measures when visiting with unvaccinated people.”  

That guidance eliminates a major incentive for getting the shots in the first place and will slow America’s recovery. Infections among the vaccinated do occur, but very rarely, and serious illness is even rarer. The Pfizer and Moderna vaccines reduce the risk of developing COVID by 90 to 95 percent, compared with being unvaccinated. US data show the risk of getting infected after these vaccines is a minuscule 0.008 percent.

The science is clear: Get vaccinated and enjoy life again.

Betsy McCaughey is a former lieutenant governor of New York.

https://nypost.com/2021/04/27/the-cdcs-reign-of-error-has-done-incalculable-harm-to-america/

Carlyle Group puts $435M on controlling stake in vaccine, gene therapy services firm

 The Carlyle Group has put a target on life sciences in recent years, looking for opportunities to take controlling stakes in promising firms. After shelling out nearly half-a-billion dollars last year on a one-fifth stake in an Indian CDMO, the DC investors have their eyes set on a company specializing in vaccine and gene therapy services.


Carlyle shelled out $435 million to acquire more than 90% of Unchained Labs, a six-year-old California-based firm, from Danish asset manager Novo Holdings and VC firms TPG Biotech and Canaan Partners.


The company has 170 employees, and expects to generate $75 million in revenue this year, according to a release. In October, Unchained launched its gene therapy tool Stunner, a platform designed to give researchers a speedy readout on AAV capsid concentration and viability. In January, it launched a mRNA vaccine application on Stunner that measures the size distribution of lipid nanoparticles and the total amount of mRNA at the same time.


In a press release, CEO Tim Harkness said:


The Unchained team has solved a ton of problems for researchers over the past few years, but we are just beginning to scratch the surface of the biologics and gene therapy opportunity. I am thrilled to welcome Carlyle as our new partner! They have the team, the vision, the conviction, the experience, and the capital to help us accelerate organic and inorganic growth and realize our full potential. I have never been more optimistic about our future and I am truly excited about joining Carlyle for the next part of our journey.



The company has grown by more than 30% year over year, according to Carlyle managing director Robert Schmidt, and the investment was made out of the $18.5 billion Carlyle Partners VII fund.


At the start of April, Unchained announced another gene therapy and vaccine application dubbed Big Tuna, that focuses on the buffer exchange, concentration and clean-up of AAVs and lipid nanoparticles.


Carlyle bought 20% of CDMO Piramal back in the summer of 2020, in a deal that brought $490 million in cash, and acquired a majority stake in health research network TriNetX. The company is leaning on Unchained’s R&D and digitization, and hinted at expansion, as Schmidt said that they hope to accelerate the company’s “aggressive growth plans.”

https://endpts.com/the-carlyle-group-shells-out-435m-for-controlling-stake-in-vaccine-gene-therapy-services-company/