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CDC Faces Dilemma Over Recommending New Covid Booster for All

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Arthur Allen
Mon, 11 Sep 2023 09:00:00 +0000

A small percentage of Americans got the most recent booster shot, and even fewer probably realize the federal government is preparing to recommend yet another shot as early as Tuesday.

Until a week or two ago, William Schaffner read that indifference as a sign the Centers for Disease Control and Prevention should advocate vaccinating only those most at risk from the virus.

But then Schaffner, an infectious disease specialist at Vanderbilt Medical Center, changed his mind.

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Members of the CDC's Advisory Committee on Immunization Practices won him over to the argument that the vaccine be recommended for all Americans above 6 months of age, he said in an interview. The committee, which sets U.S. vaccination policy and helps determine insurance coverage for vaccines, will vote on the question Tuesday as it weighs the of updated vaccines from Pfizer, Moderna, and Novavax.

Not all vaccine experts see it quite as Schaffner, a nonvoting liaison representative to the ACIP, does.

“I don't plan to get it myself,” said Paul Offit, 72, the director of the Vaccine Education Center at Children's Hospital of Philadelphia. He's had two boosters and got covid last year. Another vaccine might increase his protection against mild infection for a few months, but like most Americans' immune systems, his is already familiar enough with the virus to protect him from serious disease, Offit believes.

Some of Schaffner's scientific colleagues argue the government should be recommending the shot only for frail, older, sick, and immunocompromised people. Over 95% of the U.S. population are already covid-immunized through vaccination, infection, or both, and the risks of serious illness for healthy younger people are not great.

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Schaffner doesn't disagree. But lots of not-necessarily-vulnerable Americans do want the shot for themselves and their children, and, without a CDC recommendation, insurance companies wouldn't have to pay for the vaccine.

It's “pretty awful” that Pfizer and Moderna, the two main covid vaccine producers, have decided to charge up to $130 a shot, compared with $30 last year for the booster, which was produced under government contract, said Kathryn Edwards, a professor of pediatrics at Vanderbilt and a member of an ACIP working group on covid. (Pfizer spokesperson Amy Rose said the price was “consistent with the value delivered” and reflected higher expenses to provide the shots commercially.)

But a partial recommendation could leave the very groups who suffered most during the pandemic — minorities and other disadvantaged groups — unable to get vaccinated if they want but can't afford to.

“The last thing we need are financial barriers that would enhance disparities,” Schaffner said.

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A 1993 requires the federal government to pay for childhood vaccines recommended by the ACIP, and more recent legislation requires coverage of adult vaccines within 15 days of an ACIP recommendation.

Pfizer and Moderna continue to make billions of dollars in sales of covid vaccines, although they are producing fewer doses. Moderna CEO Stéphane Bancel told investors in August that the company expected its global covid vaccine sales to be $6 billion to $8 billion this year, depending on uptake in the U.S. Pfizer expects about $14 billion this year.

Within a few years, both companies expect to be producing combination vaccines protecting against influenza, covid, and possibly respiratory syncytial virus. About 170 million flu vaccines were distributed last flu season in the U.S., so a combination product could lock in a large market for covid vaccines as well.

Despite broad recommendations for the updated covid booster shot released last fall, only 17% of the U.S. population got it — and about 43% of those over 65. How many will get the vaccine this season is uncertain, as is the benefit of the shot. A study of the new Moderna vaccine showed that while it increased antibodies to various covid strains, it provided roughly the same protection against them as last year's booster shot, which was given again to the control group.

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The new vaccine is “not remotely a game changer,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

For healthier adults and children, “it's a boost in protection for a few months,” Moore said. Who exactly will benefit most is impossible to predict because the U.S. is “not a cookie-cutter population.” Its people have by now been exposed to a bewildering combination of vaccines, boosters, and different strains of the virus.

Christopher Ridley, a Moderna spokesperson, said the updated vaccine was well matched to current viral strains, adding, “We encourage people to get vaccinated for covid when they get their annual flu shot.”

Fearmongering has distorted the threat of the virus, Moore said. He is skeptical of the significance of the recent uptick in covid hospitalizations, and criticized social posters who have raised fears about new viral strains that don't seem to pose any fundamental to the new vaccines.

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“Editorial FOMO drove summer surge worries,” Moore said, using an acronym for “fear of missing out.” Despite worrying comments and tweets by physicians such as Eric Topol, director of the Scripps Research Translational Institute, about a new covid variant called BA.2.86, “it turned out to be a real nothingburger,” Moore said.

Even Ashish Jha, who coordinated the Biden administration's covid response until returning to his post as dean of the Brown University School of Public Health this year, agrees there is some ambiguity in the issue. While he recommends that 20-year-olds get the booster, “a reasonable person” could disagree.

Unfortunately, such discussions in the current environment are clouded by “nonsense and bad information” that causes confusion and hurts people, he said in a recent podcast interview.

Whether truly needed or not, the vaccines, proponents say, are safe enough that even the small benefit of taking them will outweigh the risks. The major, though rare, serious side effect of the Pfizer and Moderna vaccines — myocarditis, which particularly affected men in their teens and 20s — appears mainly to have occurred during the first two-shot .

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Paradoxically, those who most need protection from covid are often likely to have weakened immune systems that fail to generate the hoped-for response to vaccination.

So the vaccine is arguably most relevant for healthy people who come in frequent contact with vulnerable individuals. With that in mind, England has announced the new booster would be offered only to people who are 65 or older, in nursing homes, or immunologically vulnerable — or who work or with members of those groups.

“Any efforts to promote the new boosters should focus squarely on those at high risk,” said Norman Hearst, a family physician in San Francisco. While recommending the vaccine for older patients, he said he wouldn't advise a booster for young males because of the rare risk of myocarditis and the negligible benefit. “The question is all the other people in between.”

In a commentary last November, infectious disease Shira Doron and Monica Gandhi said vaccination campaigns should be radically honest about the limited value of vaccines for long-term protection against infection. Such a campaign might advocate vaccinating children because even though it won't protect durably, “it might prevent the rare case of severe disease.”

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Meanwhile, the vaccine makers have their own plans for publicizing the vaccines. In its call with investors last month, Moderna said it was focused on increasing sales and solidifying Moderna's market share with branded promotion. Its “awareness campaigns” will tout ACIP recommendations and “connect covid-19 with seasonal flu vaccines with the goal to consumers to get vaccinated this fall,” a company official said.

Moderna is co-sponsoring tennis' U.S. Open this year and aired a video at the event Sept. 8 honoring Arthur Ashe, the only Black man to win Grand Slam titles, whom it credited with helping destigmatize HIV by revealing he had the virus.

The video presentation suggested that Moderna, like Ashe, has done well by being bold.

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By: Arthur Allen
Title: CDC Faces Dilemma Over Recommending New Covid Booster for All
Sourced From: kffhealthnews.org/news/article/cdc-faces-dilemma-over-recommending-new-covid-booster-for-all/
Published Date: Mon, 11 Sep 2023 09:00:00 +0000

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The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care

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Michelle Andrews
Fri, 17 May 2024 09:00:00 +0000

For many , seeing a nurse practitioner has become a routine part of primary care, in which these “NPs” often perform the same tasks that patients have relied on for.

But NPs in specialty care? That's not routine, at least not yet. Increasingly, though, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income.

This worries some people who track the workforce, because current trends suggest primary care, which has counted on nurse practitioners to backstop physician shortages, soon might not be able to rely on them to the same extent.

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“They're succumbing to the same challenges that we have with physicians,” said Atul Grover, executive director of the Research and Action Institute at the Association of American Medical Colleges. The rates NPs can command in a specialty practice “are quite a bit higher” than practice salaries in primary care, he said.

When nurse practitioner programs began to proliferate in the 1970s, “at first it looked great, producing all these nurse practitioners that go to work with primary care physicians,” said Yalda Jabbarpour, director of the American Academy of Family Physicians' Robert Graham Center for Policy Studies. “But now only 30% are going into primary care.”

Jabbarpour was referring to the 2024 primary care scorecard by the Milbank Memorial Fund, which found that from 2016 to 2021 the proportion of nurse practitioners who worked in primary care practices hovered between 32% and 34%, even though their numbers grew rapidly. The proportion of physician assistants, also known as physician associates, in primary care ranged from 27% to 30%, the study found.

Both nurse practitioners and physician assistants are advanced practice clinicians who, in addition to graduate degrees, must complete distinct education, , and certification steps. NPs can practice without a doctor's supervision in more than two dozen states, while PAs have similar independence in only a handful of states.

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About 88% of nurse practitioners are certified in an area of primary care, according to the American Association of Nurse Practitioners. But it is difficult to track exactly how many work in primary care or in specialty practices. Unlike physicians, they're generally not required to be endorsed by a national standard-setting body to practice in specialties like oncology or cardiology, for example. The AANP declined to answer questions about its annual workforce survey or the extent to which primary care NPs are moving toward specialties.

Though data tracking the change is sparse, specialty practices are adding these advanced practice clinicians at almost the same rate as primary care practices, according to frequently cited research published in 2018.

The clearest evidence of the shift: From 2008 to 2016, there was a 22% increase in the number of specialty practices that employed nurse practitioners and physician assistants, according to that study. The increase in the number of primary care practices that employed these professionals was 24%.

Once more, the most recent projections by the Association of American Medical Colleges predict a dearth of at least 20,200 primary care physicians by 2036. There will also be a shortfall of non-primary care specialists, including a deficiency of at least 10,100 surgical physicians and up to 25,000 physicians in other specialties.

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When it to the actual work performed, the lines between primary and specialty care are often blurred, said Candice Chen, associate professor of health policy and management at George Washington .

“You might be a nurse practitioner working in a gastroenterology clinic or cardiology clinic, but the scope of what you do is starting to overlap with primary care,” she said.

Nurse practitioners' salaries vary widely by location, type of facility, and experience. Still, according to data from recruiter AMN Healthcare Physician Solutions, formerly known as Merritt Hawkins, the total annual average starting compensation, including signing bonus, for nurse practitioners and physician assistants in specialty practice was $172,544 in the year that ended March 31, slightly higher than the $166,544 for those in primary care.

According to forecasts from the federal Bureau of Labor Statistics, nurse practitioner jobs will increase faster than jobs in almost any other occupation in the decade leading up to 2032, growing by 123,600 jobs or 45%. (Wind turbine service technician is the only other occupation projected to grow as fast.) The growth rate for physician assistants is also much faster than average, at 27%. There are more than twice as many nurse practitioners as physician assistants, however: 323,900 versus 148,000, in 2022.

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To Grover, of the AAMC, numbers like this signal that there will probably be enough NPs, PAs, and physicians to meet primary care needs. At the same time, “expect more NPs and PAs to also flow out into other specialties,” he said.

When Pamela Ograbisz started working as a registered nurse 27 years ago, she worked in a cardiothoracic intensive care unit. After she became a family nurse practitioner a few years later, she found a job with a similar specialty practice, which trained her to take on a bigger role, first running their outpatient clinic, then working on the floor, and later in the intensive care unit.

If nurse practitioners want to specialize, often “the doctors mentor them just like they would with a physician residency,” said Ograbisz, now vice president of clinical operations at temporary placement recruiter LocumTenens.com.

If physician assistants want to specialize, they also can do so through mentoring, or they can “certificates of added qualifications” in 10 specialties to demonstrate their expertise. Most employers don't “encourage or require” these certificates, however, said Jennifer Orozco, chief medical officer at the American Academy of Physician Associates.

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There are a number of training programs for family nurse practitioners who want to develop skills in other areas.

Raina Hoebelheinrich, 40, a family nurse practitioner at a regional medical center in Yankton, South Dakota, recently enrolled in a three-semester post-master's endocrinology training program at Mount Marty University. She lives on a farm in nearby northeastern Nebraska with her husband and five sons.

Hoebelheinrich's new skills could be helpful in her current hospital job, in which she sees a lot of patients with acute diabetes, or in a clinic setting like the one in Sioux Falls, South Dakota, where she is doing her clinical endocrinology training.

Lack of access to endocrinology care in rural areas is a real problem, and many people may travel hundreds of miles to see a specialist.

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“There aren't a lot of options,” she said.

——————————
By: Michelle Andrews
Title: The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care
Sourced From: kffhealthnews.org//article/nurse-practitioners-trend-primary-care-specialties/
Published Date: Fri, 17 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/clean-needles-save-lives-in-some-states-they-might-not-be-legal/

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Kaiser Health News

Clean Needles Save Lives. In Some States, They Might Not Be Legal.

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Mahon, PA and Sarah Boden, WESA
Fri, 17 May 2024 09:00:00 +0000

Kim Botteicher hardly thinks of herself as a criminal.

On the main floor of a former Catholic church in Bolivar, Pennsylvania, Botteicher runs a flower shop and cafe.

In the former church's basement, she also operates a nonprofit organization focused on helping people caught up in the drug epidemic get back on their feet.

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The nonprofit, FAVOR ~ Western PA, sits in a rural pocket of the Allegheny Mountains east of Pittsburgh. Her organization's home county of Westmoreland has seen roughly 100 or more drug overdose deaths each year for the past several years, the majority involving fentanyl.

Thousands more residents in the region have been touched by the scourge of addiction, which is where Botteicher comes in.

She helps people find housing, jobs, and , and works with families by running support groups and explaining that substance use disorder is a disease, not a moral failing.

But she has also talked publicly about how she has made sterile syringes available to people who use drugs.

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“When that person comes in the door,” she said, “if they are covered with abscesses because they have been using needles that are dirty, or they've been sharing needles — maybe they've got hep C — we see that as, ‘OK, this is our first step.'”

Studies have identified public health benefits associated with syringe exchange services. The Centers for Disease Control and Prevention says these programs reduce HIV and hepatitis C infections, and that new users of the programs are more likely to enter drug treatment and more likely to stop using drugs than nonparticipants.

This harm-reduction strategy is supported by leading groups, such as the American Medical Association, the World Health Organization, and the International AIDS Society.

But providing clean syringes could put Botteicher in legal danger. Under Pennsylvania law, it's a misdemeanor to distribute drug paraphernalia. The state's definition includes hypodermic syringes, needles, and other objects used for injecting banned drugs. Pennsylvania is one of 12 states that do not implicitly or explicitly authorize syringe services programs through statute or regulation, according to a 2023 analysis. A few of those states, but not Pennsylvania, either don't have a state drug paraphernalia law or don't include syringes in it.

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Those working on the front lines of the opioid epidemic, like Botteicher, say a reexamination of Pennsylvania's law is long overdue.

There's an urgency to the issue as well: Billions of dollars have begun flowing into Pennsylvania and other states from legal settlements with companies over their role in the opioid epidemic, and syringe services are among the eligible interventions that could be supported by that money.

The opioid settlements reached between drug companies and distributors and a coalition of state attorneys general included a list of recommendations for spending the money. Expanding syringe services is listed as one of the core strategies.

But in Pennsylvania, where 5,158 people died from a drug overdose in 2022, the state's drug paraphernalia law stands in the way.

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Concerns over Botteicher's work with syringe services recently led Westmoreland County officials to cancel an allocation of $150,000 in opioid settlement funds they had previously approved for her organization. County Commissioner Douglas Chew defended the by saying the county “is very risk averse.”

Botteicher said her organization had planned to use the money to hire additional recovery specialists, not on syringes. Supporters of syringe services point to the cancellation of funding as evidence of the need to change state law, especially given the recommendations of settlement documents.

“It's just a huge inconsistency,” said Zoe Soslow, who overdose prevention work in Pennsylvania for the public health organization Vital Strategies. “It's causing a lot of confusion.”

Though sterile syringes can be purchased from pharmacies without a prescription, handing out free ones to make drug use safer is generally considered illegal — or at least in a legal gray area — in most of the state. In Pennsylvania's two largest cities, Philadelphia and Pittsburgh, officials have used local health powers to provide legal protection to people who operate syringe services programs.

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Even so, in Philadelphia, Mayor Cherelle Parker, who took office in January, has made it clear she opposes using opioid settlement money, or any city funds, to pay for the distribution of clean needles, The Philadelphia Inquirer has reported. Parker's position a major shift in that city's approach to the opioid epidemic.

On the other side of the state, opioid settlement funds have had a big effect for Prevention Point Pittsburgh, a harm reduction organization. Allegheny County reported spending or committing $325,000 in settlement money as of the end of last year to support the organization's work with sterile syringes and other supplies for safer drug use.

“It was absolutely incredible to not have to fundraise every single dollar for the supplies that go out,” said Prevention Point's executive director, Aaron Arnold. “It takes a lot of energy. It pulls away from actual delivery of services when you're constantly having to find out, ‘Do we have enough money to even purchase the supplies that we want to distribute?'”

In parts of Pennsylvania that lack these legal protections, people sometimes operate underground syringe programs.

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The Pennsylvania law banning drug paraphernalia was never intended to apply to syringe services, according to Scott Burris, director of the Center for Public Health Law Research at Temple . But there have not been court cases in Pennsylvania to clarify the issue, and the failure of the to act creates a chilling effect, he said.

Carla Sofronski, executive director of the Pennsylvania Harm Reduction Network, said she was not aware of anyone having faced criminal charges for operating syringe services in the state, but she noted the threat hangs over people who do and that they are taking a “great risk.”

In 2016, the CDC flagged three Pennsylvania counties — Cambria, Crawford, and Luzerne — among 220 counties nationwide in an assessment of communities potentially vulnerable to the rapid spread of HIV and to new or continuing high rates of hepatitis C infections among people who inject drugs.

Kate Favata, a resident of Luzerne County, said she started using heroin in her late teens and wouldn't be alive today if it weren't for the support and community she found at a syringe services program in Philadelphia.

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“It kind of just made me feel like I was in a safe space. And I don't really know if there was like a come-to-God moment or come-to-Jesus moment,” she said. “I just wanted better.”

Favata is now in long-term recovery and works for a medication-assisted treatment program.

At clinics in Cambria and Somerset Counties, Highlands Health provides free or low-cost medical care. Despite the legal risk, the organization has operated a syringe program for several years, while also testing patients for infectious diseases, distributing overdose reversal medication, and offering recovery options.

Rosalie Danchanko, Highlands Health's executive director, said she hopes opioid settlement money can eventually support her organization.

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“Why shouldn't that wealth be spread around for all organizations that are working with people affected by the opioid problem?” she asked.

In February, legislation to legalize syringe services in Pennsylvania was approved by a committee and has moved forward. The administration of Gov. Josh Shapiro, a Democrat, supports the legislation. But it faces an uncertain future in the full legislature, in which Democrats have a narrow majority in the House and Republicans control the Senate.

One of the bill's lead sponsors, state Rep. Jim Struzzi, hasn't always supported syringe services. But the Republican from western Pennsylvania said that since his brother died from a drug overdose in 2014, he has come to better understand the nature of addiction.

In the committee vote, nearly all of Struzzi's Republican colleagues opposed the bill. State Rep. Paul Schemel said authorizing the “very instrumentality of abuse” crossed a line for him and “would be enabling an evil.”

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After the vote, Struzzi said he wanted to build more bipartisan support. He noted that some of his own skepticism about the programs eased only after he visited Prevention Point Pittsburgh and saw how workers do more than just hand out syringes. These types of programs connect people to resources — overdose reversal medication, wound care, substance use treatment — that can save lives and lead to recovery.

“A lot of these people are … desperate. They're alone. They're afraid. And these programs bring them into someone who cares,” Struzzi said. “And that, to me, is a step in the right direction.”

At her nonprofit in western Pennsylvania, Botteicher is hoping lawmakers take action.

“If it's something that's going to someone, then why is it illegal?” she said. “It just doesn't make any sense to me.”

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This story was co-reported by WESA Public Radio and Spotlight PA, an independent, nonpartisan, and nonprofit newsroom producing investigative and public-service journalism that holds power to account and drives positive change in Pennsylvania.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

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By: Ed Mahon, Spotlight PA and Sarah Boden, WESA
Title: Clean Needles Save Lives. In Some States, They Might Not Be Legal.
Sourced From: kffhealthnews.org/news/article/clean-needles-syringe-services-programs-legal-gray-area-risk-pennsylvania/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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Watch: John Oliver Dishes on KFF Health News’ Opioid Settlements Series

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Fri, 17 May 2024 09:00:00 +0000

Opioid manufacturers, distributors, and retailers are paying tens of billions of dollars in restitution to settle lawsuits related to their role in the nation's overdose epidemic. A recent of “Last Tonight With John Oliver” examined how that money is being spent by and local governments across the United States.

The segment from the KFF Health “Payback: Tracking the Opioid Settlement Cash.” You can learn more about the issue and read our collection of articles by Aneri Pattani here.

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Title: Watch: John Oliver Dishes on KFF News' Opioid Settlements Series
Sourced From: kffhealthnews.org/news/article/watch-john-oliver-kff-health-news-payback-opioid-settlements-series/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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