C.D.C. Proposes New Guidelines for Treating Pain, Including Opioid Use

The agency threw out previous recommended limits on doses but encouraged “nonopioid therapies” wherever possible.The federal government on Thursday proposed new guidelines for prescribing opioid painkillers that remove its previous recommended ceilings on doses for chronic pain patients and instead encourage doctors to use their best judgment.But the overall thrust of the recommendations was that doctors should first turn to “nonopioid therapies” for both chronic and acute pain, including prescription medications like gabapentin and over-the-counter ones like ibuprofen, as well as physical therapy, massage and acupuncture.Though still in draft form, the 12 recommendations, issued by the Centers for Disease Control and Prevention, are the first comprehensive revisions of the agency’s opioid prescribing guidelines since 2016. They walk a fine line between embracing the need for doctors to prescribe opioids to alleviate some cases of severe pain while guarding against exposing patients to the well-documented perils of opioids.Dr. Samer Narouze, president of the American Society of Regional Anesthesia and Pain Medicine, an association of clinicians, praised the tone, level of detail and focus of the project. “It’s a total change in the culture from the 2016 guidelines,” he said, characterizing the earlier edition as ordering doctors to “just cut down on opioids — period.”By contrast, the new proposal “has a much more caring voice than a policing one, and it’s left room to preserve the physician-patient relationship,” added Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, OH.The 229-page document warns of addiction, depressed breathing, altered mental status and other dangers associated with opioids, but it also notes that the drugs serve an important medical purpose, especially for easing the immediate agony from traumatic injuries such as burns and crushed bones. In those instances when opioids seem the way to go, the recommendations said, doctors should start with the lowest effective dose and prescribe immediate-release pills rather than long-acting ones.The recommendations are now open on the Federal Register for public comment for 60 days. The agency will review the comments and most likely issue a final version by the end of 2022. Like the 2016 guidelines, they are suggested practices and not mandatory.“We are welcoming comments from patients who are living with pain every day and from their caregivers and providers,” said Christopher Jones, a co-author of the draft and acting director of the National Center for Injury Prevention and Control, the arm of the C.D.C. that released the new guidelines.Kate Nicholson, executive director of the National Pain Advocacy Center, a patient organization that says it does not take funding from the pharmaceutical industry, found much to admire in the new guidelines. “We went from one side of the pendulum, with overly liberal prescribing of opioids, and that did harm, to just looking at gross drops in prescribing without looking at individual needs. And that did harm,” said Ms. Nicholson, whose input was sought during the development of the draft. “This is closer to a Goldilocks solution where chronic pain is not a monolith.”The guidelines do not apply to patients suffering pain from cancer or sickle cell, or are in end-of-life or palliative care. Ms. Nicholson said, however, that relying on such disease categories — which insurance companies seize upon to make reimbursement rulings — “doesn’t tell us enough about who actually has severe pain.”The 2016 guidelines generated anger and fear in many chronic pain patients, many of whom rely on doses far higher than the recommended ceiling of 90 morphine milligram equivalents daily. Hundreds of pain medicine specialists protested as well.Though the dosing ceilings were merely a recommendation, dozens of states codified them. Fearing criminal and civil penalties, many doctors misapplied them as rigid standards, tapering chronic pain patients too abruptly and even tossing some from their practices.Studies show that the number of opioid prescriptions overall has been dropping since 2012, and the decline escalated after the 2016 guidelines came out.The new proposed recommendations step back from the notion of one-size dosing fits all and instead builds in “flexibility to recognize that pain care needs to be individualized,” Dr. Jones said.But the recommendations make it abundantly clear that doctors should regularly reassess the benefits and risks of opioids.“The evidence around the long-term benefits of opioids continues to remain very limited,” Dr. Jones said.In another indication that the C.D.C. sees these new guidelines as a course-correction to the earlier ones, the agency now suggests that when patients test positive for illicit substances, doctors should offer counseling, treatment and, when necessary, careful tapering. Because doctors had interpreted the 2016 dosing limits narrowly, some had worked up one-strike policies and were summarily ejecting such patients.Dr. Jones said that such results should instead be considered one piece of diagnostic information among many. An unduly high level of opioids could indicate the patient still has untreated pain or even a substance use disorder. “If you instead retain the patient and have those conversations, there’s now an opportunity to improve the patient’s life,” he said.Drawing from a mountain of research that accumulated in recent years, the proposed guidelines also offer extensive recommendations for the treatment of acute pain — short-term pain that can come with an injury like a broken bone or the aftermath of surgery. They advise against prescribing opioids, except for traumatic injuries, such as burns and auto accidents.In granular detail, they compare the relief provided by opioids to that offered by alternatives such as exercise and acupuncture and other drugs. And they give fine-tuned recommendations for discrete areas of pain, such as lower back, knees and neck.The guidelines, for example, note that opioids should not be used for episodic migraines. They endorse, among other treatments, heat therapy and weight loss for knee osteoarthritis, and, for neck pain, suggest options like yoga, tai chi, qiqong, massage and acupuncture.Dr. Marie Hanna, an associate professor of anesthesia and critical care at Johns Hopkins University School of Medicine, said she was particularly enthusiastic about the depth and breadth of research that the guidelines provide in support of nonopioid treatments, including manual manipulation, laser therapy and exercise.“This is what we’ve been talking about for years, but no one was listening. Now we have the evidence to show that these treatments are effective. I’m very optimistic,” added Dr. Hanna, a member of the American Academy of Pain Medicine, an organization of pain researchers and providers across several disciplines.The recommendations also say that many studies show that, over time, pain alleviation from opioids usually plateaus and then wanes, requiring ever higher doses.“We never wanted to pretend that opioids aren’t really important tools,” said Dr. Jeanmarie Perrone, a professor of emergency medicine at the Perelman School of Medicine at the University of Pennsylvania, who served on an advisory panel for the prescribing guidelines. “But after you’ve got that cast on, we’re going to wean you off those opioids. One long-bone fracture doesn’t mean six weeks of opioid prescriptions.”

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Tribes Reach $590 Million Opioid Settlement With J. & J. and Distributors

Money from the tentative deal would go toward addiction and treatment and would be overseen by Native American tribal leaders.Hundreds of Native American tribes that have suffered disproportionately high addiction and death rates during the opioid epidemic agreed on Tuesday to a tentative settlement of $590 million with Johnson & Johnson and the country’s three largest drug distributors.Together with a deal struck last fall between the distributors and the Cherokee Nation for $75 million, the tribes will be paid a total of $665 million.Additional money has also been committed to them by Purdue Pharma in a settlement currently in mediation.“We are not solving the opioid crisis with this settlement, but we are getting critical resources to tribal communities to help address the crisis,” said Steven Skikos, the top lawyer for the tribes.Tuesday’s settlement, announced in the U.S. District Court in Cleveland, seat of the national opioid litigation, is similar to one struck with the states and local governments last summer.If, as expected, most tribes sign on, the deal would be notable for its size as well as its acknowledgment of the 574 federally recognized tribes as a distinct litigating entity. Their voices have traditionally been excluded or downplayed in earlier national settlements involving the states, such as Big Tobacco.Roughly 15 percent of the total will go toward legal fees and costs but the bulk will be directed to addiction treatment and prevention programs, to be overseen by tribal health care experts.“My tribe has already committed to use any proceeds to confront the opioid crisis,” said Chairman Aaron Payment of the Sault Ste. Marie tribe of Chippewa in Michigan, which has 45,000 members. “The impact of the opioid epidemic is pervasive, such that tribes need all the resources we can secure to make our tribal communities whole once again.”A signature achievement of this deal is the timetable, which is far more compressed than the one struck last summer with states and local governments. Johnson & Johnson will pay the tribes its $150 million portion over two years; the distributors will pay $440 million over six and a half years.By contrast, the drug manufacturer will pay thousands of local governments and states $5 billion over nine years, with the distributors — AmerisourceBergen, Cardinal Health and McKesson — paying $21 billion over 18 years.The distributors did not respond to requests for comment. Johnson & Johnson said that the settlement did not represent an admission of wrongdoing. The company said that it would continue to defend itself in other cases.Although about 175 tribes filed cases against these and other pharmaceutical industry companies, the rest of the 574 tribes will benefit as well. Tribes range in population size from roughly 400,000 to a mere handful of people. According to 2018 census data, 6.8 million people identify as American Indian or Alaska Native, or 2.1 percent of the American population, of which slightly less than half live on or near tribal lands and are likely eligible to receive tribal services such as health care.But American Indians and Alaska Natives have endured disproportionately high opioid-related overdose deaths, by many metrics. In 2016, for example, Oglala Lakota County in South Dakota, home to the Oglala Lakota tribe, had an opioid-related death rate of 21 people per 100,000, more than twice the state average. According to one study, pregnant American Indian women were up to 8.7 times more likely than pregnant women from other groups to be diagnosed with opioid dependency or abuse.Lloyd B. Miller, a lead lawyer for the tribes, said that the settlement “provides outsized funding as compared to the states on a per-capita basis because the opioid disaster caused outsized and disproportionate devastation across tribal communities.”The agreement will go forward when 95 percent of the litigating tribes by population have formally agreed to it.

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Wary Parents Are Target of New Appeals to Vaccinate Children 5-11

Getting more young school-age children vaccinated is crucial for ending the pandemic, public health officials say, and many are focusing on that group.For weeks, the school principal had been imploring Kemika Cosey: Would she please allow her children, 7 and 11, to get Covid shots?Ms. Cosey remained firm. A hard no.But Mr. Kip — Brigham Kiplinger, the principal of Garrison Elementary School in Washington, D.C. — swatted away the “no’s.”Ever since the federal government authorized the coronavirus vaccine for children 5 through 11 nearly three months ago, Mr. Kip has been calling the school’s parents, texting, nagging, cajoling daily. Acting as a vaccine advocate — a job usually handled by medical professionals and public health officials — has become central to his role as an educator. “The vaccine is the most important thing happening this year to keep kids in school,” Mr. Kiplinger said.Largely through Mr. Kiplinger’s skill as a parent-vax whisperer, Garrison Elementary has turned into a public health anomaly: Eighty percent of the 250 Garrison Wildcats in grades kindergarten through fifth grade now have at least one shot, he said.But as the Omicron variant has stormed through America’s classrooms, sending students home and, in some cases, to the hospital, the rate of vaccination overall for America’s 28 million children in the 5-to-11 age group remains even lower than health experts had feared. According to a new analysis by the Kaiser Family Foundation based on federal data, only 18.8 percent are now fully vaccinated and only 28.1 percent have received one dose.The disparity of rates among states is stark. In Vermont, the share of children who are fully vaccinated is 52 percent; in Mississippi, it is 6 percent.“It’s going to be a long slog at this point to get the kids vaccinated,” said Jennifer Kates, a senior vice president at Kaiser who specializes in global health policy. She says it will take unwavering persistence like that of Mr. Kiplinger, whom she knows firsthand because her child attends his school. “It’s hard, hard work to reach parents.”After the Pfizer-BioNTech vaccine was authorized for younger children in late October, the out-of-the-gate surge in demand lasted a scant few weeks. It peaked just before Thanksgiving, then dropped precipitously and has since stalled. It now hovers at 50,000 to 75,000 new doses a day.“I was surprised at how quickly the interest in the vaccine for kids petered out,” Dr. Kates said. “Even parents who had been vaccinated themselves were more cautious about getting their kids vaccinated.”Kemika Cosey with her children, Zurie, left, and Zamir, students at Garrison. The principal nagged her for weeks to get them Covid shots. “But it’s a good nag,” she said.Erin Schaff/The New York TimesPublic health officials say that persuading parents to get their younger children vaccinated is crucial not only to sustaining in-person education but also to containing the pandemic overall. With adult vaccination hitting a ceiling — 74 percent of Americans who are 18 and older are now fully vaccinated, and most of those who aren’t seem increasingly immovable— unvaccinated elementary school children remain a large, turbulent source of spread. Traveling to and from school on buses, traversing school hallways, bathrooms, classrooms and gyms, they can unknowingly act as viral vectors countless times a day.Parents give numerous reasons for their hesitation. And with their innate protective wariness on behalf of their children, they are susceptible to rampant misinformation. For many working parents, the obstacle is logistical rather than philosophical, as they struggle to find time to get their children to the clinic, doctor’s office or drugstore for a vaccine.In some communities where adult opposition to vaccines is strong, local health departments and schools do not promote the shots for children vigorously for fear of backlash. Pharmacies may not even bother to stock the child-size doses.Despite the proliferation of Covid-crowded hospitals, sick children and the highly contagious aspect of Omicron, many parents, still swayed by last year’s surges that were generally not as rough on children as adults, do not believe the virus is dangerous enough to warrant risking their child’s health on a novel vaccine.Health communication experts additionally blame that view on the early muddled messaging around Omicron, which was initially described as “mild” but also as a variant that could pierce a vaccine’s protection.Many parents interpreted those messages to mean that the shots served little purpose. In fact, the vaccines have been shown to strongly protect against severe illness and death, although they are not as effective in preventing infections with Omicron as with other variants.And caseloads of children in whom Covid has been diagnosed only keep rising, as a report last week from the American Academy of Pediatrics underscores. Dr. Moira Szilagyi, the academy’s president, pressed for greater rates of vaccination, saying, “After nearly two years of this pandemic, we know that this disease has not always been mild in children, and we’ve seen some kids suffer severe illness, both in the short term and in the long term.”Recognizing the urgency, proponents of Covid shots are redoubling their efforts to convince parents. The American Academy of Pediatrics has put together talking points for pediatricians and parents. Kaiser has its own parent-friendly vaccine-information site. Patsy Stinchfield, a nurse-practitioner who is the incoming president of the National Foundation for Infectious Diseases, keeps up an exhaustive speaking schedule, answering Covid vaccine questions from parents, teenagers, pediatricians and radio talk show hosts.Only 18.8 percent of the country’s 28 million children ages 5 through 11 are fully vaccinated against Covid, a rate even lower than experts had feared.Jim Wilson/The New York TimesThe Johns Hopkins Bloomberg School of Public Health has just posted a free, online training course to help give pro-vaccine parents language and ways to approach their resistant friends. It provides vaccine facts, resources and techniques to engage them.One tip is to share personal stories about Covid, to ground the purpose of the vaccine in real-world experience. Another is to normalize Covid vaccination by proudly telling friends and family when children get Covid shots.Rupali Limaye, an associate scientist at Bloomberg who studies vaccine messaging and developed the course, said that giving parents tools to persuade others about Covid shots could improve uptake rates, particularly now that some hesitant parents are rejecting the advice of pediatricians. Peer “vaccine ambassadors,” as she calls them, have more time and exert less of a power dynamic than harried doctors. “This is a supersensitive topic for a lot of people,” Dr. Limaye added.The Coronavirus Pandemic: Key Things to KnowCard 1 of 5Omicron in retreat.

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A new poll asks: Why do some vaccinated people not get boosters?

Seven in 10 adults in America who are likely eligible for a Covid booster have received one, according to a monthly survey that explores the public’s opinion about coronavirus vaccines.“The uptake is very high compared to the initial vaccine rollout,” said Liz Hamel, who directs polling for the Kaiser Family Foundation, which conducts the monthly assessment. She said that most of the people who had made a commitment to being vaccinated were willing to get a booster.People 65 and older were most likely to report being boosted, the report found.But among all adults surveyed, including the unvaccinated, only 42 percent said they were boosted.“That means a very significant chunk of the population is not fully protected,” Ms. Hamel said.The lag reflects a pervasive pandemic fatigue that emerged elsewhere in the Kaiser poll. More than three in four adults said they believed it was inevitable that most people in the United States will contract Covid. More people reported feeling worried about the impact of the Omicron variant on the economy and hospitals than on their personal health.The poll was based on a telephone survey of 1,536 adults conducted from Jan. 11 to 23. Its booster rates are higher than those reported by the Centers for Disease Control and Prevention. According to the C.D.C.’s data, about half of fully vaccinated adults in the country have received a booster.The Kaiser survey also delved into the motivations behind people’s decisions around the booster. Among respondents who were vaccinated but not yet boosted, about 60 percent said that the Omicron variant had not made much of an impact either way on their decision whether to get the extra shot.Since the initial booster rollout in November, Black and Hispanic adults have lagged behind white adults. But when unboosted people were asked whether they intended to get one, about 40 percent said they would as soon as possible, a view echoed equally across racial lines.Those findings suggest that the racial gap may be due in part to lack of access, Ms. Hamel said.Among surveyed adults who would “definitely not” or “only if required” get a booster, 22 percent said their chief reason was that they felt they didn’t need it or didn’t feel at risk from Covid. Another 19 percent said they didn’t feel that a booster would be effective, noting that vaccinated people are still coming down with Covid.Conversely, among those not yet boosted but inclined to get the extra shot, the chief explanation they gave was pragmatic: Seventeen percent said they were not eligible because not enough time had passed since their last vaccine, and 12 percent said they had been too busy.Political affinity remained a significant fault line along the vaccine divide. Among people who were vaccinated but had not gotten a booster, 58 percent of Democrats said they would get one as soon as they could, while only 18 percent of Republicans said they would. About half of vaccinated Republicans who were not yet boosted said they either would definitely not get one or would do so only if required.But this month’s poll revealed a topic that managed to breach the partisan divide. When asked how they felt about the pandemic after nearly two years, Democrats, Independents and Republicans all gave two responses in equal and overwhelming numbers: “Tired” and “frustrated.”

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Judge Overturns Purdue Pharma’s Opioid Settlement

The ruling said the company’s owners, members of the Sackler family, could not receive protection from civil lawsuits in return for a $4.5 billion contribution.A federal judge on Thursday evening unraveled a painstakingly negotiated settlement between Purdue Pharma and thousands of state, local and tribal governments that had sued the maker of the prescription painkiller OxyContin for the company’s role in the opioid epidemic, saying that the plan was flawed in one critical area.The judge, Colleen McMahon of the U.S. District Court for the Southern District of New York, said that the settlement, part of a restructuring plan for Purdue approved in September by a bankruptcy judge, should not go forward because it releases the company’s owners, members of the billionaire Sackler family, from liability in civil opioid-related cases.Although the Sacklers did not file for personal bankruptcy protection, they had made immunization from opioid claims an absolute requirement in exchange for contributing payments amounting to $4.5 billion to the agreement.But the bankruptcy code, Judge McMahon said, does not explicitly permit a judge to grant such releases, which she called “the great unsettled question.”The Sacklers did not respond to requests for comment on Thursday evening.Lawyers for a small group of states that had appealed the plan immediately hailed the ruling. “This is a seismic victory for justice and accountability that will re-open the deeply flawed Purdue bankruptcy and force the Sackler family to confront the pain and devastation they have caused,” said William Tong, the attorney general of Connecticut.In recent months, members of Congress have proposed legislation called “The Sackler Act” to preclude owners from receiving such protections unless they file for bankruptcy themselves. But even if eventually passed, it is unlikely to become law in sufficient time to resolve the Purdue case.In her ruling, Judge McMahon all but openly invited the U.S. Court of Appeals for the Second Circuit to weigh in. Various appellate courts disagree on the matter and, in her meticulous, 142-page assessment, Judge McMahon wrote that “the lower courts desperately need a clear answer.”Within hours of the ruling, Purdue said it would appeal. Judge McMahon’s ruling “will delay, and perhaps end, the ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis,” said Steve Miller, chairman of the company’s board of directors. “These funds are needed now more than ever as overdose rates hit record-highs, and we are confident that we can successfully appeal this decision and deliver desperately needed funds to the communities and individuals suffering in the midst of this crisis.”The fates of Purdue and the Sacklers have been perhaps the most closely watched among the web of litigation brought against companies in the pharmaceutical industry seeking to hold them accountable for the epidemic of opioid addiction in the United States, which has claimed more than a half-million lives.Under the crush of thousands of lawsuits, Purdue filed for bankruptcy restructuring in September 2019, which automatically put a hold on all the claims against it.Nearly two years later, Judge Robert Drain, the bankruptcy court judge in White Plains, N.Y., confirmed a plan that had been approved by a majority of creditors who voted. Purdue would be formally dissolved and would re-emerge as a new company called Knoa Pharma that would still produce OxyContin but also other drugs. The new company’s profits would go to states and communities to fund opioid treatment and prevention efforts.The Sacklers would renounce their ownership, eventually sell their foreign pharmaceutical companies as well, and contribute $4.5 billion of their fortune to the state and local opioid abatement funds.In exchange, all lawsuits against Purdue would be extinguished, a benefit typical of bankruptcy. What made the settlement so contentious was the Sacklers’ insistence on being released from all Purdue-related opioid claims, although they had not personally filed for bankruptcy.In court, lawyers said there are more than 800 lawsuits that name the Sacklers.After Judge Drain approved the plan, it was immediately appealed by the United States Trustee, a branch of the Justice Department that monitors bankruptcy cases; eight states, including Maryland, Washington and Connecticut; the District of Columbia; and about 2,000 individuals. The appeal was filed in federal district court.Lawyers challenging the plan argued that the Sacklers had essentially gamed the bankruptcy system. Moreover, they argued, Judge Drain lacked the authority to shut off a state’s power to pursue the Sacklers under its own civil consumer protection laws.Judge Colleen McMahon of the U.S. District Court for the Southern District of New York in Manhattan.Caitlin Ochs for The New York Times“Today’s ruling is a critical development that restores the state’s ability to protect the safety of Marylanders by holding fully accountable those who created or contributed to the opioid crisis, particularly members of the Sackler family,” said Brian E. Frosh, the Maryland attorney general.During oral arguments, Judge McMahon said she was troubled by what she saw as a red flag: the more than $10 billion that the Sacklers withdrew from Purdue between 2008 and 2018, as the opioid epidemic was cresting. The Sackler dividends were largely deposited in offshore accounts and trusts that are inaccessible to American authorities.And notably, she said, the withdrawals escalated after Purdue and three top executives pleaded guilty in 2007 to federal criminal and civil charges related to aggressive marketing of opioids, paying more than $600 million.As Judge McMahon wrote: “Concerned about how their personal financial situation might be affected, the family began what one member described as an ‘aggressive[]’ program of withdrawing money from Purdue almost as soon as the ink was dry on the 2007 papers.”Those withdrawals left the company without deep cash reserves to resolve thousands of opioid lawsuits that, by late 2019, forced Purdue to seek shelter in bankruptcy. But to settle the lawsuits and emerge from bankruptcy, Purdue needed the Sacklers’ contribution.That reliance put the Sacklers in a position to make a line-in-the-sand demand: They would only give the money if they received immunity from all opioid-related cases filed in civil courts.Purdue and lawyers for creditors who approved the plan had argued that Judge Drain’s authority to grant such sweeping immunity was in fact grounded in the bankruptcy code, as well as in precedent from the Second Circuit, under whose jurisdiction the Purdue case falls. Without the Sackler contribution, the lawyers said, Purdue would likely be dissolved, leaving plaintiffs who are in sore need of resources largely uncompensated.“There is no question that the Sacklers are bad actors,” wrote lawyers for an oversight committee of creditors that ultimately supported the settlement plan. But it was the knowledge of those acts, gleaned in a scorched-earth 18-month investigation of the family’s finances, they said, that gave the plaintiffs the leverage to extract such a large settlement sum from Purdue’s owners.But lawyers for the U.S. Trustee argued that shutting down the ability of plaintiffs to sue the Sacklers violated the plaintiffs’ due process rights. The Sacklers, they argued, should not be rewarded for their contribution because they “created the need for that money” by taking it out of the company in the first place, setting up the situation where they would be protected from lawsuits “by piggybacking on the bankruptcy of their company.”On Thursday night, after the ruling, Attorney General Merrick B. Garland said in a statement, “The bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family.”In her opinion, Judge McMahon said that the case raised constitutional questions but that she did not need to reach them, having found no authority for a judge to grant immunity to parties who do not seek bankruptcy protection.Deaths from opioids, such as illegally diverted prescription painkillers, have continued to rise.George Frey/ReutersThe Sackler lawyers argued that the withdrawals had not been done in anticipation of a bankruptcy filing that occurred years later, after family members had stepped down from the Purdue board. Instead, they said, the hefty withdrawals coincided with a decade in which a key patent issue was addressed in Purdue’s favor and the company was flush with cash.During that same period, Purdue’s sales force continued to fan out across the country. The use and illegal diversion of prescription opioids skyrocketed.When Purdue filed for bankruptcy, its relationship with its owners became strained — simultaneously cooperative and adversarial. The company relies on the Sacklers to fund settlements. Yet as the debtor, Purdue conducted a forensic accounting of all of its assets, including the billions withdrawn by the Sacklers.A congressional committee found that the Sacklers are worth about $11 billion.While the Purdue Pharma bankruptcy plan — and its disbursements to help prevention and addiction treatment — is on indefinite pause, wending its way through the courts, the opioid epidemic, indifferent to negotiation, persists. Last month, federal data showed that deaths from opioids — fentanyl, heroin and illegally diverted prescription painkillers — only continue to trend upward.

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U.S. Surgeon General Says Blocking Vaccine Rules a 'Setback'

Dr. Vivek Murthy, the U.S. surgeon general, said on Sunday that if courts continue to block the Biden administration’s efforts to soon compel large companies to require a Covid vaccine or face weekly testing, it would be “a setback for public health.”A federal appeals court issued a ruling on Friday that continued to block the administration’s rule, saying the federal agency that drafted the order had “grossly” exceeded its purview.The Occupational Safety and Health Administration, an agency within the Labor Department, issued a rule earlier this month saying that companies with 100 or more employees must put a vaccine mandate in place by Jan. 4 or comply with weekly testing, as well as mandatory masking in December.The administration’s attempts, which could affect 84 million private-sector workers, 31 million of whom were believed to be still unvaccinated, have met with considerable resistance. A diverse group of states and business organizations immediately contested the order and the Court of Appeals for the Fifth Circuit in New Orleans issued a stay. The ruling by a three-judge panel on Friday affirmed the stay, turning aside a challenge by the Justice Department.On “Fox News Sunday,” Dr. Murthy said that vaccine mandates are well-established and highly successful in achieving more widespread vaccination. Schools, the military and workplaces such as hospitals have long required vaccines. Many companies have leapt ahead of a federal order, he noted, and imposed one on their own employees.At the heart of the vaccine mandate strategy, he said, is the creation of “safer workplaces for workers, for customers and to increase vaccination rates overall, because that’s ultimately how we’re going to end this pandemic.”But Ken Paxton, the attorney general of Texas, one of the plaintiffs that challenged the mandate, said on the same news program that the ruling was a victory against the Biden administration’s attempt at what he has called “bullying” of businesses. Texas employers, he has stated, should be allowed to make their own decisions about the vaccine.Chris Wallace, the host of the program, pointed out that Gov. Greg Abbott of Texas has banned businesses from ordering vaccine mandates. He asked Mr. Paxton to address the seeming incompatibility between his attack on the federal mandate and his support of the state ban of individual employers’ vaccine mandates.Mr. Paxton refused to say whether he thought that, unlike the federal government, a state had the right to tell a private business what to do. He replied: “The federal government has limited authority.”He continued: “States have a lot of authority to deal with what’s going on in their states.”

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Colorado Governor Says He Is ‘Frustrated’ With Federal Regulators On Boosters

As federal regulators consider a request to expand eligibility of Pfizer-BioNTech’s coronavirus vaccine boosters to all adults, three states decided this past week to broaden access on their own.Colorado, New Mexico and California are allowing adults to seek out boosters, provided individuals are at least six months past the second dose of the Pfizer-BioNTech or Moderna vaccines, or two months past the single-dose Johnson & Johnson vaccine.“I’ve been very frustrated with the convoluted messaging out of the C.D.C. and the F.D.A.,” said Gov. Jared Polis of Colorado on Sunday on the CBS show “Face the Nation,” referring to the Centers for Disease Control and Prevention as well as the Food and Drug Administration.Federal regulators have said that adults who received the Pfizer-BioNTech or Moderna vaccines are eligible for a booster if they are 65 or older, or if they are at increased risk because of medical conditions or where they work or live. People who got the Johnson & Johnson shot, which is available only to adults, are eligible. Those getting boosters can select any of the three vaccine brands.On Tuesday, Pfizer and BioNTech asked the F.D.A. to expand eligibility for their boosters to all adults. If the regulators sign off on that request, it would make official what health authorities say they already see happening frequently — that many people appear to be getting boosters whether or not they are technically eligible. In mid-August, President Biden announced plans to make boosters available to all adults, but the beginning of the campaign was delayed after regulators insisted they needed more time to review data.Mr. Polis signed an executive order this week on boosters, citing the significant spread of the virus across Colorado. As of Saturday, the state’s daily average of hospitalizations had increased 13 percent over the past two weeks to about 1,500, according to a New York Times database.As winter bears down, Mr. Polis said he wanted to safeguard residents as well as ski tourists.“Everybody should get the booster after six months,” he said, emphasizing its ability to help with personal protection. “That’s why my parents got it,” he added, as did he..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-1kpebx{margin:0 auto;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-1kpebx{font-size:1.25rem;line-height:1.4375rem;}}.css-1gtxqqv{margin-bottom:0;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-1g3vlj0{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-1g3vlj0{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-1g3vlj0 strong{font-weight:600;}.css-1g3vlj0 em{font-style:italic;}.css-1g3vlj0{margin-bottom:0;margin-top:0.25rem;}.css-19zsuqr{display:block;margin-bottom:0.9375rem;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}A growing body of early global research has shown that the vaccines available in the United States have remained highly protective against the disease’s worst outcomes over time.A number of published studies show that their protection against infection, with or without symptoms, has fallen. Public health experts say it does not mean the vaccines are not working. But the significance of waning effectiveness — and whether it suggests that all adults should be eligible for a booster — is still up for debate.Dr. Scott Gottlieb, a former head of the F.D.A. who now sits on Pfizer’s board, was blunt on “Face the Nation” in his criticism of the Biden administration’s approach to booster recommendations. “I think the confusing message around the boosters may end up being one of the biggest missed opportunities in this pandemic,” he said.“Anyone who’s eligible for a booster, and most Americans probably are eligible at this point, should be going out and seeking it,” he added.And on “Fox News Sunday,” Dr. Vivek Murthy, the U.S. surgeon general, tried to walk a line between acknowledging the moves of those three states and defending the slower approaches by federal regulators.“What they’re going to do is take a close look at the data,” he said of the F.D.A., to assure that the booster is safe and effective for people currently not eligible for it.He continued: “The bottom line is that millions of people can get boosted right now and we want them to get boosted, because that will both extend and enhance the protection that they’ve already been getting from the vaccine.”Giulia Heyward contributed reporting.

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The Core Legal Strategy Against Opioid Companies May Be Faltering

Two recent rulings rejected the “public nuisance” argument being used in thousands of cases against the industry, with more trials and settlement talks underway.In 2014, as overdoses and deaths from prescription opioids were catapulting, gutting the budgets of local governments that were struggling to contain the damage, lawyers began working up a novel legal strategy to hold the pharmaceutical industry responsible.That approach, which in the ensuing years became the foundation for more than 3,000 lawsuits, was soundly rejected this month by a California trial judge and, on Tuesday, the Oklahoma Supreme Court, two states where the first opioid trials have concluded.Both decisions found no merit to the plaintiffs’ core argument that, under state law, the companies created a “public nuisance” by overplaying the benefits of their opioid products and downplaying risks. Together the rulings bring into sharp relief a question that has dogged these cases for years: Was this strategy, which critics say requires an unprecedented, expansive reading of public nuisance laws, the best way forward?The rulings could well be ominous indicators for upcoming trials. Jury trials are underway in New York and Ohio. A federal judge’s decision is pending in West Virginia. More trials are on the runway.Meanwhile, settlement talks have been proceeding haltingly. Adam Zimmerman, a law professor who teaches mass litigation at Loyola Law School in Los Angeles, cautioned that the California and Oklahoma rulings have landed early in the overall march of cases but said, “If this keeps up across the other jurisdictions, it could really shift the ground in ongoing settlement talks.”The opinions could prod cities and counties, many of which have been equivocal about settlement deals brokered by states, to capitulate, he said. They could also fuel the resolve of pharmacy chains, like Walmart, Walgreens and CVS, the cluster of defendants most resistant to talks, to fight even harder.Broadly speaking, public nuisance laws, which date to the 12th century in England, bar actions that interfere with rights commonly enjoyed by the public. Just about every state has a public nuisance law; the opioid cases unfolding in federal court apply each state’s statute. In recent years, state nuisance laws have been employed, with mixed results, against manufacturers of guns, paint and vaping devices and have been an increasingly common cudgel against environmental hazards and in climate change litigation.In the opioid cases, thousands of state and local governments and tribes are arguing that companies in the pharmaceutical supply chain — manufacturers, distributors and retail pharmacies — created a “public nuisance” by impeding the public’s health.Judge Peter Wilson of Orange County Superior Court in California, in a video conference during a bench trial of opioid manufacturers in April.Orange County Superior Court, via ReutersIn pragmatic terms, the approach appears both bold and sensible. According to Mr. Zimmerman, many state public nuisance laws do not include a statute of limitations, which would restrict the time available to take legal action. The amount of money that can be recovered can be far greater than that exacted in a more conventional tort claim. And in some states, one defendant can be held liable not only for the damages it created but for those of other defendants as well.The remedy in a public nuisance lawsuit is called abatement: A defendant found liable has to take corrective action and must usually pay substantially to prevent future harm. A polluter must clean up a river, for instance. Indeed, the Oklahoma attorney general’s office worked up a voluminous allocation proposal that sought to have opioid manufacturers pay for years of addiction treatment and education programs.What is turning out to be difficult, however, is establishing an incontrovertible link between a “public nuisance” and the discrete actions of so many types of companies that provide a federally approved medication prescribed by doctors and which are supposed to be monitored by state and federal agencies.Paul Geller, a plaintiffs’ lawyer in the opioid litigation who represents local governments including the cities of San Francisco and Fort Lauderdale, as well as the state of Maryland, saw the rulings as a signal to municipalities to sign on to a $26 billion settlement offer from three distributors as well as Johnson & Johnson. He called the Oklahoma and California decisions “a stark reminder that there is no such thing as a slam-dunk case — trials involve a degree of risk, and appeals are unpredictable.”Both opinions addressed cases brought against opioid manufacturers, notably Johnson & Johnson, and concluded that public nuisance is an insufficient legal weapon. The Nov. 1 ruling was by Judge Peter Wilson of Orange County Superior Court, who presided in a bench trial in a lawsuit filed by the counties of Santa Clara, Los Angeles and Orange and the city of Oakland.Tuesday’s decision by the Oklahoma Supreme Court, the state’s top appeals court, written by Associate Justice James Winchester, overturned a 2019 ruling by the judge in a bench trial in a suit brought by the state attorney general. That judge had found Johnson & Johnson responsible for $465 million.Though the California and Oklahoma judges cited their own state statutes and cases, both opinions said that if public nuisance law were stretched to cover a legal product made by a manufacturer that then passed through numerous hands and had both healthy and dangerous effects, there would be no limit on the application of the law. The California ruling also said local governments needed to have drawn a much more taut line connecting the actions of the opioid manufacturers with overdoses and deaths.Despite the gloominess of the results for hundreds of millions of families devastated by the continuing drug epidemic, the opioid litigation, into which has already been poured billions in legal costs and fees and more than seven years of effort nationwide, is a lumbering behemoth that has come too far to be stopped and yet still has far to go.Significant mileposts have been reached.Hundreds of millions of dollars have been agreed upon in settlements with counties in Ohio and New York, and with New York State and Oklahoma. Billions are on the table from the three distributors as well as Johnson & Johnson, with numerous states and local governments having already signed on. Many states have struck agreements for how to disburse the funds for the strict purposes of treating wounds created by the epidemic.According to federal data, the opioid crisis has claimed more than 500,000 lives, and the problem has only continued to swell during the pandemic.Keith Srakocic/Associated PressThe distributors have agreed in principle to put in place far tighter monitoring programs to catch and halt suspicious opioid orders.Negotiations with Purdue Pharma, the company often portrayed as having set off the opioid crisis with its aggressive marketing of the highly addictive painkiller OxyContin, will not be affected by this month’s rulings. The company has been pursuing a national settlement with states and localities as part of a restructuring plan overseen by a federal bankruptcy judge. In 2019, Purdue, along with its owners, members of the Sackler family, who were not named in the lawsuit, settled with Oklahoma for $250 million. Other opioid manufacturers that have been sued are also moving through bankruptcy proceedings, settling claims.In the meantime, federal trials spun out from an initial compilation of cases before a federal judge in Cleveland, who ruled that the public nuisance claims could proceed, are lining up.The outcome of each trial could be affected by any number of factors, including the specifics of a state’s public nuisance statutes, the evidence a judge permits to be heard, the degree to which each company contributed to that locality’s harms, and whether the verdict is reached by a judge or jury.And of course appeals, which will almost be inevitable, could further upend the results.

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Oklahoma Supreme Court Throws Out $465 Million Opioid Ruling Against J.&J.

The 5-1 decision is a setback for those who are fighting to hold big drug makers accountable for the opioid epidemic.Oklahoma’s highest court on Tuesday threw out a 2019 ruling that required Johnson & Johnson to pay the state $465 million for its role in the opioid epidemic. It was the second time this month that a court has invalidated a key legal strategy used by plaintiffs in thousands of cases attempting to hold the pharmaceutical industry responsible for the crisis.The Oklahoma Supreme Court, 5-1, rejected the state’s argument that the company violated “public nuisance” laws by aggressively overstating the benefits of its prescription opioid painkillers and downplaying the dangers.The ruling, along with a similar opinion by a California state judge on Nov. 1, could be a harbinger that plaintiffs’ hopes for favorable resolution in courts nationwide against opioid manufacturers, distributors and retailers will be dashed. The decision could also embolden the companies to dig in.But because most public nuisance laws are state-specific, it is unclear how much impact the Oklahoma decision could ultimately have on cases elsewhere. The Oklahoma judges’ decision underscored their reading of their state’s law.“Oklahoma public nuisance law does not extend to the manufacturing, marketing and selling of prescription opioids,” the judges wrote in Tuesday’s majority opinion.According to federal data, abuse of opioids has contributed to the deaths of some 500,000 people in the United States since the late 1990s, and the toll has worsened during the Covid pandemic.The Oklahoma case was the first state lawsuit against an opioids manufacturer to come to trial. The ruling, in August 2019, was a heartening signal to plaintiffs’ lawyers around the country that their legal strategy could prevail — even though the amount of the company was ordered to pay was considerably less than the $17 billion sought.In a statement, Johnson & Johnson, referring to Janssen, its pharmaceutical division, said it had “deep sympathy” for everyone affected by the opioids epidemic. But the company added: “The clear and unassailable decision by the Oklahoma State Supreme Court reflects the facts of this case: Janssen’s actions relating to the marketing and promotion of these important prescription pain medications were appropriate and responsible and did not cause a public nuisance.”In their opinion, the judges gave weight to the company’s response that it had not promoted its products in recent years and had sold off one of its product lines in 2015. The judges decided that manufacturers could not be held “perpetually liable” for their products.The Oklahoma attorney general’s office had contended that health is a public right that Johnson & Johnson violated under the state’s public nuisance law. Other opioid manufacturers targeted in the state’s lawsuit, including Teva and Purdue Pharma, settled their cases before this bench trial against Johnson & Johnson began in May 2019. This decision does not affect those agreements.John O’Connor, the Oklahoma attorney general, expressed disappointment with the decision, but said: “We are still pursuing our other pending claims against opioid distributors who have flooded our communities with these highly addictive drugs for decades. Oklahomans deserve nothing less.”What to Know: Purdue Pharma SettlementThe maker of OxyContin won bankruptcy approval on Sept. 1 as part of a far-ranging settlement that ended thousands of lawsuits against the company and its owners, the Sacklers. In the new ruling, the judges said that Oklahoma’s 1910 public nuisance law typically referred to an abrogation of a public right like access to roads or clean water or air. The judges found fault with the state’s case, saying it failed to identify a public right under the nuisance law and had instead attempted to apply a “novel theory” to what was more likely a products liability case.The harm alleged by the state, the judges said, stemmed from the company’s legal product — prescription opioids approved by the Food and Drug Administration. Individuals suffered, the court decided, rather than the public at large.Other case flaws cited by the judges echoed critiques made earlier this month by a California state trial judge who also found in favor of Johnson & Johnson. The company, the Oklahoma judges said, had no control over the distribution and use of its product once the drug left its purview — an argument used successfully by gun manufacturers to turn aside public nuisance litigation.“Regulation of prescription opioids belongs to federal and state legislatures and their agencies,” the Oklahoma judges wrote. They were alluding to the F.D.A., as well as to the Drug Enforcement Administration, which is supposed to monitor pill diversion, and to the state’s own prescription monitoring program.Elizabeth Burch, a law professor at the University of Georgia, cautioned that these two decisions should not be interpreted too broadly to predict the fate of other cases wending their way through courts, because other states have their own public nuisance laws.She noted that the Oklahoma ruling went even further than the California decision, because it stated that public nuisance law couldn’t be used against any entity in the drug supply chain, including distributors and pharmacies.But she said the ruling could potentially influence plaintiffs’ response to Johnson & Johnson’s major national settlement offer in July, when it proposed to pay $5 billion over nine years to resolve all opioid litigation against it.The company’s offer has to be accepted by a majority of the thousands of local governments that have sued.“If I was a plaintiff that was on the fence about whether to enter the J.&J. settlement, this ruling might push me closer to settling, if I was risk averse,” Ms. Burch said.

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Covid Shots Are a Go for Children, but Parents Are Reluctant to Consent

Vaccinating 5- to 11-year-olds could be a big step toward returning to normal life in the U.S., but even parents who got the shot are worried about how it might affect their kids.The Food and Drug Administration’s authorization of a Covid-19 vaccine for ages 5 to 11 on Friday makes 28 million unvaccinated children in the United States suddenly eligible for the shot and offers the country an opportunity to make big inroads in its efforts to achieve broad immunity against the coronavirus.But in a nation that has already struggled mightily with Covid vaccine hesitancy, getting shots into those little arms may present health authorities with the toughest vaccination challenge yet.Even many parents who are themselves vaccinated and approved the shot for their teenagers are churning over whether to give consent for their younger children, questioning if the risk of the unknowns of a brand-new vaccine is worth it when most coronavirus cases in youngsters are mild.In announcing its authorization of a lower-dose shot made by Pfizer and BioNTech for the age group, the F.D.A. said clinical trial data showed the shot was safe and prompted strong immune responses in children. The most common side effects were fatigue, fever and headache. Infectious disease experts say that with approaching holiday travel and family gatherings, widespread vaccination of younger children could be a game-changer: It could help keep classes in person, reduce the likelihood of quarantines and lessen the risk of transmission to older, vulnerable adults — as well as protect the children from what has become the eighth biggest killer in their age group, according to the Centers for Disease Control and Prevention. To date, nearly two million children age 5 to 11 have been infected with the virus and 8,300 have been hospitalized. A third of those hospitalized were admitted to intensive care units, and at least 170 have died.But a report this month from researchers at Northeastern, Harvard, Rutgers and Northwestern Universities found that parental concerns around the Covid vaccination had increased “significantly” from June through September. Chief among them, researchers said, were the newness of the vaccine, whether it has been sufficiently tested, efficacy, side effects and long-term health consequences.According to a survey released Thursday by Kaiser Family Foundation, scarcely one in three parents will permit their children in this newly eligible age group to be vaccinated immediately. Two-thirds were either reluctant or adamantly opposed. An Axios-Ipsos poll found that 42 percent of parents of these children said they were unlikely to have their children vaccinated.Experts say widespread vaccinations among younger children could keep classes in person, reduce the need for face masks and help suppress virus transmission. Michael M. Santiago/Getty ImagesErin Gauch, of Middletown, R.I., got herself and her two older children, ages 14 and 12, vaccinated this summer. But she’s worried about the potential side effects of the shots for her son. One of those side effects is myocarditis, a weakening of the heart muscle, that has been reported in a very small number of teenage boys and young men after getting a Covid shot.“I’m looking at a 9-year-old and if I make a bad decision and he ends up with some debilitating side effects or lifelong adverse reaction, I don’t think I could live with that,” she said.This vaccine dilemma occurs at a turbulent cultural moment for parents of young children, who are often judged harshly on social media for their decisions. The choice can appear freighted with political affiliation. A decision can signify, intentionally or not, compassion or disregard for others and a willingness to follow or ignore advice from their pediatrician.“If we ultimately decide not to get my youngest vaccinated right now, I guess I’ll be subjected to mommy shaming but I’ll just have to deal with it,” Ms. Gauch said.Many parents, like Ms. Gauch, are focusing on some research that suggests the rare possibility that young men and boys will develop pericarditis, a weakening of the lining around the heart, and myocarditis, but the clinical trial data the F.D.A. reviewed showed no cases in the 5 to 11 age group. Many experts say that the conditions usually improve quickly and that Covid presents far greater risk of severe myocarditis.The Biden administration recently announced that the shots would be given predominantly by pediatricians, community health centers and children’s hospitals, plus pharmacies and schools, which will carry the burden of persuading parents.But a Kaiser policy brief noted that schools and pharmacists in regions where Covid vaccination rates are low may be reluctant to participate. Access in rural areas and for working parents will be considerable challenges, the authors said, and they noted that achieving equity will also be a concern: More than half of those newly eligible are children of color.After what is expected to be an initial rush of eager parents (as happened with adults and teenagers), pediatricians say they are bracing for conversations they anticipate to be among the thorniest they have ever had.Ms. Gauch and David with her daughters Claire, 12, left, and Laura, 14, who are both vaccinated.Katherine Taylor for The New York Times“I know parents are probably bombarded with misinformation about vaccines, even within their social circles: ‘My friend said this, my mother-in-law said that,’” said Dr. Katherine Williamson, a pediatrician in Orange County, Calif. “I’m hoping I can make a difference.”The decision is particularly hard for parents to make on behalf of their first child, said Emily Brunson, a medical anthropologist at Texas State University who researches parent vaccination choices. Because vaccine decision-making is so personal and complicated, she said, many parents are likely to put it off.Vic Sandrin, who works for a bicycle company in Vancouver, Wash., supports vaccines but cautiously. He, his wife and their 18-year-old got the Covid vaccine grudgingly, to travel for work and family visits.For his 11-year-old twins, however, he is content to wait: “I’m willing to take a chance on myself, and that made sense, I’m an adult,” Mr. Sandrin said. “But for kids who already have strong immune systems, I don’t know if there’s a reason to get them vaccinated, or at least not just quite yet. ”At heart, the decision is about which unknown—Covid or the vaccine— that parents fear more. They may stack factors such as social routines, older relatives, school protocols and the likelihood of severe illness to confirm their intuitive bias about whether to allow their child to get the shot.Ms. Gauch, a mechanical engineer, calculated each family member’s risk individually. She has asthma, so, for her, the vaccine was a no-brainer. Her 14-year-old daughter got her first job this summer; getting vaccinated meant she wouldn’t have to wear a face mask at work. And her 12-year-old daughter saw that getting vaccinated could open up possibilities of being maskless in public. Done and done.But not only does Ms. Gauch worry about side effects in her 9-year-old son, she says that getting vaccinated won’t release him from following other Covid rules because his school insists on masks and social distancing. “He is much less likely to get Covid if they’re taking all these precautions,” she said. “So I just don’t see the risk payoff of the vaccine.”Parents who were predisposed not to vaccinate their child tended to dismiss the threat of serious illness from Covid as minuscule, saying that children who became seriously ill most likely had underlying conditions..css-1kpebx{margin:0 auto;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-1kpebx{font-size:1.25rem;line-height:1.4375rem;}}.css-1gtxqqv{margin-bottom:0;}.css-k59gj9{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;width:100%;}.css-1e2usoh{font-family:inherit;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;border-top:1px solid #ccc;padding:10px 0px 10px 0px;background-color:#fff;}.css-1jz6h6z{font-family:inherit;font-weight:bold;font-size:1rem;line-height:1.5rem;text-align:left;}.css-1t412wb{box-sizing:border-box;margin:8px 15px 0px 15px;cursor:pointer;}.css-hhzar2{-webkit-transition:-webkit-transform ease 0.5s;-webkit-transition:transform ease 0.5s;transition:transform ease 0.5s;}.css-t54hv4{-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-1r2j9qz{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-e1ipqs{font-size:1rem;line-height:1.5rem;padding:0px 30px 0px 0px;}.css-e1ipqs a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;}.css-e1ipqs a:hover{-webkit-text-decoration:none;text-decoration:none;}.css-1o76pdf{visibility:show;height:100%;padding-bottom:20px;}.css-1sw9s96{visibility:hidden;height:0px;}.css-1in8jot{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;font-family:’nyt-franklin’,arial,helvetica,sans-serif;text-align:left;}@media (min-width:740px){.css-1in8jot{padding:20px;width:100%;}}.css-1in8jot:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1in8jot{border:none;padding:10px 0 0;border-top:2px solid #121212;}What to Know About Covid-19 Booster ShotsThe F.D.A. has authorized booster shots for millions of recipients of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines. Pfizer and Moderna recipients who are eligible for a booster include people 65 and older, and younger adults at high risk of severe Covid-19 because of medical conditions or where they work. Eligible Pfizer and Moderna recipients can get a booster at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shot at least two months after the first.Yes. The F.D.A. has updated its authorizations to allow medical providers to boost people with a different vaccine than the one they initially received, a strategy known as “mix and match.” Whether you received Moderna, Johnson & Johnson or Pfizer-BioNTech, you may receive a booster of any other vaccine. Regulators have not recommended any one vaccine over another as a booster. They have also remained silent on whether it is preferable to stick with the same vaccine when possible.The C.D.C. has said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney or liver disease; dementia and certain disabilities. Pregnant women and current and former smokers are also eligible.The F.D.A. authorized boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The C.D.C. says that group includes: emergency medical workers; education workers; food and agriculture workers; manufacturing workers; corrections workers; U.S. Postal Service workers; public transit workers; grocery store workers.Yes. The C.D.C. says the Covid vaccine may be administered without regard to the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.The argument that vaccinating children contributes to the community’s overall health does not get much traction, either. Parents’ paramount focus is the well-being of their own child. Although health officials contend an important reason to vaccinate is to protect the child, some parents said they believed that their healthy children would be injected with a novel vaccine largely to safeguard older adults, who had already lived full lives.Abby Cooper of Bergen County, N.J., says she has been champing at the bit to have all five of her children — from left, Ilana, 12, Atara, 10, Shira, 2, Noam, 8, and Yair, 5 — vaccinated.Bryan Anselm for The New York TimesIn interviews, some parents said that if the vaccine gained full approval for children (as the adult dose has) and schools required it, they would consider withdrawing their students. Dr. Cynthia Bader, a pediatrician in the Seattle area with an 8-year-old son, said that if her school district issued a vaccine mandate, she would clap her hands with joy but “then cringe at the idea of all the parents who will be coming to me seeking counseling for vaccine exemption forms.”Parents are siloing themselves with like-minded friends, which reinforces their thinking. “It used to be that more people with different opinions would mesh, but now I don’t think that is the case,” said Abby Cooper of Bergen County, N.J., who is eager to get her five children vaccinated.But she has friends who refuse. “Their kids are going to school with my kids and putting them at risk for no reason. It’s very upsetting. So, sadly, I’ve lost friends over this.”Many parents worry that the tension will infect the children themselves. Some foresee having to set boundaries about unvaccinated playmates, especially if exposure to the virus could jeopardize someone else in the home.Many parents will be difficult to persuade. The C.D.C. and the American Academy of Pediatrics have published talking points for pediatricians and other proponents of the Covid vaccine for children.Consensus: First, address the parents’ questions. But if they don’t want to hear The Talk, don’t force it.Consensus: Fear tactics — generalized descriptions of children suffering in Covid wards — don’t work.Consensus: Emphasize the benefits of the Covid vaccine to the child in terms of emotional and physical well-being, including some semblance of pre-Covid social life. Invoke quarantines, remote learning.Kim Cobb hopes that her family’s Covid ordeals will show others the benefits of vaccinating all eligible family members. She, her husband and their two older daughters, 14 and 12, got vaccinated quickly. But in August, her unvaccinated 10-year-old twins came down with Covid. Soon after, Dr. Cobb, a climate scientist at Georgia Tech, and her husband tested positive for breakthrough infections. Their two vaccinated children remained healthy.The parents became miserably ill but did not require hospitalization, which they believe is because they were vaccinated.All recovered, but Dr. Cobb and one twin have lingering respiratory distress.“We’re in the third month post-infection and we have to see pulmonologists, we have inhalers, we’re on medication and we’re still having breathing difficulties,” Dr. Cobb said. “And this is not a kid who ever had respiratory symptoms.”“It was not foreseeable,” she continued. “If you could avoid it, you would.”

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