F.D.A. Approves Narcan for Over-the-Counter Sales

The nasal spray reverses opioid overdoses and public health officials hope that making it more widely available could save lives and reduce the nation’s high rates of drug fatalities.Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter, the Food and Drug Administration said on Wednesday, authorizing a move long-sought by public health officials and treatment experts, who hope wider availability of the medicine will reduce the nation’s alarmingly high drug fatality rates.By late summer, over-the-counter Narcan is expected to be for sale in big-box chains, supermarkets, convenience stores, gas stations and online retailers. New York City plans to install Narcan vending machines later this year.The commissioner of the F.D.A., Dr. Robert M. Califf, said in a statement that the over-the-counter authorization was meant to address a “dire public health need.”“Today’s approval of O.T.C. naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” Dr. Califf said. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”Narcan is a nasal spray version of naloxone, a drug that blocks an opioid’s effect on the brain. As the overdose crisis has worsened, with more than 100,000 drug-related deaths in the United States for each of the last two years, millions of doses have been administered by outreach workers, health care providers and emergency responders.But for people who use drugs, as well as for their friends and relatives, ready access to the prescription medication has been elusive.Naloxone access laws in every state allow pharmacists to have a standing prescription so they can dispense Narcan or a generic brand to anyone who requests it. But many pharmacies choose not to do so, preferring not to engage customers around illicit drug use, especially without a doctor’s oversight. Of the nearly 17 million naloxone doses distributed in 2021, only 2.64 million were from pharmacies, according to a recent report.Public health officials were quick to hail the F.D.A.’s authorization, the first time that an overdose reversal spray has been deemed safe for over-the-counter sales. With overdoses and overdose fatalities occurring in college dorms, public libraries, households, night clubs and restaurants, public health advocates hope that naloxone nasal sprays will soon become a staple of first-aid kits and family medicine cabinets.“Naloxone can mean the difference between life and death for someone experiencing an overdose and — as a city and a country — we have every reason to want people to have it in hand,” Dr. Ashwin Vasan, the health commissioner of New York City, said. “It is safe and effective, and with increasing fentanyl in our drug supply, we need it everywhere, to save lives.” The city provided more than 200,000 Narcan kits to community groups in 2022.One reason the F.D.A. approved Narcan for general sales is that it is easy to administer. Bystanders who see that a person slumped over is unresponsive to shaking and shouting, with slowed breathing — signs of a possible overdose — only have to unwrap the palm-size device, insert the tip into the person’s nostril and depress the plunger. In most situations, the medication revives the person within two or three minutes.Narcan will not work if the person has taken nonopioid drugs like methamphetamines or xylazine, an animal tranquilizer that has been infiltrating street drug supplies. But addiction experts note that because the supply of illegal drugs has become increasingly tainted with fentanyl, an opioid, there is no downside to using Narcan, regardless of what drug the person was believed to have taken.Although over-the-counter status will make Narcan more widely available, the cost of the medicine could be a deterrent to many.Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance, or has a co-pay of less than $10. But public and private insurance programs do not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve.This month, a big-box pharmacy in Manhattan was charging $98 for the two-dose box of prescription Narcan to customers without insurance. Another pharmacy chain in New Jersey charged $73.The company that makes Narcan, Emergent BioSolutions, declined to disclose the price it plans for an over-the-counter version, which will take several months to relabel and repackage. On Wednesday morning, after the F.D.A.’s announcement, the company released a statement that did not discuss cost.“We are dedicated to improving public health and assisting those working hard to end the opioid crisis — so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan to help save a life,” Robert G. Kramer, the company’s chief executive officer, said in the statement.In its announcement of the authorization, the F.D.A. acknowledged the concern about price, urging other manufacturers of prescription naloxone to apply for over-the-counter approval, which could make pricing more competitive.“We will work with any sponsor seeking to market a nonprescription naloxone product,” said Dr. Patrizia Cavazzoni, director of the F.D.A.’s Center for Drug Evaluation and Research. She added that they were encouraging manufacturers “to contact the agency as early as possible to initiate discussions. ”The price of Narcan, or any naloxone nasal spray, can affect where the product is placed in a store. One intention behind making Narcan more widely available was to help consumers leapfrog awkward conversations with pharmacists and possible entanglements with insurance providers.But higher-priced items are vulnerable to shoplifting, so retailers may consign them to being secured behind a pharmacist’s counter, or in a locked glass box, both of which would require the customer to seek out a salesperson. Those placements, public health advocates said, could be a barrier to people who can afford Narcan, but may be too embarrassed to ask for it. Naloxone is also manufactured in vials of liquid that are accompanied with a syringe, which is substantially cheaper than the nasal spray and an option favored by many community outreach groups.“All naloxone should have been moved over the counter,” said Dennis Cauchon, president of Harm Reduction Ohio, a nonprofit group that distributes free naloxone doses. “Now you have the expensive version available without a prescription but the cheaper versions need a prescription. It’s important that brand name Narcan be priced much lower over the counter than it is now. The price needs to be less than $30 for a two-dose kit, preferably much lower.”

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How to Use Narcan, the Overdose-Reversing Nasal Spray

The F.D.A.’s decision to allow the overdose-reversing nasal spray to be sold over the counter means it will become much more widely available. Here is some guidance for using it correctly.Narcan, a nasal spray that can quickly reverse an opioid overdose, has now received federal approval to be sold over the counter. By late summer, it should be widely available — not just on pharmacy shelves but also at convenience stores, big box chains and possibly through online retailers.If used in time, Narcan, a version of the drug naloxone, which blocks the opioid’s effect on the brain, can be a lifesaver for someone taking opioids, including oxycodone, heroin or fentanyl.Think of Narcan or any naloxone nasal spray as a fire extinguisher, said Corey Davis, director of the Harm Reduction Legal Project at the Network for Public Health Law. “Hopefully you’ll never need it,” he said. “But at some point maybe the kitchen’s going to catch on fire and you won’t have time to run to the fire extinguisher store.”Here is some guidance for using Narcan correctly:How do I know if someone is overdosing?Their breathing may be slowed, with gurgling, or stopped altogether. Their pupils may be narrowed to a pinpoint, and their lips or fingernails may turn blue or purple. Their skin could be clammy to the touch. Even by shaking them and shouting loudly, you cannot wake them.What’s in the Narcan box?A box contains two palm-size nasal spray plunger devices, each with four milligrams of naloxone.Should I test the plunger first to make sure it’s working?No. If you prime the spray’s plunger you will release the dose and waste it.How should I use it?Gently tilt back the person’s head. Insert the spray tip into one nostril until both fingers are against the nose. Push the plunger to release the full dose.Shouldn’t I call 911 first?Call 911 after you use the spray. This is an emergency, but it can take precious minutes to alert a dispatcher. .What do I do after I’ve given the spray and called 911?Make sure the person’s airways are protected and clear. Roll the person on their side, propping their hands under their head. Bend their knees to prevent them from rolling over on their stomach or back.Please stay with the person for a few hours or until an emergency responder arrives.The kits have two doses. Should I use the second?Usually one dose will be sufficient. But if the person has not begun to wake up after two or three minutes, apply the second dose in the other nostril, particularly if you know a stronger opioid like fentanyl could have been involved.Will the spray be harmful if it turns out the person wasn’t overdosing on an opioid?No. Unless someone has an allergy to naloxone, which is rare, the safest bet is to use the spray.Are there side effects?Narcan may provoke withdrawal symptoms, including vomiting. The airways have to be kept open, to prevent choking.Other symptoms of withdrawal include: diarrhea, body aches, increased heart rate, fever, goose bumps, sweating and irritability. Remember that though opioid withdrawal is miserable, you are saving a life.Who should carry naloxone?According to reports by the Centers for Disease Control and Prevention, in 2021, bystanders were present at 46 percent of fatal opioid overdoses. If they had been carrying naloxone and knew how to use it, lives could have been saved.If you know people who use drugs even casually, or if you use opioids yourself, there is no downside to carrying Narcan. If you work at a business that has a first-aid kit on hand, why not keep a naloxone spray in it? Parents of teenagers or young adults, what about a box in your medicine cabinet? College dorms? The school nurse’s office? Libraries?Think of it much like an EpiPen for allergies, or an asthma inhaler — or, indeed, like a fire extinguisher.

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Over-the-Counter Narcan Could Save More Lives. But Price and Stigma Are Obstacles

The Food and Drug Administration is expected this week to allow the overdose-reversal medication to be sold without a prescription, a step toward making it a common emergency tool.If Narcan, the nasal spray that saves lives by reversing opioid overdoses, receives approval to be sold over the counter, public health officials hope the palm-size plunger could one day become as commonplace as a kitchen fire extinguisher.The Food and Drug Administration is expected to authorize the switch from prescription status this week, a step long sought by state health officials and welcomed by parents worried about teens taking counterfeit, fentanyl-tainted pills and by owners of businesses from clubs to mall shops where people have succumbed to overdoses. By late summer, the rescue medication could be available in corner convenience stores, vending machines and through online retailers, and it could help to reduce national overdose deaths, which have exceeded 100,000 annually in the last two years.But clinics and harm reduction groups, who have long pressed for the switch, worry that several factors may still impede widespread access to the medication — namely its price and the stigma that surrounds it.Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance, or costs, at most, less than $10. But public and private insurance programs do not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve.This month, a big-box pharmacy in Manhattan was charging $98 for the two-dose box of Narcan to customers without insurance. Another pharmacy chain in New Jersey charged $73.Narcan’s manufacturer, Emergent BioSolutions, declined to disclose the price plans for an over-the-counter version, pending F.D.A. approval. The company said it would “work with public interest” groups, who are now charging about $47.50 a box. Health economists predict the new price could land somewhere between $35 and $65 — plus a retailer’s markup.So the cost of the new out-of-pocket Narcan could make the spray prohibitive for many individuals, especially for those who inject opioids, and, indirectly, for the organizations that buy the medication in bulk.“People who really need it won’t be able to afford it, so it is much more likely that it becomes an item that is shoplifted,” said Jim Thacker, who directs the Target4 Project, a statewide program based at the University of Kentucky that focuses on H.I.V. prevention and gives out free Narcan.And that, he said, may create another obstacle: “Then Narcan will probably be put behind the pharmacist’s counter or behind glass, which creates a barrier to the people who can afford it but don’t want to ask for it,” he said.An outreach worker with Prevention Point Philadelphia, a health services center, distributing Narcan sprays throughout the city’s Kensington neighborhood.Hilary Swift for The New York TimesMany community groups distribute a liquid, injectable version of naloxone, which works swiftly and is far cheaper than Narcan.Kendrick Brinson for The New York TimesWalgreens, CVS and Walmart would not comment on product placement for Narcan. A spokeswoman for the Consumer Healthcare Products Association, a trade group, would say only that “individual retailers work with manufacturers on in-store placements and make their own decisions regarding approaches to theft prevention.”Narcan is the nasal spray version of the drug naloxone, which blocks an opioid’s effect on the brain. It has become naloxone’s dominant brand, because even a panicky, untrained bystander can easily administer it. A major impetus behind making Narcan more accessible is to encourage onlookers to step up during emergencies. The Centers for Disease Control and Prevention said that in 2021, bystanders had been present at about 46 percent of fatal overdoses.Often bystanders are themselves people who have become dependent on opioids. Clinics and many harm reduction groups, who distribute millions of naloxone doses a year for free, fear that their ability to keep doing so could be compromised by the growing focus on the Narcan brand.That is because many groups distribute a different form of naloxone: a liquid, that comes in a vial with a small syringe. Some studies say the injectable version of the medication works more swiftly than the spray.Most critically, it is far less expensive. Maya Doe-Simkins, a co-director of Remedy Alliance, which distributes hundreds of thousands of injectable naloxone doses to community groups in 44 states, Washington, D.C., and Puerto Rico, said that as Narcan blankets the market, “States are spending their entire naloxone budget on expensive product, and there’s not enough money left for cheap injectable products.” Typically, these groups rely on state health department allotments, state and federal grants, plus newly released settlement funds from the national opioid litigation to pay for naloxone.Some health economists predict that Narcan prices will gradually decrease, as volume increases and competitors enter the over-the-counter market. Ironically, two of the likely competitors have ties to pharmaceutical companies that were targets of litigation for their role in the opioid epidemic.James Moore of Hattiesburg, Miss., lowers a purple flag to half-mast when someone in the area dies from an overdose. He gives out Narcan for free at his bicycle shop.Edmund D. Fountain for The New York TimesWhenever people ask for Narcan, Mr. Moore always trains them in how to use it.Edmund D. Fountain for The New York TimesOne, a naloxone nasal spray called RiVive, is awaiting F.D.A. approval. It is made by Harm Reduction Therapeutics, a nonprofit company whose goal is to develop a low-cost, over-the-counter naloxone spray to sell mostly to community groups and clinics, bypassing retailers’ markups. Since 2018, the company has received nearly $24 million from Purdue Pharma, the makers of the prescription painkiller OxyContin, a highly addictive opioid medication that is widely thought to have been a primary cause of the ongoing opioid epidemic.Purdue is going through bankruptcy proceedings to settle thousands of opioid lawsuits against it, and will be restructured into a public benefit corporation. Last week, a bankruptcy judge authorized Purdue to donate another $9 million to Harm Reduction Therapeutics. Both companies said that Purdue had no commercial stake in RiVive.Another naloxone nasal spray, currently available by prescription, is made by Teva Pharmaceuticals, a manufacturer of generic and branded drugs, including opioids. Teva will donate large quantities of its overdose reversal product as part of its opioid settlement agreements.Under naloxone access laws, every state already permits pharmacists to dispense the nasal sprays to anyone who asks for it, regardless of whether the person has a prescription. But according to a recent report by the Reagan-Udall Foundation, an independent group that analyzes issues facing the F.D.A., of the 16.95 million naloxone doses distributed in 2021 — an acknowledged underestimate — just 2.64 million went through pharmacies. Most doses are given to emergency responders, clinics and community outreach workers.That’s because in addition to price, there are other access barriers to naloxone. Studies show that independent pharmacists in particular, especially those in rural and impoverished urban areas, do not regularly stock the nasal sprays, often saying they do not want to engage with people who use drugs.“Because of stigma, a large percentage of pharmacists will not offer naloxone to patients,” said Evan Peet, a health economist at the Rand Corporation who favors over-the-counter naloxone but is concerned about out-of-pocket costs.Mr. Moore and his son, Jeffrey, who died in 2015 from an overdose. Mr. Moore hadn’t known about naloxone when Jeffrey was alive.Edmund D. Fountain for The New York TimesJeffrey’s childhood bicycle on the wall of Mr. Moore’s shop. Mr. Moore donates refurbished bikes to people who need transportation to and from drug court.Edmund D. Fountain for The New York TimesThat deeply embedded stigma, plus price, are why direct naloxone distribution by clinics and harm reduction groups nationwide is vital to the people who most often need the medication.James Moore, who owns a family-friendly bicycle shop in Hattiesburg, Miss., is trying to combat bias as well as the price of Narcan, which, he said, in his area can run well over $100 for a double-dose box without insurance. At his shop, he gives out free Narcan and training to anyone who asks for it.Mr. Moore said he was excited about the spray becoming available over the counter because he thought it could eventually help to ease the stigma toward people who struggle with addiction — people like his son Jeffrey, who died in 2015 from an overdose.Mr. Moore hadn’t known about naloxone when Jeffrey was alive. Ever since, he has worked tirelessly to educate families, students and law enforcement about its lifesaving properties. Television stations run his Narcan public service announcements.Addiction and overdose fatalities are often still hushed up in Hattiesburg, Mr. Moore said. So when he learns about someone local who has just died from an overdose, he lowers the American flag over his shop and flies a purple flag at half-mast for five days. He hosts annual candlelight services for friends and families of loved ones who struggle with addiction. He takes people enrolled in inpatient rehabilitation programs out for group bike rides, and donates refurbished bicycles to those needing transportation to and from drug court.But Mr. Moore, who receives Narcan from state mental health services, also worries about the out-of-pocket price for Narcan if it is approved for open shelf sales.“As much as I love Narcan’s existence,” he said, “it pains me to know what it costs an individual without insurance every time they go to buy it. So I’m anxious to see it go up on Walmart’s shelves, and for the competitors to come along. I want somebody to be able to buy Narcan for the price of a hamburger.”

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Narcan Is Safe to Sell Over the Counter, Advisers to the F.D.A. Conclude

The overdose reversal drug has been administered mostly by emergency responders and outreach workers. If the agency approves a nonprescription version, it could become as easily available as aspirin.Two federal panels of addiction experts on Wednesday unanimously recommended that Narcan, the overdose-reversing nasal spray, be made widely available without a prescription, a significant step in the effort to stem skyrocketing drug fatalities.Making Narcan an over-the-counter drug has been urged by doctors, patient advocacy groups and the Biden administration.The unanimous vote by the committees, which advise the Food and Drug Administration, makes it highly likely that the F.D.A. will approve an over-the-counter version, also known generically as naloxone, next month. It could potentially become available in vending machines, schools, convenience shops, big box stores and supermarkets by summer.As the overdose crisis worsened in recent years, the use of Narcan has become commonplace, but the millions of doses have been administered largely by outreach workers, health care providers and emergency responders. For people who use drugs as well as their friends and relatives, ready access to the prescription medication has been elusive.Many public health experts believe that if more people were to have the spray readily available at home, or in their pockets or knapsacks, many fatalities could be averted.Fentanyl Overdoses: What to KnowCard 1 of 5Devastating losses.

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Animal Sedative Mixed With Fentanyl Brings Fresh Horror to US Drug Zones

PHILADELPHIA — Over a matter of weeks, Tracey McCann watched in horror as the bruises she was accustomed to getting from injecting fentanyl began hardening into an armor of crusty, blackened tissue. Something must have gotten into the supply.Switching corner dealers didn’t help. People were saying that everyone’s dope was being cut with something that was causing gruesome, painful wounds.“I’d wake up in the morning crying because my arms were dying,” Ms. McCann, 39, said.In her shattered Philadelphia neighborhood, and increasingly in drug hot zones around the country, an animal tranquilizer called xylazine — known by street names like “tranq,” “tranq dope” and “zombie drug” — is being used to bulk up illicit fentanyl, making its impact even more devastating.Xylazine causes wounds that erupt with a scaly dead tissue called eschar; untreated, they can lead to amputation. It induces a blackout stupor for hours, rendering users vulnerable to rape and robbery. When people come to, the high from the fentanyl has long since faded and they immediately crave more. Because xylazine is a sedative and not an opioid, it resists standard opioid overdose reversal treatments.More than 90 percent of Philadelphia’s lab-tested dope samples were positive for xylazine, according to the most recent data.“It’s too late for Philly,” said Shawn Westfahl, an outreach worker with Prevention Point Philadelphia, a 30-year-old health services center in Kensington, the neighborhood at the epicenter of the city’s drug trade. “Philly’s supply is saturated. If other places around the country have a choice to avoid it, they need to hear our story.”A study published in June detected xylazine in the drug supply in 36 states and the District of Columbia. In New York City, xylazine has been found in 25 percent of drug samples, though health officials say the actual saturation is certainly greater. In November, the Food and Drug Administration issued a nationwide four-page xylazine alert to clinicians.Shawn Westfahl, center left, attended to a man who Mr. Westfahl believed had just injected tranq dope, in the Kensington section of Philadelphia.Hilary Swift for The New York TimesTracey McCann is in recovery from tranq dope at a treatment center near St. Louis. “I’d wake up in the morning crying because my arms were dying,” she said.Neeta Satam for The New York TimesIn December, the Office of National Drug Control Policy said it was tracking the spread closely, and the journal Pediatrics published an analysis of three cases of xylazine ingestion by toddlers.But xylazine’s true prevalence is unknown. Hospitals don’t test for it. Some state medical examiners don’t routinely do so, either.The drug exists in a legal gray zone. Approved 50 years ago by the F.D.A. as a veterinarian-prescribed analgesic, it is not listed as a controlled substance for animals or humans and so is not subject to strict monitoring. Thus, it has not been on the radar of federal law enforcement for diversion or abuse.As with many trapped by tranq, Ms. McCann’s hellish descent began with prescription opioids. In 2009, when she was 27, she developed a dependence on painkillers prescribed after a severe car crash. A boyfriend she met at one of her six stays in rehab introduced her to heroin. Cheaper and more potent fentanyl elbowed heroin off the streets. Then, as the Covid-19 pandemic descended in 2020, tranq stormed Philadelphia.Fentanyl Overdoses: What to KnowCard 1 of 5Devastating losses.

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Tranq Dope: Animal Sedative Mixed With Fentanyl Brings Fresh Horror to U.S. Drug Zones

PHILADELPHIA — Over a matter of weeks, Tracey McCann watched in horror as the bruises she was accustomed to getting from injecting fentanyl began hardening into an armor of crusty, blackened tissue. Something must have gotten into the supply.Switching corner dealers didn’t help. People were saying that everyone’s dope was being cut with something that was causing gruesome, painful wounds.“I’d wake up in the morning crying because my arms were dying,” Ms. McCann, 39, said.In her shattered Philadelphia neighborhood, and increasingly in drug hot zones around the country, an animal tranquilizer called xylazine — known by street names like “tranq,” “tranq dope” and “zombie drug” — is being used to bulk up illicit fentanyl, making its impact even more devastating.Xylazine causes wounds that erupt with a scaly dead tissue called eschar; untreated, they can lead to amputation. It induces a blackout stupor for hours, rendering users vulnerable to rape and robbery. When people come to, the high from the fentanyl has long since faded and they immediately crave more. Because xylazine is a sedative and not an opioid, it resists standard opioid overdose reversal treatments.More than 90 percent of Philadelphia’s lab-tested dope samples were positive for xylazine, according to the most recent data.“It’s too late for Philly,” said Shawn Westfahl, an outreach worker with Prevention Point Philadelphia, a 30-year-old health services center in Kensington, the neighborhood at the epicenter of the city’s drug trade. “Philly’s supply is saturated. If other places around the country have a choice to avoid it, they need to hear our story.”A study published in June detected xylazine in the drug supply in 36 states and the District of Columbia. In New York City, xylazine has been found in 25 percent of drug samples, though health officials say the actual saturation is certainly greater. In November, the Food and Drug Administration issued a nationwide four-page xylazine alert to clinicians.Shawn Westfahl, center left, attended to a man who Mr. Westfahl believed had overdosed on tranq dope, in the Kensington section of Philadelphia.Hilary Swift for The New York TimesTracey McCann is in recovery from tranq dope at a treatment center near St. Louis. “I’d wake up in the morning crying because my arms were dying,” she said.Neeta Satam for The New York TimesIn December, the Office of National Drug Control Policy said it was tracking the spread closely, and the journal Pediatrics published an analysis of three cases of xylazine ingestion by toddlers.But xylazine’s true prevalence is unknown. Hospitals don’t test for it. Some state medical examiners don’t routinely do so, either.The drug exists in a legal gray zone. Approved 50 years ago by the F.D.A. as a veterinarian-prescribed analgesic, it is not listed as a controlled substance for animals or humans and so is not subject to strict monitoring. Thus, it has not been on the radar of federal law enforcement for diversion or abuse.As with many trapped by tranq, Ms. McCann’s hellish descent began with prescription opioids. In 2009, when she was 27, she developed a dependence on painkillers prescribed after a severe car crash. A boyfriend she met at one of her six stays in rehab introduced her to heroin. Cheaper and more potent fentanyl elbowed heroin off the streets. Then, as the Covid-19 pandemic descended in 2020, tranq stormed Philadelphia.Fentanyl Overdoses: What to KnowCard 1 of 5Devastating losses.

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Opposition to School Vaccine Mandates Has Grown Significantly, Study Finds

A third of parents now feel they should be the ones to decide whether to get their children immunized against measles, mumps and other childhood diseases.For generations of most American families, getting children vaccinated was just something to check off on the list of back-to-school chores. But after the ferocious battles over Covid shots of the past two years, simmering resistance to general school vaccine mandates has grown significantly. Now, 35 percent of parents oppose requirements that children receive routine immunizations in order to attend school, according to a new survey released Friday by the Kaiser Family Foundation.All of the states and the District of Columbia mandate that children receive vaccinations against measles, mumps, rubella and other highly contagious, deadly childhood diseases. (Most permit a few limited exemptions.)Throughout the pandemic, the Kaiser foundation, a nonpartisan health care research organization, has been issuing monthly reports on changing attitudes toward Covid vaccines. The surveys have showed a growing political divide over the issue, and the latest study indicates that division now extends to routine childhood vaccinations.Forty-four percent of adults who either identify as Republicans or lean that way said in the latest survey that parents should have the right to opt out of school vaccine mandates, up from 20 percent in a prepandemic poll conducted in 2019 by the Pew Research Center. In contrast, 88 percent of adults who identify as or lean Democratic endorsed childhood vaccine requirements, a slight increase from 86 percent in 2019.The survey found that 28 percent of adults overall believed parents should have the authority to make school vaccine decisions for their children, a stance that in the 2019 Pew poll was held by just 16 percent of adults.Read More on the Coronavirus PandemicUpdated Shots: The Food and Drug Administration expanded eligibility for the updated coronavirus boosters to children as young as 6 months old.Plummeting Demand: A key partner of Covax, the organization leading efforts to bring Covid vaccines to poor and middle-income countries, will stop supplying the shots to a huge part of the global population in 2023.Pregnant Women: Even though studies have shown that the Covid vaccine is safe for expectant women, many have avoided getting the shots, unaware of the risks that the virus poses.Pandemic Response: Some experts fear that the chance to create an independent panel to investigate the pandemic response is slipping away.The shift in positions appears to be less about rejecting the shots than a growing endorsement of the so-called parents’ rights movement. Indeed, 80 percent of parents said that the benefits of vaccines for measles, mumps and rubella outweighed the risks, down only slightly from 83 percent in 2019. “The talking point that has been circulated is the concept of taking away parents’ rights,” said Dr. Sean O’Leary, chairman of the American Academy of Pediatrics’ committee on infectious diseases. “And when you frame it that simply, it’s very appealing to a certain segment of the population. But what about the right to have your children be safe in school from vaccine-preventable diseases?”An anti-vaccine demonstration outside the California Capitol in Sacramento in 2020. Rich Pedroncelli/Associated Press Still, Dr. O’Leary said that he wasn’t overly worried that school vaccine mandates would be lifted but that the growing embrace of parents’ rights might further slow compliance with state-required immunization schedules, a timeline that has long been endorsed by pediatricians.“We know a lot of kids missed their vaccines during the pandemic, not because they were refusing, but because, for many reasons, people weren’t going to the doctor,” he said. “And we do have a global dip in vaccine coverage. So this is not a time to be considering a rollback of these laws.”The latest survey was based on interviews with a nationally representative sample of 1,259 adults and was conducted from Nov. 29 through Dec. 8.It showed disappointing rates of uptake of the latest Covid booster, a “bivalent” shot that targets both the original coronavirus and the Omicron variant and has been available since September. Just four in 10 adults said they had either gotten the booster or intended to do so. Among those 65 and older — the age group at the highest risk — about one in four said they had been too busy to get it or hadn’t found the time to do so.Even among adults who had received previous Covid vaccines, the survey found that more than four in 10 said they felt they did not need this latest shot.Only about a third of respondents said they personally feared getting very ill from Covid, though half expressed concerns in general about rising rates of Covid this winter. About two-thirds of Black and Latino adults were apprehensive about Covid rates, compared with about four in 10 white adults.The survey also found that about half of parents worried that their children could fall sick this winter from Covid-19, the flu or R.S.V. (respiratory syncytial virus), a sign that Covid-19 was increasingly becoming normalized in the public’s perception and joining the landscape of seasonal illnesses.

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Race Question in Supreme Court Adoption Case Unnerves Tribes

The issue is whether a federal law that seeks to place Native American foster children in Native American homes is constitutional. The case could turn on whether the justices see tribes as racial groups or sovereign nations.The little girl who will soon be known by the nine justices of the United States Supreme Court as Y.R.J. is now 4 years old. For much of her short life she has been living with Dr. Jennifer Brackeen and Chad Brackeen, a suburban Texas couple fighting with the Navajo Nation to adopt her. Y.R.J.’s birth mother is Navajo. The Brackeens are white.On Wednesday, the Supreme Court will hear arguments in their case, which could affect not only the little girl’s adoption but those of thousands of Native American children in foster care. Depending on how broadly the justices rule, the outcome of the case, Brackeen v. Haaland, could also start the unraveling of other federal protections that have long been extended to tribes.That is because the case, which primarily pits the Brackeens and Texas against the U.S. Department of the Interior and five tribes, could turn on whether the Supreme Court finds that tribes are racial classifications rather than political ones — a prospect that the tribes find deeply threatening.“It would put at risk every treaty, every property and political right and every power that Indian nations possess today,” said Robert Miller, a professor of federal Indian law at Arizona State University, tribal court judge and enrolled citizen of the Eastern Shawnee Tribe.“All of a sudden, lands would be owned by ‘a race of Indian people,’ not a tribal government,” he said. “Your borders, your police laws, everything on the reservation would be in question. I’m not being hyperbolic. I am afraid of this case.”Specifically, the Brackeens want the Supreme Court to overturn a federal law, the Indian Child Welfare Act of 1978. The law says that when a child who is eligible for tribal membership winds up in state foster care, the child should, whenever possible, be adopted by a tribal family.Lawyers for the Brackeens argue that the law discriminates against Native American children as well as non-Native families who want to adopt them because it determines placements based on race. But tribes say they are political entities, not racial groups.Legal scholars said that, beyond resolving the Solomonic fight over the fate of a child, a decision against the tribes could, in the long term, shake their centuries-old legal status as sovereign nations with a unique relationship to the U.S. government. For 250 years, that relationship has been the foundation of treaties and regulations for tribal health and education benefits; criminal jurisdiction; and hunting, fishing, oil, mineral and gaming rights.In the short term, if the Supreme Court determines that tribal citizenship is based on race, the child welfare law, often known as the I.C.W.A., will be struck down for violating the equal protection rights of Native children and non-Native adoptive families.Matthew McGill, a lawyer for the Brackeens, said that catastrophic predictions about the ramifications of overturning the law were overblown. The law is unique in the federal Indian canon, he said, because it deals with Indian child welfare cases occurring off tribal lands. (On reservations, those cases are overseen by tribal social workers and tribal courts.)Understand the Supreme Court’s New TermCard 1 of 6A race to the right.

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CVS and Walgreens Near $10 Billion Deal to Settle Opioid Cases

The dual agreements would resolve thousands of lawsuits over the retailers’ role in the addiction crisis. But a large majority of state, local and tribal governments must sign on.CVS and Walgreens, two of the nation’s largest retail pharmacy chains, said on Wednesday that they had reached tentative agreements to pay about $5 billion each to settle thousands of lawsuits over their role in the opioid crisis, a development that could signal the beginning of the end of years of opioid litigation.Since 2013, a snowballing number of state, local and tribal governments have been seeking to make companies across the pharmaceutical industry pay to reduce the ongoing costs of addiction, death and crime in an epidemic that began with prescription painkillers. While most of the big opioid manufacturers and drug distributors agreed to pay billions of dollars in national settlements in recent years, the retail chains had so far resisted negotiating a broad settlement deal.Wednesday’s announcements change the narrative.“My sense is that we’re nearing the end of the saga,” said Alexandra Lahav, who teaches complex litigation at Cornell University Law School.Citing recent court decisions, she added: “Things weren’t looking super for them, so it makes sense that they were finally coming to the table. And I’m guessing the rest of the defendants are going to follow.”In a sign that others may indeed follow, a person familiar with the negotiations said that Walmart had agreed to pay $3.1 billion in its settlement negotiations. The company declined to comment.“We’re a lot closer to the end today than we were yesterday,” said Jayne Conroy, a lawyer on the negotiating committee who represents cities and counties.CVS and Walgreens disclosed the tentative agreement in government filings. Finalization is conditional on an overwhelming majority of plaintiffs signing on, they said.Fentanyl Overdoses: What to KnowCard 1 of 5Devastating losses.

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Half of Adults Have Heard Little or Nothing About New Covid Boosters, Survey Finds

The latest shots, which target Omicron and its subvariants, could offer protection against a winter surge in cases. But many people are unsure if they’re eligible.The new, redesigned Covid booster, which now protects against Omicron and its extremely contagious subvariants, appears to have a visibility problem.Federal authorities authorized the shot at the end of August, but by mid- to late September, nearly half of adults had heard little or nothing about it, according to a report by the Kaiser Family Foundation, based on the latest of its monthly surveys about attitudes toward the Covid vaccines. That could have troubling implications. The Biden administration has been touting the booster as a means of warding off a fresh fall or winter surge of the virus.“America is not rushing out to get the new booster,” said Drew Altman, the president of the Kaiser Family Foundation. “Most are only dimly aware of it, which is not surprising in a country that seems to have mostly moved on.” He added, “The exception may be older folks, who are at greater risk and early on are more interested in the new booster.” The survey was conducted from Sept. 15 to 26, online and by telephone, among a nationally representative sample of 1,534 adults.Read More on the Coronavirus PandemicAn ‘Anti-Vax’ Capital No More: Vaccine skeptics once found a home in Marin County Calif. Now, the pandemic has made them unwelcome, as Covid vaccine rates soar there.New Boosters: The updated shots were authorized at the end of August, but nearly half of U.S. adults had heard little or nothing about it by mid- to late September, according to a new report.A Persistent Variant: Ten months have passed since Omicron’s debut. Since then it has displayed a remarkable capacity to evolve new tricks.A Blunted Response: Major data gaps, the result of decades of underinvestment in public health, have undercut the U.S. government’s response to Covid — and now to monkeypox.Ever since the first shots were rolled out, people 65 and older, who are the most vulnerable to Covid complications, have been the most compliant with getting the vaccine. They also displayed the broadest awareness of the new booster, the survey found, with almost half reporting either having already received the new dose or aiming to get it “as soon as possible.” Nearly a third of adults overall said they had planned to get it soon as well.But otherwise, confusion over eligibility seemed widespread, according to the survey.The Food and Drug Administration authorized the new booster made by Pfizer and BioNTech for fully vaccinated people as young as 12 and the new Moderna booster for those 18 and older. But among fully vaccinated adults 30 and under, 43 percent said they were unsure of whether the dose had been approved for them, and an additional 19 percent said they did not believe it had been.Dr. Mary Politi, a professor in the Division of Public Health Sciences at the Washington University School of Medicine, said that Americans had been experiencing Covid information overload and, as a consequence, decision-making fatigue. One way to overcome both, she said, “is to keep information simple, clear and consistent.” She added, “Unfortunately, the information coming from various sources has often been conflicting, with uncertain, unclear or changing guidelines.”Older adults were also better informed about their booster eligibility status. Among those 65 and older, more than half knew the booster was recommended, as did nearly half of those between the ages of 50 and 64.While the Centers for Disease Control and Prevention recommends that fully vaccinated people 12 and older get the updated booster, it urges those 50 and older in particular to get it.The report, which also looked at parents’ views of the vaccine, found that there had been a modest uptick in vaccination among the youngest children since July, when Covid vaccines for those between six months and 4 years old received emergency authorization. At the time, scarcely 7 percent of parents said they intended to get their children vaccinated; that percentage has risen to 19 percent, or nearly one in five parents.But more parents are refusing the vaccine for their children, too. Now 53 percent of parents of children between six months and 4 years say they will “definitely not” let their children get the shots. Last January, 26 percent held that view.While some 60 percent of parents said that their children between the ages of 12 and 17 had been vaccinated, about 30 percent of parents with children in that age group said their children would definitely not get the Covid vaccine.Overall, 77 percent of respondents said they had gotten at least one dose of the Covid vaccine, with nearly half of those saying they had received at least one booster. But 23 percent said they were not vaccinated, and nearly all of that group said they would “definitely not” get it.

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