What FDA's Planned Limits on COVID Vaccinations Mean for Health
Larry Saltzman has blood cancer. He's also a retired doctor, so he knows getting covid-19 could be dangerous for him — his underlying illness puts him at high risk of serious complications and death. To avoid getting sick, he stays away from large gatherings, and he's comforted knowing healthy people who get boosters protect him by reducing his exposure to the virus.
Until now, that is.
Vaccine opponents and skeptics in charge of federal health agencies — starting at the top with Health and Human Services Secretary Robert F. Kennedy Jr. — are restricting access to covid shots that were a signature accomplishment of President Donald Trump's first term and cost taxpayers about $13 billion to develop, produce, and distribute. The agencies are narrowing vaccination recommendations, pushing drugmakers to perform costly clinical studies, and taking other steps that will result in fewer people getting protection from a virus that still kills hundreds each week in the U.S.
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'There are hundreds of thousands of people who rely on these vaccines,' said Saltzman, 71, of Sacramento, California. 'For people who are immunocompromised, if there aren't enough people vaccinated, we lose the ring that's protecting us. We're totally vulnerable.'
The Trump administration on May 20 rolled out tougher approval requirements for covid shots, described as a covid-19 'vaccination regulatory framework,' that could leave millions of Americans who want boosters unable to get them.
The FDA will encourage new clinical trials on the widely used vaccines before approving them for children and healthy adults. The requirements could cost drugmakers tens of millions of dollars and are likely to leave boosters largely out of reach for hundreds of millions of Americans this fall.
Under the new guidance, vaccines will be available for high-risk individuals and seniors. But the FDA will encourage drugmakers to commit to conducting post-marketing clinical trials in healthy adults when the agency approves covid vaccines for those populations.
For the past five years, the shots have been recommended by the Centers for Disease Control and Prevention for everyone 6 months and older. They have been available each fall after being updated to reflect circulating strains of the virus, and the vaccines have been shown to be safe and effective in clinical trials.
Vinay Prasad, who leads the FDA's division overseeing vaccines, cited 'distrust of the American public' as he announced the new guidelines at a May 20 briefing.
'We have launched down this multiyear campaign of booster after booster after booster,' he said, adding that 'we do not have gold-standard science to support this for average-risk, low-risk Americans.'
The details were outlined in a May 20 article in The New England Journal of Medicine, written by FDA Commissioner Marty Makary. He and Prasad later followed up with the briefing, which appeared the same day on YouTube.
The added limits on access aren't the result of any recent data showing there are new health risks from the covid vaccines. Instead, they reflect a different regulatory stance from Kennedy, who has a history of anti-vaccine activism, and Makary, who has questioned the safety data on covid mRNA shots.
Announcing a major regulatory change in a medical journal and YouTube video is a highly unusual approach that still leaves many questions about implementation unanswered. It remains unclear when the changes will go into effect or whether there will be any public comment period. The changes were announced by the administration before an FDA advisory committee meeting on May 22 to consider the 2026 covid vaccine formula.
It's a sharp reversal from the first Trump administration, which launched Operation Warp Speed — the effort that led to the development of the covid shots. Trump called the vaccines the 'gold standard' and a 'monumental national achievement.'
Concerns About Higher Transmission
The announcement is rattling some patient advocacy groups, doctors, nursing home leaders, and researchers who worry about the ramifications. They say higher-risk individuals will be more likely to get covid if people who aren't at risk don't get boosters that can help reduce transmission. And they say the FDA's restrictions go too far, because they don't provide exceptions for healthy individuals who work in high-risk settings, such as hospitals, who may want a covid booster for protection.
The limits will also make it harder to get insurance coverage for the vaccines. And the FDA's new stance could also increase vaccine hesitancy by undermining confidence in covid vaccines that have already been subject to rigorous safety review, said Kate Broderick, chief innovation officer at Maravai Life Sciences, which makes mRNA products for use in vaccine development.
'For the public, it raises questions,' she said. 'If someone has concerns, I'd like them to know that of all the vaccines, the ones with the most understood safety profile are probably covid-19 vaccines. There is an incredible body of data and over 10 billion doses given.'
Some doctors and epidemiologists say it could leave healthy people especially vulnerable if more virulent strains of covid emerge and they can't access covid shots.
'It's not based on science,' said Rob Davidson, an emergency room doctor in Michigan and executive director of the Committee to Protect Health Care, which works to expand health care access. 'It's what we were all worried would happen. It risks peoples' lives.'
Current federal regulators say there is no high-quality evidence showing that vaccinating healthy people, including health workers who are near or around immunocompromised people, provides an additional benefit.
'It is possible, actually, that such approvals and strategies provide false reassurance and lead to increased harms,' Prasad said.
The covid vaccines underwent clinical trials to assess safety, and they have been subject to ongoing surveillance and monitoring since they obtained emergency use authorization from the FDA amid the pandemic. Heart issues and allergic reactions can occur but are rare, according to the CDC.
On a separate track, the FDA on May 21 posted letters sent in April to makers of the mRNA covid vaccines to add information about possible heart injury on warning labels, a move that one former agency official described as overkill. The action came after the Permanent Subcommittee on Investigations, a panel of the Senate Homeland Security and Governmental Affairs Committee, held a hearing on alleged adverse events associated with covid vaccines.
Limiting boosters to healthy people goes against guidance from some medical groups.
'The COVID-19 vaccine is safe, effective, and the best way to protect children,' Sean O'Leary, chair of the Committee on Infectious Diseases at the American Academy of Pediatrics, said in an email. 'Young children under 5 continue to be at the highest risk, with that risk decreasing as they get older.'
Unsupported Claims About mRNA Vaccines
The covid booster clampdown is supported by many adherents of the ' Make America Healthy Again ' movement, which casts suspicion on traditional medicine. Some opponents of covid mRNA vaccines say without evidence that the shots cause 'turbo' cancer, are genetic bioweapons, and cause more heart damage than the covid virus.
There is no evidence the shots lead to rapid and aggressive cancers. Cancer rates decreased an average of 1.7% per year for men and 1.3% for women from 2018 to 2022, according to the National Institutes of Health. The covid vaccines debuted in 2021.
Federal regulators say narrowing who can get the boosters will align the U.S. with policies of European nations. But other countries have vastly different economic structures for health care and approaches to preventive care. Many European countries, for example, don't recommend flu shots for the entire population. The U.S. does in part because of the financial drain attributed to lost productivity when people are sick.
They also want more information. 'I think there's a void of data,' Makary told CBS News on April 29. 'And I think rather than allow that void to be filled with opinions, I'd like to see some good data.'
A massive five-year study on covid vaccine safety by the Global Vaccine Data Network, involving millions of people, was underway, with about a year left before completion. The Trump administration terminated funding for the project as part of cuts directed by the president's Department of Government Efficiency, and work on the study has stopped for now.
There are a multitude of studies, however, on the vaccines' effectiveness in preventing severe illness, hospitalization, and death.
Limiting boosters for healthy people can be risky, some doctors say, because people don't always know when they fall into higher-risk categories, such as individuals who are prediabetic or have high blood pressure. The covid vaccine restrictions could deter them from getting boosted, and they might experience worse complications from the virus as a result. For example, about 40% of people with hepatitis C are unaware of their condition, according to a study published in 2023.
The number of people getting covid vaccines has already dropped significantly since the height of the crisis. More than half of the more than 258 million adults in the U.S. had gotten a covid vaccination as of May 2021, according to the CDC. In each of the past two seasons, less than 25% of Americans received boosters, CDC data shows.
While deaths from the virus have dropped, covid remains a risk, especially when cases peak in December and January. Weekly covid deaths topped 2,580 as recently as January 2024, according to CDC data.
Some high-risk individuals are worried that the new restrictions are just the first salvo in halting all access to mRNA shots. 'The HHS motivation really is hidden, and it's to dismiss all mRNA technology,' said Michael Osterholm, an epidemiologist at the University of Minnesota.
Officials at the NIH have told scientists to remove references to mRNA in grant applications. HHS also announced plans in May to develop new vaccines without mRNA technology, which uses messenger RNA to instruct cells to make proteins that trigger an immune response.
Rose Keller, 23, is concerned about future access to covid shots. She would be eligible under the current announcement — she has cystic fibrosis, a progressive genetic condition that makes the mucus in her lungs thick and sticky, so covid could land her in the hospital. But she is concerned the Trump administration may go further and restrict access to the vaccines as part of a broader opposition to mRNA technology.
'I've had every booster that's available to me,' said Keller, a government employee in Augusta, Maine. 'It's a real worry if I don't have the protection of a covid booster.'
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Red Alert: A refinery spilled toxic waste into the community and knew about it for months
The Atlantic Alumina, a.k.a. Atalco, bauxite refinery in Gramercy, Louisiana. (Wes Muller/Louisiana Illuminator) This article is the first in a series on the environmental costs of America's last remaining alumina refinery. GRAMERCY — For several months, a River Parishes refinery unlawfully discharged industrial toxic waste containing arsenic, cadmium, chromium and other toxic heavy metals into public areas and waterways, state records show. The company, Atlantic Alumina, also known as Atalco, has so far racked up 23 violation notices from the Louisiana Department of Environmental Quality after inspectors first discovered the pollution in August. It involves a slurry of industrial 'red mud' byproduct that has eroded through the giant levees surrounding the facility's waste containment lakes and spilled onto public property. The toxic sludge has killed vegetation and contaminated the land along its path to a local drainage system that flows to the Blind River Swamp of Lake Maurepas, according to a 606-page LDEQ inspection report finalized in March. The incident marks the first known case of red mud levee breaches at an American bauxite refinery. When asked for details, LDEQ spokesman Gregory Langley had little information to share about the prolonged discharge other than to say it is currently under investigation with the agency's enforcement division. The only enforcement action taken as of May 29 is a warning letter LDEQ sent to Atalco. A review of thousands of pages of state and federal documents and interviews with scientists and area residents indicate that Atalco polluted public land and state waterways with the most toxic non-radioactive elements on the planet and allowed that pollution to continue for months — never notifying the outside community. Atalco's refinery occupies roughly 3 square miles of land where St. James and St. John the Baptist parishes meet on the Mississippi River's east bank. The site specializes in refining bauxite, a rust-colored powder of raw metals and minerals, into aluminum oxide or 'alumina' in the form of an ultra-fine white powder. Atalco sells the alumina to metal smelters that need it to make finished aluminum. Opened in 1958 as Kaiser Aluminum, the Gramercy facility is the only remaining bauxite refinery in the United States and therefore the nation's only domestic source of a critical metal feedstock. Atalco produced 669,261 metric tons of aluminum oxide last year, state records show. For every ton of aluminum produced from Atalco's work, bauxite refining generates an estimated 2.5 tons of waste byproduct, according to the U.S. Environmental Protection Agency. One of the main problems in refining bauxite is there are not many good options for what to do with all that waste, most of which takes the form of a thick red mud. The waste comes from a part of the process in which bauxite is heated in a pressurized vessel with sodium hydroxide, a highly caustic chemical. The alumina compounds are then filtered out and separated, while the toxic byproduct is stored in the facility's six red mud lakes. The lakes are open-air ponds, each roughly 150-200 acres in size surrounded by large earthen levees, some as high as 50 feet, meant to contain the thick liquid waste. Four of the lakes, including a 'surge' or overflow basin, were constructed in the early 1970s without any liners that would help prevent the heavy metals and chemicals from seeping into the soil below. 'It is very dangerous,' said Slawomir Lomnicki, an environmental scientist at LSU. 'There can be a lot of toxic metals leaching out of it and getting into the groundwater.' Groundwater contamination from leaching is a constant risk that exists when Atalco's systems are operating normally. The public drinking water system in St. James Parish regularly monitors for that kind of contamination, according to Parish President Peter Dufresne. Officials with the St. John Parish water system did not answer multiple phone calls last week. A greater risk to the community from bauxite refineries in general is the rare case of a levee breach at a red mud lake, which can cause toxic waste to directly contaminate public waters and soils, scientists said. Until this reporting, the last known breach at a bauxite refinery occurred in Hungary in 2010. The failure of a red mud reservoir sent 35 million cubic feet of waste into nearby villages, killing 10 people and injuring 150 others. In the wake of that incident, industry officials told the American public that a levee breach at Louisiana's bauxite refinery would be unlikely because the levees are 'periodically checked by state and federal regulators,' according to a news report from that time. That unlikely event has happened at Atalco. With a caustic level higher than drain cleaner and elevated concentrations of heavy metals, Atalco's waste slurry eroded through levees in multiple locations at multiple lakes, forming canyons as deep as 10 feet that allowed the toxic waste to escape, records show. A water sample LDEQ had tested from a public ditch outside the plant detected arsenic at a concentration nearly 1,400% higher than the level considered safe by state groundwater and EPA drinking water limits. The sample also contained cadmium at levels above those same limits. A soil sample taken from the same ditch contained mercury, beryllium, cadmium and chromium — all at concentrations above the average background levels found in U.S. soils. The cadmium was nearly 400% higher, and the chromium was 900% higher than LDEQ's standard limits for soil. Chromium is the most toxic non-radioactive element on earth and is about three times more poisonous than arsenic, according to EPA toxicity factors. Historic water quality data for the Blind River, recorded from 1979-99, show heavy metal concentrations nowhere near those levels. 'With this kind of facility, the worst major accident that can happen is a breach of the lake [levees],' said Corinne Gibb, a chemist who works with the environmental watchdog Louisiana Bucket Brigade. The group has monitored incidents at the alumina refinery for years. It is unknown when the mud lake levees first began to erode, but state and federal records show the pollution lasted for months and continued even after Atalco became aware of the problem. The company has not responded to the Illuminator's multiple requests for an interview. Federal inspectors with the Mine Safety and Health Administration (MSHA) documented several hazards at Atalco's levees last summer and voiced concerns about the risks they posed to the workers at the plant. 'There were several mud lakes at the facility that was (sic) not being maintained,' MSHA inspector Brandon Olivier wrote in a citation dated June 25, 2024. Trees and shrubs obscured sections of the levees, making thorough inspections impossible, Olivier added. A few weeks later, on Aug. 14, the MSHA issued Atalco another citation after inspectors discovered caustic waste 'seeping through various locations on the east and west side of Mud Lake #4' and flowing downhill 'into the roadway and ditches.' LDEQ later noted the Aug. 14 citation was the first formal written notice Atalco received about the levees having a breach with dangerous toxic waste escaping from its facility. Other dangers present at the Atalco plant had already drawn regulators' attention at that time. Just days prior, on Aug. 4, the public was reminded just how dangerous the chemicals at Atalco could be when 45-year-old Curtis Diggs, a contract worker from Waste-Pro USA, fell into a pit of sodium hydroxide at the plant because a grate that covered the pit was missing and the entire floor was flooded with several inches of the caustic cloudy liquid. The chemical, the same that is stored in the red mud lakes, left Diggs with severe burns from which he did not recover, according to LDEQ records. He died in a New Orleans hospital on Sept 2. MSHA investigated the fatality and learned that Atalco personnel had removed the grate on July 30, 2024, to try to pump out the flooded area and failed to put anything in its place or even a warning marker, creating a dangerous pitfall left open for five days and virtually invisible. MSHA charged Atalco with three regulatory violations and charged Waste-Pro USA with two, faulting both companies for 'aggravated conduct' that involved an extraordinary pattern of negligence, though it's unclear if any fines or penalties have been issued as of May 30, according to federal records. Atalco uses sodium hydroxide to refine bauxite into alumina. After the refinement process, it stores the used sodium hydroxide in the lakes with the other waste. Despite the heightened scrutiny from state and federal regulators at the time, by mid-September Atalco still had not repaired the levee breaches to Red Mud Lake 4 that federal inspectors cited the month before. Nor did the company thoroughly inspect its other lakes to look for similar breaches because, as the records indicate, similar breaches were there — if only the company had looked. On Sept. 17, MSHA inspectors found a breach in the levee around another lake, Red Mud Lake 1 East, with a stream of hazardous waste flowing freely across the roadway. 'The caustic was observed seeping through the side of the levee for approximately 50 yards across the roadway and to the ditch,' the citation states. 'The mud lake is access[ed] by the plant operators daily and contractors for service, and this condition exposes them to injuries if there is a dam failure due to the seepage.' Based on further inspections that same day, MSHA cited Atalco for a third levee break — at Red Mud Lake 2. On that single day, three of Atalco's six waste lakes had confirmed breaches with streams of poisonous chemicals flowing freely to areas they weren't permitted to go, including the Blind River Swamp — a popular recreational fishing spot in the Lake Maurepas backwaters. LDEQ officials first arrived at the plant Sept. 20 to initiate a routine compliance inspection. Agency records show state officials met with Atalco managers, conducted an interview and toured parts of the facility. However, they were unable to inspect some of the lakes and levees because the plant manager told them the access roads were too wet to travel on. LDEQ first documented the levee breaches five days later when they were contacted by the federal inspectors, according to state records. Atalco had still not officially notified LDEQ of the levee breaches — something the company should have done immediately upon learning of them in accordance with Atalco's permit requirements as well as state and federal laws. Local officials have also been kept in the dark. When asked about the events during an impromptu meeting with a reporter Thursday at the State Capitol, St. James Parish President Peter Dufresne said he was unaware of Atalco's levee breaks that contaminated neighboring land and drainage with toxic waste. Dufresne declined an interview but asked the Illuminator for copies of LDEQ's inspection reports. In October, the records show, state inspectors discovered erosion channels in the levee of a fourth lake, Red Mud Lake 3. They also saw for themselves the levee breaches that federal inspectors documented two months before. The erosion channels were still there, and the caustic waste was still escaping from those lakes. So much waste had escaped that it also overwhelmed the facility's secondary containment system, which is a network of interior ditches just outside of the levees used to catch any chemical spills or leaks from the lakes. The backup ditch at one location had overflowed, sending the toxic slurry across the highway just north of the Veterans Memorial Bridge. Atalco was also, as a matter of protocol, unlawfully using a stormwater ditch as a backup containment ditch. Three company officials, apparently unaware that they weren't permitted to use the ditch for toxic waste disposal, told LDEQ inspectors that they routinely used it for containment, according to the inspection files. In other areas, LDEQ inspectors saw that the waste slurry had accumulated to 'nearly the height of the levee' in some of the lakes, the agency's files note. The waste level in the lakes should never be allowed to rise higher than two feet from the top of the levee. Ultimately, in site visits over the next three months, LDEQ inspectors viewed and documented levee breaches at four of Atalco's six lakes, prompting the state agency to cite Atalco multiple times for failing to inspect and failing to repair the levees. Erosion of the levees was a very real possibility that Atalco had long known about. In its 2010 permit renewal applications with the state, the company had addressed the topic at length, promising to prevent erosion by conducting daily inspections of the levees and keeping written logs of those inspections. The state included those as specific ongoing requirements in the final permit issued to Atalco. At that time, the company was in the process of raising its levees from 30 feet to 50 feet high, according to the permit application. By the time state and federal officials began prodding the company last August, Atalco had not consistently inspected its lakes and levees in over three years and was missing hundreds of daily inspection records from July 30, 2021, to Dec. 18, 2024, according to LDEQ's summary of violations. On Oct. 23, state officials noted the company was constructing a new berm to contain the breach at Red Mud Lake 4, which Atalco had known about since at least Aug. 14. The breach at Red Mud Lake 3 continued until Dec. 4, according to the LDEQ file. On that day, Atalco managers accompanied state inspectors into the field when they noticed multiple streams emerging near an access road and traced it back to 'one erosion channel with an estimated depth of at least 10 feet.' You would definitely get injuries and skin burns from it. The plants and any fish in the area would die from that. You can't survive that high of a pH. – Corinne Gibb, chemist, Louisiana Bucket Brigade During their site visits in October, the state inspectors took pH readings from various pools of standing waste that had escaped from the lakes The pH scale ranges from 0 to 14, with water having a neutral pH of around 7. Lower values indicate acidity, while higher values indicate alkalinity. Substances at the extreme ends of the scale in either direction can eat through solid materials such as steel and concrete and are very dangerous to most life forms. The LDEQ detected high pH at every location, with one puddle logged at a high of 12.49 — the same alkalinity as most caustic drain clog removers and ammonia-based cleaners. The inspectors also photographed dead or dying vegetation, petrochemical sheens, and white and yellow chemical residues in many of the locations where the slurry had traveled. 'Just the pH by itself is concerning … That is very high,' Gibb, the chemist, said. 'You would definitely get injuries and skin burns from it. The plants and any fish in the area would die from that. You can't survive that high of a pH.' State inspectors had testing done on water and soil samples from off-site locations in the public drainage system and on-site locations near the erosion streams. Simultaneously, Atalco personnel collected their own batch of samples and sent them to a separate lab for independent testing. LDEQ's soil samples contained significantly elevated levels of cadmium, chromium and nickel — all toxic carcinogens. Atalco's samples reaffirmed the LDEQ's lab results and detected even higher levels at one location. The company's sample taken from public property outside the facility contained cadmium at roughly 1,000% higher than what the state considers safe for people. Additionally, the levels of chromium and nickel measured 1,700% and 300% above their respective state standards, the lab reports show. Gibb and Lomnicki, the LSU scientist, said these three heavy metals, along with arsenic, are among the most dangerous non-radioactive substances on the planet. Exposure to excessive levels can cause a range of serious health issues, including cancer and blood poisoning. Ganga Hettiarachchi, a Kansas State University professor of soil and environmental chemistry, said cadmium could pose the greatest long-term risk because it spreads easily and accumulates in living organisms over time. Enough small doses during a given time period can add up to a fatal dose, she said. Cadmium is highly toxic to humans in short- and long-term exposure settings. Small concentrations ingested or inhaled can cause gastrointestinal or respiratory illness, while higher concentrations can cause cancer, cell death, neurological damage and organ system failure, according to the National Institutes of Health. Increasing the risk from cadmium is that it can be easily spread across far distances and transfer from soil into crops, Hettiarachchi said, posing risks to humans and animals if they eat those crops. 'It could easily end up in our food,' she said. 'That has been historically the main pathway for cadmium.' If cadmium gets into surface water or groundwater, it can become an even bigger problem, especially if that water is used for irrigation, she added. 'The area of damage can expand further and further over time,' Hettiarachchi said. Cadmium was present at elevated levels in two of Atalco's water samples and four of LDEQ's. The highest concentration was 400% above the level considered safe in a water sample taken from an erosion channel within the perimeter of the facility. It also had high levels of chromium and lead. All seven water samples that LDEQ had tested contained elevated levels of arsenic. One of them taken from outside the levee of a red mud lake detected arsenic at a level 9,000% higher than state and federal safe limits, and it contained high levels of cadmium, nickel and thallium. Six out of the seven samples Atalco personnel collected contained arsenic at levels beyond what is considered safe. LDEQ has yet to address the risks Atalco's red mud runoff could pose to the community. Langley, the agency's spokesman, said it has yet to determine what the public impact might be. 'Obviously those are things we don't want going into state waterways,' Langley said. Part Two: For some nearby residents, the levee breaches at Atalco are just the latest incident in a familiar pattern. The second story in this series reveals why the incident at Atalco was foreseeable based on the history of the plant and the many accidents and environmental exposures to the nearby communities. 'They're turning a blind eye to it,' said Gail LeBouef, who's lived near the plant since 1999. SUPPORT: YOU MAKE OUR WORK POSSIBLE
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Washington overdose deaths decline after years of growth, data show
(Photo by Darwin Brandis/iStock Getty Images Plus) Washington is showing promise in its work to combat the epidemic of drug overdose deaths that has ravaged the state and country in recent years. In 2024, fatal overdoses in the state dropped nearly 11% from the previous year, from 3,512 to 3,137, according to preliminary data released by the federal Centers for Disease Control and Prevention. 'There's been not a lot of good news in this space, and this is good news,' said Dr. Herbert Duber, regional medical officer at the state Department of Health. 'I think that we need to get more time, though, to see how it sticks.' Last year's total is still nearly 14% higher than the deaths recorded in 2022. Washington saw the downward overdose trend reversed in the last few months of 2024, noted Duber. The past month has also seen a significant increase. Washington's decrease last year was far below the national average of more than 25%. Only two states saw upticks in overdose deaths: Nevada and South Dakota. Nationally, overdose remains the leading cause of death for Americans ages 18 to 44, health officials say. Fatal overdoses had been rising quickly in Washington. In 2019, fewer than 1,300 residents died, according to state data. Highly potent fentanyl drove that rise, along with increased drug use during the pandemic. In 2019, just over 300 people in Washington died from synthetic opioids like fentanyl. By 2023, that had skyrocketed to more than 2,600, according to the state Department of Health. Federal health officials cite the Overdose Data to Action program as a way to continue reducing deaths through statistic-guided prevention efforts. The state Department of Health, as well as the King and Snohomish County health departments, have received federal money under Overdose Data to Action. In Washington, Duber sees increasing access to treatment as a catalyst for the improvement seen last year, especially to the medication buprenorphine meant to treat opioid addiction. Duber, an emergency department physician, will prescribe Suboxone, a medication containing both buprenorphine and naloxone that reduces opioid withdrawal symptoms. 'There's just been an increasing level of comfort and education and engagement on opioids, trying to figure out a way where the healthcare community can really impact this epidemic,' Duber said. The state is looking to keep the progress going. The two-year state budget Gov. Bob Ferguson signed last week included money for a new hotline to facilitate access to services and medication like buprenorphine. The earliest that could be launched is in September, a Department of Health spokesperson said. The goal is to lower barriers as much as possible to give people the chance to get treatment. But the so-called 'big, beautiful bill' the U.S. House passed last month could threaten the progress. The Medicaid program for low-income Americans is the largest payer for opioid use disorder treatment in Washington, according to the state Health Care Authority. The Republican-backed legislation proposes cutting Medicaid by hundreds of billions of dollars over the next decade, a move that could cost Washington about $2 billion over the next four years and force around 194,000 to lose coverage, local leaders have warned.
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Trevi Therapeutics Announces Positive Topline Results from the Phase 2b CORAL Trial of Haduvio in Patients with Idiopathic Pulmonary Fibrosis Chronic Cough
Haduvio met the primary endpoint with statistically-significant reductions in 24-hour cough frequency across all dose groups (108 and 54 mg BID p<0.0001; 27 mg BID p<0.01); a -43.3% placebo-adjusted change from Baseline was achieved at the 108 mg BID dose group Patients saw a rapid reduction in 24-hour cough frequency at Week 2, the first time point measured Haduvio was generally well-tolerated at all doses; discontinuation rates due to adverse events were similar in the Haduvio and placebo groups, 5.6% and 5.0%, respectively Trevi plans to request an End-of-Phase 2 meeting with the FDA later this year and is planning to initiate the Phase 3 program in the first half of 2026 Company to host a conference call and webcast today at 8:30 a.m. ET and will be joined by the study's UK Lead Investigator, Professor Philip Molyneaux NEW HAVEN, Conn., June 2, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), is pleased to announce today positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF (N=165). The primary endpoint in the CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6. The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved reductions from Baseline of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01), respectively, compared to a placebo reduction from Baseline of 16.9%1. Statistically significant improvements were observed across secondary endpoints at Week 6 in the 108 mg BID and 54 mg BID dose groups. "The CORAL trial is the first positive Phase 2b parallel group study for the treatment of chronic cough in patients with IPF, a significant milestone for patients and Trevi," said Jennifer Good, President and CEO of Trevi Therapeutics. "Chronic cough is one of the most debilitating comorbidities for patients with IPF, impacting an estimated 85% of these patients. There are no approved therapies for chronic cough in this population and with these data, Trevi is one step closer to addressing this unmet need." "In my patients with IPF, chronic cough is one of the most challenging comorbidities I face clinically," said Philip Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London. "IPF treatments focus on slowing disease progression but have not shown benefit on chronic cough, which can lead to poor health outcomes and quality of life. I am excited about the CORAL data and the potential continued development of nalbuphine ER for this significant unmet need among IPF patients." Primary Endpoint – Relative Change from Baseline in 24-hour Cough Frequency (coughs per hour) at Week 6Placebo1 (N=39) Haduvio 27 mg BID (N=42) Haduvio 54 mg BID (N=43) Haduvio 108 mg BID (N=40) Baseline 24-hour Cough Frequency (coughs/hour) 29.4 24.6 28.0 31.5 Relative Change from Baseline in 24-hour Cough Frequency at Week 6 -16.9 % -47.9% (p<0.01) -53.4% (p<0.0001) -60.2% (p<0.0001) Placebo-adjusted difference - -30.9 % -36.5 % -43.3 %1One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat (mITT) population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from Baseline in the placebo group and much greater placebo-adjusted differences. The primary efficacy endpoint was the relative change in objective 24-hour cough frequency (coughs per hour) for the mITT population at the end of Week 6 versus Baseline for Haduvio compared to placebo. The mITT population consists of all randomized patients who received at least one dose of study drug or placebo. Additional Trial Results A rapid reduction was seen in 24-hour cough frequency at Week 2 with Haduvio, the first time point measured. A 50% reduction in 24-hour cough frequency at Week 6 vs Baseline was seen in 65% of patients on 108 mg BID Haduvio (p<0.001), 63% of patients on 54 mg BID Haduvio (p<0.001) and 60% of patients on 27 mg BID Haduvio (p<0.001) dose groups, compared to 19% of placebo patients. A statistically-significant response was observed on the cough-severity numerical rating scale (CS-NRS), a secondary endpoint, at Week 6 on Haduvio in both the 108 mg BID and 54 mg BID dose groups. There was a mean reduction on a 0 – 10 scale of 3.0 points on the 108 mg BID (p<0.05), 3.2 points on the 54 mg BID (p<0.01) and 2.0 points on the 27 mg BID (p=0.46) dose groups compared to a 1.5-point reduction on placebo at Week 6. The 108 mg BID and 54 mg BID dose groups were statistically-significant (p<0.01) on the patient-reported outcome E-RS®: IPF Cough Subscale, a secondary endpoint, with mean relative change from Baseline of -42.4% and -43.1%, respectively at Week 6, compared to -23% for those on placebo at Week 6. The 27 mg BID dose group was not statistically-significant with a mean relative change from Baseline of –31.6%. Discontinuation rates due to adverse events were similar in the combined Haduvio groups (5.6%) and placebo group (5.0%). The safety profile observed in the trial was generally consistent with the known safety profile of Haduvio from previous trials. The most common adverse events experienced included: nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events (all non-fatal) were reported for four patients (10.0%) in the placebo group and for two patients (1.6%) across all Haduvio doses combined. James Cassella, Ph.D., Chief Development Officer of Trevi Therapeutics added, "We are very pleased with the findings from the CORAL trial, which continue to demonstrate the robust cough suppressant activity of nalbuphine ER. The study has provided critical dose-ranging data to inform the planning of our Phase 3 program. We intend to request an End-of-Phase 2 meeting with the FDA to discuss our plans for initiating the Phase 3 program for the treatment of chronic cough in patients with IPF. I would like to take the opportunity to thank the patients, investigators and site staff for moving research forward for these patients. We look forward to advancing development of this program." Conference Call/Webcast The Company will host a conference call and webcast to review the topline results today, June 2nd, at 8:30 a.m. ET. The live webcast, including audio and presentation slides, will be accessible at the time of the meeting and can be accessed here. To participate in the live conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. An archived replay of the webcast will also be available for 30 days on the Company's website following the event. About the CORAL TrialThe Phase 2b Cough Reduction in IPF with Nalbuphine ER (CORAL) trial was a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27 mg, 54 mg, and 108 mg twice daily) compared to placebo for the treatment of chronic cough in patients with IPF over a 6-week treatment period. 165 patients with IPF chronic cough were randomized 1:1:1:1 to one of three Haduvio doses or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial was the relative change in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for the modified intent-to-treat (mITT) population at the end of Week 6 versus Baseline for Haduvio compared to placebo. The mITT population consisted of all patients who were randomized and received at least one dose of study drug or placebo. About Idiopathic Pulmonary Fibrosis (IPF) Chronic CoughChronic cough is a highly prevalent condition in patients with IPF, impacting up to 85% of the IPF population. There are ~140,000 patients in the U.S. with IPF. The impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough and any associated damage may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in patients with IPF and current off-label treatment options provide minimal benefit to patients. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials of patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan CarlsonTrevi Therapeutics, Inc.(203) 654 3286carlsonj@ Media Contact Rosalia Scampoli914-815-1465rscampoli@ 2Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis as collected in the EXACT® (EXAcerbation of Chronic pulmonary disease Tool). EXACT© 2013, Evidera, Inc. All rights reserved. View original content to download multimedia: SOURCE Trevi Therapeutics, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
