The Food and Drug Administration on Monday approved Merck‘s new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.

Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form. 

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia. 

“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease, and then being in the hospital, losing out on work,” Heather Platt, Merck’s product development team lead for the newly cleared vaccine, told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year, Platt said. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

Even after the FDA approval, the company’s single-dose vaccine won’t reach patients just yet. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee’s decision and is ready to supply the vaccine by late summer. 

Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028. 

The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts. 

Merck’s newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. For example, the company’s existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older.

Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, is the current leader in the market for adults. But Merck expects its new shot to capture the majority of market share among adults, Platt said. 

“We do expect there to be rapid uptake of” Capvaxive, she said, adding that the company is confident that data on the shot will “really resonate” with clinicians and policymakers. 

Merck’s pneumococcal vaccine protects against eight strains of the bacteria that are not included in any other approved shot for the disease. Those eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 and above, according to a release from Merck, citing CDC data from 2018 to 2021. 

The 21 strains included in Merck’s shot account for roughly 85% of invasive pneumococcal disease cases in adults 65 and above, Merck, citing the CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for roughly 51% of cases in that age group, based on the same CDC data. 

The FDA’s approval is partly based on Merck’s late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer’s Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine.

Correction: This story has been updated to reflect 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.

Bristol Myers Squibb on Friday announced it agreed to buy biopharmaceutical company Karuna Therapeutics for $14 billion in cash, or $330 per share.

Karuna’s stock closed up more than 47% on the news Friday, hitting $317.85 a share. Bristol Myers Squibb shares closed up 2%.

The deal will help expand Bristol Myers’ drug pipeline after competition from a generic offering caused demand for the company’s blood cancer drug Revlimid to tumble in its third quarter.

The boards of directors at both Bristol Myers and Karuna unanimously approved the acquisition, and it is expected to close in the first half of 2024, according to a release.

Karuna develops medications for patients living with neurological and psychiatric conditions. The company’s lead asset is an antipsychotic called KarXT, which is expected to serve as a treatment for adults with schizophrenia beginning in late 2024, the release said.  

“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” Bristol Myers Squibb CEO Christopher Boerner said in a statement.

KarXT is also being evaluated as a possible treatment for Alzheimer’s disease psychosis and a form of bipolar disorder, according to the release. Karuna CEO Bill Meury said the company’s portfolio “offers advancements in treatment not seen in many years.”

“With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis,” he said in a statement. 

Citi and Gordon Dyal & Co. advised Bristol Myers on the deal, while Goldman Sachs served as the exclusive advisor for Karuna.

— CNBC’s Annika Kim Constantino contributed to this report.

Don’t miss these stories from CNBC PRO:

The Federal Trade Commission on Thursday sued the largest anesthesiology provider in Texas, claiming the company has wielded monopoly power to drive up prices for patients and boost its profits.

The FTC asked a federal judge in Houston, Texas, to break up U.S. Anesthesia Partners’ alleged monopoly power and permanently bar the company from engaging in anti-competitive practices.

The agency claims that New York-based private equity firm Welsh, Carson, Anderson & Stowe founded U.S. Anesthesia Partners in 2012 to pursue an aggressive consolidation strategy that exploited Texas’ fragmented market for anesthesiology providers.

The FTC complaint says that Welsh Carson sought to make USAP the dominant provider in Texas by hoovering up the numerous independent practices that previously competed against one another, keeping prices lower.

Welsh Carson and USAP engaged in what the companies called a “roll-up,” buying nearly every large anesthesia practice in Texas, according to the complaint.

Since 2013, USAP has grown from 400 anesthesia providers at 45 health-care facilities to 4,500 providers at 1,100 facilities in 2021.

USAP has established monopoly power in Houston and Dallas, the two largest cities in Texas, and a dominant position in Austin, the state’s capital, according to the complaint.

The company has used its dominance to raise prices, raking in tens of millions of dollars, the FTC alleges.

USAP is so powerful in Austin, Dallas and Houston that it can raise prices while still gaining market share because it is difficult for competitors to enter the market, and patients typically cannot forgo anesthesia, according to the complaint.

Dr. Derek Schoppa, a USAP board member, told CNBC that the FTC’s complaint is based on flawed legal theories and a lack of medical understanding about anesthesiology.

“The FTC’s intended outcome threatens to disrupt and restrict patients’ equitable access to quality anesthesia care in Texas and will negatively impact the Texas hospitals and health systems that provide care in underserved communities,” Schoppa said in a statement.

Heather Le Biller shed 9 pounds within the first week of taking Novo Nordisk‘s blockbuster diabetes drug Ozempic – and then even more as she continued treatment. 

Le Biller, a flight attendant who lives in France, noticed her appetite quiet down while taking the weekly injection. But so did her cravings for wine, a drink she called “almost customary to pair with every dinner” in France. 

“When I was on Ozempic, it made me not want that as much anymore,” Le Biller told CNBC. “I could have a few sips of wine and just be satisfied and move on. I didn’t need multiple glasses a night, so it definitely seems to help with that.” 

Le Biller is among several patients who took diabetes and weight loss drugs and also noticed an effect on their cravings for alcohol, nicotine, opioids or even some compulsive behaviors, such as online shopping and gambling.

Those drugs – including Ozempic and its weight loss counterpart from Novo Nordisk, Wegovy – are called GLP-1 agonists, which mimic a hormone produced in the gut to suppress a person’s appetite. 

These anecdotal reports add to the growing list of potential benefits of GLP-1s beyond shedding unwanted pounds. Dramatic weight loss is the primary reason why those drugs have skyrocketed in popularity in the U.S., despite the fact that they can cost around $1,000 a month and some health insurers have stopped covering them altogether. 

“We’re prescribing these drugs and seeing this effect as a secondary benefit in patients. One of my patients even said they’re not doing as much online shopping, which is helping their wallet,” said Dr. Angela Fitch, an obesity medicine physician and president of the Obesity Medicine Association. That group is the largest organization of physicians, nurse practitioners and other health-care providers dedicated to treating obesity. 

This striking effect of GLP-1s isn’t a new idea. Several studies have demonstrated that certain GLP-1s curb alcohol intake in rodents and monkeys. 

More research needs to be done, particularly on humans, to prove that the drugs have that effect. That means it could take years before the Food and Drug Administration and other regulators worldwide approve drugs like Ozempic and Wegovy as addiction treatments. 

Novo Nordisk told CNBC in a statement that they aren’t pursuing that research.

“Pharma has this general lack of interest in investing in the addiction field” due to a perfect storm of factors, including the high stigma around addiction disorders among doctors, physicians and even patients, according to Dr. Lorenzo Leggio, clinical director of the National Institute on Drug Abuse, or NIDA.

Leggio and other scientists are working to fill the gap – and have already made strides toward confirming the potential of GLP-1s as addiction treatments.

Scientists have published nearly a dozen studies showing how GLP-1s stop binge drinking in rats and mice, reduce their desire for alcohol, prevent relapse in addicted animals and decrease alcohol consumption overall. 

Earlier studies have examined older, less potent GLP-1s such as exenatide, a drug approved for diabetes under the names Byetta and Bydureon. 

But more recent studies on semaglutide – the generic name for Ozempic and Wegovy – and another drug from Eli Lilly called dulaglutide “are the most promising” because they reduced alcohol intake in animals by 60% to 80%, according to pharmacologist Elisabet Jerlhag. 

Studies have also shown that rats that stop taking dulaglutide, which is approved for diabetes under the name Trulicity, “take weeks before they start drinking again,” she said.

Jerlhag and her colleagues at the University of Gothenburg in Sweden have studied the effect of GLP-1s on addictive behaviors for more than a decade. 

Other studies on animals have also found that GLP-1 drugs reduce the consumption of nicotine, cocaine, heroin and amphetamines. 

Few studies have been done on humans, but six clinical trials are now underway investigating how semaglutide may alter people’s drinking and smoking habits. 

The reason behind this anti-addiction effect of GLP-1s is that those drugs also affect the brain, not just the gut, according to NIDA’s Leggio. 

“The mechanism in the brain that regulates overeating is important in regulating addictive behaviors as well,” Leggio told CNBC. “There is a clear shared overlap. So it’s possible that the medications may help people with addiction by acting on that specific mechanism.”

GLP-1s specifically decrease the amount of dopamine the brain releases after people indulge in behaviors like drinking, smoking or even eating a sweet dessert, according to Dr. Steven Batash, a gastroenterologist who provides nonsurgical weight loss procedures in Queens, New York. 

Batash said dopamine is a neurotransmitter that “reinforces the pleasure” of doing those activities. When GLP-1s take away that pleasure, they also eliminate the motivation to do those activities. 

Still, NIDA’s Leggio advises against using GLP-1s off-label to reduce addictive behaviors, “simply because there’s not enough evidence in humans that they work.” 

“The animal studies are very promising and what people are reporting is very, very important, but as a scientist, I will also tell you that that’s not enough,” he told CNBC. 

Leggio said scientists need to conduct more double-blind, randomized, placebo-controlled studies on humans – or trials where both participants and researchers don’t know who is getting randomly selected to receive a placebo or an actual drug. Those types of studies are “the gold standard” for proving whether a treatment achieves a certain effect or not, he added

But even if those trials confirm that GLP-1s can reduce addictive behaviors in humans, “it will most likely work for some patients and not others,” according to Leggio. 

“We already know, as a matter of fact, that these medications and any drug overall do not work for everybody,” he said. 

For example, the only clinical study in this area investigated whether exenatide could treat alcohol use disorder in people, as compared with cognitive behavioral therapy.

But a subgroup analysis of that 2022 study found that exenatide reduced drinking in a subgroup of participants who had obesity, while the drug actually increased drinking in people who didn’t. 

The reason may be that “leaner patients” treated with exenatide experienced a larger decrease in blood sugar, which might be associated with increased cravings for alcohol, the researchers wrote in the study.

But even that hypothesis needs to be confirmed with further research. 

It’s also unclear how long the anti-addiction effect of GLP-1s will last. That’s already one complaint patients have when it comes to weight loss: People who lose weight after taking Ozempic or Wegovy tend to gain most of it – or even more – back within a few years. 

“It’s possible that some people will relapse and go back to heavy drinking if they stopped taking the medication,” Leggio said. He added that some patients will need constant treatment because addiction is a chronic disease. 

However, Leggio said there’s “nothing wrong” with a patient seeking GLP-1s to treat diabetes or obesity, in addition to an addiction disorder. 

“If you want to see whether Ozempic will help you better control the sugar in your blood but also help you with your drinking, that’s wonderful. Killing two birds with one stone,” Leggio said. “But if the only reason you want to take the drug is because of your alcohol or smoking, then you should wait for more evidence.” 

It may take years, but scientists and other health experts hope that a new class of treatments for alcohol use disorder, smoking and other addictive behaviors is on the horizon. 

“It may be that three, four or five years from now, you and I are going to say that GLP-1 agonists are wonderful for treating mild diabetes, wonderful for weight loss, and perhaps we will also say that they are wonderful for curbing addictive behaviors,” Batash told CNBC.

But even if GLP-1s get approved to treat addiction, it’s unclear how many people would take them. Uptake of existing medications for addiction is already low.

About 14 million American adults had alcohol use disorder – a disease associated with uncontrolled drinking – in the past year as of 2019. But only 1.6% used any of the three FDA-approved drugs for the condition. 

The National Institutes of Health is rolling out one of the largest studies in the world to understand long Covid in a high-stakes effort to find definitive answers about a multitude of seemingly unrelated and sometimes debilitating symptoms that have plagued patients and confounded physicians.

The $1.15 billion taxpayer-funded study, called Recover, aims to enroll nearly 40,000 people by the end of this year. It will follow those participants over four years, comparing people with Covid to those who’ve never had it, with the goal of identifying all the long-term symptoms and finding out how the virus is causing them. The Patient-Led Research Collaborative said there were more than 200 long Covid symptoms across 10 organ systems, according to a study published last year in The Lancet.

It’s a massive undertaking, and expectations are high. The size of the budget, breadth, depth and scope of the study are rarely seen in scientific studies.

The study’s conclusions could play a pivotal role in developing diagnostic tests and finding treatments for patients who remain sick months after contracting Covid-19. If the scientists can produce clinical definitions of the various long-term illnesses associated with the virus, patients will stand on firmer ground when trying to convince health insurers to cover their treatments and getting disability claims approved.

Dr. Walter Koroshetz, who serves on Recover’s executive committee, said the study has been designed to investigate long Covid from every possible angle and provide definitive answers. But Koroshetz acknowledged that even a study this size will face major challenges in delivering on such ambitious goals.

“I’m worried that this is not an easy answer. The post-infectious persistent symptoms that go on to chronic fatigue syndrome have defied anybody’s explanation,” said Koroshetz, the director of the National Institute of Neurological Disorders and Stroke.

The Recover study aims to complete enrollment of more than 17,000 adults by September and 20,000 children by the end of the year, according to Dr. Stuart Katz, who is coordinating the nationwide rollout of the Recover study at its central hub at New York University Langone Health. The study will have research teams at more than 30 universities and medical institutions across the U.S.

As of this week, 5,317 adults and 269 children have been enrolled, taken together about 15% of the total population of nearly 40,000, according to Katz, a cardiologist who studies congestive heart failure. Katz caught Covid in December 2020 and suffered symptoms for about a year.

The National Institutes of Health is also planning to launch a “suite of clinical trials” on possible treatments in the coming months, according to Dr. Gary Gibbons, director of the National, Heart Lung and Blood Institute. Gibbons said NIH is in active discussions with the pharmaceutical industry on studying whether antivirals and other interventions can prevent or treat long Covid.

“These are exploratory with companies that have agents that may go before the FDA for approval,” Gibbons said. “There’s an interest both for public-private collaboration in this space and we’re very hopeful that something will emerge in the next several months.”

However, Gibbons said NIH will likely need more funding from Congress for the trials given the scope and complexity of the problem.

“We would anticipate to really fully do the clinical trial portfolio that patients with long Covid deserve, it probably will exceed $1.15 billion initial allocation that Congress awarded,” Gibbons said.

While the public uses long Covid for shorthand, the scientific name is post-acute sequelae of Covid, or PASC. Researchers believe it is not a single disease but several distinct illnesses affecting many organ systems.

Scientists still do not know how the virus triggers such a wide spectrum of symptoms that can persist months after the initial infection, why some of these symptoms show up in some patients but not in others, or what exactly the risk factors are for developing them.

“Everyone’s immune system is different, so everyone’s going to respond to a novel virus in a different way,” said David Putrino, a physiotherapist and director of rehabilitation innovation at Mount Sinai Health System in New York City. Putrino has helped treat long Covid patients since the early days of the pandemic in 2020. Mount Sinai’s Icahn School of Medicine is one the institutions participating in Recover.

Putrino said many patients who come to Mount Sinai for treatment suffer cognitive impairments that are similar to traumatic brain injuries, commonly referred to as brain fog, in which they struggle with speech fluency and making plans to deal with life’s daily challenges. They can also often have abnormal heartbeat, tingling sensations, painful cramps and feelings of anxiety.

Any form of physical or mental exertion worsen these symptoms. As a consequence, about 60% of the long Covid patients at Mount Sinai struggle to continue at their jobs, Putrino said. They either had to shift to part-time work from full time, retire early or became unemployed. Almost all of the patients report a deterioration in their qualify of life due to their symptoms, he added.

The nation’s health agencies do not yet know exactly how many people suffer from the condition. The answer to that question, which Recover hopes to shed more light on, could have major implications for the nation’s health and economy.

The Centers for Disease Control and Prevention, in a study that examined nearly 2 million patient records, found that one in five Covid survivors ages 18 to 64 and one in four ages 65 and older developed a health problem that could be related to long Covid. If the findings prove accurate for the broader population, millions of people in the U.S. may have some form of the condition.

People who survived the virus were twice as likely to develop respiratory conditions or a pulmonary embolism, according to the CDC study. The authors said long Covid can impair a person’s ability to work which could have economic consequences for their families.

The severity and duration of patients’ long Covid symptoms vary widely, Katz said. The population of people permanently disabled by long Covid is likely a fraction of those who have some form of the condition, he said. Still, there’s likely a very large number of people who have a disability from long Covid given the reality that at least 87 million people in the U.S. have contracted the virus at some point, Katz said.

With so many unanswered questions, physicians don’t have a precise way to diagnose patients with long Covid. Treatments at this point are mostly managing symptoms, not addressing the underlying cause of the illnesses, Putrino said. Scientists need to define the different types of long Covid so they can tailor treatments to individual patients, he added.

The challenge with diagnosing and treating patients with long Covid is that many of the symptoms are also associated with other diseases, said Katz. Recover contains control groups, people who have never had Covid, so scientists can define which symptoms are actually occurring more often in people who do have a history of infection, Katz said.

All the participants in Recover will undergo a battery of lab tests, vital signs and physical assessments, as well as a survey of symptoms and underlying health conditions among many other questions at enrollment and at regular intervals throughout the study. Smaller populations of participants will undergo more intense evaluations that include electrocardiograms, brain MRIs, CT scans and pulmonary function tests.

The scientists aim to identify clusters of symptoms associated with various abnormalities in the lab tests and uncover the mechanisms in the body causing those symptoms through advanced imaging, Katz said. Abnormalities found in lab tests, blood samples for example, that are associated with long Covid could serve as the basis for future diagnostic tests, he said.

By defining the different types of long Covid, the study will also guide clinical trials by providing a clearer idea of what treatments might prove most effective at targeting the underlying causes.

“Clinicians really need us to clarify what is the clinical spectrum, the definition of long Covid — that’s critical to treating it,” Gibbons said. “If you’re going to do a clinical trial, you really want to know that you might treat brain fog different from the cardiopulmonary symptoms,” he said.

Recover will also analyze tens of millions of electronic patient health records and study tissue samples from autopsies of people who had Covid when they died. All of the Recover data will go into a database that investigators at sites across the country can use in research on specific aspects of long Covid that they can pitch to Recover’s leadership.

Dr. Grace McComsey, the principal investigator for the Recover site at Case Western Reserve University in Cleveland, said the study design will allow her team to access a large pool of patient data that they otherwise wouldn’t have the time or resources to collect on their own. McComsey, an infectious disease expert who researched HIV before the pandemic, has submitted a concept with her team to look at how the virus is causing inflammation in patients.

“You’ll be able to access a lot of data, lots of samples on patients that otherwise I can’t do from my own site. It will take me obviously a lot of time and a lot of resources that I don’t have,” McComsey said. “The huge amount of data and huge amount of patients. I think it’s definitely a big plus in Recover.”

However, the pace of the federal government’s efforts to address the long-term health impact of Covid has come under criticism. Some of the nation’s leading health experts described research into long Covid as “achingly slow,” according to a March report whose authors included several former members of President Joe Biden’s Covid transition team, including Zeke Emanuel.

It’s been more than a year and a half since Congress OK’d $1.15 billion to study the long-term impact of Covid in December 2020. Francis Collins, NIH director at the time, announced in February 2021 the launch of a nationwide study. The following May, NIH awarded $470 million to New York University Langone to set up the observational part of the study led by Katz and his team.

Koroshetz acknowledged the frustration with the pace of the research, but he said the study is designed through its size and scope to answer questions smaller studies cannot.

“We put this together to not miss anything,” Koroshetz said. “It’s kind of like a battleship. That’s part of the problem.”

Although Recover will follow participants for four years, researchers will publish their findings throughout the duration of study, Katz said. The first report, based on the initial assessment of participants, should publish shortly after enrollment is complete, he said.

“In comparison with other large multisite studies, this was all done at breakneck speed because there was a recognition that there is an urgent public health need,” said Katz.

Putrino said NIH-funded research is usually slow, risk averse and normally doesn’t lead to rapid implementation of treatments that help patients. He said NIH typically doesn’t invest in high-risk research because it doesn’t want to be perceived as gambling with taxpayer money. Putrino said his team applied for a Recover grant in December 2021 and hasn’t heard back yet.

He said NIH should act more like industry by moving quickly to invest in high-risk research that can lead to disruptive innovations.

“The NIH has the capacity to follow a process similar to industry — it’s not typical but they can do it,” said Putrino, who was one of the authors on the March report that criticized the pace of the federal government’s long Covid efforts. “We need a high-risk investment right now,” he said.

In April, President Biden directed Health and Human Services Secretary Xavier Becerra to develop a national research action plan on long Covid in collaboration with the secretaries of Defense, Labor, Energy and Veterans Affairs. HHS is supposed to have the plan ready next month, according to Biden’s directive.

JD Davids, a patient advocate, said the NIH should model the federal response on long Covid after its success in researching and developing HIV treatments. That includes creating a central office at NIH with budgetary authority, similar to the Office of Aids Research, that develops a strategy every year with input from patients on how to use funds for research, said Davids, a member of the Patient-Led Research Collaborative.

Koroshetz and Gibbons said Recover is moving as quickly as possible to get clinical trials on treatments started. “We’re not going to wait four years and then do the trials. We’re going to whatever rises to the top in terms of ideas,” Koroshetz said.

Gibbons said NIH can’t provide a timeline right now on how long the clinical trials will take. Although NIH is soliciting concepts, it doesn’t have any finished plans for how the trials will proceed yet, he said.

“It’s probably not a satisfying answer, but we can only move at the pace of the science,” Gibbons said. “If you establish the protocol, you have to enroll participants and you have to let the protocol play out. We don’t have a protocol yet in hand.”