Health

(NEW YORK) — Drugs such as Ozempic, Mounjaro and Wegovy have been flying off pharmacy shelves across the country, touted as breakthrough drugs for patients looking to lose weight. Celebrities like Rosie O’Donnell, Chelsea Handler, Millionaire Matchmaker star Patti Stanger and social media influencers claimed to have used the medications and credit them with changing their lives.

But with the increased demand have come reports of access problems for diabetic patients with dire health issues, many of whom are scrambling to get the pen-shaped injectors.

“I hear about it every day,” Dr. Veronica Johnson an obesity specialist at Northwestern Medicine, told “Impact x Nightline.” “I saw how many patients today? Every one of them was like, ‘Well, I can’t find that dose anymore, so what am I supposed to do?’ Unfortunately, it’s a daily struggle that we’re dealing with because of shortages of this drug.”

As debates swirl about the drugs on social media and beyond, “Impact x Nightline” explores the controversy surrounding these medications, the concerns over access to Ozempic and Mounjaro and the effects it’s having on patients who have been struggling with weight loss in an episode now streaming on Hulu.

Ozempic and Mounjaro were approved by the FDA in 2017 and 2022, respectively, as treatments for Type 2 diabetes. They are not approved for weight loss but can be prescribed off-label by doctors. Wegovy, meanwhile, is FDA approved for obesity and diabetes.

More than 40% of the U.S. population is obese, which puts tens of millions of Americans at risk of heart disease, stroke, Type 2 diabetes, certain types of cancers and even death, according to the U.S. Centers for Disease Control and Prevention.

The medications mimic a hormone in the body that makes you feel full. Dr. Barrie Weinstein, the medical director and endocrinologist at New York City-based Well by Messer, told “Impact” that patients who take the injections still eat their normal meals but without feeling the need to overeat.

“I hear it time and time again from my patients. They’re not thinking about food. That they can go about their day,” she said.

She added that since digestion is slowed down, it also leads to side effects like constipation, acid reflux and nausea.

Weinstein said the patients to whom she’s prescribed the drugs, like Caley Svensson, have seen improvements in their weight and mental health.

Svensson told “Impact” that she has struggled with mental health issues regarding her weight ever since she was a child and grew more frustrated after multiple diets were not working.

“I was really struggling after my third pregnancy to lose the rest of the baby weight. I was not able to do the things I loved anymore,” she told “Impact.” My life centers around being outside, horseback riding, being with my kids, running around.”

Svensson said she has lost 60 pounds since she started taking Mounjaro last summer. Dr. Weinstein said she’s seen a vast improvement since Svensson started taking the drug.

“She walked into the first follow-up smiling so brightly. That’s what I noticed, her smile and her glow,” Dr. Weinstein said.

However, Svensson said that she’s had to deal with a looming problem that’s hitting a lot of patients who use the drugs: the shortage.

Pharmacies around the country said they don’t have enough supply to meet demand, sending some patients into a panic.

Shane Anthony, a 57-year-old diabetic, told “Impact” that Ozempic dramatically dropped his glucose levels.

He said though, that last year he struggled to get a refill and blames, in part, the way the drugs have become popular across social media.

“Things just kind of went crazy,” he told “Impact.” “I had to go to something that was much, much older, and really isn’t working as effectively as the other was.”

Anthony’s wife, Gerilyn Oenning, a nurse, expressed her frustrations with the situation in a viral social media post that blamed people who obtain the drugs but aren’t obese or diabetic for the shortages.

Kaitlyn Wade, who was diagnosed by her doctor as pre-diabetic before being prescribed Mounjaro, said she was lucky to receive a temporary coupon from Eli Lilly, the drug’s manufacturer, to help pay for the medication. When the coupon expires, she and other patients will be forced to pay out of pocket.

“It’s kind of the insurance game to see if I can get my insurance to approve it or if it gets this fast track for approval for weight loss,” Wade, who has lost over 60 pounds since starting the medication, told “Impact.”

Ozempic’s manufacturer Novo Nordisk said in a statement that “intermittent supply disruptions” on its pen are anticipated through mid-March “due to the combination of incredible demand coupled with overall global supply constraints.” The company also makes Wegovy, saying “All dose strengths … became available to retail pharmacies nationwide.”

Eli Lilly, the maker of Mounjaro, said in a statement that its priority is making sure that Mounjaro is available to patients with Type 2 diabetes and that it “does not promote or encourage the off-label use” of its medicines.

Eli Lilly added, “all doses of Mounjaro are available, with no backorders at wholesalers.”

“Lilly is shipping all six doses of Mounjaro on an ongoing basis. As Mounjaro is still a launch product with dynamic demand, some pharmacies may experience an intermittent delay in receiving product from time to time,” the company said in a statement.

Dr. Weinstein said it was not advisable to prescribe Ozempic and Mounjaro to patients who aren’t obese.

“If you’re just looking to lose 10 or 15 pounds and you’re starting on a medication that is just going to lead you into a cycle of gain and loss, why would you go down that pathway if there was something else that would be better for you?” Weinstein said.

Dr. Johnson said there is another issue at play, as there have been reports that people have asked for medications through Groupon ads and med spas instead of pharmacies.

“I would much rather prefer that you get a prescription from me and you actually go to the pharmacy, so we know that you’re getting the FDA-approved product,” she said.

Groupon said in a statement that it is aware of the ads for Semaglutide, the active ingredient in Ozempic, and reiterated that it “is only available with a prescription.” Groupon added that medical professionals “alone make any decisions regarding the diagnoses and treatments of their patients.”

One of the companies that advertise on Groupon, Take Care Medspa, told “Impact” in order to qualify for the medication, customers need to be obese or be overweight with a weight-related condition.

Groupon says if customers don’t meet those criteria then they’ll get a refund.

Dr. Johnson emphasized that the medications aren’t “miracle drugs” but she says they show much promise and are really needed for patients who are suffering from diabetes and obesity.

Doctors say there may be other reasons to prescribe the drug, and each person’s medical care should involve a nuanced conversation with their doctor.

Beyond the current shortages, Dr. Johnson said many of her patients have trouble getting insurance companies and Medicaid to reimburse the drugs. Many insurance providers do not reimburse for obesity and weight loss.

Johnson said this could lead to a wider disparity around the country between those who can afford and get easier access to the medications and those who can’t.

“Until we can finally allow for all patients to have equal access to the drug, we’re never going to address the obesity epidemic,” she said.

ABC News’ Sony Salzman contributed to this report.

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(PLEASANTON, Texas) — A Texas woman who nearly lost her life after giving birth was reunited at home this month with her now-4-month-old daughter and 2-year-old son.

Krystina Pacheco, 29, of Pleasanton, Texas, gave birth to her daughter Amelia on Oct. 24, 2022, in what she described as an uneventful C-section delivery.

Two days later, on the day she was discharged from the hospital, Pacheco said she started feeling feverish but assumed it was just part of her recovery post-C-section and was given ibuprofen by a nurse.

When she continued to feel unwell at home, Pacheco said she went to see a doctor, who sent her to a local emergency room.

From there, Pacheco was airlifted to a hospital in San Antonio, where doctors discovered her body was in septic shock.

“I just remember I couldn’t breathe anymore and I couldn’t see anymore and I just started slowly fading out,” Pacheco told ABC News. “My husband, I could just hear him saying, ‘Please come back to us, please, your babies need you. I need you. I need you to be here and help me with our babies,’ and that’s the last thing I remember.”

Septic shock is the most dangerous stage of sepsis, which occurs when your body has an extreme response to infection. According to the National Institutes of Health, “without quick treatment, it can lead to tissue damage, organ failure, and even death.”

In septic shock, the body has dangerously low blood pressure. Risk factors include recent infection or surgical procedure.

According to the Centers for Disease Control and Prevention, sepsis is the second leading cause of pregnancy-related death in the United States, behind only cardiovascular conditions.

In Pacheco’s case, the condition began to affect her heart, lungs and kidneys, according to her husband, Jacob Pacheco.

Jacob Pacheco said his wife was simultaneously put on dialysis to help her kidneys and on an ECMO machine, a lifesaving device that removes carbon dioxide from the blood and sends back blood with oxygen to the body, allowing the heart and lungs time to rest and heal.

“They didn’t want to tell us how close she was [to death] but you could see it in their faces every time I asked,” Jacob Pacheco said, adding that doctors at the time gave his wife a 20% survival rate. “It was scary.”

Jacob Pacheco, a coach and teacher, who met Krystina because they both work in the special education field, said he relied on family and friends for support as he stayed by his wife’s bedside while also needing to care for their newborn daughter and young son.

“We would bring them to the hospital and our families would meet there and we would take care of them in the lobby,” he said of their children, Amelia and Owen. “It was, you know … living just day by day, just trying to take care of Krystina.”

For the two weeks Krystina Pacheco remained in the intensive care unit and on dialysis and the ECMO machine, Jacob Pacheco said he and his mother-in-law and father-in-law took turns sitting by her bedside.

In mid-November, Krystina Pacheco began to turn a corner and improved enough that doctors were able to take out her breathing tube so she could speak.

“The first thing she said to me was, ‘What happened to me? Did I almost die?,'” Jacob Pacheco recalled. ” And we had a moment of tears — tears of sadness, tears of joy, just a bunch of emotions coming over us.”

Though Krystina Pacheco was now awake, she still had to face what she now describes as the “hardest thing” she’s been through.

Just before Thanksgiving, she said doctors told her they would need to amputate both of her feet and hands because of the damage they had sustained while she was in intensive care.

One of the risk factors of an ECMO machine is poor blood flow to the limbs, which can result in the need for amputation, according to the Cleveland Clinic, which was not involved in Krystina Pacheco’s medical care.

“My hands and feet were black. They looked like a person who had gotten frostbite,” she said, adding that her medical team “tried to do everything they could” to avoid having to amputate.

“I was just breaking down and being absolutely crushed that that’s where we were at, at that point,” Krystina Pacheco said of learning amputations were necessary. “And crying with my family, crying with Jacob, and just being sad that my life would no longer be the same.”

In addition to undergoing an initial surgery to amputate both arms below the elbows followed by a second surgery days later to amputate both legs below the knees, Krystina Pacheco said she underwent nearly one dozen skin grafts over the next several weeks because the skin around her amputations was so damaged.

“Every day I woke up and thought about my babies and every time I went into a surgery, my thought was, I have to get home to be with my babies, so if that means going through one more surgery, then ultimately I have to go through another surgery,” she said. “They were my number one motivation, hands down.”

In late January, three months after she was admitted, Krystina Pacheco was discharged from the hospital and moved to TIRR Memorial Hermann, a rehabilitation center in Houston.

There, Krystina Pacheco, who previously taught group fitness classes outside of her full-time job, spent several weeks healing her amputation wounds and learning to live as a double amputee, while also rebuilding her strength after a three-month hospital stay.

“Any task, any exercise, I tried it and I gave it my 100%,” she said, adding that she started applying the motivation she had taught in group fitness to herself. “I would self-talk to myself, like, ‘Come on. You’ve got this. Just get this,’ so I would push a little. I even surprised myself some of the time.”

Dr. Vinay Vanodia, medical director of the amputee and limb loss rehabilitation program at TIRR Memorial Herman, said Krystina Pacheco’s self-motivation helped her progress really quickly in rehab.

“When she first came in, I had received a message about this young patient who came in with these unfortunate amputations after pregnancy and her baby was at home while she was here,” Vanodia told ABC News. “But when we went to see her, she was such a bright light and it just changed the whole mood.”

He continued, “Any challenge we put in front of her, she was able to accomplish. She just gave 100% and was able to make a lot of progress while she was with us.”

On Feb. 11 — more than 100 days after she was hospitalized and away from her newborn daughter and son — Krystina Pacheco was able to return home.

“I cried,” she said of the moment she arrived home. “I hugged [Jacob] really right. He knew I was overcome with emotions.”

Krystina Pacheco said she has no lingering medical complications from her septic shock scare beyond her amputations. She is currently doing workouts at home to rebuild her strength and will start outpatient rehabilitation soon so she can get stronger and be self-sufficient in tasks like transferring herself from her bed to a chair and the shower.

The Pachecos said they have been overwhelmed with the help they’ve received from friends, family and their community over the past several months, from helping to take care of their children to raising money to help them cover medical costs and costs associated with making their home wheelchair-friendly.

Jacob Pacheco said that new challenges have arisen as his wife has settled in at home, but they are moving forward, looking at each new challenge as a new “chapter” in their story.

“It’s not easy, and it’s not going to be easy,” he said. “We were definitely crying yesterday and … it’s okay to feel those things. It’s not easy, but if we’re sticking together, it makes it that much better.”

Krystina Pacheco said she plans to return to work as a licensed specialist in school psychology, and wants to share her story to inspire other people and raise awareness of limb differences. She will soon be able to use state-of-the-art prosthetics for both her hands and feet, according to Vanodia.

When it comes to her kids, she described them as “resilient” and said her 2-year-old son Owen is always by her side and willing to help his mom with everyday tasks like pushing up her sleeves and opening her makeup.

Her 4-month-old daughter Amelia is now catching up on the bonding time she missed with her mom in the very first months of her life.

“That’s one of the things that does break my heart a little bit still and that I’m working through is that mommy guilt of not being able to be with my baby every day for her first three months of her life,” Krystina Pacheco said. “But you know, I’m home now and we’re making those adaptations as we go and we’re adjusting and being a little family again.”

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(NEW YORK) — As the pandemic seemingly enters a new phase with the public health emergency ending in early May, many COVID data trackers are shutting down, no longer sharing data such as number of cases or hospitalizations, despite about 500 Americans dying each day from the disease.

Experts interviewed by ABC News detail how the onset of the pandemic brought a slew of data trackers to monitor numbers to inform officials. They warn that investments in epidemiological tracking can’t dwindle, especially as respiratory illnesses like influenza and RSV placed a heavy burden on some hospitals across the nation this past winter.

John Hopkins University reported their Coronavirus Resource Center will be shut down in early March. The site was one of the first to track real-time COVID data and was widely appreciated — even the White House relied on the site in the very beginning of the pandemic to learn about the outbreak that was occurring abroad, explained Dr. Blythe Adamson Ph. D., CEO and founder of infectious economics and former member of the White House Coronavirus Task Force, told ABC News.

“Clearly the challenges, especially at the earliest outset of a pandemic, was that there was not really good data infrastructure to report aggregate data, like case counts. The Johns Hopkins tracker played a real vital role in filling in some of those gaps,” said John Brownstein, Ph.D., an ABC News contributor and chief innovation officer at Boston Children’s Hospital.

Other trackers, like the one managed by the Department of Health and Human Services are being shut down as well, in favor of the dashboard managed by the Centers for Disease Control and Prevention.

Accurate data has been essential for public health officials and policymakers to develop and adjust COVID policies. Yet, almost no jurisdiction is widely imposing any policies like mask-wearing or social distancing.

“These trackers are only as valuable as the actions that they inform and where we’re at in the pandemic. There are still a lot of important decisions that need to be made, actions that can be taken and I would argue that the type of information that we need to make those decisions is different now than it was at the beginning of the pandemic,” Adamson said.

Losing momentum on the investments made in public health data may place communities in vulnerable positions, experts say.

“The investments that took place in COVID should extend out to other public health crises and I think that has always been a worry, that post-response we’d be left with a graveyard of software code that would basically be never utilized and that would be such a shame,” Brownstein said.

At-home tests have now made case numbers less reliable, although officials continue to encourage anonymously reporting tests to MakeMyTestCount.org — a site led by the National Institutes of Health. Experts say tracking cases can still help inform public health agencies.

“For infectious diseases, it’s very important for public health agencies – I’m really referring to state and local health departments and CDC – to continuously monitor how many people are getting sick, who is getting sick and of course to evaluate the pathogen itself,” said Dr. Jay Varma, director of the Cornell Center for Pandemic Prevention and Response.

Tracking cases is also important because it alerts officials of potential surges. There have been some notable ones like the Delta surge in the summer of 2021 which impacted many hospitals.

Yet, the Omicron surge obliterated its predecessors in terms of the sheer numbers of cases. Since then, small rises in cases have all been attributed to offshoots of the variant.

“I don’t think we fully know the intrinsic versus extrinsic factors that are influencing these cycles. There’s absolutely a behavioral component. There’s an intrinsic biological component. We’re seeing waves of different magnitude, at three to six months increments,” Brownstein said.

“The reality is sometimes it can take many years after a new pathogen enters the world for us to understand what these patterns are, and what the factors are that drive them,” Varma said.

COVID numbers will continue to ebb and flow, yet a serious surge would most likely require a completely new variant, experts believe.

“I think, without a doubt, we will have surges. The frequency and size of those surges is still very hard to predict. In all likelihood, we will see a bigger surge at some point in the coming year or two. We will likely be challenged with a new variant, no mitigation strategies and waning immunity and I think that recipe will lead to a surge,” Brownstein said.

In general, predicting COVID numbers — just like predicting how the stock market will do — is an almost impossible task.

“One of the most important lessons of the COVID pandemic has been that subject matter experts, like myself, have to be very humble about making predictions for the future,” Varma said

However, experts are optimistic that things will get better.

“The most likely scenario is that through repeated infections, and through vaccination, COVID will overtime cause fewer hospitalizations and deaths than it has over the past few years,” he added.

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(NEW YORK) — A new World Health Organization report found that maternal mortality rates have either increased or remained the same in nearly all regions of the world in the past five years.

“In 2020, we estimate that 287,000 women died globally from a maternal cause, and that’s equivalent to almost 800 deaths a day, or a death every 2 minutes,” said Dr. Jenny Cresswell, an epidemiologist and author of the WHO report, during a press briefing on Tuesday.

Experts say this trend is a stark reversal from previous significant progress in reducing maternal deaths between 2000 and 2015, revealing a major setback for global maternal health and highlighting disparities in healthcare access.

In the United States, maternal mortality rates increased by 75 percent over the past 20 years — from roughly 12 maternal deaths per 100,000 live births in 2000 to 21 maternal deaths per 100,000 live births in 2020. The U.S. is one of the eight countries and territories the report flagged as having a significant percentage increase in maternal mortality rates. The list also includes Cyprus, Puerto Rico, Greece, and the Dominican Republic.

The report revealed large inequities between regions of the world. Maternal deaths continue to be largely concentrated in the lowest income areas of the world and the countries most affected by conflict. The highest maternal mortality was reported in Sub-Saharan Africa, with an estimated 545 maternal deaths for every 100,000 live births. Globally, an estimated 7 out of 10 maternal deaths take place in this region.

“Maternal mortality is a key indicator of how a health system is functioning,” said Dr. Lale Say of the Department of Reproductive Health and Research at WHO.

WHO experts say maternal deaths increase when women have less access to quality healthcare services, particularly around the time of delivery. Leading causes of maternal death include severe bleeding, high blood pressure, infection, and complications from unsafe abortion. With modern clinical knowledge and technology, the majority of maternal deaths are preventable. However, solutions may not be accessible or implemented in low resource settings, putting some groups at higher risk.

“No woman should die in childbirth. I think that’s a human right that should apply in every country, and that’s what every government should aim to ensure,” said Dr. Anshu Banerjee, Director for the Department of Maternal, Newborn, Child and Adolescent Health and Ageing at WHO.

“An investment in women is an investment in the future of communities and countries,” said Say.

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(WASHINGTON) — From soy to macadamia, a variety of plant-based milk alternatives have begun filling shelves in recent years.

Now, the U.S. Food and Drug Administration has caught up with the trend, issuing new guidance for plant-based labels.

On Wednesday, the FDA shared its proposed draft for naming conventions and guidelines on how these products are marketed and sold.

Although the guidance is not final, the FDA suggests that any non-milk product that uses the word “milk” — i.e. nut milk, soy milk — should add a voluntary nutrient statement to convey how the product’s nutritional value compares to that of regular milk, based on the U.S. Department of Agriculture’s Food and Nutrition Service criteria.

For example, according to the draft guidance, the label could read: “Contains lower amounts of vitamin D and calcium than milk.”

FDA Commissioner Robert M. Califf, M.D., said the guidance was developed “to help address the significant increase in plant-based milk alternative products” that have become available over the last 10 years.

He added that the recommendations “should lead to providing consumers with clear labeling to give them the information they need to make informed nutrition and purchasing decisions on the products they buy for themselves and their families.”

Regular dairy milk serves as an important source of vitamins and nutrients for many people. The FDA’s proposal aims to raise consumer awareness that non-dairy milks may not contain the same nutritional value as regular milk.

Back in 2018, the agency requested public feedback on plant-based milk alternatives that used terms like “milk,” “cultured milk,” “yogurt” and “cheese” in their labeling, to better understand “how consumers use these plant-based products and how they understand terms such as, for example, ‘milk’ or ‘yogurt’ when included in the names of plant-based products.”

The agency ultimately received more than 13,000 comments on the request and determined that while consumers “generally understand that [plant-based milk alternatives] do not contain milk,” many are not aware of the nutritional differences between milk and plant-based alternatives, such as whether plant-based products contain calcium.

Plant-based alternatives are not included as part of the dairy group in the USDA and U.S. Department of Health and Human Services’ 2020-2025 Dietary Guidelines.

ABC News’ Anne Flaherty contributed to this report.

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(NEW YORK) — Everyone has different relationships with diet and sugar, but when that sweet tooth turns on, it can be hard to combat cravings in a healthy way.

ABC News chief medical correspondent Dr. Jennifer Ashton lent her expertise as a nutritionist to break down the overall impact sugar has on our bodies as well as some alternate ways to satisfy that sweet tooth.

How much added sugar is recommended for adults?

The brain, as with every cell in our bodies, needs glucose to function, so while not all sugar is bad, too much added sugar can pose problems.

For most adult women, the American Heart Association suggests a stricter added-sugar limit of no more than 100 calories per day, which is equal to about 6 teaspoons or 24 grams; for most men, the suggestion is no more than 150 calories per day, which is about 9 teaspoons or 36 grams of sugar.

However, common processed snacks and drinks can contain much more than the recommended amount, which is why reading labels is so pivotal.

For example, a 12-ounce can of cola contains 10 1/4 teaspoons of sugar; a 12-ounce glass of orange juice contains 13 teaspoons of sugar; a cup of frosted corn flakes cereal has 3.65 teaspoons; and sweetened applesauce has a little over 5 teaspoons in one cup.

Negative impact of too much sugar in the body

Using a wet sponge, Dr. Ashton demonstrated how too much sugar can be damaging to the way a body processes and stores it.

The water in the sponge represents insulin — a hormone mainly responsible for regulating blood sugars that allows cells to take in the sugar — and when a small amount of sugar is sprinkled evenly over the surface, the sugar is absorbed quickly and easily. But on a second sponge topped with heaping spoonfuls of sugar, the sponge is unable to absorb all of the water, which is what it would look like if insulin was overloaded with sugar intake.

“You take a lot of sugar, your body can overwhelmed and you develop what’s called insulin resistance and that sugar stays there. It then gets deposited as fat, it causes inflammation,” Dr. Ashton explained. “Fat is hormonally active tissue, and then that gets you on the path to cancers, cardiovascular disease.”

How sugar affects pregnant women, in utero environment

Dr. Ashton merged her combined knowledge and two specialties as an OB-GYN and nutritionist to explain the impact sugar can have on a baby in pregnant women.

“There is good data for this phenomenon known as epigenetics, meaning [when] a pregnant woman consumes too much sugar, the fetus sees that high sugar environment, and then there are changes in DNA and increases the risk of that offspring then develops metabolic syndrome Type 2 diabetes, obesity,” she said.

Top sugar substitutes and tips

Dr. Ashton suggests people “take a five-day, two-day approach” which means being very strict Monday through Friday, then easing up for two days.

“Read the labels, use those spices as substitutes and be patient with yourself because it takes time to retrain your taste buds,” she said of three easy ways to cut down on sugar.

Swerve, avocado, whole fruit like citrus or apples, and honey are “all great sugar substitutes if you’re cooking or baking,” Ashton added.

Finally, anything that tastes “sweet” tends to produce the same reaction in the brain, activating the “reward center” and making you want more.

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(NEW YORK) — After decades of research, a first-of-its kind vaccine designed to protect newborns against RSV, or respiratory syncytial virus, could be approved by August.

Pfizer, the maker of the vaccine, announced Tuesday that the U.S. Food and Drug Administration has accepted its application for review and will make a decision on whether or not to approve the vaccine by August 2023.

“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” Annaliesa Anderson, Ph.D., Pfizer’s senior vice president and chief scientific officer of vaccine research and development, said in a statement. “We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”

Pfizer’s protein-based RSV vaccine works by vaccinating a pregnant person, who then passes on some protective antibodies to the infant.

The company has also said the vaccine has shown promising data in adults 65 and older.

RSV usually causes mild, cold-like symptoms, but can become serious, especially for infants and older adults. Premature infants and young children with weakened immune systems, congenital heart or chronic lung disease, and adults with chronic health conditions like heart or lung disease are among the most vulnerable to complications from RSV, according to the Centers for Disease Control and Prevention.

Infants who are 12 weeks of age or younger at the start of RSV season are also at greater risk for serious illness.

The virus is the most common cause of bronchiolitis and pneumonia in kids under the age of 1 in the U.S., according to the CDC.

According to data collected from preliminary studies, Pfizer’s vaccine was 82% effective at protecting newborns, within the first three months of life, from severe RSV illness. Within six months of an infants’ life, the vaccine effectiveness dropped to 69%, according to Pfizer.

The company announced in November that given promising preliminary data on their maternal RSV vaccine for newborns, the FDA granted a green light to stop enrolling new patients in the vaccine’s studies.

“Among very young children, particularly those [younger] than 6 months of age, we have a high probability now of protecting against serious illness and hospitalization,” Pfizer’s Dr. William Gruber, who has been personally working on the RSV vaccine for over 40 years, told ABC News in November. “To be able to be in a position where we have the potential to provide 80% or more protection against serious disease is a dream fulfilled.”

Currently, there is no approved RSV vaccine.

Pfizer’s vaccine would be the first RSV vaccine given to pregnant people to protect infants. The company said that there were “no safety concerns” for vaccinated pregnant participants and their newborns during the trial.

If the FDA approves the vaccine in August, it will then go to the CDC for final approval.

The FDA is also currently reviewing nirsevimab, a drug that is not a vaccine but a monoclonal antibody designed to protect infants from RSV complications. The medication, developed by Sanofi and AstraZeneca, is administered to infants as a one-time injection after birth.

Nirsevimab is already approved in Europe and the United Kingdom, according to Sanofi, and was accepted for FDA review in January.

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab is being developed jointly by Sanofi and AstraZeneca and, if approved, would be the first protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. The FDA has indicated they will work to expedite their review. The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023.

The news comes as pediatric hospitals across the country have experienced a rise in the number of patients admitted with RSV. Infections due to RSV spiked by 69% last fall and appeared earlier than usual, according to the CDC.

Late last year, pediatric bed occupancy in the U.S., hit its highest in two years, with 75% of the estimated 40,000 beds filled, according to an ABC News analysis.

Infants and toddlers can usually recover at home with RSV unless they start to have difficulty breathing, increased irritability, are not eating or drinking, or appear more tired than usual, in which case parents should contact their pediatrician and/or take their child to the emergency room.

At-home care for kids with RSV can include Tylenol and Motrin for fevers, as well as making sure the child is hydrated and eating.

Doctors tell ABC News that parents can help protect their kids from RSV by continuing to follow as much as possible the three Ws of the coronavirus pandemic: Wear a mask, wash your hands and watch your distance.

Infants who are either born prematurely (less than 35 weeks) or born with chronic lung disease may benefit from a medication to prevent complications of RSV since they are at increased risk of severe disease. Parents should discuss this with their pediatrician.

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(COLUMBUS, OH) — Abortion rights supporters in Ohio took the first step Tuesday in potentially getting the issue on the ballot in November in a statewide election.

Two groups — Ohioans for Reproductive Freedom and Ohio Physicians for Reproductive Rights — submitted language to the state Attorney General’s Office that could have residents vote on whether or not they want a constitutional amendment to protect abortion access.

Currently, abortion is legal in Ohio up until 22 weeks’ gestation, according to the Guttmacher Institute. Gov. Mike DeWine signed a law in April 2019 prohibiting abortions after cardiac activity can be detected, which is typically around the six-week mark, before many women even know they’re pregnant.

The law was blocked but temporarily went into effect after the Supreme Court overturned Roe v. Wade last summer. However, in October, a judge issued an injunction while litigation plays out.

The proposal from the two groups would amend Article I, Section 22 of Ohio’s constitution and state every individual has a right “to make and carry out one’s own reproductive decisions” on contraception, fertility treatment, continuing one own’s pregnancy, miscarriage care and abortion.

The amendment would also prevent state officials from interfering, prohibiting or penalizing a person for making choices related to reproductive health.

“Ohioans are perilously close to losing access to safe, legal, comprehensive reproductive medical care,” OPRR executive director Dr. Lauren Beene said in a statement. “As we saw first-hand when Ohio’s abortion ban went into effect last year, withholding that care puts people’s lives and health at risk.”

Her statement continued, “This commonsense amendment ensures that physicians will be able to provide the care our patients need and deserve free from government interference.”

The move in Ohio comes after five states put abortion on the ballot during the 2022 midterm elections. Voters enshrined abortion rights in their state constitutions in three states — California, Michigan and Vermont — and voted against further restricting access to abortion services in two states — Kentucky and Montana.

It also comes several months after Kansas became the first state to leave abortion up to voters following the Supreme Court’s decision. Residents decisively rejected a bid in August to remove abortion protections from its state constitution.

Anti-abortion groups have vowed to fight the proposed constitutional amendment, including Ohio Right to Life.

“The language of this ballot initiative is extremely vague, making it even more dangerous than we originally believed it would be,” said Elizabeth Marbach, communication director for the group, in a statement. “They believe that they can rewrite our state Constitution to eliminate all protections for the unborn, including abortions after the point at which babies feel pain — endangering the health and wellbeing of both women and children.”

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(EAST PALESTINE, Ohio) — Standing around her kitchen sink, East Palestine, Ohio, resident Carolyn Brown told Ohio Gov. Mike DeWine, EPA Administrator Michael Regan and other officials that it is the “uncertainty” that weighs on her, and her community, right now.

“There’s so much uncertainty about it. And that really gets to me emotionally,” Brown said. “My main concern is for the people that was closest to that accident, and a lot of them are younger than me and have children and — I just feel — it’s hard to see people going through things, you know, and the uncertainty of everything,” she said, her voice quavering slightly.

“You don’t know who to trust, that’s a big part of it, the uncertainty, you don’t know if you’re going to have to move,” she said. “We need to feel that we’re safe.”

It was 18 days ago that 50 cars on a Norfolk Southern Railroad train traveling from Illinois to Pennsylvania derailed in East Palestine. Eleven of those cars contained hazardous materials, five of which contained vinyl chloride, a highly volatile colorless gas produced for commercial uses. Officials decided, in order to avoid a major explosion, to evacuate the area around the derailment and burn off the chemicals.

In the days since they were allowed to return, residents have complained of itchy eyes and skin and respiratory problems.

“We know this is a long road, and we will be here until the end,” Regan said Tuesday.

DeWine said the community would not be forgotten, even after the cameras were gone. He said that testing would continue and the health clinic, set to open Tuesday, would be there to address people’s concerns.

Brown’s house is connected to the municipal water supply, she said, and DeWine told her the testing had come back so far showing that water was “safe.”

“We just need to continue to test. We think things are alright. We know things are all right now. And we just need to make sure that in the future they’re all right as well,” he said.

“So, it’s safe to drink the water?” Brown asked. “Because I haven’t even brushed my teeth with it.”

The officials assured her that it was safe.

“Did someone want to drink the water?” Brown asked.

In a chorus, the officials said, absolutely. Brown poured glasses of water from her tap. The group clinked glasses and took a sip.

“We believe in science,” Regan said. “We don’t feel like we’re being your guinea pig, but we don’t mind proving to you that we believe the water is safe.”

The officials next visited the home of a former chemistry teacher, Andris Baputnis. They drank his tap water too.

An EPA official demonstrated the sensitivity of the air quality monitors they’re using.

“As you can see in your home right now, it fluctuates a little bit,” the official said. “It’ll pick up like, hairspray … like when I hold it close to my body, it’ll pick up my deodorant. … So, that’s how sensitive these things are and that’s what we’ve been using to screen the homes and we assume it’s worst case until we can prove otherwise.”

“If there’s anything we can do at EPA, please let us know,” Regan told Baputnis.

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(NEW YORK) — ABC News’ Good Morning America co-anchor Robin Roberts said she is “beaming in gratitude” as she marks the 10th anniversary of her return to GMA after undergoing a lifesaving bone marrow transplant.

On Feb. 20, 2013, Roberts returned to the GMA set after spending nearly six months off the air while undergoing treatment.

“I have been waiting 174 days to say this, ‘Good morning, America,'” Roberts said in her first on-camera remarks upon her return.

Nearly one year prior, in June 2012, Roberts announced to GMA viewers that she had been diagnosed with myelodysplastic syndrome, a condition that occurs when blood cells don’t form and don’t work properly, according to the National Cancer Institute.

Roberts, who years earlier had beat breast cancer, would go on to endure months of treatment at Memorial Sloan Kettering Cancer Center in New York City.

On Sept. 20, 2013, Roberts underwent a lifesaving bone marrow transplant using stem cells from her sister Sally-Ann Roberts, who was her perfect match.

“I was blessed to have the perfect match, the greatest gift from my sister Sally-Ann,” Roberts said Tuesday on GMA. “In those challenging moments to follow, focusing in on the fight and not the fright during my intensive treatment at Memorial Sloan Kettering.”

Roberts shared her health journey with GMA viewers, following a lesson she said she learned from her beloved mother, Lucimarian Roberts, to “make my mess my message.”

Her hope, she said, in sharing her own story was to “help others through their own journey.”

That hope continued for Roberts when she returned to the GMA anchor desk on Feb. 20, 2013.

“Those 174 days there was a lot of challenges. There was a lot of fear,” Roberts said. “I was really grateful to be able to once again say, ‘Good morning, America,’ and also grateful and hopeful that by being back, I could somehow be a symbol to others going through something that this too shall pass.”

In the decade since her return to GMA, Roberts has continued to “make her mess her message” by raising awareness about the need for bone marrow donation.

While Roberts’ sister was luckily her perfect match, about 70% of patients on bone marrow registry lists do not have a family match and rely on anonymous donors for a cure, according to the Be The Match registry, a nonprofit organization operated by the National Marrow Donor Program, which manages the world’s largest bone marrow donor registry.

Even then, a patient’s chance of having a matched, available donor on the Be The Match registry ranges from 29% to 79%, depending on the patient’s ethnic background.

Over the past decade, Roberts and GMA have continued to report extensively about blood stem cell transplants, which can cure or treat more than 75 different diseases, such as leukemias and lymphomas, and spread awareness of the importance of the Be The Match registry.

Now more than ever the need is urgent as over 12,000 people are diagnosed each year with conditions that require a blood stem cell transplant from an unrelated donor, according to Be The Match.

Be The Match reports regional and national recruitment efforts decreased 36% during the height of the coronavirus pandemic, and that only 50% of people on the registry will go on to make a donation when they’re a match for a patient in need.

Be The Match has put a call out in particular for younger donors under the age of 40, as research has shown younger donors help improve overall outcomes for patients, according to the Mayo Clinic.

To celebrate the 10th anniversary of Roberts’ return to GMA, the show partnered with Be The Match to host bone marrow registry drives across the country.

The effort focused particularly on college campuses in order to reach donors under the age of 40.

“Still a decade later, our hope is to inspire others to help others be a match,” Roberts said Tuesday, adding that she is “filled with gratitude” for the “love, support and prayers” she has received over the years.

Learn how to take the first step to sign up to become a Be The Match bone marrow donor today.

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