(CNN) — Advisers to the US Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV.
Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus.
Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment.
The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable.
If approved, it will be the first single-dose preventative treatment for all infants against RSV. Unlike with a vaccine, with which the body builds up its immunity in reaction over time, a monoclonal antibody works right away.
In trials, nirsevimab reduced the risk of RSV-linked lower respiratory tract infections that needed medical attention by about 75% and RSV-related hospitalization by about 78% when compared with a placebo. No major safety concerns were identified; some common side effects were rash and injection-site reactions.
Another monoclonal antibody treatment approved in the US and Europe, palivizumab, or Synagis, protects against infection in high-risk infants. With that treatment, infants get an intramuscular injection every month during RSV season, and it usually requires five doses.
Last month, the FDA’s vaccine advisers voted in support of a new vaccine to prevent RSV in infants.That maternal vaccine is a single-dose shot that would be given to a pregnant people late in pregnancy, triggering the development of antibodies that are passed on to the fetus and providing protection for about the first six months of a baby’s life. Trials show that the vaccine, made by Pfizer, cuts the risk that infants would need to see a doctor or be admitted to the hospital with a moderate to severe infection.
Nearly every child gets RSV before the age of 2, according to the US Centers for Disease Control and Prevention, but last winter, the virus overwhelmed pediatric hospitals all across the United States. Although it’s often a milder respiratory infection for children and most adults, studies show that it is still a leading cause of hospitalization among infants.
Globally, in 2019 alone, there were 33 million cases and more than 3.6 million hospitalizations. It’s estimated that there were 26,300 in-hospital RSV deaths of children younger than 5 and 101,400 deaths overall, according to a 2022 study published in the Lancet.
(WISH) — A boy got a second chance at hearing.
Sensorineural hearing loss happens from damage to the inner ear, the place of origin of the nerve that runs from the ear to the brain, or to the brain. There are 66,000 new cases every year. Researchers at Cleveland Clinic, a nonprofit academic medical center, worked on modifying the cochlear implant to save children’s hearing as early as possible.
That’s what happened with Corbin Lapso. Now, the 2-year-old is the life of the party.
Corbin was born with bilateral severe to profound sensorineural hearing loss, meaning he couldn’t hear anything, even with regular hearing aids.
Makaela Lapso, Corbin’s mother, recalled the doctor’s giving them the diagnosis. “I remember her saying, ‘It’s lifelong and permanent and can only be reversed with hearing technology,’ and, at that point, the room kind of went black.”
Pediatric audiologist Samantha Anne recommended Corbin undergo bilateral implant surgery at 7 months old to restore his hearing.
Anne said that the U.S. Food and Drug Administration’s approval “for implantation for infants with bilateral severe to profound sensorineural hearing loss is 9 months of age. At Cleveland Clinic Children’s Hospital, we strongly believe that we should get these babies to hear as early as possible, as long as it’s done in a safe manner.”
Corbin has fully recovered. Anne said, “He is thriving. He is doing probably more than he should be at his age.”
His mother said, “For some, that was, like, the end of the journey, like, he was treated, he was ‘fixed.’ But, for us, that was just the start. You know, we were finally able to see what this little guy is capable of.”
Anne and her colleagues discovered through their research that the risks of performing the surgery earlier rather than later were the same, but the outcome was much better.
Health Spotlight is presented by Community Health Network. This story was created from a script aired on WISH-TV.
INDIANAPOLIS (WISH) — There’s a shortage of mental health workers across Indiana, according to a professor of family medicine at Indiana University.
Hannah Maxey says the consequences of untreated mental illness are far-reaching, and they’re impacting Indiana citizens and communities.
“They can be seen in homelessness and unemployment as well as incarceration rates and low graduation rates. Perhaps most alarming is the impact that untreated mental illness may be having on our youth. Recent reports suggest that more than half of Indiana youth aged 12-17 that report having depression also report that they have not received any treatment for it.”
Maxey says she and her colleagues at IU are working on a project to strengthen Indiana’s behavioral health workforce by aligning the training pipeline and Indiana’s behavioral health service needs.
Mental health resources
- Be Well Indiana
- Indiana Suicide Prevention
- Indiana Department of Child Services’ Children’s Mental Health Initiative
- National Suicide Prevention Lifeline: 988 or 800-273-8255
- More resources
INDIANAPOLIS (WISH) — There’s a cloud of concern as many parts of the country are coping with the Canadian wildfires’ smoke smothering skies.
While Indiana has been spared from higher levels of particle pollution, Hoosiers are being asked to reduce their time outdoors as the wildfires’ smoke travels across the state.
The Indiana Department of Environmental Management has issued a seventh-straight Air Quality Action Day for Friday.
Thomas Evans, an Indianapolis resident, said, “Unfortunately, there’s nothing that we can do about it but fight it as it comes.”
“We’ve been seeing what it’s like over there in New York and it’s completely orange over there and it does look like an apocalypse,” Evans said.
Dr. Graham Carlos from Eskenazi Health says more and more patients are raising concerns about the decrease in air quality due to the Canadian wildfires. “We are worried and anxious about it. Thankfully, it’s not as bad as it seems to be on the East Coast, but for some patients it doesn’t take much for them to have trouble and tip them over, and, for some, maybe it is the smoke causing their trouble.”
Indiana Department of Environmental Management says the air quality index is above 100, which is unhealthy, especially for people with lung disease, older adults, and children.
“I’ve been talking with my colleagues here at Eskenazi and they have seen more than they expected in terms of breathing trouble,” Carlos said. “There’s also still some viruses circulating and other things going on, so it’s hard to know for sure, but it’s something we’re keeping a very, very close eye on.”
He says some people may experience increased inflammation, an attack of asthma, or emphysema. “If you are having breathing trouble, don’t delay seeking medical care. Suffering in silence at home is one of the ways that can really get people into trouble.”
Austin Evans says he struggles with asthma. He says recently it’s been harder to breathe outside. “I have an inhaler, so I did notice a little more difficulty breathing over the past couple of days, but I think pollen might be an issue, too.”
Those with chronic respiratory illnesses are encouraged to limit their time outdoors.
INDIANAPOLIS (WISH) — Every year in the United States, almost 800,000 people will suffer a stroke, which is 1 person every 40 seconds. And every year, 140,000 people will die from a stroke.
While recovery is possible, many will live with a serious disability caused by the stroke, including lasting problems with mobility in their arms, hands, and legs. Researchers are now using neurotechnology to instantly give patients lost mobility back.
Heather Rendulic was 22 years old when she had a series of 5 strokes. The fifth and final stroke was massive, leaving the left side of her body paralyzed.
She was unable to use her left arm and hand, until she became the first person to enroll in a study at the University of Pittsburgh Medical Center. The study used electricity to reconnect her brain to the nerves in her arm.
By implanting two thin neuro electrodes on top of the spinal cord, neurosurgeons reconnected the signals, which allowed the brain to communicate to her arm once again.
Within minutes, Heather’s brain found ways to send impulses to her arm muscles. She says even at night when the device was turned off, her mobility continued to improve.
The trial at UPMC lasted for four weeks. At the end of the trial, Rendulic’s implant was removed, and she says she will be the first in line to get the implant once it is FDA-approved.
This type of technology is already FDA-approved to treat chronic pain. The next step in the research is to make it a device that won’t have to be removed.
The team at UPMC is hoping that FDA-approval will make this the first treatment to effectively treat paralysis for people years after having a stroke.
Health Spotlight is presented by Community Health Network. This story was created from a script aired on WISH-TV.
INDIANAPOLIS (WISH) – The Indiana Department of Health on Wednesday released new COVID-19 data on the state’s coronavirus dashboard.
The data was collected through Tuesday. The state’s dashboard is updated weekly on Wednesdays.
Indiana’s COVID-19 death toll rose to 25,274 on Tuesday from 25,241 on May 23. That’s an increase of 33.
The amount of probable deaths increased to 1,228 on Tuesday from 1,232 on May 23. That’s a a decrease of four.
The total of COVID-19 positive cases in Indiana rose to 2,080,067 on Tuesday from 2,078,280 on May 23. That’s an increase of 1,787.
The state recorded a seven-day average of 14 hospital admissions and 137 emergency room visits on Tuesday.
IDOH says 3,864,233 Hoosiers had completed the primary vaccination series through Tuesday. That’s about 55.5% of the total population.
A total of 899,762 Hoosiers had received the most recent booster shot through Tuesday and were up to date on vaccinations.
More Indiana information, including interactive graphs, can be found online.
- COVID-19 vaccinations in Indiana: Get details and sign up
- Indiana coronavirus resources and timeline of events
- More coronavirus coverage from WISH-TV
INDIANAPOLIS (WISH) — June is men’s health month and with Father’s Day quickly approaching, it may be time to take another look at the impact a sedentary lifestyle can have on dads.
It’s important to know that the “Dad Bod” can pose serious health risks.
Community Health Network registered dietitian, Kaitlyn Wong, joined Daybreak to talk about the different ways to avoid those risks.
ZIONSVILLE, Ind. (WISH) — Cases of pink eye, also known as conjunctivitis, are increasing throughout central Indiana, one doctor says.
Dr. Michael McKenna, a pediatrician with Ascension Medical Group in Zionsville, told News 8, “I like to tell people pink eye is basically a cold, but it’s in your eye, and you just get it from dirty hands, touching your eye, touching something else, touching somebody else’s eye.”
McKenna on Tuesday saw three patients suffering from pink eye. Cases have surged among children and young adults.
Butler student Ava Beeler caught pink eye shortly before the school year ended. The symptoms were not pleasant. “They were like burning pain, a lot of goop and gross stuff was collecting in my tear ducts and coming out of my eyes, and there would be moments where my vision would go blurry.”
Although most cases of pink eye are viral, some are caused by bacteria, such as a dirty contact lens, or a foreign object.
Pink eye will not cause blindness.
McKenna said, “We will see, especially here in Indiana, now that the white poufy things are flying through the sky, allergic conjunctivitis is very common, and then you can get things from irritants and chemicals. Those are pretty rare in kids.”
Doctors can prescribe and an antibiotic to treat pink eye, but the virus will need to run its course.
Over-the-counter eye drops will not treat it.
The best way to prevent pink eye is handwashing.
For younger children, some day care centers and summer camps will require children to stay home for at least 24 hours after first being diagnosed with pink eye so they do not spread it.
INDIANAPOLIS (WISH) — Almost 10 million Americans have osteoporosis, and another 44 million are at risk of developing the disease. While medications can slow the disease’s progression, nothing has been known to stop it.
Now, scientists are working with new nanotechnology that could prevent, treat, and even cure the debilitating disease.
Dr. Mehdi Razavi, assistant professor at University of Central Florida’s College of Medicine, is using nanobubbles to destroy the genes that cause the disease. These bubbles are so small they are invisible to the human eye.
The bubbles enter into bone cells, then search and find the genes that cause osteoporosis and deliver treatment. An ultrasound is then used to supercharge the treatment, causing the infected gene to disappear.
Razavi says the bubbles will not only stop osteoporosis from worsening, but can reverse the damage done and increase bone formation.
Experts predict that by 2025, osteoporosis will be responsible for 3 million bone fractures and $25 billion in medical costs annually.
Currently, the treatment is being used to treat cancer patients, but scientists are hoping to expand the treatment and treat Alzheimer’s, as well.
FORT WAYNE, Ind. (WISH) — Starting in July, Lutheran Hospital of Indiana in Fort Wayne will no longer offer heart transplants and inpatient burn care, according to the Lutheran Health Network.
Indiana University Health’s Methodist Hospital and Ascension St. Vincent Hospital Indianapolis will be the only hospitals in the state to offer heart transplants, both in Indianapolis.
According to the network, 10 patients had a heart transplant at the hospital in 2022, and one transplant has been performed in 2023.
In 2022, 88 patients received burn care, a 20% decrease from 2021. Over 75% of burn patients at the hospital came from areas outside of Allen County.
“Our long-term strategy is focused on services that patients are using most,” Clyde Wood, CEO of Lutheran Hospital, said.
The hospital plans to help patients who are on the heart transplant waiting list to transfer their care to one of the two transplant centers in Indianapolis.
The inpatient burn unit will evaluate its patients and help them transfer to another burn center.
The hospital will continue to provide emergency burn care.