Members of the CDC’s Advisory Committee On Immunization Practices at the Center for Disease Control (CDC) headquarters in Atlanta, Georgia, US, on Friday, Dec. 5, 2025. (Megan Varner/Bloomberg via Getty Images)
(NEW YORK) — The Centers for Disease Control and Prevention (CDC) announced on Monday it is changing the childhood immunization schedule.
The federal health agency is removing the universal recommendation for multiple shots, in what it calls an attempt to mirror the schedules of peer countries.
Instead of being universally recommended for almost all children at certain age cut offs, vaccines are now split into three categories: vaccines for all children, vaccines for certain high-risk groups and vaccines based on shared clinical decision making.
Shared clinical decision making is the term used by CDC to imply that patients, and parents, should talk to their provider about whether they should be vaccinated.
Some of the vaccines and immunizations that are no longer universally recommended include RSV, flu and COVID, as well as the hepatitis and meningococcal vaccines.
For children not in certain high-risk groups, no vaccine is recommended before the age of two months.
The change comes after President Donald Trump signed a memo in early December last year directing Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. to examine how other nations structure their childhood vaccine schedules.
HHS officials say the change will not affect health insurance coverage of vaccines.
“President Trump directed us to examine how other developed nations protect their children and to take action if they are doing better,” Kennedy said in a statement. “After an exhaustive review of the evidence, we are aligning the U.S. childhood vaccine schedule with international consensus while strengthening transparency and informed consent. This decision protects children, respects families, and rebuilds trust in public health.”
The changes drew rebuke from doctors, who expressed concern that such a change did not undergo further debate before being implemented.
The CDC’s vaccine advisory committee met last month to discuss the childhood vaccine schedule, but only voted to remove the universal recommendation for the hepatitis B vaccine at birth.
“I thought there might be proposals that were debated amongst experts in a public meeting, and then maybe something like this resulting from that, but not in the way this has been done, where a new schedule is released, which has already been signed on to by all the health advisors for the president,” Dr. Dave Margolius, an internal medicine physician and director of public for the city of Cleveland, told ABC News.
Dr. Demetre Daskalakis, former director of the CDC’s National Center for Immunization and Respiratory Diseases, said altering the schedule without consulting U.S. experts in pediatrics, infectious diseases and public health “undermines both scientific rigor and transparency.”
He told ABC News that the American health care system is unique, which makes it difficult to align the U.S. vaccine schedule to those of peer nations.
“Vaccine schedules should be crafted to reflect the specific patterns of disease and access to healthcare in the United States; unfortunately, these vital factors were not adequately considered in the development of the new schedule,” Daskalakis said.
In a press briefing representing the American Academy of Pediatrics (AAP), Dr. Sean O’Leary, an infectious disease physician and chair of the AAP Committee on Infectious Diseases, said the federal government can no longer be trusted in its role to protect American children from vaccine-preventable diseases.
“Tragically, our federal government can no longer be trusted in this role,” O’Leary said. “Unfortunately, our government is making it much harder for pediatricians to do our jobs, and they’re making it much harder for parents to know what to do.”
O’Leary confirmed the AAP was not consulted by HHS ahead of this decision to change the vaccine schedule.
Additionally, Sen. Bill Cassidy (R-La.), a physician and chair of the Senate’s health committee, distanced himself from the CDC’s decision to change the childhood vaccine schedule.
“Changing the pediatric vaccine schedule based on no scientific input on safety risks and little transparency will cause unnecessary fear for patients and doctors, and will make America sicker,” Cassidy wrote in a post on X, rejecting the recent changes.
Cassidy added that the schedule is “not a mandate,” but rather a recommendation that gives parents the “power” to choose which vaccines their children receive.
Stock photo of a sick woman. Guido Mieth/STOCK PHOTO/Getty Images
(NEW YORK) — Flu activity is continuing to climb across the U.S. as hospitalizations rise, according to newly released data from the Centers for Disease Control and Prevention.
The percent of outpatient visits for respiratory illnesses are now at the highest rate on record.
About 8% of visits to a health care provider were labeled as flu-like illness, surpassing any levels seen since 1997, the earliest for which data is available. Flu-like illness accounts for patients that have a fever as well as a cough and/or sore throat.
These visits are largely among children and young adults. About 35% of outpatient visits for a respiratory illness were among people unde. 24 years old and children under age 5 made up about 20% of those.
The CDC estimates there have been 120,000 hospitalizations so far this season, a 48.1% increase from the prior week.
Additionally, the CDC says there have been at least 11 million illnesses and 5,000 deaths due to flu so far this season, including at least nine pediatric deaths.
In New York, health officials recently reported the highest number of flu hospitalizations recorded in a single week.
“This is really quite a severe flu season right now,” Dr. James McDonald, health commissioner for New York state, told “Good Morning America” on Saturday.
Recently, New York also reported a record-breaking number of flu cases in a single week with 72,133 infections for the week ending Dec. 20, according to health department.
Data shows that the majority of this season’s cases are linked to a new flu strain called subclade K — a variant of the H3N2 virus, which is itself a subtype of influenza A.
Subclade K has been circulating since the summer in other countries and was a main driver of a spike in flu cases in Canada, Japan and the U.K.
Of the 994 flu samples tested since Sept. 30, nearly all were influenza A. Of those samples that underwent further testing roughly 90% were H3N2, CDC data shows.
Experts expect flu-like illnesses to continue to climb in the coming weeks and warn that this season’s peak has likely not been reached yet.
In addition to influenza, COVID-19 and respiratory syncytial virus (RSV) are also circulating this time of year and are contributing to respiratory illness activity.
Currently, the CDC recommends that everyone ages 6 months and older, with rare exceptions, get an annual flu vaccine.
The federal health agency states on its website that getting an annual flu shot prevents millions of illnesses and flu-related doctors’ visits every year and is especially important for those at higher risk of serious complications.
Amid surging cases and hospitalizations, the number of adults and kids who have received a flu shot remains relatively unchanged. As of Dec. 13, around 42.2% of adults and 42.3% of kids have received the flu vaccine despite the flu shot being widely available across the country.
Last season, 289 children died from flu and nearly all were unvaccinated. This was the highest number of deaths ever recorded since tracking pediatric deaths became mandatory in 2004. One additional pediatric death was reported this week from the 2024-2025 flu season to reach the record.
An Influenza Vaccine is prepared for a patient on September 12, 2025, in Coral Gables, Florida. Joe Raedle/Getty Images
(ATLANTA) — Flu activity is continuing to climb across the U.S. as hospitalizations rise, according to newly released data from the Centers for Disease Control and Prevention.
The CDC estimates there have been 120,000 hospitalizations so far this season, a 38.8% increase from the prior week.
Additionally, the CDC says there have been at least 11 million illnesses and 5,000 deaths due to flu so far this season.
This is a developing story. Please check back for updates.
In this handout from Merck & Co, a box and vial of Gardasil, a new cervical cancer vaccine, is seen is this undated photo. Russell Kirk/Merck & Co. via Getty Images
(NEW YORK) — A major update to federal women’s health preventive guidance will make it easier for women to get screened for cervical cancer, including a self-collection option that allows some women to test themselves at home instead of going to a doctor for a pelvic exam.
The new option will be covered by private insurance beginning in January 2027.
The updated Health Resources and Services Administration (HRSA) guidance now advises that people receive a high-risk HPV test – which checks for the virus types most likely to cause cervical cancer – every five years for average-risk women ages 30 to 65 as the preferred screening approach. This can be done with a clinician-collected sample or by the patient at home.
Women in that age group still have other choices: a combination of an HPV and Pap test every five years, or Pap testing alone every three years if HPV testing isn’t available.
“The addition of self-collection really empowers women to make this choice for themselves,” Ann Sheehy, MD, the HRSA’s chief medical officer, told ABC News. “We do retain the option for Pap smear … this is just an additional choice for women.”
For women ages 21 to 29, the recommendations stay the same: Pap tests every three years, which Sheehy said aligns with available evidence.
“By doing this, we’re going to get some of those people that have been falling through the cracks and not getting this testing done in advance,” Tom Engels, administrator of the HRSA, told ABC News. “And by doing that, we’re going to save lives.”
Engels emphasized that the update is meant to expand testing options, not replace the Pap test. Self-collection is intended to remove barriers for women who find in-office screening difficult to schedule, uncomfortable, or hard to access, he stressed.
American Cancer Society (ACS) guidelines updated in December, by contrast, recommend that cervical cancer screening should begin at age 25 and centers on primary HPV testing, including self-collection tests.
“The combination of good evidence of the benefits of self-collection, which include increased access to cervical cancer screening, combined with FDA approval, led the ACS and HRSA to include self-collection in their guideline update,” Dr. Robert Smith, senior vice president, Early Cancer Detection Science at the American Cancer Society and author of the organization’s updated guidelines, told ABC News.
Cervical cancer screening is often cited as a major public health success. Over the last 50 years, cervical cancer incidence and deaths have fallen by more than 50% in the U.S., according to the American Cancer Society, largely because screening can catch precancerous changes early, before patients notice any symptoms.
When cervical cancer is found early, five-year survival is higher than 90%, Centers for Disease Control and Prevention (CDC) data suggests. But the HSRA guidance notes that more than half of diagnoses happen beyond the earliest stage, after the disease is spread to other areas of the body. In those later stages, five-year survival is only about 20%, according to the CDC.
Wide use of the HPV vaccine is expected to push cervical cancer rates even lower over time, but most of the historical decline happened before widespread vaccination efforts.
Sheehy said she has seen the consequences when screening doesn’t happen, and why early detection matters.
“I’ve seen women who didn’t have access to screening, and their cancer presented at a very late stage,” she said. “Most women who have early-stage cervical cancer or precancer lesions are asymptomatic, and the only way we’re going to detect that is with screening.”
The updated guidance aims to address stubborn gaps despite the decades of progress, she added, pointing out that about half of women diagnosed with cervical cancer have either never been screened or their screening isn’t up to date, and about one in four women in the U.S. are not up to date with screening, according to the CDC.
Only FDA-approved tests are recommended for self-collection. The FDA first expanded approvals in May 2024 to allow patients to self-collect samples in a clinical setting. In May 2025, the FDA approved the first at-home self-collection cervical cancer screening kit.
The at-home option is available by prescription. Exactly how patients access a covered self-collecting test may vary by insurer and plan.
“There’s some FDA tests that are approved for self-collection in an office-based setting and there is one that is available for self-collection at home,” Sheehy noted.
Sheehy and Smith both added that a positive HPV result is not a cancer diagnosis, but it can mean additional testing is necessary.
The updated guidance also aims to reduce costs that can pile up after an abnormal screening result by clarifying what insurers must cover without cost-sharing, including follow-up testing and diagnostic evaluation such as Pap testing, biopsy, and lab work, depending on individual needs.
A separate HRSA guideline that took effect Jan. 1 also requires insurance coverage for patient navigation services that help women schedule screenings, address care challenges, and follow up after abnormal results.
“We know the health care system is incredibly complicated for patients to navigate,” Sheehy said.
Both Engles and Sheehy emphasized how optimistic they are about the potential benefits of expanding access to cervical screening.
“This could be really, really, game-changing for women,” Sheehy said.
Radhika Malhotra, MD, is an internal medicine-preventive medicine resident at Rutgers New Jersey Medical School and a member of the ABC News Medical Unit.
ABC News’ Liz Neporent contributed to this report.
In this handout from Merck & Co, a box and vial of Gardasil, a new cervical cancer vaccine, is seen is this undated photo. Russell Kirk/Merck & Co. via Getty Images
(NEW YORK) — A major update to federal women’s health preventive guidance will make it easier for women to get screened for cervical cancer, including a self-collection option that allows some women to test themselves at home instead of going to a doctor for a pelvic exam.
The new option will be covered by private insurance beginning in January 2027.
The updated Health Resources and Services Administration (HRSA) guidance now advises that people receive a high-risk HPV test – which checks for the virus types most likely to cause cervical cancer – every five years for average-risk women ages 30 to 65 as the preferred screening approach. This can be done with a clinician-collected sample or by the patient at home.
Women in that age group still have other choices: a combination of an HPV and Pap test every five years, or Pap testing alone every three years if HPV testing isn’t available.
“The addition of self-collection really empowers women to make this choice for themselves,” Ann Sheehy, MD, the HRSA’s chief medical officer, told ABC News. “We do retain the option for Pap smear … this is just an additional choice for women.”
For women ages 21 to 29, the recommendations stay the same: Pap tests every three years, which Sheehy said aligns with available evidence.
“By doing this, we’re going to get some of those people that have been falling through the cracks and not getting this testing done in advance,” Tom Engels, administrator of the HRSA, told ABC News. “And by doing that, we’re going to save lives.”
Engels emphasized that the update is meant to expand testing options, not replace the Pap test. Self-collection is intended to remove barriers for women who find in-office screening difficult to schedule, uncomfortable, or hard to access, he stressed.
American Cancer Society (ACS) guidelines updated in December, by contrast, recommend that cervical cancer screening should begin at age 25 and centers on primary HPV testing, including self-collection tests.
“The combination of good evidence of the benefits of self-collection, which include increased access to cervical cancer screening, combined with FDA approval, led the ACS and HRSA to include self-collection in their guideline update,” Dr. Robert Smith, senior vice president, Early Cancer Detection Science at the American Cancer Society and author of the organization’s updated guidelines, told ABC News.
Cervical cancer screening is often cited as a major public health success. Over the last 50 years, cervical cancer incidence and deaths have fallen by more than 50% in the U.S., according to the American Cancer Society, largely because screening can catch precancerous changes early, before patients notice any symptoms.
When cervical cancer is found early, five-year survival is higher than 90%, Centers for Disease Control and Prevention (CDC) data suggests. But the HSRA guidance notes that more than half of diagnoses happen beyond the earliest stage, after the disease is spread to other areas of the body. In those later stages, five-year survival is only about 20%, according to the CDC.
Wide use of the HPV vaccine is expected to push cervical cancer rates even lower over time, but most of the historical decline happened before widespread vaccination efforts.
Sheehy said she has seen the consequences when screening doesn’t happen, and why early detection matters.
“I’ve seen women who didn’t have access to screening, and their cancer presented at a very late stage,” she said. “Most women who have early-stage cervical cancer or precancer lesions are asymptomatic, and the only way we’re going to detect that is with screening.”
The updated guidance aims to address stubborn gaps despite the decades of progress, she added, pointing out that about half of women diagnosed with cervical cancer have either never been screened or their screening isn’t up to date, and about one in four women in the U.S. are not up to date with screening, according to the CDC.
Only FDA-approved tests are recommended for self-collection. The FDA first expanded approvals in May 2024 to allow patients to self-collect samples in a clinical setting. In May 2025, the FDA approved the first at-home self-collection cervical cancer screening kit.
The at-home option is available by prescription. Exactly how patients access a covered self-collecting test may vary by insurer and plan.
“There’s some FDA tests that are approved for self-collection in an office-based setting and there is one that is available for self-collection at home,” Sheehy noted.
Sheehy and Smith both added that a positive HPV result is not a cancer diagnosis, but it can mean additional testing is necessary.
The updated guidance also aims to reduce costs that can pile up after an abnormal screening result by clarifying what insurers must cover without cost-sharing, including follow-up testing and diagnostic evaluation such as Pap testing, biopsy, and lab work, depending on individual needs.
A separate HRSA guideline that took effect Jan. 1 also requires insurance coverage for patient navigation services that help women schedule screenings, address care challenges, and follow up after abnormal results.
“We know the health care system is incredibly complicated for patients to navigate,” Sheehy said.
Both Engles and Sheehy emphasized how optimistic they are about the potential benefits of expanding access to cervical screening.
“This could be really, really, game-changing for women,” Sheehy said.
Radhika Malhotra, MD, is an internal medicine-preventive medicine resident at Rutgers New Jersey Medical School and a member of the ABC News Medical Unit.
ABC News’ Liz Neporent contributed to this report.
Stock photo of a sick child. (Natalia Lebedinskaia/STOCK PHOTO/Getty Images)
(NEW YORK) — New York is reporting the highest number of flu hospitalizations recorded in a single week, the state’s health department said on Friday.
During the week ending Dec. 27, 4,546 people were hospitalized with flu, a 24% increase from the 3,666 who were hospitalized the previous week, according to data from the New York State Department of Health (NYSOH)
It comes after the state reported a record-breaking number of flu cases in a single week with 72,133 infections during the week ending Dec. 20.
NYSDOH issued a declaration last month stating influenza is prevalent in New York, which requires health care facilities and agencies to ensure any staff who have not received this year’s flu vaccine wear masks in any areas where patients and residents may be present.
“We are having a more severe flu season than prior years, almost 1,000 more people were admitted to a hospital during this most recent seven-day period compared to the prior week,” Dr. James McDonald, the state’s health commissioner, said in a statement on Friday.
Meanwhile, flu activity is also spiking nationwide. The Centers for Disease Control and Prevention estimates there have been at least 7.5 million illnesses, 81,000 hospitalizations and 3,100 deaths from flu so far this season.
New York is one of 20 states recording “very high” levels of respiratory illness activity, according to the latest CDC data.
Public health experts previously told ABC News that many of this season’s cases are linked to a new flu strain called subclade K — a variant of the H3N2 virus, which is itself a subtype of influenza A.
Subclade K has been circulating since the summer in other countries and was a main driver of a spike in flu cases in Canada, Japan and the U.K.
Of the 1,600 flu samples tested by the CDC, roughly 92% were H3N2. Of those samples, nearly 90% belonged to subclade K.
Experts expect flu-like illnesses to continue to climb in the coming weeks after holiday gatherings and colder weather.
Currently, the CDC recommends that everyone aged 6 months and older, with rare exceptions, get a flu vaccine.
The federal health agency states on its website that getting an annual flu shot prevents millions of illnesses and flu-related doctors’ visits every year and is especially important for those at higher risk of serious complications.
The flu vaccine is currently available to New Yorkers aged 2 years and older at a health care provider’s office or at participating pharmacies while children aged 6 months and older can receive the flu vaccine at a health care provider’s office, according to the state health department.
“There is still time to get a flu shot and remember, flu can be treated with antiviral medication if started within 48 hours of symptom onset and your doctor deems appropriate,” McDonald said.
ABC News’ Youri Benadjaoud contributed to this report.
A child receives a standard immunization on September 15, 2025, in Coral Gables, Florida. Joe Raedle/Getty Images
(NEW YORK) — Children who miss early vaccinations are far more likely to miss the measles, mumps, rubella (MMR) vaccine by age 2, a new study found.
The findings come as the U.S. recently surpassed 2,000 measles cases for the first time in more than 30 years, according to data from the Centers for Disease Control and Prevention (CDC).
CDC data shows that MMR vaccination declined over the last several years, but the authors say that factors linked to delayed or missed vaccination since the COVID-19 pandemic have not been well studied.
For the new study, published Friday in the journal JAMA Network Open, the team looked data from Truevata, an electronic health records database that includes several U.S. health care systems.
Participants included more than 321,000 children who received routine care within the first two months, first year and second year of life between Jan. 1, 2018 and April 30, 2025.
The CDC currently recommends that people receive two doses of the MMR vaccine, the first at ages 12 to 15 months and the second between 4 and 6 years old. One dose is 93% effective, and two doses are 97% effective against measles, the CDC says.
Most children during the study period received the MMR vaccine on time, with 78.4% doing so.
About 13.9% of children had delayed vaccination, 1% received the MMR vaccine early and 6.7% did not receive the MMR vaccine by age 2, according to the study.
The strongest predictors for no MMR vaccination was delay in receiving the recommended 2-month and 4-month vaccines, the study noted.
These early vaccines included diphtheria, tetanus, and acellular pertussis (DTaP); Haemophilus influenzae type b (Hib); pneumococcal conjugate vaccine (PCV); and the inactivated poliovirus vaccines (IPV).
Nina Masters, lead author of the study and senior applied research scientist at Truveta, told ABC News that it’s not surprising children who miss early vaccines also miss later vaccines, but it highlights that some parents become vaccine hesitant when their children are young.
“This also means the opportunity for intervention to engage parents and provide more education about the safety and effectiveness of vaccines has to happen very early,” she said. “This may be challenging as parents may have yet had the time to forge a strong bond with their child’s pediatrician, but the study highlights the importance of pediatric providers having vaccination discussions and building trust as early as possible with parents.”
Results from the study showed that those who received their 2-month vaccines on time were seven times more likely to get the MMR vaccine.
The team found that the percentage of children who received the MMR vaccine on time changed over the study period, increasing from 75.6% in 2018 to 79.9% in 2021, and then falling to 76.9% in 2024.
This decrease between 2021 and 2024 was associated with an increase in the percentage of children who did not receive the MMR vaccine by age 2, increasing from 5.3% in 2020 to 7.7% in 2024, according to the study.
Children who were more likely to be unvaccinated for the MMR shot by age 2 were boys, and white and non-Hispanic or Latino, the study found.
Rural residence slightly increased the risk of no MMR vaccination, even among children receiving routine care, according to the study.
The study only included children with regular access to care, so real-world vaccination delays may be worse in the broader U.S. population, the team noted.
The authors added that these results point to increased vaccine hesitancy or unmeasured access challenges, highlighting the importance of timely intervention so children are less likely to delay or miss vaccination.
Dr. Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security, who was not involved in the study, said the findings have major public health implications because there are questions about whether the U.S. will retain its measles elimination status and increasing vaccination is “the way out of this problem.”
“If you want to live in a society where measles is a problem of the past, where we don’t have to think about it, where schools don’t have to come up with contingency plans, where we don’t have children unnecessarily dying from measles, then that’s a reason to get the vaccine,” he told ABC News.
Adalja added that vaccination doesn’t just protect the individual against infection, but it also has a community benefit.
“The higher the vaccination level is in a given community, the more resilient that community will be to those infectious diseases,” he said. “And if you’re someone that’s immunocompromised, you may want to live in to live in an area that has high vaccination rates because you are at higher risk, and if you’re in a high vaccination area, there’s going to be a lowering of that risk because of the community level immunity that exists in that area.”
Crystal Richards, MD, MS is a pediatric resident doctor at New-York Presbyterian Hospital Columbia University Medical Center and a member of the ABC News Medical Unit.
A box of biles for Measles Vaccinations offered by Harris Public Health is photographed on Saturday, April 5, 2025 in Houston. (Raquel Natalicchio/Houston Chronicle via Getty Images)
(NEW YORK) — The U.S. has surpassed 2,000 measles cases for the first time in more than 30 years, according to data from the Centers for Disease Control and Prevention.
As of Dec. 23, a total of 2,012 cases have been reported in the U.S. Of those cases, 24 were reported among international visitors to the U.S.
States with confirmed cases include Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming.
The last time the U.S. recorded more than 2,000 cases occurred in 1992, when there were 2,126 confirmed infections over the course of a year, CDC data shows.
The CDC says 11% of measles patients in the U.S. this year have been hospitalized, over half of whom are under age 19.
Among the nationally confirmed cases, the CDC says about 93% are among people who are unvaccinated or whose vaccination status is unknown.
Meanwhile, 3% of cases are among those who have received just one dose of the measles, mumps, rubella (MMR) vaccine and 4% of cases are among those who received the recommended two doses, according to the CDC.
There have been 50 outbreaks reported across the U.S. in 2025, CDC data shows. By comparison, 16 outbreaks were reported during 2024.
South Carolinas department of public heath reports that 179 cases have been confirmed as of Dec. 30 with the most cases (176) around Spartanburg County, which sits on the border with North Carolina.
Over the course of the outbreak, hundreds of students have been forced to quarantine at home due to outbreaks at their schools.
The CDC currently recommends that people receive two doses of the MMR vaccine, the first at ages 12 to 15 months and the second between 4 and 6 years old. One dose is 93% effective, and two doses are 97% effective against measles, the CDC says.
However, CDC data shows vaccination rates have been lagging in recent years. During the 2024-2025 school year, 92.5% of kindergartners received the MMR vaccine, according to data. This is lower than the 92.7% seen the previous school year and the 95.2% seen in the 2019-2020 school year, prior to the COVID-19 pandemic.
(NEW YORK) — From robotic surgery performed 7,000 miles away to the first blood test to help diagnose Alzheimer’s disease, 2025 has been a year full of medical breakthroughs.
Scientists discovered a brain implant to give some patients back their independence, prevented others from needing to take opioids and made a discovery that could help solve the organ shortage crisis.
Here are seven of the biggest innovations in the health and science space this year.
ALS patient is 1st to control iPad by thought with implantable brain sensor
A patient with amyotrophic lateral sclerosis (ALS) became the first person in the world to control an iPad entirely by thought, neurotech company Synchron announced earlier this year.
The patient, Mark Jackson, from western Pennsylvania, controls the tablet without using his hands or voice command but rather with an implantable brain-computer interface (BCI) that translates his thoughts into actions.
At the time, Jackson told ABC News he doesn’t have use of his arms so the BCI helps him watch TV shows, listen to audiobooks, browse social media and send text messages to his children.
BCIs are sensors implanted in the brain and translate brain signals into actions outside of the body. The BCI that Jackson is using was developed by the company Synchron, which involves a device implanted into one of the veins within the brain in a minimally invasive procedure.
“This is really an exciting field, because I think the opportunities are boundless,” Dr. Leah Croll, a neurologist at Maimonides Medical Center in New York City, told ABC News. “I think that we’re going to see, moving forward, not only using BCIs to control other electronic devices, but also using them to give patients back movement, to give patients back language, really bodily functions that they weren’t able to do after whatever neurologic insult happened to them.”
Croll said it’s important, going forward, to consider legal and ethical considerations such as privacy and data storage.
She also encouraged more research and clinical trials to generate data on how patients can be protected in both research and real-world settings.
“There’s so much we haven’t figured out legally and ethically when it comes to storing personal, private data from your brain, and how is that used, and how do we manage that responsibly,” she said. “There’s a lot of bio-ethical minds at work as to how we deal with this issue and how do we make it so that a patient isn’t sort of signing away the rights to their entire brain and inner world and manage something responsibly for them that’s helpful and not harmful.”
First pill for obstructive sleep apnea may be around the corner
The first oral pill for obstructive sleep apnea (OSA) could soon be available after a late-clinical showed positive results, according to pharmaceutical company Apnimed Inc.
The drug, AD109, showed “clinically meaningful and statistically significant reductions” in airway obstruction after 26 weeks, the company said in a press release in July.
OSA is a sleep disorder in which the airways become narrowed or blocked while sleeping, causing breathing to pause.
The investigational once-daily pill is a neuromuscular modulator that stabilizes upper airway muscles and prevents them collapsing, improving oxygenation.
OSA patients treated with the medication saw a nearly 50% reduction in the severity from baseline at week 26, compared to 6.8% of those in the placebo group.
The reduction was “significant” at the end of the study period, which concluded at 51 weeks. At the end of the trial, nearly 23% of participants saw “complete disease control.”
More recent trial data published in October found that a meaningful number of patients achieved complete disease control and experienced significant improvements in oxygenation measures.
First non-opioid medication in more than 20 years approved by FDA
Earlier this year, the FDA approved a new type of non-opioid pain medication to treat moderate to severe acute pain, the first of its kind on more than 20 years.
Suzetrigine, also known by the brand name, Journavx, is manufactured by biotech company Vertex Pharmaceuticals and doesn’t have addictive properties, unlike opioids often used for this type of pain.
“It’s significant in light of all the concerns about the opioid epidemic and addiction substance use disorder,” Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic, told ABC News.
In two clinical trials, tested on adults between ages 18 and 80, Journavx was found to reduce moderate to severe acute pain for adults from baseline by about 50% in 48 hours.
The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group, according to the trial.
Cheng, who was not involved in the clinical trials, said the studies demonstrated efficacy of the drug not compared to not only placebo, but also to weak opioids.
“Its efficacy is as good as a weak opioid. So why that is important?” Cheng said. “Because not all patients need opioids, and not all patients need a strong opioid. … If most of them do need a weak opioid, and if this can replace the weak opioid, that can be a big deal.”
Although gene-edited pig kidneys have been seen as a way to help ease the shortage of organs available for those on transplant waiting lists, many of the organs have been rejected not long after transplant surgery.
“Until 2021, we had never put one of these gene-edited pig organs into a human … so it was a bit of a mystery when we started doing the pig-to-human transplants, about what we were going to encounter,” Dr. Robert Montgomery, director of the NYU Langone Transplant Institute, told ABC News.
Last month, a team at NYU Langone Health published a study in which they discovered immune reactions that may explain why these organs get rejected.
The team collected two months of data from a patient who was brain dead and had a genetically engineered pig kidney transplanted into them. The family had donated the patient’s body to science.
The team learned that pig organs were being rejected due to an immune system reaction from specific antibodies — which recognize and attach themselves to foreign substances so they can be removed from the body — and from T cells, which are white blood cells that help the body fight off germs and other unfamiliar invaders.
‘So you have this very coordinated immune response that involves antibodies and white cells, and it seems to happen somewhere between two and four weeks after the transplant,” said Montgomery, lead author of the study. “Now the good news on that front is that we can detect when it’s coming before rejection happens, and we can begin to respond, and we have very good therapeutics that can block the rejection and prevent it from causing damage.”
After rejection, the team used an FDA-approved drug combination to successfully reverse it, with no signs of permanent damage or reduced kidney function.
In a second study, Montgomery and his team looked at the body’s immune response to the pig organ in greater detail. By measuring levels of biomarkers in the blood, they were able to spot an attack up to five days before it would be visible in bodily tissue.
Montgomery said the findings could lead to a future where gene-edited pig organs are a realistic alternative to human organs.
“The pig organ can really replace a human organ and do all the things that a human organ can do, and it’s really just a matter of overcoming the immunosuppression and preventing rejection,” he said. “I think it’s going to happen … and people will be receiving xenotransplants on a regular basis. It’s going to be normalized, and it’s going to be something that will benefit thousands, first, and then millions of people around the world.”
FDA clears 1st blood test to help diagnose Alzheimer’s disease
In May, the FDA cleared the first blood test to help diagnose Alzheimer’s disease.
The test, manufactured by Fujirebio Diagnostics, is for those aged 55 and older who are already exhibiting signs and symptoms of the disease, according to the federal health agency.
The new blood test works by measuring the ratio of two proteins — pTau217 and β-amyloid 1-42 — which are found in human plasma, a component of blood. That ratio is then linked to the presence or absence of amyloid plaques in the brain to determine whether a patient is showing signs of Alzheimer’s disease.
In a clinical study, more than 91% of nearly 500 cognitively impaired patients who tested positive on the blood test had their results confirmed by other diagnostic tools.
“Essentially, it does provide a first quantitative measure of an Alzheimer’s disease diagnosis,” Dr. Jeffrey Savas, an associate professor in the department of neurology at Northwestern University Feinberg School of Medicine, told ABC News. “This is very important to identify patients which could be good candidates for some of the emerging therapeutics.
Savas said the test is rapid, highly accurate and less expensive or invasive compared to previous diagnostic tests.
Because many Alzheimer’s patients need to wait months to see a specialist, the test can allow primary care providers to start the diagnostic process.
“Many neurological research centers have huge backlogs of patients, and there’s not enough physicians or nurses to really see the patients in a timely manner,” Savas said.
“Having this quick diagnostic test, which could be taken in other medical settings, should pave the way for quicker, more effective opportunities and chances for being treated in a timely manner.”
In October, the FDA cleared a second blood-based test called Elecsys pTau181, made by Roche.
Groundbreaking remote robotic surgery
A patient living in Angola with prostate cancer underwent surgery this year to cut the cancer out, but the doctor performing the surgery was 7,000 miles away in Orlando, Florida.
The patient was the first in a groundbreaking human clinical trial approved by the FDA to test transcontinental robotic telesurgery.
A team at OrlandoHealth operated on the patient via a multimillion-dollar robot with enhanced visuals and nimble controls.
Using a robot allows for the procedure to be less invasive, more precise and typically comes with a faster recovery time.
The team has said underserved areas in the U.S. and around the world could benefit from the technology by having a surgeon perform an operation even if they are not nearby.
1st-ever gene fix for rare deadly disease saves baby’s life
A baby with a rare and life-threatening metabolic disorder underwent a personalized treatment involving a first-of-its-kind type of gene-editing.
KJ Muldoon was diagnosed as a newborn with carbamoyl-phosphate synthetase 1 deficiency as a newborn. The disorder affects a bodily cycle that causes deadly levels of ammonia to build up in the blood, which can lead to severe and permanent brain damage.
If left untreated, it will typically result in the death of the patient, according to the National Organization for Rare Disorders.
The treatment for KJ involved the powerful gene-editing tool CRISPR, which allows scientists to precisely slice and repair faulty genes. Using CRISPR, the team was able to create a treatment tailored to the baby’s specific genetic mutation.
In June, KJ went home after spending the majority of his life at Children’s Hospital of Philadelphia. Earlier this month, he reached a big milestone: taking his first steps ahead of Christmas.
Stock photo of a sick child. Natalia Lebedinskaia/STOCK PHOTO/Getty Images
(NEW YORK) — Flu activity is increasing across the U.S. amid holiday travel and gatherings, according to the latest data the Centers for Disease Control and Prevention.
The CDC estimates there have been at least 4.6 million illnesses, 49,000 hospitalizations and 1,900 deaths from flu this season so far, according to data updated as of Dec. 19, and experts expect these numbers will continue to rise.
Public health experts previously told ABC News that many of this season’s cases are linked to a new flu strain called subclade K — a variant of the H3N2 virus, which is itself a subtype of influenza A — that has been circulating since the summer in other countries.
Of the 163 samples of H3N2 viruses collected since Sept. 28 and genetically characterized, 89% were subclade K, according to the CDC.
Additionally, three pediatric flu deaths have been reported so far this season, according to an ABC News tally.
Last season, the U.S. saw 288 children die from flu, which is the same number of children who died during the 2009 H1N1 pandemic. About 90% of kids who died from flu last year were not vaccinated, a CDC study published earlier this year found.
Meanwhile, New York state is reporting the highest number of flu cases it has ever recorded in a single week.
“The emergency room has been busy, and we’ve been following these numbers,” Dr. Darien Sutton, a board-certified emergency medical physician and ABC News medical correspondent, told “Good Morning America” on Monday. “Just a note, national numbers typically lag during the holiday, but state health department numbers are giving us insight to just how severe this flu season is.”
A total of 71,123 flu cases were reported for the week ending Dec. 20, according to the New York State Department of Health (NYSDOH). This marks the highest number of flu cases in a single week since it became mandatory for states to report in 2004.
This is also 38% higher compared to the previous week which saw 51,365 infections reported, bringing the total flu cases reported in the state to 189,312.
Hospitalizations climbed by 63% in the most recent week, increasing from 2,251 to 3,666 weekly admissions, according to data from NYSDOH.
Sutton said it’s important to understand that flu is present and to take steps to reduce risk, including masking, washing hands with soap and water and getting the flu vaccine.
Currently, the CDC recommends that everyone aged 6 months and older, with rare exceptions, get a flu vaccine.
The federal health agency states on its website that getting an annual flu shot prevents millions of illnesses and flu-related doctors’ visits every year and is especially important for those at higher risk of serious complications.
“The flu is so much more than a simple cold. I am treating it in the emergency room,” Sutton said. “Understand that people are coming in feeling like they are so sick that it has to be something else than the flu.”
Sutton noted that he is seeing more people in the emergency room and more people being hospitalized but that the disease itself is not more severe, adding “it’s not like a super flu.”
