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How a different therapy is being used to treat 10-year-old Uvalde shooting survivor

Gladys Gonzales and her 10-year-old daughter Caitlyne Gonzales. - Courtesy of Gonzales family

(UVALDE, Texas) -- Gladys Gonzales says she felt the urgent need within hours to find mental health services for her 10-year-old daughter, Caitlyne Gonzales, who survived the massacre at Robb Elementary School in Uvalde, Texas.

"I came home to the realization of what had transpired, and it hit me that they had undergone a terrible, terrible thing, and so I knew right then and there that she was going to need in-depth therapy," the mother told ABC News.

Nineteen children and two of their teachers were shot to death by an 18-year-old shooter, a former student, who attacked the school on May 24, 2022. Caitlyne's best friend, 9-year-old Jackie Cazares, was one of the children killed.

Caitlyne has been outspoken since the shooting and has advocated for gun reform. She traveled to Washington, D.C, in December and called for an assault weapons ban to be passed on Capitol Hill.

"I decided to be a voice for my friends who can't use their voice no more," Caitlyne said at the time.

Gonzales said her daughter went through several traditional cognitive behavior therapists for post-traumatic stress disorder, but Caitlyne had a difficult time making progress and instead began "regressing." Gonzales says she even brought her daughter to the Uvalde Together Resiliency Center, a site for long-term mental health services offered by Uvalde County officials and Texas Gov. Greg Abbott, however, Gonzales said the services weren't effective for Caitlyne.

Gonzales said that as Caitlyne began to regress, she lost interest in her favorite activities, became more isolated, and more paranoid about the thought of losing her mother.

It was last summer that Gonzales says she took Caitlyne to a grief camp in San Antonio and met a counselor who suggested Caitlyne try a form of therapy called eye movement desensitization and reprocessing, or EMDR.

The American Psychological Association describes EMDR as an eight-phase treatment in which patients "briefly focus on the trauma memory while simultaneously experiencing bilateral stimulation." The bilateral stimulation is typically done with side-to-side eye movements or other rhythmic stimulations like taps or tones. This treatment causes a reduction in the "vividness and emotion associated with the trauma memories."

According to a spokesperson for the APA, EMDR is "conditionally recommended" in their 2017 Clinical Practice Guideline for the treatment of PTSD and "evidence that indicates that they can lead to good treatment outcomes."

In an email to ABC News, a spokesperson for the World Health Organization said that EMDR can be an effective treatment for children and is a recommended option for PTSD in the WHO guidelines.

Danielle Brown, an associate professor of social work at the University of Southern California and a licensed clinical social worker and psychotherapist who uses EMDR in her private practice, said that in simpler terms, EMDR "re-files" traumatic memories and allows the brain to make new connections around them.

"We're not wiping out memories, but we're reprocessing and reintegrating them with more positive—more kind of clear-eyed associations—so that it's something that you'll remember but it won't trigger the same emotional or physiological response that we see in PTSD," Brown said in an interview with ABC News.

Gonzales says Caitlyne's struggles with talk therapy caused some of those emotional and physiological triggers, but in addition to this, Gonzales recalled one specific example in which she says a cognitive behavioral therapist dismissed her concerns.

"That therapist—after one session—told me, 'There's nothing wrong with her,' those were her words and I was just shocked," Gonzales said.

But Gonzales knew better since Caitlyne opened up to her about how she was feeling, and she says she also began experiencing night terror, which left Caitlyne unable to sleep alone because of excruciating fear. Gonzales also attributed her current graduate studies in counseling at Sul Ross Rio Grande College, and her previous work as a mental health caseworker for children who had severe emotional disturbance.

Caitlyne was officially diagnosed with PTSD in December, Gonzales said.

Gonzales said she had never heard of EMDR prior to the grief camp's recommendation, and after an arduous approval process and waitlist, Caitlyne finally started EMDR therapy in San Antonio in January.

"I made a promise [the day of the shooting] that I would help my daughter the best to my ability, and if it's driving an hour and a half to two hours to get her the appropriate health services, then so be it," she said.

The 10-year-old survivor immediately expressed her satisfaction after the first session and her mom said she is finding success so far with EMDR.

Brown, who does not treat Caitlyne, said she is not surprised to hear about the trajectory of Caitlyne's therapy.

"A lot of CBT approaches have you retell or recount the story start to finish, which is problematic in a couple of ways," Brown said. "If you don't have the language for the experience—which often happens in trauma because our language centers can turn off during a trauma—you'll hear victims sometimes say, 'I don't have the words,' or 'I can't articulate it,' because literally the language isn't there, so there's not a cohesive narrative to describe."

"The other problem is that sometimes recounting the details, that in itself is re-traumatizing," she said. "So with EMDR, we approach it from a different way. You don't have to have all the words and you don't have to have all the memories for it and you don't have to retell the story and relive it as we're reprocessing the events or the memory."

Gonzales said she now aspires to become an EMDR therapist and hopes that spreading awareness about her daughter's experience will help inform other families dealing with PTSD.

"If a therapist doesn't work for your child, don't stay there, move on to the next one until you do find the correct therapist for your child," she said. "For kids going through PTSD and trauma, it's so important because they already have these risk factors in the future, and I would hate for them to fall into the cracks just because they didn't receive appropriate treatment."

Even though CBT did not work for Caitlyne, it still remains one of the recommended interventions for PTSD, according to the APA.

Copyright © 2023, ABC Audio. All rights reserved.


Excessive screen time during infancy may be linked to lower cognitive skills later in childhood

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(NEW YORK) -- The amount of time babies spend watching computer, TV and phone screens in their first year of life may be indirectly linked to lower cognitive skills later in life, according to a new study.

Babies who watched on average two hours of screen time per day performed worse later on, at age 9, on executive functions, according to the study, which was published Monday in the journal JAMA Pediatrics.

Executive functions, linked to long-term academic success, are defined by the study's researchers as "a collection of higher-order cognitive skills essential for self-regulation, learning, and academic achievement, as well as mental health."

The researchers studied more than 400 children.

"They did EEGs to test and study brain waves at about 18 months and then connected the dots between how much screen time they were seeing in infancy to how they performed on memory and attention tests around the age of 9," explained Dr. Jennifer Ashton, ABC News chief medical correspondent, who was not involved with the study. 'What they found was that the babies who had the most screen time ... did the worst on attention and memory testing by age 9."

The study did not prove that screen time directly leads to lower cognitive functioning. Other factors, such as a family's income level, also seemed to be linked to lower cognitive functioning scores.

Nevertheless, the findings track with guidance from the American Academy of Pediatrics that children under the age of 2 should not have any screen time.

The AAP recommends that children between the ages of 2 to 5 be limited to just one hour of screen time per day that is supervised by a caregiver.

More than 75% of children younger than 2 and 64% of kids ages 2 to 5 exceed the recommended guidelines, according to researchers at the University of Calgary, who analyzed over 60 studies looking at more than 89,000 children around the world.

Above the age of 5, the AAP says parents should set boundaries on screen time and work with their children to create a Family Media Use Plan that sets time limits and establishes guidelines on the type of media children are consuming.

"There are some studies that suggest with older children, particularly adolescents, that there could be some social or emotional advantages," Ashton said. "So it’s really not only how much, it's what our teenagers and children are consuming on the screen that really makes a big difference."

Earlier this week, U.S. Surgeon General Dr. Vivek Murthy made headlines by saying he believes 13 is too young for children to be on social media platforms, despite some of the most popular platforms, including Facebook and Instagram, setting that as their minimum age requirement.

Social media use has been linked with symptoms of depression and anxiety, body image issues, and lower life satisfaction for some teens and adolescents, research shows. Heavy social media use around the time adolescents go through puberty is linked with lower life satisfaction one year later, one large study found.

Not every teen has those experiences. Researchers are still working to understand who is most at risk of negative effects from social media, and it's not clear yet if there are differences in mental health effects based on when kids first start using social media.

For parents trying to navigate guidance around social media and screen time with their kids, Ashton shared these four tips:

1. No phones at the table for meals or family gatherings.

2. Stop screen time one hour before bedtime.

3. Keep phones and screens out of the bedroom when sleeping.

4. Lead by example as parents by limiting your own screen time and social media use.

Copyright © 2023, ABC Audio. All rights reserved.


What the end of the COVID-19 emergencies in the US means

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(NEW YORK) -- On May 11, the U.S. will no longer officially be in a COVID-19 emergency for the first time since the pandemic began three years ago.

While hundreds of COVID-19 deaths are still reported each day in the U.S. -- adding to a toll of more than one million -- public health experts said the Biden administration is likely looking to end the national and public health emergencies related to COVID-19 because the omicron subvariants that are circulating are producing milder disease and the U.S. has high levels of immunity from previous vaccinations or infections.

The threat of the virus has also receded for many Americans, thanks to testing, treatments and vaccines.

Jen Kates, with the nonpartisan nonprofit Kaiser Family Foundation (KFF), called the end of the emergencies "symbolically a big change." But it will also alter systems that people have come to rely on without realizing they were temporary, at the same time that experts say that it's unclear what the future will hold.

"I think the administration is hoping that we are clearly transitioning into an endemic period, and that the pandemic period is in the past," Dr. William Schaffner, a professor of preventive medicine at the Vanderbilt University Medical Center in Nashville, Tennessee, told ABC News.

"Now, that said, those of us in infectious diseases and public health are a little nervous. And the reason is, here we are at the end of January predicting what the circumstances will be in May," Schaffner added. "This is a very unpredictable virus."

Here are the biggest impacts of the public health and national emergencies ending, according to experts:

Millions could lose Medicaid

After three years of major enrollment increases for Medicaid, anywhere from five to 14 million Americans could soon lose their access to the government's health insurance program for low-income people and others, according to KFF, which focuses on national health.

And according to estimates from the U.S. Department of Health and Human Services, nearly seven million of these people could still be eligible but will fall through the cracks of the renewal process and lose their health insurance.

For context, almost 20 million people enrolled in Medicaid during the COVID-19 public health emergency, an increase of nearly 30% since before the pandemic, and uninsured rates dropped to record lows.

That increase was fueled by a rule under the public health emergency that barred states from removing anyone from Medicaid while the pandemic was at its worst -- allowing people to avoid the bureaucratic renewal processes that experts said could often lead to people losing their coverage even when they were still eligible.

But a recently passed law in Congress returned the right to states to disenroll people from Medicaid beginning on April 1, ending the continuous enrollment afforded to people during the public health emergency.

"This is going to lead to people who are eligible for the program losing out," said Kates, a senior vice president at KFF. "And so I think this is a concern right now, because they would lose coverage for all of their health care during that period."

In the year after the Medicaid rules change, KFF estimates that enrollment will decline between 5% and 13%.

There are efforts to catch some of those people who lose their Medicaid insurance, like a special open enrollment period through the Affordable Care Act.

And some Americans will be disenrolled from Medicaid because they get a job that offers health insurance instead -- or because they then are making too much money to qualify for Medicaid.

"As a person on the street, I understand where the government is going. But as a physician, I'm a little bit worried, because [losing Medicaid] makes a difference between the haves and have nots," Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, told ABC News.

"Particularly with a price tag of $500 for a Paxlovid course [to treat COVID-19], $130 for a shot, we already know how much testing costs for going to Walgreens and CVS," he continued. "So I think all of these things together makes it difficult for everyone to protect not only themselves but each other."

New COVID costs for tests and treatments

The end of the public health emergency will mean that Americans start paying more for certain COVID-19 health measures, but the increase likely won't all be felt at once.

One of the most obvious new costs will be at-home rapid tests, which have been free for most of the time they've existed. People can get eight free tests a month covered by their insurance, for example, or order free tests in the mail from the government.

But that ends with the public health emergency on May 11, Kates at KFF said. The same is true for walking into a clinic or doctor's office to get a test. That could come with costs in the future, whereas it is free under the emergency order.

As for treatments, like the antiviral Paxlovid, that will depend on when the federal government's supply runs out, at which point insurance companies will change their policies. Until then, people will likely not see a huge cost increase on treatments.

"The federal declaration has big implications, mainly financial, that many people don't even realize," Chin-Hong said.

"All of a sudden, you have to be paying for copays and office visits, or even lab tests," he added. "And then people may not want to seek health care because they are afraid of paying some sort of copay or being saddled with a huge bill."

But vaccines will remain free for people with insurance. Because of work in Congress and by the Centers for Disease Control and Prevention, COVID-19 vaccines are mandated to be covered by insurance -- through the end of the public health emergency and even once the government stops buying and distributing them for free.

Telehealth access remains through Medicare

Congress moved to ensure telehealth access for all Medicare recipients for the next two years, so the audio and video visits that those patients have come to rely on are not threatened by the end of the emergency.

As for people on private insurance, telehealth access will depend on state laws and insurance company policies. People can check with their providers for more information, as there's no one-size-fits-all answer.

Pandemic data may be harder to track

The public health emergency mandated that states share certain data with the CDC, like COVID-19 case counts and deaths. Though a senior Biden administration official said that the CDC will continue to encourage states to voluntarily share that information with them, some states will choose not to.

The result could be a cloudier picture of the pandemic, including less insight into possible infection surges and slower responses from health officials.

"It means that we won't be able to track simple things like hospital capacity," Chin-Hong said.

"So there'll be less ability to sound the alarm before the storm comes essentially," he said.

Schaffner, the professor of preventive medicine, said that the end of all the emergency measures will signal to the public that the pandemic is over -- when infections and deaths continue.

"Somewhere between 300 to 500 people die of COVID in the United States daily, at the present time," he said. "So we're going to have to keep our guard up. But if we declare an official end, I think the general public will hear that as a message that they don't have to worry about it anymore and that may lead, as you can imagine, to an increase in COVID."

Title 42 is still up in the air

The end of the COVID-19 emergencies is linked to a very different issue -- immigration.

The public health emergency has allowed both the Trump and Biden administrations to cite Title 42 of federal law to quickly expel migrants seeking asylum from the border based on the threat of spreading COVID-19.

While the Biden administration is now seeking to end Title 42, a group of mostly Republican-led states wants to keep it in place, arguing they would be harmed from the resulting immigration.

The issue is before the Supreme Court. Their decision will come sometime before June, when the court's term ends.

Student loan debt cancellation may get more complicated

Ending the COVID-19 emergencies could legally complicate the position the Biden administration has taken while arguing it has the ability to cancel government-held student loan debt for some 40 million Americans.

That plan has been challenged in court and goes before the Supreme Court next month.

The administration has been using the COVID-19 national emergency as justification for the secretary of education's authority to change the status and terms of the student debt.

"There was a national emergency that impacted millions of student borrowers. Many of those borrowers still face risk of default on their student loans due to that emergency. Congress gave the Secretary of Education the authority under the HEROES Act to take steps to prevent that harm, and he is," an administration official said in a statement to ABC News.

Nebraska and five other GOP-led states challenging the plan argued in court filings that the White House can't have it both ways, pointing to President Joe Biden's remarks last year suggesting Americans could live with the virus going forward.

"The government has been undermining what the [Department of Education] said in the rationale memo. As to the COVID-19 justification, the president declared 'the pandemic...over' in September 2022. And as to the current economic conditions, the White House announced that 'household finances are stronger than pre-pandemic,'" the GOP states argued.

Copyright © 2023, ABC Audio. All rights reserved.


US births increased in 2021 for first time in seven years: CDC

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(NEW YORK) -- The number of births in the United States increased in 2021 for the first time in seven years, reversing trends that continued during the pandemic, according to new federal data.

A report published early Tuesday by the Centers for Disease Control and Prevention's National Center for Health Statistics showed there were 3,664,292 babies born in 2021, which is a 1% increase from 2020.

The figure marks the first increase seen since 2014. Between 2014 and 2019, births were declining by an average of 1% per year, and there was a decline of 4% from 2019 to 2020.

The report did not provide reasons for the increase, but Pew Research Center polls suggest women in the U.S. delayed having babies during the first year of the pandemic due to public health and economic uncertainty, so the rising number could be the result of a rebound.

The report also found the fertility rate for women in the U.S. rose by 1% from 2020 to 2021, sitting at 56.3 births per 1,000 women who are of reproductive age. It's also the first increase since 2014 after the rate declined by 4% from 2019 to 2020 and by 2% per year on average from 2014 to 2019.

Although the overall number of births rose from 2020 to 2021, the figure was still lower than the 7.74 million recorded in 2019, according to federal data.

When researchers looked at the number of births by race/ethnicity, disparities could be seen.

Among white and Hispanic women, the number of births rose 2% for each group between 2020 and 2021.

For Black and Asian women, the number of births declined by 2% from 2020 to 2021, and for American Indian/Alaskan Native women, the number of births declined 3%, the report showed.

According to the report, birth rates declined for women aged 15 to 24, rose for those aged 25 to 44 and were unchanged for the youngest age group, ages 10 to 15, and the oldest, ages 45 to 59.

The birth rate for those between ages 15 and 19 declined from 7% in 2020 down to 13.9 per 1,000 and the rate for those aged 20 to 24 fell by 3% to 63.3 per 1,000.

According to the report, both rates are record lows for their respective age groups.

By state, the number of births increased in 16 states from 2020 to 2021 and declined in one state, New Mexico. Of those 16 states, Connecticut, Massachusetts and New Hampshire had the highest increases of between 5% and 6%.

The report also looked at infant characteristics. Researchers found the premature birth rate rose 4% from 2020 to 2021, to 10.49%, which was the highest recorded figure since at least 2007.

The biggest increase was among early pre-term infants, or those born under 34 weeks gestation, at 4% from 2020 to 2021 compared to late pre-term infants, which are those born between 34 weeks and 37 weeks gestation.

Additionally, the number of babies with a low birth weight -- less than 5 pounds, 8 ounces -- rose 3% in 2021 to 8.52 from 2020.

It comes after the low birth weight declined from 2019 to 2020 following nearly 29 consecutive years of increases.

Copyright © 2023, ABC Audio. All rights reserved.


US Surgeon General says 13-year-olds are too young to be on social media

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(NEW YORK) -- U.S. Surgeon General Dr. Vivek Murthy said he believes 13 is too young for children to be on social media platforms, despite some of the most popular platforms, including Facebook and Instagram, allowing users to be that age.

Murthy told CNN on Sunday that he believes being on social media "does a disservice" to kids early in their teen years.

"I, personally, based on the data I've seen, believe that 13 is too early," Murthy said on CNN Newsroom. "It's a time where it's really important for us to be thoughtful about what's going into how they think about their own self-worth and their relationships and the skewed and often distorted environment of social media often does a disservice to many of those children."

Murthy did not say if there will be any official guidelines or advisory based on that perspective.

Meta, the parent company of Facebook and Instagram, requires users to be at least 13 years old to use its platforms, according to the company's website.

TikTok and Snapchat each also require users to be at least 13 years old, according to their respective websites.

Google, the parent company of YouTube, does not allow kids under age 13 to create their own Google Account. YouTube allows parents to set up a "supervised account" for a child under age 13, for which they can control the content settings, according to its website.

In most cases, the social media sites require people to enter their birth dates in order to sign up as users.

Murthy said he would like to see parents "band together" to keep their young teens off social media given they are allowed on the platforms starting at age 13.

"If parents can band together and say you know, as a group, we're not going to allow our kids to use social media until 16 or 17 or 18 or whatever age they choose, that's a much more effective strategy in making sure your kids don't get exposed to harm early," he told CNN.

Murthy's comments come just over one year after he issued an advisory highlighting a crisis in youth mental health, and said the need to address the issue was "critical."

Murthy's advisory noted that technology can have many benefits for youth, but can also expose kids to unhealthy content. It also urged stakeholders throughout society to take action to address youth mental health challenges.

Social media use is linked with symptoms of depression and anxiety, body image issues, and lower life satisfaction for some teens and adolescents, research shows. Heavy social media use around the time adolescents go through puberty is linked with lower life satisfaction one year later, one large study found.

But not every teen has those experiences. Researchers are still working to understand who’s most at risk of negative effects from social media, and it’s not clear yet if there are differences in mental health effects based on when kids first start using social media.

“We still know very little about what age is right for young people to start using social media, especially as social media use is very varied and impacts different people in different ways,” Amy Orben, a psychologist who heads the Digital Mental Health program at the University of Cambridge, said in an email to ABC News.

Tips for parents

With social media such a prevalent part of daily life, it may seem overwhelming for some parents to try to limit their child's use.

The Centers for Disease Control and Prevention recommends no more than two hours of screen time or social media use a day for young people.

For children under the age of 2, the American Academy of Pediatrics recommends no screen time at all.

For older kids, limits on screen time should be individualized and age-based, according to the AAP.

The AAP recommends parents encourage physical activity, set social media and screen time limits for older kids -- such as not going on social media while doing homework -- and create unplugged spaces, like the dinner table, in the home. The organization also recommends parents create a "Family Media Plan" with their kids that can help set priorities and act as a type of contract.

In 2019, ABC News' Diane Sawyer led a special report, that looked at the impact of screen time and social media.

In the special, a panel of experts shared tips for parents looking to rein in children and teenagers' use of technology, in their homes and in their day-to-day lives.

Here are their seven tips:

1. Children younger than 18 months should avoid screens entirely with the occasional exception of a few minutes of FaceTime with family, according to Dr. Kathy Hirsh-Pasek, director of Temple University's Infant Language Lab, and Tracy Dennis-Tiwary, a professor of psychology at New York's Hunter College and the Graduate Center of the City University of New York.

2. For children older than the age of 2, limit screen use to one hour with parental supervision, according to Hirsh-Pasek and Dennis-Tiwary.

3. Have an open-ended discussion about screen time in the house and what family members feel they need. Allow everyone to weigh in on the conversation, according to husband-and-wife therapists Don and Carrie Cole of the renowned Gottman Institute in Seattle.

4. Agree on some simple things, like establishing one phone-free hour after dinner so that everyone can do something together, Don and Carrie Cole recommend.

5. Use social media to connect with each other rather than making it the enemy, according to the Coles.

6. If there's conflict or the screen-time plan doesn't seem to be working, take a deep breath, be kind to each other and begin again -- without criticism, defensiveness or contempt, according to the Coles.

7. Discuss the consequences for breaking a screen time limit ahead of time so that if your child has a meltdown, the consequence is known, according to Don Cole.

Copyright © 2023, ABC Audio. All rights reserved.


COVID-19 pandemic 'is probably at a transition point,' WHO says

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(NEW YORK) -- The World Health Organization said Monday that COVID-19 remains a public health emergency but the pandemic is at a "transition point."

The agency said its International Health Regulations Emergency Committee met on Friday to analyze data on the state of the pandemic.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus "acknowledges the Committee's views that the COVID-19 pandemic is probably at a transition point and appreciates the advice of the Committee to navigate this transition carefully and mitigate the potential negative consequences," the statement read.

According to a transcript of Tedros' speech at the meeting provided by the WHO, he said there is still a high risk of COVID-19 global transmission, which means the virus is still classified as a Public Health Emergency of International Concern.

However, he said the world is in the best position it has been in -- due to diagnostics, vaccines and treatments -- to beat back COVID.

"As we enter the fourth year of the pandemic, we are certainly in a much better position now than we were a year ago, when the omicron wave was at its peak, and more than 70,000 deaths were being reported to WHO each week," Tedros said during the meeting, according to a transcript provided by the WHO.

"When you last met in October, the number of weekly reported deaths was near the lowest since the pandemic began -- less than 10 thousand a week. However, since the beginning of December, the number of weekly reported deaths globally has been rising," Tedros continued. "But the global response remains hobbled because in too many countries, these powerful, life-saving tools are still not getting to the populations that need them most – especially older people and health workers."

Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children's Hospital, said the WHO's comments show that the agency recognizes the public health emergency is winding down but that the virus' threat remains.

"What we have to remember is the pandemic won't end on a given day," said Brownstein, an ABC News contributor. "The metrics around cases, hospitalizations and deaths are painting a more optimistic picture and we're seeing more countries getting out of this acute phase."

He added that the danger of COVID is still very real, with deaths twice as high from COVID as they are from the flu.

"If you look at data around deaths, we're still seeing twice as many people dying from COVID than flu every season and flu is only a quarter of a year, and we're seeing that number," Brownstein said.

During the WHO meeting, Tedros urged groups at higher risk of severe disease and death -- including those who are immunocompromised and elderly -- to be fully vaccinated and boosted.

He also encouraged more countries to ramp up testing and use antivirals early on among those who test positive for COVID-19.

Copyright © 2023, ABC Audio. All rights reserved.


COVID-19 may have impacted our children’s learning progress in school: Where do we go from here?

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(NEW YORK) -- School-aged children faced significant learning loss during the early days of the COVID-19 pandemic, data shows.

The finding shows that, even though we have developed new tools, like effective vaccines, to protect us from COVID-19, long-term ramifications persist.

Children lost out on about one-third of what they usually would have learned during the academic year from 2020 to mid-2022, according to a new analysis published in the journal Nature Human Behavior.

"Children still have not recovered the learning that they lost out at the start of the pandemic," said Bastian Betthäuser, an assistant professor at the Observatoire Sociologique du Changement at Sciences Po in France and lead author of the new study, during a press briefing.

They didn't appear to lose additional ground as the pandemic went on, he said -- but governments also weren't able to recover the initial deficits, the study said.

The new data joins a bigger-picture evaluation of how the disruptions caused by the pandemic -- like school closures, widespread illness and social changes -- affected children's learning. And it's contributing to the growing efforts to figure out the best way to move forward.

"It's very hard to recover learning deficits, once they're there," Betthauser said during the press briefing.

To understand learning loss during the pandemic, researchers collected data from 42 previous studies from 15 countries, published within the March 2020 to August 2022 time frame. The researchers estimated that, collectively, students experienced a decline in knowledge and skills equivalent to approximately 35% of the overall school years' worth of learning. These deficits remained constant for the approximately 2.5-year time period studied.

The research team saw a similar pattern when they looked at data from the United States alone.

The new study also suggested that COVID-19 increased the educational inequalities between children of different socioeconomic backgrounds.

Although most data was from high-income countries and middle-income countries, researchers found that students in middle-income countries had greater learning deficits than students in higher-income countries.

The new study also showed that math skills were harder hit than reading skills.

That might be because parents were better equipped to help their kids with reading than math, and the greater need for closer guidance in the STEM fields, the research team suggested in the study.

What contributed to learning loss?

The new study did not evaluate the actual causes of the learning losses, but experts point to a number of factors -- changes to the school environment, disruption in family life, limited face-to-face instruction, reduced extracurriculars, along with many other possibilities.

"There's been a lot of debate on how variation in academic decline plays out across states and policy choices about closing schools, but, at this point, it's not clear that school closure policies were the main driver of the drops in performance," Nathaniel Schwartz, director of applied research at Brown University's Annenberg Institute for School Reform, told ABC News.

And it's not clear what the alternatives could have been, experts said. During the start of the pandemic, when much was still unknown about the virus, policy makers and school leaders across the world had to make quick decisions and adapt to a volatile landscape.

Rachel Ohayon, a former 5th grade science teacher at a New York City charter school experienced the challenges of transitioning to online school. Setting disciplinary boundaries and simulating the classroom environment in a completely new virtual platform was not easy, she told ABC News.

"I think my school had a slight advantage because we gave out chrome books to our students, so they were all set up when we went remote," she said.

But even with these measures in place she said it was still difficult to achieve the same level of focus among her students.

School closings likely impacted more than just educational progress. Children's learning online may have also impacted their social and emotional development according to Paul Peterson, director of the program on Education Policy and Governance at Harvard University.

"The transition back to in person learning was exhausting and stressful, we had to deal with a lot of acting out and intense emotions as children came back to school," said Ohayon.

How do we help kids recover?

Along with understanding the learning gaps, experts are working to identify the best way to recover from them.

"There are two points of view: that we can make it up or that we can't make it up," Peterson said.

"I'm concerned we didn't really think about this during the pandemic -- what we would do the day schools reopened," he said.

Peterson added that actions taken to help combat these deficits may have been insufficient and too slow.

Schools are also struggling to find staff for programs that could try to close gaps, Shwartz said.

"Schools and districts are facing a landscape where hiring for these positions is difficult, where other ongoing work is crowding out possible new programs -- and truly, where many of the people in schools at both the staff and student level are often feeling drained," Schwartz said.

Betthäuser is more optimistic.

"I wouldn't say it's a hopeless case at all," he said in the briefing.

Peterson said one-to-one instruction may be the most effective type of intervention.

"My own view is that tutoring is the best intervention. It's expensive but allows you to target the intervention to the specific child," he said.

Parents can also use time at home to provide one-to-one support to their kid, he said.

In Ohayon's school, they tripled the size of the guided reading program in an effort to "close the gap from remote learning," she said.

It's hard to balance additional instruction against the risks of overloading kids with work.

"Kids only have so much capacity to take in new material to learn new skills," Betthauser said in the briefing.

He thinks summer time break may be a good time for targeted interventions.

"We know from the summer learning literature that there is potential for summer learning programs to help children learn and also to prevent inequalities from widening during this period," he said.

Experts said there needs to be a collaborative effort to critically assess how these gaps can be addressed. Such actions are especially critical in lower-income settings, where access and quality of education was already compromised. Students with special educational needs may also require extra attention.

Ohayon said her biggest takeaway as a science teacher was on the "importance of connecting with students." The best way she's found to help her students make up their gaps is by coming up with creative ways to engage them in the classroom.

"There's a lot that can be done," Betthauser said in the briefing, "I think it's important that we're honest about the size of the problem and try to match that."

Copyright © 2023, ABC Audio. All rights reserved.


FDA withdraws emergency use authorization of COVID drug because it is unlikely to be effective against new variants

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(WASHINGTON) -- The U.S. Food and Drug Administration said Thursday it is withdrawing its emergency use authorization of a COVID-19 antibody therapy as a prevention tool because it is unlikely to be effective against variants that are currently circulating.

Evusheld, which is made by British-Swedish pharmaceutical and biotechnology company, AstraZeneca, was first authorized in December 2021 as pre-exposure prophylaxis against the virus for those who are immunocompromised and less likely to generate antibodies from vaccination.

However, the FDA said the medication does not neutralize several omicron subvariants including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5.

According to the Centers for Disease Control and Prevention, these subvariants make up at least an estimated 90% of cases in the U.S.

"This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants," the FDA said in a press release.

"Today's action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product," the press release continued.

The FDA has been warning for months that Evusheld might not be very effective, starting in February 2022 when data showed a higher dose may be able to prevent against infection from omicron subvariants BA.1 and BA.1.1 than the originally approved dose.

As recently as Jan. 6 of this year, the FDA said it didn't believe Evusehld would be able to neutralize the XBB.1.5 subvariant "because of its similarity to variants that are not neutralized by Evusheld."

AstraZeneca did not immediately reply to ABC News' request for comment. In a statement, the pharmaceutical company said it is aware of the decision and that it is cooperating with the FDA.

"AstraZeneca will continue to work with the FDA and other health authorities to collect, assess and share relevant data regarding Evusheld and SARS-CoV-2 variants," the statement read. "Evusheld currently remains authorized in other countries where it is approved for COVID-19 pre-exposure prophylaxis and treatment, including the EU and Japan."

Evusheld is a type of monoclonal antibody treatment, which are a cocktail of antibodies that are manufactured in a lab and mimic the antibodies the body naturally creates when fighting the virus.

They bind to the spike protein, which prevents the virus from attaching to -- and infecting -- cells.

The FDA said if someone tests positive for COVID-19 and develops symptoms, they should contact their primary care provider and, if needed, ask to receive antiviral medications Paxlovid, molnupriavir or remdesivir, which work against the currently circulating variants.

Despite Evusheld losing emergency use authorization status, the FDA urged providers not to discard their doses of the drug.

"The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future," the FDA said in its press release.

Copyright © 2023, ABC Audio. All rights reserved.


Peloton instructor reveals breast cancer diagnosis at age 35

Courtesy of Peloton

(NEW YORK) -- A Peloton instructor is opening up for the first time about her battle with breast cancer, revealing she got a lifesaving second opinion after discovering a lump on her breast.

Leanne Hainsby, a 35-year-old cycling instructor for the fitness company, revealed on Instagram that she was diagnosed with breast cancer last August.

She wrote that she self-discovered a lump on her breast and was told "everything was OK" at a doctor's appointment that same day.

"I trusted my gut and got a second opinion. That saved my life," Hainsby wrote, adding to her followers, "Check, and check again."

Hainsby, who is based in London, said that in the past six months since her diagnosis, she has undergone surgery as well as 12 weeks of chemotherapy.

She said she will next undergo two weeks of radiation.

"Treatment will continue for a long time for me, hospital visits are the norm, and I focus on one step at a time," wrote Hainsby, who did not share what stage of cancer she is battling.

Hainsby also shared that prior to chemotherapy, she underwent in-vitro fertilization, or IVF, which can be done if there is concern that the chemotherapy medicine may cause infertility.

"I was lucky enough to be given time ahead of chemotherapy to do a round of IVF," Hainsby wrote, adding of her and her partner, a fellow Peloton instructor, "We weren't mentally prepared, but we got it done and we're so grateful."

Hainsby's confirmation of her diagnosis at age 35 underscores the warning that breast cancer can impact women of all ages, though most breast cancers are diagnosed in women ages 50 and older, according to the Centers for Disease Control and Prevention.

In the United States, breast cancer is the second-most common cancer among women, with over 260,000 new cases reported in 2019, the latest data available, according to the CDC.

Although the risk for breast cancer in young women remains low, breast cancer found in young women can be more aggressive and more difficult to treat, Dr. Margaret Thompson, a doctor in breast services at Cleveland Clinic Florida, told ABC News in October.

Breast cancer can also be more difficult to spot in young women.

Younger breast tissue tends to be more dense so spotting tumors, even on mammograms, can be more challenging and may be misdiagnosed, according to the Cleveland Clinic.

Mammogram screenings are recommended once every two years for women age 50 to 74 years who have an average risk of breast cancer, according to U.S. Preventive Services Task Force guidelines.

Women ages 40 to 49 may choose to begin screening once every two years if they "place a higher value on the potential benefit than the potential harms" of the mammogram, according to the guidelines.

For women of all ages, when an ultrasound shows a concerning finding, a follow-up visit should be scheduled to discuss next steps with your healthcare provider.

Copyright © 2023, ABC Audio. All rights reserved.


Study finds autism rates have tripled among young kids: What to know

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(NEW YORK) -- Autism is on the rise among young children, according to a new study.

The study, published Thursday in the journal Pediatrics, found that autism rates tripled over the last 16 years.

Researchers at Rutgers University looked at more than 4,000 8-year-olds in the New York and New Jersey areas.

They said the sharp rise in autism rates is largely due to greater awareness, better diagnosis tools and a broader definition of autism. Researchers also noted the greatest increases in diagnoses were amongst affluent children, concluding that children in underserved communities are not getting the same access to medical resources.

Autism, also known as autism spectrum disorder, is defined by the Centers for Disease Control and Prevention as a "developmental disability that can cause significant social, communication and behavioral challenges."

On the national scale, around one in 44 children has been diagnosed with autism spectrum disorder, according to the CDC.

The disorder begins before a child turns 3 and can last through their lifetime, though symptoms may improve and vary, the CDC notes.

"You want to talk to your child’s pediatrician about this because early intervention makes a big difference," said Dr. Jennifer Ashton, ABC News chief medical correspondent, adding, "Remember, those children [with autism spectrum disorder] grow up to be teens and adults, so the more we can help them the better their outcomes can be."

What to know about autism

People with autism have a wide variety of traits affecting communication, behavior and socialization, according to the CDC.

The “spectrum” means that there’s a wide range of symptoms and severity.

A child of any race, socioeconomic status or ethnic group can get ASD. Boys, however, are four times more likely to be diagnosed with autism than girls based on a study of children aged 8 years old. Kids that have a sibling with autism, and especially a twin, are more likely to have autism. Those with developmental disabilities or genetic and chromosomal diseases such as Down syndrome are also more likely to have ASD. There is also evidence that kids born to older parents have an increased risk of autism, according to several studies.

Autism can be identified as early as infancy, although most children are diagnosed after the age of 2. There is no medical test to diagnose autism, so doctors watch a child's behavior and development to make a diagnosis, according to the CDC.

The American Academy of Pediatrics recommends all children be formally screened for autism spectrum disorder at their 18- and 24-month-old well-child visits. The AAP says pediatricians though will begin monitoring babies at their first well-child visit by observing their behaviors.

“It is those observations -- in combination with family history, health examinations, and parents' perspectives -- that help pediatric primary health care providers identify children at risk for ASD,” the AAP says on its website.

The CDC notes that in some cases people are not diagnosed with autism until they are teens or adults.

Experts say though that early detection of ASD is key, as is early intervention.

Early signs of autism in children may include, but are not limited to, little or no smiling and limited eye contact by 6 months; little to no babbling, pointing or response to their name by 12 months; and few or no meaningful two-word phrases by 24 months, according to the CDC.

Additional signs of autism may include delayed social interactions, exhibiting repetitive behaviors or showing a limited interest in activities and sensory issues like sensitivity to noise or sound.

“Someone might have the communication delay but may not have the motor skill delay,” said Dr. Jen Clark, a New York-based clinical psychologist and specialist in autism, told ABC News last year. “They may experience sounds and lights in a very different way than you and I would and sometimes they can experience a sensory overload and they may wear headphones and this will help to make the noise not as severe, but also they may avoid certain situations where it's just too overwhelming.”

Treatment comes in many different forms, from mental health therapy to occupational, physical and speech therapies. Sometimes medications can be helpful for things related to ASD, like mood problems or inability to focus.

Copyright © 2023, ABC Audio. All rights reserved.


FDA proposes allowing gay and bisexual monogamous men to donate blood

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(WASHINGTON) -- The U.S. Food and Drug Administration announced Friday it will ease blood donation restrictions on gay and bisexual men, allowing those in monogamous relationships to donate.

The policy change comes after years of urging by public health experts, blood banks and LGBTQ advocacy groups. The new policy would address future blood shortages and remove the stigma around gay men, experts say.

Additionally, the American Red Cross and the American Medical Association have both supported a risk-based approach to donor eligibility.

"Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day," said FDA Commissioner Robert M. Califf. "Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so."

Rather than a blanket ban due to sexual orientation, the relaxation of the rule would screen potential donors on their risk of contracting and transmitting HIV.

In 1985, in response to the HIV/AIDS crisis in the 1980s, the FDA banned all blood donations from men who have sex with men.

The policy did not change until 2015, when rules were slightly relaxed to allow this group of donors to give blood as long as they abstained from sex for one year. In 2020, amid severe blood shortages during the start of the COVID-19 pandemic, the FDA shortened the abstinence period to 90 days.

The policy change means gay and bisexual men in monogamous relationships can donate without abstaining from sex as long as they test HIV negative and are practicing safe sex.

It also means the U.S. will join several Western countries, including the United Kingdom, France, Greece and the Netherlands, which have recently either dropped bans or eased restrictions.

Last month, the FDA told ABC News the evidence analyzed so far will "likely support a policy transition" that focuses screening blood donations based on each person’s HIV risk.

In 2020, the FDA launched a study called ADVANCE to look into alternative solutions to its current policy. The FDA is currently reviewing research from the American Red Cross, OneBlood and Vitalant to determine if eligibility based on an individual's risk can replace the current time-based deferral system while maintaining the safety of the blood supply.

Experts say the updated policy will also help address the national blood shortage and, in turn, save lives. In January 2022, the American Red Cross said it was facing its worst blood shortage in more than a decade, although it is no longer in a crisis.

Despite the easing of rules, non-monogamous men are not allowed to donate even if they produce a negative HIV test, practice safe sex with condoms or take pre-exposure prophylaxis, or PrEP -- a daily pill containing two medications that prevent HIV-negative patients from being infected.

ABC News’ Sony Salzman and Kiara Alfonseca contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


TikTok-famous dad behind 'Enkyboys' dies at 35 following cancer battle

@enkyboys/TikTok

(NEW YORK) -- Randy Gonzalez, the Texas father behind the popular "Enkyboys" account on social media died Wednesday at age 35, his mother Beatrice Gonzalez and brother David Gonzalez confirmed to ABC News.

Gonzalez's death came less than one year after he announced he had been diagnosed with stage 4 colon cancer.

Gonzalez and his son Brice became famous on TikTok for their funny father-son comedy bits and dances.

"At first, we were kind of shy but we broke out of that shell because people love Brice so much and then they love the duo of the father and son, so we were just like, 'Let's go! Let's do it!'" Gonzalez told Good Morning America back in 2020 about the rise of "Enkyboys."

Last April, Gonzalez revealed in a video post that he had been diagnosed with stage 4 colon cancer in November 2021.

"I kept it to myself and I felt like it was selfish because I didn't want to tell everybody my business because it was personal. But I feel like I can use my situation to give awareness for young men like myself because I'm only 34, and they say it's very rare for a young guy like myself to catch colon cancer," Gonzalez said in the video at the time, adding that a doctor had told him he had a life expectancy between two and five years.

"I didn't know how to take it. You know, it was devastating," Gonzalez continued.

In the video, Gonzalez also opened up about one of his initial symptoms that led him to see a doctor in the first place.

"I want to help other people and start awareness for young men to go get checked for colon cancer, to go get a colonoscopy. How I figured out, I was having a problem with my upper abdomen and I was always in pain," he said. "And luckily, my wife told me to go get a colonoscopy because I was just gonna get an EGD [esophagogastoduodenoscopy] through my throat because they thought it was a ulcer or something. But long story short, I wanted to start awareness of colon cancer for young men to start, to go get checked in the early ages, 30 years old."

Since then, the "Enkyboys" social media accounts have featured posts aimed at raising colon cancer awareness, with Gonzalez sharing the symptoms he experienced, such as abdominal pain and constipation, and taking fans along as he underwent chemotherapy treatments.

According to the Centers for Disease Control and Prevention, colon or colorectal cancer is a type of cancer originating from polyps in the colon or rectum. In the U.S., it has become the second-leading cause of cancer-related deaths.

The disease can affect men and women of any racial and ethnic background. People at increased risk of developing colon cancer include individuals with a family history of colon polyps or colon cancer and those with bowel diseases like Crohn's disease or ulcerative colitis. Lifestyle can also play a role and increase a person's risk, such as a diet high in fat and low in fiber, the use of alcohol and tobacco and a lack of physical activity.

Last year, a major study showed that more young people, including more individuals of non-Hispanic Black and Hispanic descent and those between the ages of 20 and 29, have been getting diagnosed with late-stage colon cancer in recent years, prompting doctors to call for more early detection and colon cancer screenings of individuals younger than 50.

Who should get screened for colon cancer?

The U.S. Preventive Services Task Force and CDC currently recommend that people between the ages of 45 and 75 get regular colon cancer screenings, while those older than 75 should consult with their doctor before getting a screening. If at increased risk due to family history of colon polyps or colon cancer or for those with bowel diseases, screening may start before the age of 45, but this should be discussed with a doctor beforehand. A screening can consist of a stool test, a flexible sigmoidoscopy where a doctor places a tube in the rectum to check for polyps, a colonoscopy, or a CT colonography or virtual colonoscopy.

What are the symptoms of colon cancer?

An individual with colon cancer may not always exhibit symptoms initially, according to the CDC, and they can vary. Symptoms include:

  • Abdominal aches, pain or cramps
  • Bowel habit changes, including a feeling that the bowel does not empty entirely
  • Blood in the stool
  • Constipation
  • Diarrhea
  • Unexplained weight loss

Gonzalez is survived by his wife Kimberly and their three kids, son Brice and daughters Lauren and Nylah. Kimberley Gonzalez and her daughters also have their own TikTok and social media accounts called "Enkygirls."

Copyright © 2023, ABC Audio. All rights reserved.


Senior FDA official resigns in wake of 2022 infant formula shortage, acknowledges FDA communication breakdowns

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(WASHINGTON) -- FDA's Deputy Commissioner for Food Policy and Response, Frank Yiannas, has announced he is resigning from his post. His departure comes in the wake of last year's infant formula shortage, throughout which Yiannas held a prominent leadership role.

The decision also comes amid the ongoing HHS-OIG audit into whether the FDA responded adequately to the mounting crisis, as ABC News was first to report -- and whether the agency followed proper recall protocol once a deadly bacteria had been detected inside Abbott's Michigan formula plant.

Additionally, the FDA is preparing to give an update later this month on steps it plans to take to strengthen its foods program, following an independent review that found it lacks leadership and mission clarity.

An FDA spokesperson tells ABC News that "by the end of February," they will also offer additional updates on how they're improving their organizational structure -- including how Yiannas' position responsibilities will be handled moving forward.

Yiannas had been in his role since December 2018. His resignation will be effective February 24, writing in a tweet he is "honored to have served the American public, alongside each and every one of you, over these past four years."

Yiannas was among the senior officials who was involved in responding to the formula crisis and admitted to lawmakers in May 2022 that a string of internal failures and communication breakdowns at his agency contributed to how bad the situation had grown.

Lawmakers and the public alike repeatedly pushed for further clarity on why it took so long for federal regulators to respond to the mounting crisis.

Months before Abbott's massive formula recall in February of last year, there had already been warnings about quality and safety concerns at the key facility.

There had been a whistleblower report alleging a "litany of violations" and safety issues at Abbott's key plant sent to the FDA in October 2021 -- however, as Yiannas said under oath before Congress in May 2021, he and other FDA leaders didn’t learn that report for months. The agency blamed their mailroom and called it an "isolated failure" that was "likely due to COVID-19 staffing issues.”

Yiannas said the complaint was not immediately escalated, and he didn't see it until mid-February, roughly four months after it had been sent.

By that time, as ABC News has reported, reports of infants getting sick and hospitalized after consuming Abbott's formula had already been emerging, including one who had already died -- in addition to the quality and safety concerns flagged at their Sturgis facility.

However, Abbott maintains none of the bacterial strains found at their plant matched the samples genetically sequenced from the hospitalized infants, and that there is no conclusive evidence that its products contributed to the ultimate death of two infants.

"Why is it then, if you're the deputy commissioner for food policy, you didn't get the report?" Rep. Gary Palmer (R-AL) asked during the previous May hearing. "How is it that it got tied up in bureaucracy and it didn’t get to the person who arguably should be responsible for responding to it?"

"Yeah, I'm not sure why the report wasn’t shared with me and how it didn't get escalated," Yiannas said. "As you’ve heard the commissioner state, I know there's going to be a review, and we're going to try to get to the bottom of it."

Yiannas' boss, FDA Chief Robert Califf, acknowledged the response to the formula crisis had been "too slow," and that "there were decisions that were suboptimal along the way."

In his resignation letter, tendered to Califf on Wednesday, Yiannas does not own any responsibility for the agency's missteps during the formula crisis -- rather, he touts his achievements.

"In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the foods program that you and I both inherited, significantly impaired FDA’s ability to operate as an integrated food team and protect the public," Yiannas' letter says.

"It was also in February of 2022 that I first learned of the infant formula incidents that had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facility now reopened, infant formula availability more prevalent, and – very importantly - the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position."

In a statement to ABC News, the FDA thanked Yiannas for his "service and dedication."

"The FDA can confirm Frank Yiannas has resigned from his position as deputy commissioner for Food Policy and Response effective February 24. The agency thanks Mr. Yiannas for his service and dedication to the FDA’s public health mission," the agency said. "Mr. Yiannas has served as a valued member of the agency’s leadership team, spearheading important initiatives including the New Era of Smarter Food Safety to help create a safer and more digital, traceable food system for our country."

ABC News' Anne Flaherty contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


Support grows for a new approach to COVID vaccine schedule, as proposed by FDA

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(WASHINGTON) -- A panel of public health experts for the Food and Drug Administration convened for an all-day meeting on Thursday to discuss whether the U.S. is ready to start treating COVID boosters like an annual flu vaccine, a move that would normalize COVID shots as permanent public health upkeep.

Creating a yearly COVID shot schedule would mean updating the shot once a year and hoping that it matches whichever variant is circulating that upcoming winter season, similar to how the flu shot schedule works. No longer would public health agencies and vaccine companies attempt to reactively update the COVID vaccine when variants come on the scene.

It would also eliminate the two-shot primary series for most unvaccinated people, in favor of a mainstreamed program.

"This is a consequential meeting to determine if we've reached a point in the pandemic that allows for simplifying the use of current COVID-19 vaccines," Dr. David Kaslow, director of the FDA's Office of Vaccines Research and Review, told the group of advisors on Thursday.

Dr. Peter Marks, the FDA's vaccine chief, said the virus has evolved so rapidly that the FDA has constantly needed to revise its approach. Now, he said, it was time to determine if they could do that on a schedule rather than at the whim of the virus' evolutions.

"We're now in a reasonable place to reflect on the development of the COVID-19 vaccines to date to see if we can simplify the approach to vaccination in order to facilitate the process of optimally vaccinating and protecting the entire population moving forward," Marks said.

The goal, FDA officials said, would be to deliver simpler messaging in the hope of reaching more Americans.

The way it stands now, people get different numbers of vaccines depending on their age and prior vaccination status. For example, unvaccinated people get their initial series in two shots, a few weeks apart, while vaccinated people have been encouraged to get a booster every few months, depending on how old they are.

The plan proposed by the FDA is to recommend every American get a single shot every year, with a few exceptions.

It's based on the idea that the vast majority of Americans already have some immunity in their system, either because they've been exposed to COVID itself or gotten vaccinated.

"Presumably, at this point in the pandemic, most of the general U.S. population have been sufficiently exposed to spike protein, either to infection, vaccination or both, such that a single dose of a COVID-19 vaccine would induce or restore vaccine effectiveness," Kaslow said.

But older, high-risk and immunocompromised Americans could still be recommended to get two shots a year, as could young children when they reach the age eligible for vaccinations.

"It could be that more than one dose is needed for high-risk older adults, persons with compromised immunity and young children who have not yet been completely immunized. At this time, those risk based adjustments remain to be determined," Kaslow said.

Responding to the proposal, some experts on the panel emphasized that people who haven't had COVID or been vaccinated might still need to get two shots to shore up their immunity.

But the members were broadly supportive of the move to simplify the COVID vaccine schedule.

"I certainly support this approach. Simpler is better," said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego and a member of the FDA's panel.

"I think this is definitely the way to go as soon as we can figure out how to do it," he said.

More data is necessary to decide exactly who will be protected enough by one dose, experts said.

"My general feeling from the committee is that we need more data to figure out exactly who should get the two-dose schedule, who should get the one," said Dr. Stanley Perlman, an infectious disease expert with the University of Iowa and a member of the panel.

"So all that kind of information will help determine this immunization schedule, but in general principle, the committee was supportive of going forward with this," Perlman said.

The FDA will likely not make any concrete decisions until later in February, after a panel of experts at the Centers for Disease Control and Prevention has a similar public discussion on the newly-proposed schedule.

And just which variants the updated booster would target for next season won't be decided until this summer, likely in early June, for distribution sometime in the fall.

Of course, the reality is that a small percentage of Americans have opted to get the current booster — around 16%, despite recent CDC research showing that it can cut risk of symptomatic infection by around half. And because less and less people have opted for a booster shot each time one has been recommended, the appetite could be lower by next fall.

But Marks, the FDA's vaccine chief, was optimistic that aligning the COVID vaccine on a yearly schedule with the flu shot could encourage more people to make it a routine.

"If we can see the influenza vaccine and the COVID-19 vaccines occurring at the same visit, it facilitates a vaccination program that may lead to more people getting vaccinated and being protected, and reducing the amount of disease we see," Marks said.

"So I think that overall, this seems like a reasonable way to go."

ABC News' Nicole Wetsman and Youri Benadjaoud contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


FDA says new process is needed for regulating CBD products due to risks

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(WASHINGTON) -- The U.S. Food and Drug Administration announced Thursday that it will not review or allow the marketing of cannabidiol, or CBD, products as food items or dietary supplements.

Up until recently, the health agency has not allowed any company to make claims about health benefits from wellness CBD products.

The FDA said after "careful review" it has determined that its current framework for evaluating food and supplements is not set up well for CBD because of safety risks and that substances, including CBD, have to meet specific safety standards to be lawfully marketed as a dietary supplement or a food additive.

"The use of CBD raises various safety concerns, especially with long-term use," FDA Principal Deputy Commissioner Dr. Janet Woodcock said in a statement. "Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system."

The statement continued, "CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant."

Woodcock said animals are also at risk of side effects from CBD. People might not know they've been exposed to the ingredient if they consume meat, milk and eggs from animals fed CBD, she said.

"Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food," she said.

The FDA said it plans to "work with Congress" to create new rules for regulating these products, which could include requiring clear labels, preventing contamination, content limits and even a minimum purchase age.

CBD and tetrahydrocannabinol, or THC, both come from the cannabis plant. While THC is the main psychoactive ingredient that gives users the "high," CBD is believed to behind therapeutic effects associated with marijuana such as relief from nausea and pain relief.

The agency also announced it is denying three petitions submitted by citizens asking CBD products to be marketed as dietary supplements.

"Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives," Woodcock said. "For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods."

ABC News' Eric Strauss contributed to this report.

Copyright © 2023, ABC Audio. All rights reserved.


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